chapter 25. controlled substances, drugs, devices, and cosmetics

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CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS Subch. Sec. A. CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS ................................................. 25.1 B. HEARING AID SALES AND REGISTRATION ................. 25.201 Authority The provisions of this Chapter 25 issued under the Controlled Substance, Drug, Device and Cos- metic Act (35 P. S. §§ 780-101—780-144), unless otherwise noted. Source The provisions of this Chapter 25 amended July 5, 1974, effective July 6, 1974, 4 Pa.B. 1371, unless otherwise noted. Cross References This chapter cited in 28 Pa. Code § 113.15 (relating to locked storage); 28 Pa. Code § 113.23 (relating to records); 28 Pa. Code § 561.1 (relating to drugs and biologicals); 28 Pa. Code § 561.15 (relating to locked storage); 28 Pa. Code § 601.3 (relating to requirements for home health care agen- cies); and 49 Pa. Code § 21.284b (relating to prescribing, administering and dispensing controlled substances). Subchapter A. CONTROLLED SUBSTANCES, DRUGS, DEVICES AND COSMETICS GENERAL PROVISIONS Sec. 25.1. Definitions. GOOD MANUFACTURING PRACTICE IN MANUFACTURE, PROCESSING, PACKING OR HOLDING OF DRUGS 25.11. Buildings. 25.12. Equipment. 25.13. Personnel. 25.14. Components. 25.15. Production and control records. 25.16. Production and control procedures. 25.17. Product containers and their components. 25.18. Packaging and labeling. 25.19. Laboratory controls. 25.20. Distribution records. Ch. 25 DRUGS, DEVICES, COSMETICS 28 25-1 (367111) No. 466 Sep. 13

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Page 1: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES,AND COSMETICS

Subch. Sec.A. CONTROLLED SUBSTANCES, DRUGS, DEVICES AND

COSMETICS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25.1B. HEARING AID SALES AND REGISTRATION . . . . . . . . . . . . . . . . . 25.201

Authority

The provisions of this Chapter 25 issued under the Controlled Substance, Drug, Device and Cos-metic Act (35 P. S. §§ 780-101—780-144), unless otherwise noted.

Source

The provisions of this Chapter 25 amended July 5, 1974, effective July 6, 1974, 4 Pa.B. 1371,unless otherwise noted.

Cross References

This chapter cited in 28 Pa. Code § 113.15 (relating to locked storage); 28 Pa. Code § 113.23(relating to records); 28 Pa. Code § 561.1 (relating to drugs and biologicals); 28 Pa. Code § 561.15(relating to locked storage); 28 Pa. Code § 601.3 (relating to requirements for home health care agen-cies); and 49 Pa. Code § 21.284b (relating to prescribing, administering and dispensing controlledsubstances).

Subchapter A. CONTROLLED SUBSTANCES, DRUGS, DEVICES ANDCOSMETICS

GENERAL PROVISIONS

Sec.25.1. Definitions.

GOOD MANUFACTURING PRACTICE IN MANUFACTURE,PROCESSING, PACKING OR HOLDING OF DRUGS

25.11. Buildings.25.12. Equipment.25.13. Personnel.25.14. Components.25.15. Production and control records.25.16. Production and control procedures.25.17. Product containers and their components.25.18. Packaging and labeling.25.19. Laboratory controls.25.20. Distribution records.

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25.21. Stability.25.22. Expiration dating.25.23. Complaint files.

STANDARDS OF OPERATION FOR DRUG, DEVICE OR COSMETICDISTRIBUTORS

25.31. Sanitation requirements.25.32. Warehousing requirements.25.33. Distribution.25.34. Personnel.

EMERGENCY DISPENSING

25.41. Pharmacist.25.42. Emergency conditions.25.43. Immediate writing required.25.44. Unfamiliar practitioners.25.45. Emergency oral prescription.25.46. Failure to deliver written prescription.

PRESCRIPTIONS

25.51. Definition of ‘‘prescription.’’25.52. Purpose.25.53. Prescription orders.25.54. Posting notice.25.55. Dispensing.25.56. Prescription record keeping.25.57. Nonprescription orders.25.58. Generically equivalent drug products.

SECURITY REQUIREMENTS

25.61. General provisions.25.62. Security controls for distributors.25.63. Security controls for practitioners and research personnel.

SCHEDULES OF CONTROLLED SUBSTANCES

25.72. Schedules of controlled substances.25.73. [Reserved].

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25.74. [Reserved].25.75. Paregoric.25.76. [Reserved].

NONPROPRIETARY DRUGS

25.81. Classification of nonproprietary drugs.

LABELING OF DRUGS, DEVICES AND COSMETICS

25.91. Labeling.25.92. Control numbers in labeling of controlled substances and other drugs but

excluding prescription orders.25.93. Labeling—drug code number.25.94. Expiration date of drug.25.95. Mandatory compliance.

MISBRANDING

25.101. Standards.

SALVAGE OF DISTRESSED DRUGS, DEVICES AND COSMETICS

25.102. Definition.25.103. Distressed drugs, devices or cosmetics.25.104. Prohibitions.25.105. Normal return for credit.

REGISTRATION

25.113. Requirements for registration.25.114. Persons exempt from registration.25.115. Registration fees.25.116. Time and method of payment; refund.

SAMPLES

25.121. Official samples for analysis.25.122. Quantity of sample.25.123. Disposition of sample.

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25.124. Destruction of samples.25.125. Payment for samples.

REPORTS OF SCHEDULE II CONTROLLED SUBSTANCES

25.131. Every dispensing practitioner.

Cross References

This subchapter A cited in 49 Pa. Code § 27.201 (relating to electronically transmitted prescrip-tions).

GENERAL PROVISIONS

§ 25.1. Definitions.

The following words and terms when used in this chapter, have the followingmeanings, unless the context clearly indicates otherwise:

Act—The Controlled Substance, Drug, Device and Cosmetic Act (35 P. S.§§ 780-101—780-144).

Department—The Department of Health of the Commonwealth.Device—Includes the following:

(i) An instrument, apparatus or contrivance, including their compo-nents, parts and accessories, intended as follows:

(A) For use in the diagnosis, cure, mitigation, treatment or preventionof disease of man or other animals.

(B) To affect the structure or a function of the body of man or otheranimals.(ii) The term device shall include the following:

(A) Artificial eyes.(B) Artificial limbs.(C) Bandages and dressings, including, but not limited to, adhesive

bandages, sterile gauze and cotton products, and elastic bandages andbraces.

(D) Birth control devices, including, but not limited to, intrauterinedevices, prophylactics, and vaginal diaphragms.

(E) Blood pressure testing apparatus.(F) Body braces and supports, including, but not limited to, crutches,

walkers and orthopedic braces and supports.(G) Cardiac pacemakers and accessories.(H) Colostomy and ileostomy appliances, bags and supplies.

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(I) Corn pads or plasters.(J) Dental materials which are transferred to the patient, including, but

not limited to, dentures, fillings, crowns, inlays, bridges, and apparatus.(K) Dialysis machines and artificial kidneys.(L) Electronic therapeutic or diagnostic products.(M) Eyeglasses and hard contact lenses.(N) Hearing aids.(O) Inhalation therapy equipment and emergency breathing equipment,

including but not limited to atomizers, intermittent positive pressurebreathing units, iron lungs, vaporizers, and oxygen equipment.

(P) Lamps, ultra-violet or infra-red.(Q) Needles.(R) Syringes.(S) Physical therapy equipment for professional or home use, includ-

ing but not limited to diathermy machines, electronic muscle stimulators,traction units, therapeutic vibrators, and whirlpool units.

(T) Surgical implants.(U) Sutures.(V) Thermometers.(W) Urine test kits sold over-the-counter for home use.(X) Wheelchairs.

Secretary—The Secretary of Health of the Commonwealth.

Authority

The provisions of this § 25.1 issued under section 2102 of The Administrative Code of 1929 (71P. S. § 532); and sections 6 and 35 of the Controlled Substance, Drug, Device and Cosmetic Act (35P. S. §§ 780-106 and 780-135).

Source

The provisions of this § 25.1 amended April 8, 1977, 7 Pa.B. 997. Immediately preceding textappears at serial page (17625).

GOOD MANUFACTURING PRACTICE IN MANUFACTURE,PROCESSING, PACKING OR HOLDING OF DRUGS

§ 25.11. Buildings.

Buildings shall be maintained in a clean and orderly manner and shall be ofsuitable size, construction, and location to facilitate adequate cleaning, mainte-nance, and proper operations in the manufacturing, processing, packing, labelingor holding of a drug. The buildings shall conform with the following:

(1) Provide adequate space for the following:

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(i) Orderly placement of equipment and materials to minimize any riskof mixups between different drugs, drug components, in-process materials,packaging materials or labeling, and to minimize the possibility of contami-nation.

(ii) The receipt, storage and withholding from use of components pend-ing sampling, identification, and testing prior to release by the materialsapproval unit for manufacturing and packaging.

(iii) The holding of rejected components prior to disposition to precludethe possibility of their use in manufacturing or packaging procedures forwhich they are unsuitable.

(iv) The storage of components, containers, packaging materials, andlabeling.

(v) Any manufacturing and processing operations performed.

(vi) Any packaging or labeling operations.

(vii) Storage of finished products.

(viii) Control and production-laboratory operations.

(2) Provide adequate lighting, ventilation and screening and, when neces-sary for the intended production or control purposes, provide facilities foradequate air-pressure, microbiological, dust, humidity and temperature controlsto insure the following:

(i) Minimize contamination of products by extraneous adulterants,including cross-contamination of one product by dust or particles of ingredi-ents arising from the manufacture, storage or handling of another product.

(ii) Minimize dissemination of micro-organisms from one area toanother.

(iii) Provide suitable storage conditions for drug components, in-processmaterials and finished drugs in conformance with stability information asderived under § 25.21 (relating to stability).

(3) Provide adequate locker facilities and hot and cold water washingfacilities, including soap or detergent, air dryer or single service towels andclean toilet facilities near working areas.

(4) Provide an adequate supply of potable water under continuous positivepressure in a plumbing system free of defects that could cause or contribute tocontamination of any drug. Drains shall be of adequate size and, where con-nected directly to a sewer, shall be equipped with traps to prevent back-siphonage.

(5) Provide suitable housing and space for the care of all laboratory ani-mals.

(6) Provide for safe and sanitary disposal of sewage, trash and other refusewithin and from the buildings and immediate premises.

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§ 25.12. Equipment.Equipment used for the manufacture, processing, packing, labeling, holding,

testing or control of drugs shall be maintained in a clean and orderly manner andshall be of suitable design, size, construction and location to facilitate cleaning,maintenance and operation for its intended purpose. These regulations permit theuse of precision automatic, mechanical or electronic equipment in the productionof drugs when adequate inspection and checking procedures are used to assureproper performance. The equipment shall conform with the following:

(1) Be so constructed that all surfaces that come into contact with a drugproduct shall not be reactive, additive or absorptive so as to alter the safety,identity, strength, quality or purity of the drug or its components beyond theofficial or other established requirements.

(2) Be so constructed that any substances required for operation of theequipment, such as lubricants or coolants, do not contact drug products so asto alter the safety, identity, strength, quality or purity of the drug or its compo-nents beyond the official or other established requirements.

(3) Be constructed and installed to facilitate adjustment, disassembly,cleaning and maintenance to assure the reliability of control procedures, unifor-mity of production, and exclusion from the drugs of contaminants from previ-ous and current operations that might affect the safety, identity, strength, qual-ity or purity of the drug or its components beyond the official or otherestablished requirements.

(4) Be of suitable type, size and accuracy for any testing, measuring, mix-ing, weighing or other processing or storage operations.

§ 25.13. Personnel.(a) A person may not operate as a manufacturer of drugs unless the drugs are

manufactured under the supervision of a registered pharmacist, chemist or otherperson possessing at least 5 years’ experience in the manufacture of drugs oranother person approved by the secretary as qualified by scientific or technicaltraining or experience to perform the duties of supervision as may be necessaryto protect the public health and safety.

(b) A person shown at any time (either by medical examination or supervi-sory observation) to have an apparent illness or open lesions that may adverselyaffect the safety or quality of drugs shall be excluded from direct contact withdrug products until the condition is corrected. Employes shall be instructed toreport to supervisory personnel conditions that may have an adverse effect ondrug products.

§ 25.14. Components.Components and other materials used in the manufacture, processing and pack-

aging of drug products, and materials necessary for building and equipment

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maintenance, upon receipt shall be stored and handled in a safe, sanitary andorderly manner. Adequate measures shall be taken to prevent mixups and cross-contamination affecting drugs and drug products. Components shall be withheldfrom use until they have been identified, sampled and tested for conformancewith established specifications and are released by a materials approval unit.Control of components shall include the following:

(1) Each container of component shall be examined visually for damage orcontamination prior to use, including examination for breakage of seals whenindicated.

(2) An adequate number of samples shall be taken from a representativenumber of component containers from each lot and shall be subjected to one ormore tests to establish the specific identity.

(3) Representative samples of components liable to contamination withfilth, insect infestation, or other extraneous contaminants shall be appropriatelyexamined.

(4) Representative samples of all components intended for use as activeingredients shall be tested to determine their strength in order to assure con-formance with appropriate specifications.

(5) Representative samples of components liable to microbiological con-tamination shall be subjected to microbiological tests prior to use. Such com-ponents shall not contain microorganisms that are objectionable in view of theirintended use.

(6) Approved components shall be appropriately identified and retested asnecessary to assure that they conform to appropriate specifications of identity,strength, quality, and purity at time of use. This requires the following:

(i) Approved components shall be handled and stored to guard againstcontaminating or being contaminated by other drugs or components.

(ii) Approved components shall be rotated in such a manner that theoldest stock is used first.

(iii) Rejected components shall be identified and held to preclude theiruse in manufacturing or processing procedures for which they are unsuitable.(7) Appropriate records shall be maintained, including the following:

(i) The identity and quantity of the component, the name of the sup-plier, the supplier’s lot number, and the date of receipt.

(ii) Examinations and tests performed and rejected components andtheir disposition.

(iii) An individual inventory and record for each component used ineach batch of drug manufactured or processed.(8) An appropriately identified reserve sample of all active ingredients

consisting of at least twice the quantity necessary for all required tests, exceptthose for sterility and determination of the presence of pyrogens, shall beretained for at least 2 years after distribution of the last drug lot incorporating

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the component has been completed or 1 year after the expiration date of thislast drug lot, whichever is longer.

Cross References

This section cited in 28 Pa. Code § 25.19 (relating to laboratory controls).

§ 25.15. Production and control records.

(a) To assure uniformity from batch to batch, a master production and con-trol record for each drug product and each batch size of drug product shall beprepared, dated, and signed or initialed by a competent and responsible individualand shall be independently checked, reconciled, dated and signed by a secondcompetent and responsible individual. The master production and control recordshall include:

(1) The name of the product, description, of the dosage form, and a speci-men or copy of each label and all other labeling associated with the retail orbulk unit, including copies of such labeling signed or initialed and dated by theperson or persons responsible for approval of such labeling.

(2) The name and weight or measure of each active ingredient per dosageunit or per unit of weight or measure of the finished drug, and a statement ofthe total weight or measure of any dosage unit.

(3) A complete list of ingredients designated by names or codes suffi-ciently specific to indicate any special quality characteristic; and accurate state-ment of the weight or measure of each ingredient regardless of whether itappears in the finished product, except that reasonable variations may be per-mitted in the amount of components necessary in the preparation in dosageform provided that provisions for such variations are included in the masterproduction and control record; an appropriate statement concerning any calcu-lated excess of an ingredient; an appropriate statement of theoretical weight ormeasure at various stages of processing; and a statement of the theoreticalyield.

(4) A description of the containers, closures, and packaging and finishingmaterials.

(5) Manufacturing and control instructions, procedures, specifications, spe-cial notations, and precautions to be followed.(b) The batch production and control record shall be prepared for each batch

of drug produced and shall include complete information relating to the produc-tion and control of each batch. These records shall be retained for at least twoyears after the batch distribution is complete or at least 1 year after the batchexpiration date, whichever is longer. These records shall identify the specificlabeling and lot or control numbers used on the batch and shall be readily avail-able during such retention period. The batch record shall include:

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(1) An accurate reproduction of the appropriate master formula recordchecked, dated, and signed or initialed by a competent and responsible indi-vidual.

(2) A record of each significant step in the manufacturing, processing,packaging, labeling, testing, and controlling of the batch, including dates, indi-vidual major equipment and lines employed; specific identification of eachbatch of components used; weights and measures of components and productsused in the course of processing; in-process and laboratory control results; andidentifications of the individuals actively performing and the individualsdirectly supervising or checking each significant step in the operation.

(3) A batch number that identifies all the production and control docu-ments relating to the history of the batch and all lot or control numbers asso-ciated with the batch.

(4) A record of any investigation made according to § 25.16(8) (relating toproduction and control procedures).

§ 25.16. Production and control procedures.

Production and control procedures shall include all reasonable precautions,including the following, to assure that the drugs produced have the safety, iden-tity, strength, quality, and purity they purport to possess:

(1) Each significant step in the process, such as the selection, weighing,and measuring of components, the addition of ingredients during the process,weighing and measuring during various stages of the processing, and the deter-mination of the finished yield, shall be performed by a competent and respon-sible individual and checked by a second competent and responsible individual;or if such steps in the processing are controlled by precision automatic,mechanical, or electronic equipment, their proper performance is adequatelychecked by one or more competent and responsible individuals. The writtenrecord of the significant steps in the process shall be identified by the indi-vidual performing these tests and by the individual charged with checking thesesteps. Such identifications shall be recorded immediately following the comple-tion of such steps.

(2) All containers, lines, and equipment used during the production of abatch of a drug shall be properly identified at all times to accurately and com-pletely indicate their contents and, when necessary, the stage of processing ofthe batch.

(3) To minimize contamination and prevent mixups, equipment, utensils,and containers shall be thoroughly and appropriately cleaned and properlystored and have previous batch identification removed or obliterated betweenbatches or at suitable intervals in continuous production operations.

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(4) Appropriate precautions shall be taken to minimize microbiological andother contamination in the production of drugs purporting to be sterile or whichby virtue of their intended use should be free from objectionable micro-organisms.

(5) Appropriate procedures shall be established to minimize the hazard ofcross-contamination of any drugs while being manufactured or stored.

(6) To assure the uniformity and integrity of products, there shall beadequate in-process controls, such as checking the weights and disintegrationtimes of tablets, the adequacy of mixing, the homogeneity of suspensions, andthe clarity of solutions. In-process sampling shall be done at appropriate inter-vals using suitable equipment.

(7) Representative samples of all dosage form drugs shall be tested to deter-mine their conformance with the specifications for the product before distribution.

(8) Procedures shall be instituted whereby review and approval of all pro-duction and control records, including packaging and labeling, shall be madeprior to the release or distribution of a batch. A thorough investigation of anyunexplained discrepancy or the failure of a batch to meet any of its specifica-tions shall be undertaken whether or not the batch has already been distributed.This investigation shall be undertaken by a competent and responsible indi-vidual and shall extend to other batches of the same drug and other drugs thatmay have been associated with the specific failure. A written record of theinvestigation shall be made and shall include the conclusions and followup.

(9) Returned goods shall be identified as such and held. If the conditionsunder which returned goods have been held, stored, or shipped prior to or dur-ing their return, or the condition of the product, its container, carton, or label-ing as a result of storage or shipping, cast doubt on the safety, identity, strength,quality, or purity of the drug, the returned goods shall be destroyed or subjectedto adequate examination or testing to assure that the material meets all appro-priate standards or specifications before being returned to stock for warehousedistribution or repacking. If the product is neither destroyed nor returned tostock, it may be reprocessed provided the final product meets all its standardsand specifications. Records of returned goods shall be maintained and shallindicate the quantity returned, date, and actual disposition of the product. If thereason for returned goods implicates associated batches, an appropriate inves-tigation shall be made in accordance with the requirements of paragraph (8).

Cross References

This section cited in 28 Pa. Code § 25.15 (relating to production and control records); 28 Pa. Code§ 25.18 (relating to packaging and labeling); 28 Pa. Code § 25.23 (relating to complaint files).

§ 25.17. Product containers and their components.Suitable specifications, test methods, cleaning procedures and, when indicated,

sterilization procedures shall be used to assure that containers, closures and other

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component parts of drug packages are suitable for their intended use. Productcontainers and their components shall not be reactive, additive or absorptive soas to alter the safety, identity, strength, quality or purity of the drug or its com-ponents beyond the official or established requirements and shall provideadequate protection against external factors that can cause deterioration or con-tamination of the drug.

§ 25.18. Packaging and labeling.Packaging and labeling operations shall be adequately controlled: To assure

that only those drug products that have met the standards and specificationsestablished in their master production and control records shall be distributed; toprevent mixups between drugs during filling, packaging, and labeling operations;to assure that correct labels and labeling are employed for the drug; and to iden-tify the finished product with a lot or control number that permits determinationof the history of the manufacture and control of the batch. An hour, day, or shiftcode is appropriate as a lot or control number for drug products manufactured orprocessed in continuous production equipment. Packaging and labeling opera-tions shall conform with the following:

(1) Be separated, physically or spatially, from operations on other drugs ina manner adequate to avoid mixups and minimize cross-contamination. Two ormore packaging or labeling operations having drugs, containers, or labelingsimilar in appearance shall not be in process simultaneously on adjacent ornearby lines unless these operations are separated either physically or spatially.

(2) Provide for an inspection of the facilities prior to use to assure that alldrugs and previously used packaging and labeling materials have beenremoved.

(3) Include the following labeling controls:(i) The holding of labels and package labeling upon receipt pending

review and proofing against an approved final copy by a competent andresponsible individual to assure that they are accurate regarding identity,content, and conformity with the approved copy before release to inventory.

(ii) The maintenance and storage of each type of label and packagelabeling representing different products, strength, dosage forms, or quantityof contents in such a manner as to prevent mixups and provide proper iden-tification.

(iii) A suitable system for assuring that only current labels and packagelabeling are retained and that stocks of obsolete labels and package labelingare destroyed.

(iv) Restriction of access to labels and package labeling to authorizedpersonnel.

(v) Avoidance of gang printing of cut labels, cartons, or inserts whenthe labels, cartons, or inserts are for different products or different strengthsof the same products or are of the same size and have identical or similar

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format and/or color schemes. If gang printing is employed, packaging andlabeling operations shall provide for added control procedures. These addedcontrols should consider sheet layout, stacking, cutting and handling duringand after printing.(4) Provide strict control of the package labeling issued for use with the

drug. Such issue shall be carefully checked by a competent and responsibleperson for identity and conformity to the labeling specified in the batch pro-duction record. Said record shall identify the labeling and the quantities issuedand used and shall reasonably reconcile any discrepancy between the quantityof drug finished and the quantities of labeling issued. All excess package label-ing bearing lot or control numbers shall be destroyed. In event of any signifi-cant unexplained discrepancy, an investigation should be carried out accordingto § 25.16(h) (relating to production and control procedures).

(5) Provide for adequate examination or laboratory testing of representa-tive samples of finished products after packaging and labeling to safeguardagainst any errors in the finishing operations and to prevent distribution of anybatch until all specified tests have been met.

Cross References

This section cited in 28 Pa. Code § 113.25 (relating to drug distribution systems).

§ 25.19. Laboratory controls.Laboratory controls shall include the establishment of scientifically sound and

appropriate specifications, standards, and test procedures to assure that compo-nents, in-process drugs, and finished products conform to appropriate standardsof identity, strength, quality, and purity. Laboratory controls shall include the fol-lowing:

(1) The establishment of master records containing appropriate specifica-tions for the acceptance of each lot of drug components, product containers,and their components used in drug production and packaging and a descriptionof the sampling and testing procedures used for them. Said samples shall berepresentative and adequately identified. Such records shall also provide forappropriate retesting of drug components, product containers, and their compo-nents subject to deterioration.

(2) A reserve sample of all active ingredients as required by § 25.14 (8)(relating to components).

(3) The establishment of master records, when needed, containing specifi-cations and a description of sampling and testing procedures for in-processdrug preparations. Such samples shall be adequately representative and prop-erly identified.

(4) The establishment of master records containing a description of sam-pling procedures and appropriate specifications for finished drug products.Such samples shall be adequately representative and properly identified.

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(5) Adequate provisions for checking the identity and strength of drugproducts for all active ingredients and for assuring:

(i) Sterility of drugs purported to be sterile and freedom from objec-tionable micro-organisms for those drugs which should be so by virtue oftheir intended use.

(ii) The absence of pyrogens for those drugs purporting to be pyrogen-free.

(iii) Minimal contamination of ophthalmic ointments by foreign particlesand harsh or abrasive substances.

(iv) That the drug release pattern of sustained release products is testedby laboratory methods to assure conformance to the release specifications.(6) Adequate provision for auditing the reliability, accuracy, precision, and

performance of laboratory test procedures and laboratory instruments used.(7) A properly identified reserve sample of the finished product (stored in

the same immediate container closure system in which the drug is marketed)consisting of at least twice the quanitity necessary to perform all the requiredtests, except those for sterility and determination of the absence of pyrogens,and stored under conditions consistent with product labeling shall be retainedfor at least 2 years after the drug distribution has been completed or at least 1year after the drug’s expiration date, whichever is longer.

(8) Provision for retaining complete records of all laboratory data relatingto each batch or lot of drug to which they apply. Such records shall be retainedfor at least 2 years after distribution has been completed or 1 year after thedrug’s expiration date, whichever is longer.

(9) Provision that animals shall be maintained and controlled in a mannerthat assures suitability for their intended use. They shall be identified andappropriate records maintained to determine the history of use.

(10) Provision that firms which manufacture non penicillin products, includ-ing certifiable antibiotic products, on the same premises or use the same equip-ment as that used for manufacturing penicillin products, or that operate underany circumstances that may reasonably be regarded as conducive to contami-nation of other drugs by penicillin, shall test such non penicillin products todetermine whether any have become cross-contaminated by penicillin. Suchproducts shall not be marketed if intended for use in man or animals and theproduct is contaminated with an amount of penicillin equivalent to 0.05 unit ormore of penicillin G per maximum single dose recommended in the labeling ofa drug intended for parenteral administration or an amount of penicillin equiva-lent to 0.5 unit or more of penicillin G per maximum single dose recommendedin the labeling of a drug intended for oral use.

§ 25.20. Distribution records.(a) Finished goods warehouse control and distribution procedures shall

include a system by which the distribution of each lot of drug can be readily

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determined to facilitate its recall if necessary. Records within the system shallcontain the name and address of the consignee, date and quantity shipped, and lotor control number of the drug. Records shall be retained for at least 2 years afterthe distribution of the drug has been completed or 1 year after the expiration dateof the drug, whichever is longer.

(b) To assure the quality of the product, finished goods warehouse controlshall also include a system whereby the oldest approved stock is distributed firstwhenever possible.

§ 25.21. Stability.There shall be assurance of the stability of finished drug products. This stabil-

ity shall be in accordance with the following:(1) Determined by reliable, meaningful, and specific test methods.(2) Determined on products in the same container closure systems in which

they are marketed.(3) Determined on any dry drug product that is to be reconstituted at the

time of dispensing, as directed in its labeling, as well as on the reconstitutedproduct.

(4) Recorded and maintained in such manner that the stability data may beutilized in establishing product expiration dates.

Cross References

This section cited in 28 Pa. Code § 25.11 (relating to buildings); and 28 Pa. Code § 25.22 (relat-ing to expiration date).

§ 25.22. Expiration dating.To assure that drug products liable to deterioration meet appropriate standards

of identity, strength, quality, and purity at the time of use, the label of all suchdrugs shall have suitable expiration dates which relate to stability tests performedon the products.

(1) Expiration dates appearing on the drug labeling shall be justified byreadily available data from stability studies such as described in § 25.21 (relat-ing to stability).

(2) Expiration dates shall be related to appropriate storage conditionsstated on the labeling wherever the expiration date appears.

(3) When the drug is marketed in the dry state for use in preparing a liquidproduct, the labeling shall bear expiration information for the reconstitutedproduct as well as an expiration date for the dry product.

§ 25.23. Complaint files.Records shall be maintained of all written and oral complaints regarding each

product. An investigation of each complaint shall be made in accordance with§ 25.16(8) (relating to production and control procedures). The record of each

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investigation shall be maintained for at least 2 years after distribution of the drughas been completed or 1 year after the expiration date of the drug, whichever islonger.

STANDARDS OF OPERATION FOR DRUG, DEVICE ORCOSMETIC DISTRIBUTORS

§ 25.31. Sanitation requirements.Those areas of drug, device or cosmetic distributing establishments where

drugs, devices or cosmetics are warehoused or stored shall be maintained in aclean, orderly condition, free from vermin infestations, accumulated waste anddebris. Preventive measures shall include, but shall not be limited to, the follow-ing:

(1) Warehousing facilities shall be of construction, material, and finish thatwill permit the ready and efficient cleaning of all surfaces, having regard to thenature of the operations being performed.

(2) Adequate lighting shall be provided in all working areas.(3) Sufficient working and storage space shall be provided to permit

adequate cleaning and housekeeping.(4) The establishments shall be free from accumulations of water not nec-

essary for operational or sanitation procedures.(5) Proper and adequate toilet facilities shall be provided and kept in sat-

isfactory condition at all times with sufficient lighting and ventilation. Suchfacilities shall be separate from operational areas of such establishments. Hand-washing facilities shall be available and rules shall require their use beforereturning to work.

(6) The establishment shall have a proper program for maintaining theconditions specified above.

§ 25.32. Warehousing requirements.(a) Establishments warehousing products which require refrigeration shall be

equipped with adequate facilities for storage at the proper reduced temperatures.(b) Distributors dealing in controlled substances shall have adequate storage

facilities and safeguards to comply with the regulations of the Federal DrugEnforcement Administration.

(c) Distributors dealing in drugs shall have adequate storage facilities andsafeguards to prevent loss or minimize deterioration.

(d) Each distributor’s establishment shall provide for a systematic rotation ofstock.

(e) Damaged, out-dated or otherwise unfit drugs, devices or cosmetics not inconformity with the provisions of the act or regulations thereunder, shall beremoved from active stock and held for proper disposition in a quarantine orother clearly defined area.

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(f) A distributor dealing in nonproprietary drugs or controlled substancesshall have operating and storage facilities which have entrances used only by thatdistributor and which are separate from living quarters. Facilities shall be securedso that persons in an adjoining structure, business or residence cannot traversethrough the operating and storage areas used for nonproprietary drugs or con-trolled substances.

Authority

The provisions of this § 25.32 issued under section 35 of the Controlled Substance, Drug, Deviceand Cosmetic Act (35 P. S. § 780-135); and section 2102(g) of The Administrative Code of 1929 (71P. S. § 532(g)).

Source

The provisions of this § 25.32 amended September 12, 1986, effective September 13, 1986, 16Pa.B. 3396. Immediately preceding text appears at serial page (96886).

§ 25.33. Distribution.(a) Distributing establishments shall not distribute nonproprietary drugs or

controlled substances to persons unauthorized by the act to receive them.(b) No person shall buy, sell, cause to be sold or offer for sale any drug or

device which bears or which package bears or originally did bear, the inscription‘‘sample’’ or ‘‘not for sale’’ or words of similar import. This subsection does notapply to the production of promotional samples by one manufacturer for distribu-tion by another manufacturer.

(c) Distributors shall keep records of all purchases or other receipts and salesor other distribution of drugs, devices and controlled substances, other than thoseexempt by regulation, for 2 years from the date of receipt and distribution. Suchrecords shall include the following:

(1) Name and address of person from whom received.(2) Name and address of person to whom distributed.(3) Date of receipt and distribution.(4) Quantity involved.

§ 25.34. Personnel.(a) The personnel responsible for the supervision of a drug, device or cos-

metic distributing establishment shall have appropriate technical qualifications orshall be qualified by job training and experience, to assure the proper handling ofproducts in the establishment.

(b) No person may operate as a distributor of nonproprietary drugs or con-trolled substances unless the distribution is performed while a registered pharma-cist, chemist or other person who possesses at least 3 years experience in the dis-tribution or sale of drugs or controlled substances is present in the distributingestablishment and is responsible for the activities. Other persons may meet thisrequirement for supervision, if approved by the Secretary as qualified by scien-tific training to perform the duties of supervision.

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Authority

The provisions of this § 25.34 issued under section 35 of the Controlled Substance, Drug, Deviceand Cosmetic Act (35 P. S. § 780-135); and section 2102(g) of The Administrative Code of 1929 (71P. S. § 532(g)).

Source

The provisions of this § 25.34 amended September 12, 1986, effective September 13, 1986, 16Pa.B. 3396. Immediately preceding text appears at serial page (96886).

EMERGENCY DISPENSING

§ 25.41. Pharmacist.A pharmacist may dispense to the ultimate user a controlled substance listed in

Schedule II which is a prescription drug as determined under the Federal FoodDrug and Cosmetic Act, 21 U.S.C.A. § 812 upon receiving oral authorizationwithout the written prescription order of a licensed practitioner only under thefollowing emergency situations:

(1) That immediate administration of the controlled substance is necessaryfor proper treatment of the intended ultimate user.

(2) That no appropriate alternative treatment is available including admin-istration of a drug that is not a controlled substance under Schedule II of theact, 21 U.S.C.A. § 812.

Cross References

This section cited in 28 Pa. Code § 551.3 (relating to definitions).

§ 25.42. Emergency conditions.The quantity prescribed and dispensed under emergency conditions is limited

to the amount adequate to treat the patient during the emergency period.

Cross References

This section cited in 28 Pa. Code § 551.3 (relating to definitions).

§ 25.43. Immediate writing required.The prescription shall be immediately reduced to writing by the pharmacist and

shall contain all the information required under section 4 of the act (35 P. S.§ 780-104) except the signature of the prescribing licensed practitioner.

Cross References

This section cited in 28 Pa. Code § 551.3 (relating to definitions).

§ 25.44. Unfamiliar practitioners.If the prescribing practitioner is not known to the pharmacist, he must make a

reasonable effort to determine that the oral authorization came from a licensed

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practitioner, which may include a call back to the practitioner using the phonenumber listed in the telephone directory of other good faith efforts to insure hisidentity.

Cross References

This section cited in 28 Pa. Code § 551.3 (relating to definitions).

§ 25.45. Emergency oral prescription.Within 72 hours after authorizing an emergency oral prescription, the prescrib-

ing practitioner shall have a written prescription for the emergency quantity pre-scribed delivered to the dispensing pharmacist. In addition to conforming to therequirements of these regulations, and the act, the prescription shall have writtenon its face ‘‘Authorization for Emergency Dispensing’’ and the date of the oralorder. Upon receipt the dispensing pharmacist shall attach this prescription to theoral emergency prescription which had earlier been reduced to writing.

Cross References

This section cited in 28 Pa. Code § 551.3 (relating to definitions).

§ 25.46. Failure to deliver written prescription.The pharmacist shall notify the nearest office of the Federal Drug Enforcement

Administration if the prescribing individual practitioner fails to deliver a writtenprescription to him; failure of the pharmacist to do so shall void the authorityconferred by this section to dispense a controlled substance without a writtenprescription of a prescribing individual practitioner.

Cross References

This section cited in 28 Pa. Code § 551.3 (relating to definitions).

PRESCRIPTIONS

§ 25.51. Definition of ‘‘prescription.’’The term ‘‘prescription’’ or ‘‘prescription order’’ means an order for a con-

trolled substance, other drug, or device for medication which is dispensed to orfor an ultimate user, but does not include an order for a controlled substance,other drug, or device for medication which is dispensed for immediate adminis-tration to the ultimate user. For example, an order to dispense a drug to a bedpatient for immediate administration in a hospital is not a prescription order.

Cross References

This section cited in 28 Pa. Code § 551.3 (relating to definitions); 49 Pa. Code § 18.6a (relatingto prescribing, dispensing and administering drugs); 49 Pa. Code § 18.158 (relating to prescribing anddispensing drugs, pharmaceutical aids and devices); 49 Pa. Code § 25.177 (relating to prescribing anddispensing drugs, pharmaceutical aids and devices); and 49 Pa. Code § 21.284a (relating to prescrib-ing and dispensing drugs).

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§ 25.52. Purpose.(a) A prescription for a controlled substance must be issued for a legitimate

medical purpose by a licensed practitioner in the usual course of professionalpractice. The responsibility for proper prescribing of controlled substances isupon the practitioner but a corresponding responsibility rests with the pharmacistwho dispenses the medication and interprets the directions of the prescriber to thepatient.

(b) A prescription may not be issued by a practitioner to obtain controlledsubstances for use in his routine office practice nor for general dispensing to hispatients.

(c) A prescription may not be issued for the dispensing of controlled sub-stances listed in any schedule to a drug dependent person for the purpose of con-tinuing his dependence upon such drugs, nor in the course of conducting anauthorized clinical investigation in a narcotic dependency rehabilitation program.

Notes of Decisions

A pharmacist who fills numerous prescriptions emanating from a dentist for medications whichclearly do not comport with a dental practice (such as birth control drugs and unusually large dosagesof valium) violates the standards of his profession and the duty imposed by the provisions of this sec-tion. Askin v. Department of Public Welfare, 423 A.2d 1371 (Pa. Cmwlth. 1981).

Cross References

This section cited in 28 Pa. Code § 551.3 (relating to definitions); 49 Pa. Code § 18.6a (relatingto prescribing, dispensing and administering drugs); 49 Pa. Code § 18.158 (relating to prescribing anddispensing drugs, pharmaceutical aids and devices); 49 Pa. Code § 25.177 (relating to prescribing anddispensing drugs, pharmaceutical aids and devices); and 49 Pa. Code § 21.284a (relating to prescrib-ing and dispensing drugs).

§ 25.53. Prescription orders.(a) Prescription orders may be written on prescription blanks or may be oral,

if allowed by law.(b) If prescriptions are issued in writing, the bottom of every prescription

blank shall be imprinted with the words ‘‘substitution permissible’’ and shall con-tain one signature line for the physician’s or other authorized prescriber’s signa-ture. The prescriber’s signature shall validate the prescription, and unless the pre-scriber handwrites ‘‘brand necessary’’ or ‘‘brand medically necessary’’ shalldesignate approval of substitution of a drug by a pharmacist, pursuant to the act.Imprinted conspicuously on the prescription blanks shall be the words: INORDER FOR A BRAND NAME PRODUCT TO BE DISPENSED, THE PRE-SCRIBER MUST HANDWRITE ‘‘BRAND NECESSARY’’ OR ‘‘BRANDMEDICALLY NECESSARY’’ IN THE SPACE BELOW.’’ Information printed onthe prescription blank shall be in 8 point, upper-case print. The followingexample would be acceptable:SUBSTITUTION PERMISSIBLE M.D.*

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IN ORDER FOR A BRAND NAME PRODUCT TO BE DISPENSED, THEPRESCRIBER MUST HANDWRITE ‘‘BRAND NECESSARY’’ OR ‘‘BRANDMEDICALLY NECESSARY’’ IN THE SPACE BELOW.*as appropriate

(c) If prescription orders are given orally, substitution is permissible unlessthe prescriber expressly indicates to the pharmacist that the brand name drug isnecessary and that substitution is not allowed.

(d) Prescriptions for controlled substances shall be written in indelible ink,indelible pencil or typewriter and shall include the following information:

(1) The date of issue.(2) The name and address of the patient, or if the patient is an animal, the

name and address of the owner and the species of the animal.(3) Directions for administration.(4) The name, address and Federal Drug Enforcement Administration reg-

istration number of the prescribing practitioner.(5) The signature of the prescribing practitioner in the manner described in

subsection (b).(e) The Federal Drug Enforcement Administration registration number cannot

be preprinted on the prescription form.

Authority

The provisions of this § 25.53 issued under section 5(a) of the act of November 24, 1976 (P. L.1163, No. 259) (35 P. S. § 960.5); amended under section 3 of the act of November 24, 1976 (P. L.1163, No. 259) (35 P. S. § 960.5); and section 2102(g) of The Administrative Code of 1929 (71 P. S.§ 532(g)).

Source

The provisions of this § 25.53 amended through June 24, 1977, 7 Pa.B. 1815; amended October26, 1990, effective October 27, 1990, 20 Pa.B. 5426. Immediately preceding text appears at serialpages (116446) to (116447).

Cross References

This section cited in 28 Pa. Code § 551.3 (relating to definitions); 49 Pa. Code § 18.6a (relatingto prescribing, dispensing and administering drugs); 49 Pa. Code § 18.158 (relating to prescribing anddispensing drugs, pharmaceutical aids and devices); 49 Pa. Code § 25.177 (relating to prescribing anddispensing drugs, pharmaceutical aids and devices); and 49 Pa. Code § 21.284a (relating to prescrib-ing and dispensing drugs).

§ 25.54. Posting notice.(a) Every pharmacy shall post a sign which shall read as follows: ‘‘PENN-

SYLVANIA LAW PERMITS PHARMACISTS TO SUBSTITUTE A LESSEXPENSIVE GENERICALLY EQUIVALENT DRUG FOR A BRAND NAMEDRUG UNLESS YOU OR YOUR PHYSICIAN DIRECT OTHERWISE.’’ Thissign will be printed in boldface letters not less than one inch or 2.54 centimeters

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in height on a white background and posted in a prominent place that is in clearand unobstructed public view at or near the place where prescriptions are dis-pensed.

(b) Every pharmacy shall post in a conspicuous place, easily accessible to thegeneral public, a list of commonly used generically equivalent drug productsfrom the Department Formulary containing brand names, names of the manufac-turers, and generic names. This list shall be alphabetized by brand name, each ofwhich shall be followed by the generic name, and printed in boldface type clearlylegible and accessible to the general public.

(c) Every pharmacy shall have available to the public a listing of the regularand customary retail prices of that pharmacy for brand name and generic equiva-lent drug products, with the name of the manufacturer, available for selection bythe person presenting the prescription.

AuthorityThe provisions of this § 25.54 issued under section 5(a) of the act of November 24, 1976 (P. L.

1163, No. 259) (35 P. S. § 960.5).

SourceThe provisions of this § 25.54 amended June 24, 1977, 7 Pa.B. 1742. Immediately preceding text

appears at serial page (17641).

Cross ReferencesThis section cited in 28 Pa. Code § 551.3 (relating to definitions); 49 Pa. Code § 18.6a (relating

to prescribing, dispensing and administering drugs); 49 Pa. Code § 18.158 (relating to prescribing anddispensing drugs, pharmaceutical aids and devices); 49 Pa. Code § 25.177 (relating to prescribing anddispensing drugs, pharmaceutical aids and devices); and 49 Pa. Code § 21.284a (relating to prescrib-ing and dispensing drugs).

§ 25.55. Dispensing.(a) Where the pharmacist is to substitute a less expensive generically equiva-

lent drug for a brand name drug at the pharmacy, notification to the person pre-senting the prescription shall be made by the pharmacist, either directly orthrough a pharmacy intern or other person under the supervision of the pharma-cist authorized to assist the pharmacist by the State Board of Pharmacy. Suchnotification shall be limited to advising the person presenting the prescription thatsubstitution is possible, to advising the person of the amount of the retail pricedifference between the brand name and the generically equivalent drug productsubstituted for it, and to informing the person that he may refuse the substitution.Questions by the person presenting the prescription for drug product informationshall be answered only by the pharmacist or pharmacy intern. The notificationdescribed in this subsection of a possible substitution and retail price differencemay be oral or may be in a written statement similar to the following: ‘‘Yourphysician has indicated that this prescription, identified as , may befilled with one of the generic drug products listed in the Pennsylvania Departmentof Health Formulary. This lower cost generically equivalent product has beenselected by our pharmacy in order to save you, the purchaser, a total of$ . Please indicate whether you do � or do not � wish to have thelower priced drug. Signed .’’

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(b) Where the pharmacist is to substitute a less expensive generically equiva-lent drug product for a brand name drug by mail, the following provisions mustbe complied with:

(1) The mail order pharmacy, in all communications in connection with thesolicitations of mail order customers, whether by direct mailings, generaladvertising, or on order forms, shall include notice in upper case letters and inboldface type as follows:

PENNSYLVANIA LAW PERMITS PHARMACISTS TO SUBSTI-TUTE A LESS EXPENSIVE GENERICALLY EQUIVALENTDRUG FOR A BRAND NAME DRUG UNLESS YOU OR YOURPHYSICIAN DIRECT OTHERWISE.� CHECK HERE IF YOU DO NOT WISH A LESS EXPENSIVEBRAND OR GENERIC DRUG ‘‘PRODUCT.’’

(2) After receiving a prescription order by mail, a mail order pharmacyshall substitute a less expensive generically equivalent drug product listed inthe Formulary unless expressly directed otherwise by the person presenting theprescription or the prescribing physician.

(3) When a generically equivalent drug product is dispensed by mail, thepharmacy shall notify the person presenting the prescription of the substitutionand shall indicate the retail price difference between the brand name drug andthe generic equivalent drug product substituted for it.(c) Any pharmacist substituting a less expensive drug product shall charge

the person presenting the prescription the regular and customary retail price ofthat pharmacy for the generically equivalent drug.

(d) No pharmacist shall substitute a generically equivalent drug product for aprescribed brand name drug product if the brand name drug product or thegeneric drug type is not included in the Formulary developed by the Departmentand found at § 25.58 (relating to generically equivalent drug products).

(e) Prescription refills, where permitted by the practitioner, shall be com-pleted using the identical product (same distributor and manufacturer) as dis-pensed on the original, unless the person presenting the prescription and thepractitioner authorize in advance a different manufacturer’s generic equivalentproduct. Advance authorization is not required in an emergency, but the physicianshall be notified by the pharmacist as soon as possible thereafter.

Authority

The provisions of this § 25.55 issued under section 5(a) of the act of November 24, 1976 (P. L.1163, No. 259) (35 P. S. § 960.5).

Source

The provisions of this § 25.55 amended June 24, 1977, effective June 25, 1977, 7 Pa.B. 1742.Immediately preceding text appears at serial pages (17641) and (17642).

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Cross References

This section cited in 28 Pa. Code § 551.3 (relating to definitions); 49 Pa. Code § 18.6a (relatingto prescribing, dispensing and administering drugs); 49 Pa. Code § 18.158 (relating to prescribing anddispensing drugs); 49 Pa. Code § 25.177 (relating to prescribing and dispensing drugs, pharmaceuti-cal aids and devices); 49 Pa. Code § 21.284a (relating to prescribing and dispensing drugs); and 49Pa. Code § 43b.7 (relating to schedule of civil penalties—pharmacists and pharmacies).

§ 25.56. Prescription record keeping.(a) Prescription orders for controlled substances in Schedules I and II shall be

maintained in a file separate from all other records of the pharmacy.(b) Prescription orders for controlled substances in Schedules III, IV and V

shall be maintained either in a separate prescription file or in such form that theyare readily retrievable from the other prescription records of the pharmacy. Theywill be deemed readily retrievable if, at the time they are initially filed, the faceof the prescription is marked in red ink in the lower right corner with the letter‘‘C,’’ no less than one inch high and filed in the usual consecutively numberedprescription file for noncontrolled substances.

(c) When a pharmacist substitutes a generically equivalent drug product for abrand name product, he shall maintain a record of the substitution by making anotation indicating the generic equivalent drug name, using abbreviations if nec-essary, and the name of the manufacturer and distributor of the product dispensedon the original prescription order retained by the pharmacist, or the pharmacistmay store it in a functionally equivalent retrieval system.

Authority

The provisions of this § 25.56 issued under section 5(a) of the act of November 24, 1976 (P. L.1163, No. 259) (35 P. S. § 960.5).

Source

The provisions of this § 25.56 adopted June 24, 1977, effective June 25, 1977, 7 Pa.B. 1742.

Cross References

This section cited in 28 Pa. Code § 551.3 (relating to definitions); 49 Pa. Code § 18.6a (relatingto prescribing, dispensing and administering drugs); 49 Pa. Code § 18.158 (relating to prescribing anddispensing drugs); 49 Pa. Code § 21.284a (relating to prescribing and dispensing drugs); 49 Pa. Code§ 25.177 (relating to prescribing and dispensing drugs, pharmaceutical aids and devices) and 49Pa. Code § 43b.7 (relating to schedule of civil penalties—pharmacists and pharmacies).

§ 25.57. Nonprescription orders.A controlled substance listed in Schedules III, IV, or V which is not a prescrip-

tion drug as determined under the Federal Food, Drug, and Cosmetic Act, 21U.S.C. §§ 301—392, may be dispensed without a prescription to a purchaser atretail provided that the following conditions are met:

(1) Such distribution is made only by a registered pharmacist and not by anonpharmacist employe even if under the direct supervision of a pharmacist;although, after the pharmacist has fulfilled his professional and legal responsi-bilities, the actual cash, credit transaction, or delivery may be completed by anonpharmacist.

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(2) Not more than 240 milliliters, eight fluid or avoirdupois ounces of anysuch controlled substance listed in Schedule V containing opium nor more than120 milliliters, four fluid or avoirdupois ounces of any other controlled sub-stance listed in Schedule V may be distributed at retail to the same purchaserin a given 72-hour period, except under a written or oral prescription of alicensed practitioner in possession of a DEA number.

(3) The purchaser is at least 18 years of age.(4) The pharmacist requires every purchaser of a controlled substance

listed in Schedule V not known to him to furnish suitable identification, includ-ing proof of age where appropriate.

(5) A bound record book for distributions of controlled substances, otherthan by prescription order, is maintained by the pharmacist. This book shallcontain the name and address of the purchaser, the name and quantity of con-trolled substance purchased, the date of each purchase, and the name or initialsof the dispensing pharmacist.

(6) No individual other than a registered manufacturer, distributor, practi-tioner, or pharmacy in possession of a Federal DEA registration shall acquireor attempt to acquire controlled substances containing opium listed in ScheduleV in excess of eight fluid or avoirdupois ounces nor any other controlled sub-stance if listed in Schedule V in excess of four fluid or avoirdupois ounces forany individual in a 72-hour period, except when dispensed pursuant to a pre-scription or prescription order.

Authority

The provisions of this § 25.57 issued under section 5(a) of the act of November 24, 1976 (P. L.1163, No. 259) (35 P. S. § 960.5).

Source

The provisions of this § 25.57 adopted June 24, 1977, effective June 25, 1977, 7 Pa.B. 1742.

Cross References

This section cited in 28 Pa. Code § 551.3 (relating to definitions); 49 Pa. Code § 18.6a (relatingto prescribing, dispensing and administering drugs); 49 Pa. Code § 18.158 (relating to prescribing anddispensing drugs); 49 Pa. Code § 21.284a (relating to prescribing and dispensing drugs); and 49Pa. Code § 25.177 (relating to prescribing drugs, pharmaceutical aids and devices).

§ 25.58. Generically equivalent drug products.The following is a formulary of generically equivalent drug products and the

names of their corresponding distributors and manufacturers:

ACETAMINOPHENCapsules

Brand Name/Generic Name Distributed By: Manufactured By:

Acetaminophen Danbury Pharmacal Danbury PharmacalAcetaminophen West-ward West-wardAcetaminophen Henry Schein West-wardAcetaminophen Gen-King Products West-wardHalenol Halsey Drug Halsey DrugAcetaminophen United Research Labs Halsey Drug

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Acetaminophen Glenlawn Labs Halsey DrugAcetaminophen Geneva Generics Cord LabsAcetaminophen Superpharm Corp Superpharm CorpBiolenol Bioline Labs Superpharm CorpAcetaminophen Parmed Pharmaceuticals KV PharmaceuticalAmidol Amide Pharmaceutical Amide PharmaceuticalAcetaminophen United Research Labs PharmacapsAcetaminophen United Research Labs Sidmak LabsAcetaminophen United Research Labs B T ProductsAcetaminophen United Research Labs Ohm LabsAcetaminophen Barr Labs Barr LabsAcetaminophen Rugby Labs Chelsea LabsAcetaminophen American Therapeutics American TherapeuticsAcetaminophen Mutual Pharmaceutical Mutual Pharmaceutical

ACETAMINOPHENCapsules—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Acetaminophen United Research Labs Mutual PharmaceuticalAcetaminophen Genetco Mutual Pharmaceutical

ACETAMINOPHENChewable Tablets

Tylenol McNeil Labs McNeil Labs

ACETAMINOPHENElixir

Acetaminophen Lederle Labs National PharmaceuticalAcetaminophen United Research Labs National PharmaceuticalAcetaminophen Peoples Drug National PharmaceuticalAcetaminophen Vangard Labs National PharmaceuticalAcetaminophen Ascot National PharmaceuticalAPAP Barre Drug National PharmaceuticalAPAP Bioline Labs National PharmaceuticalAPAP Henry Schein National PharmaceuticalAPAP H L Moore Drug Exchange National PharmaceuticalAPAP ACA National PharmaceuticalAPAP Murray Drug National PharmaceuticalAPAP Harber Pharmaceutical National PharmaceuticalAPAP Rugby Labs National PharmaceuticalPampa Pharmco National PharmaceuticalFendon American Pharmaceutical National PharmaceuticalRevinol Revco Drug National PharmaceuticalTylenol McNeil Labs McNeil LabsAcetaminophen Rugby Labs West-wardAcetaminophen West-ward West-wardAcetaminophen Pediatric Lannett LannettLiquinol Life Labs Life LabsAcetaminophen Purepac Pharmaceutical Purepac PharmaceuticalAcetaminophen Superpharm Corp Superpharm CorpAPAP Henry Schein Halsey DrugHalenol Halsey Drug Halsey DrugAPAP Rugby Labs Naska PharmacalAPAP Goldline Labs Barre-National

ACETAMINOPHENSolution

Tylenol Drops McNeilab McNeilabMyapap My-K Labs My-K Labs

ACETAMINOPHENSuppositories

Acephen G & W Labs G & W LabsAcetaminophen West-ward G & W LabsAcetaminophen United Research Labs G & W LabsAcetaminophen Upsher-Smith Upsher-SmithAcetaminophen Geneva Generics Chase Chemical

ACETAMINOPHENTablets

Acetaminophen Richlyn Labs Richlyn LabsAcetaminophen Purepac Pharmaceutical Purepac PharmaceuticalAcetaminophen Barr Labs Barr LabsAcetaminophen Roxane Labs Roxane LabsAcetaminophen ICN Pharmaceuticals ICN Pharmaceuticals

28 § 25.58 PREVENTION OF DISEASES Pt. III

25-26(366332) No. 464 Jul. 13 Copyright � 2013 Commonwealth of Pennsylvania

Page 27: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

Acetaminophen West-ward West-wardAcetaminophen Danbury Pharmacal Danbury PharmacalAcetaminophen Geneva Generics Danbury PharmacalAcetaminophen McKesson Labs MK LabsAcetaminophen Lederle Labs Lederle LabsAcetaminophen United Research Labs Sidmak LabsAcetaminophen United Research Labs B T ProductsAcetaminophen United Research Labs Ohm LabsAcetaminophen United Research Labs Bowman PharmaceuticalsAcetaminophen Bowman Pharmaceuticals Bowman PharmaceuticalsAcetaminophen American Therapeutics American TherapeuticsAPAP Heather Drug Heather DrugAPAP Rugby Labs Chelsea LabsAPAP Lannett Lannett

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

25-26.1(271549) No. 315 Feb. 01

Page 28: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

25-26.2(271550) No. 315 Feb. 01 Copyright � 2001 Commonwealth of Pennsylvania

Page 29: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

ACETAMINOPHENTablets—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

APAP Superpharm Corp Superpharm CorpBiolenol Bioline Labs Superpharm CorpAmidol Amide Pharmaceutical Amide PharmaceuticalTylenol McNeil Labs McNeil LabsValadol E R Squibb & Sons E R Squibb & SonsTapar Parke-Davis Parke-DavisAcetaminophen United Research Labs Danbury PharmacalAcetaminophen Mutual Pharmaceutical Mutual PharmaceuticalAcetaminophen United Research Labs Mutual PharmaceuticalAcetaminophen J J Balan Mutual PharmaceuticalAcetaminophen Vita-Rx Mutual PharmaceuticalAcetaminophen Genetco Mutual PharmaceuticalAcetaminophen Warner Chilcott Labs Mutual Pharmaceutical

ACETAMINOPHEN/BUTALBITAL/CAFFEINETablets

Butalbital, APAP andCaffeine Halsey Drug Halsey Drug

Butalbital, APAP andCaffeine United Research Labs Halsey Drug

Butalbital, Acetaminophenand Caffeine Geneva Generics Halsey Drug

ACETAMINOPHEN/CHLORPHENIRAMINE MALEATE/PSEUDOEPHEDRINE HCLTablets

Sinus American Therapeutics American Therapeutics

ACETAMINOPHEN/CODEINE PHOSPHATECapsules

Phenaphen w/Codeine A H Robins A H RobinsAcetaminophen and CodeinePhosphate Qualitest Zenith LabsAcetaminophen/Codeine Major Pharmaceutical Corp American Therapeutics

ACETAMINOPHEN/CODEINE PHOSPHATEElixir

APAP w/Codeine Barre Drug National PharmaceuticalAPAP w/Codeine Henry Schein National PharmaceuticalAPAP w/Codeine Rugby Labs National PharmaceuticalAPAP w/Codeine Glenlawn Labs National PharmaceuticalAPAP w/Codeine Bioline Labs National PharmaceuticalAPAP w/Codeine Bell Pharmacal National PharmaceuticalAPAP w/Codeine United Research Labs National PharmaceuticalAPAP w/Codeine Qualitest National PharmaceuticalAPAP w/Codeine Goldline Labs Barre-NationalTylenol with Codeine McNeil Labs McNeil LabsMyapap and Codeine My-K Labs My-K LabsAcetaminophen/Codeine Roxane Labs Roxane LabsAcetaminophen/Codeine Pharmaceutical Basics Pharmaceutical Basics

ACETAMINOPHEN/CODEINE PHOSPHATETablets

Acetaminophen/Codeine Roxane Labs Roxane LabsSK-APAP w/Codeine Smith, Kline & French Labs Roxane LabsEmpracet/Codeine Burroughs-Wellcome Burroughs-WellcomeAcetaminophen/Codeine Halsey Drug Halsey DrugAcetaminophen/Codeine Rugby Labs Halsey DrugAcetaminophen/Codeine Henry Schein Halsey DrugAcetaminophen/Codeine Purepac Pharmaceutical Halsey DrugAcetaminophen/Codeine Interstate Drug Exchange Halsey DrugAcetaminophen/Codeine Towne, Paulsen Towne, PaulsenAcetaminophen/Codeine Parke-Davis Parke-DavisAcetaminophen/Codeine United Research Labs Halsey DrugTylenol with Codeine McNeil Labs McNeil LabsAcetaminophen/Codeine Lemmon Co Lemmon CoAcetaminophen/Codeine Zenith Labs Zenith LabsAcetaminophen/Codeine Gen-King Products Zenith LabsAcetaminophen/Codeine H L Moore Drug Exchange Zenith LabsAcetaminophen/Codeine Interstate Drug Exchange Zenith LabsAcetaminophen/Codeine Regal Labs Zenith LabsAcetaminophen/Codeine Murray Drug Zenith Labs

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

25-27(202435) No. 253 Dec. 95

Page 30: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

ACETAMINOPHEN/CODEINE PHOSPHATETablets—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Acetaminophen/Codeine Henry Schein Zenith LabsAcetaminophen/Codeine Cooper Zenith LabsAcetaminophen/Codeine Cord Labs Cord LabsAcetaminophen/Codeine Geneva Generics Cord LabsAcetaminophen/Codeine Purepac Pharmaceutical Purepac PharmaceuticalAcetaminophen/Codeine Gen-King Products Halsey DrugAcetaminophen/Codeine Glenlawn Labs Halsey DrugAcetaminophen/Codeine H L Moore Drug Exchange Halsey DrugAcetaminophen/Codeine Murray Drug Halsey DrugCodaca Arkansas Cooperative Halsey DrugAPAP w/Codeine Phosphate Bioline Labs Halsey DrugAcetaminophen/Codeine Barr Labs Barr LabsAcetaminophen/Codeine Rugby Labs Barr LabsAcetaminophen/Codeine Bell Pharmacal Zenith LabsAcetaminophen/Codeine Rugby Labs Chelsea LabsAcetaminophen/Codeine KV Pharmaceutical KV PharmaceuticalAcetaminophen/Codeine Parmed Pharmaceuticals KV PharmaceuticalAcetaminophen/Codeine Duramed Pharmaceuticals Duramed PharmaceuticalsAcetaminophen/Codeine Parmed Pharmaceuticals Towne, PaulsenAcetaminophen/Codeine Parmed Pharmaceuticals Boots LabsAcetaminophen/Codeine Boots Labs Boots LabsAcetaminophen/Codeine United Research Labs Lemmon CoAcetaminophen/Codeine Richie Pharmacal Lemmon CoAcetaminophen/Codeine Interstate Drug Exchange Lemmon CoAcetaminophen/Codeine Purepac Pharmaceutical Lemmon CoAcetaminophen/Codeine Purepac Pharmaceutical Barr LabsAcetaminophen/Codeine Geneva Generics Zenith LabsAcetaminophen/Codeine Qualitest Zenith LabsAcetaminophen/Codeine Vitarine Pharmaceutical Vitarine PharmaceuticalAcetaminophen/Codeine Geneva Generics Vitarine PharmaceuticalAcetaminophen/Codeine Superpharm Corp Superpharm CorpAcetaminophen/Codeine Bioline Labs Superpharm CorpAcetaminophen/Codeine Goldline Labs Superpharm CorpAcetaminophen/Codeine Rondex Labs KalipharmaAcetaminophen/Codeine Goldline Labs Zenith LabsAcetaminophen/Codeine Major Pharmaceutical Corp Zenith LabsAcetaminophen/Codeine Bioline Labs Zenith LabsAcetaminophen/Codeine American Therapeutics American TherapeuticsAcetaminophen/Codeine Qualitest Halsey DrugAcetaminophen/Codeine Goldline Labs Halsey DrugAcetaminophen/Codeine Mutual Pharmaceutical Mutual PharmaceuticalAcetaminophen/Codeine United Research Labs Mutual PharmaceuticalAcetaminophen/Codeine J J Balan Mutual PharmaceuticalAcetaminophen/Codeine Warner Chilcott Labs Mutual PharmaceuticalAcetaminophen/Codeine Genetco Mutual PharmaceuticalAcetaminophen/Codeine Dixon-Shane Mutual PharmaceuticalAcetaminophen/Codeine Medicopharma Charlotte Pharm.

ACETAMINOPHEN/DICHLORALPHENAZONE/ISOMETHEPTENE MUCATECapsules

Isocom Nutripharm Labs Central Pharmaceuticals

ACETAMINOPHEN/HYDROCODONE BITARTRATETablets

Hydrocodone Bitartrateand Acetaminophen Halsey Drug Halsey Drug

Hydrocodone Bitartrateand Acetaminophen Qualitest Halsey Drug

Hydrocodone Bitartrateand Acetaminophen Pharmaceutical Basics Pharmaceutical Basics

Hydrocodone Bitartrateand Acetaminophen Best Generics Pharmaceutical Basics

Hydrocodone Bitartrateand Acetaminophen Barr Labs Barr Labs

Hydrocodone Bitartrateand Acetaminophen Goldline Labs Barr Labs

Hydrocodone Bitartrateand Acetaminophen Bioline Labs Barr Labs

Hydrocodone Bitartrateand Acetaminophen Regal Labs Barr Labs

Hydrocodone Bitartrateand Acetaminophen Genetco Barr Labs

Hydrocodone Bitartrateand Acetaminophen J J Balan Barr Labs

Hydrocodone Bitartrateand Acetaminophen H L Moore Drug Exchange Barr Labs

28 § 25.58 PREVENTION OF DISEASES Pt. III

25-28(202436) No. 253 Dec. 95 Copyright � 1995 Commonwealth of Pennsylvania

Page 31: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

ACETAMINOPHEN/HYDROCODONE BITARTRATETablets—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Hydrocodone Bitartrateand Acetaminophen Parmed Pharmaceuticals Barr Labs

Hydrocodone Bitartrateand Acetaminophen Texas Drug Reps Barr Labs

Vapocet Major Pharmaceutical Corp Barr LabsHydrocodone Bitartrate

and Acetaminophen LuChem Pharmaceuticals LuChem PharmaceuticalsHydrocodone Bitartrate

and Acetaminophen Watson Labs Watson LabsHycotab Medicopharma Charlotte Pharm.Hydrocodone Bitartrate

and Acetaminophen Martec Pharmaceutical Charlotte Pharm.

ACETAMINOPHEN/OXYCODONE HCLCapsules

Oxycodone and Acetaminophen Halsey Drug Halsey Drug

ACETAMINOPHEN/OXYCODONE HCLTablets

Oxycodone HCl/Acetaminophen Barr Labs Barr LabsOxycodone HCl/Acetaminophen Rugby Labs Barr LabsOxycodone HCl/Acetaminophen Interstate Drug Exchange Barr LabsOxycodone HCl/Acetaminophen Henry Schein Barr LabsOxycodone HCl/Acetaminophen Roxane Labs Roxane LabsOxycet Halsey Drug Halsey DrugAcetaminophen/Oxycodone Goldline Labs Halsey DrugAcetaminophen/Oxycodone Purepac Pharmaceutical Halsey DrugAcetaminophen/Oxycodone Interstate Drug Exchange Halsey DrugOxycodone HCl with APAP Qualitest Halsey DrugApap and Oxycodone HCl Goldline Labs Barr Labs

ACETAMINOPHEN/PHENYLTOLOXAMINE CITRATETablets

Phenyltoloxamine-Apap Richlyn Labs Richlyn LabsSupergesic Superpharm Corp Superpharm CorpBiogesic Bioline Labs Superpharm CorpPhenylgesic Amide Pharmaceutical Amide PharmaceuticalPhenylgesic Goldline Labs Superpharm Corp

ACETAMINOPHEN/PROPOXYPHENE HCLTablets

Propoxyphene HCl/Acetaminophen Geneva Generics Mylan PharmaceuticalsPropoxyphene HCl/Acetaminophen Bioline Labs Mylan PharmaceuticalsPropoxyphene HCl/Acetaminophen Interstate Drug Exchange Mylan PharmaceuticalsPropoxyphene HCl/Acetaminophen H L Moore Drug Exchange Mylan PharmaceuticalsPropoxyphene HCl/Acetaminophen Rugby Labs Mylan PharmaceuticalsPropoxyphene HCl/Acetaminophen Henry Schein Mylan PharmaceuticalsPropoxyphene HCl/Acetaminophen United Research Labs Mylan PharmaceuticalsPropoxyphene HCl/Acetaminophen Parmed Pharmaceuticals Mylan PharmaceuticalsPropoxyphene HCl/Acetaminophen Purepac Pharmaceutical Mylan PharmaceuticalsPropoxyphene HCl/Acetaminophen Mylan Pharmaceuticals Mylan PharmaceuticalsPropoxyphene HCl/Acetaminophen Lemmon Co Mylan PharmaceuticalsPropoxyphene HCl/Acetaminophen Goldline Labs Mylan PharmaceuticalsPropoxyphene HCl/Acetaminophen Qualitest Mylan PharmaceuticalsDolene - AP Lederle Labs Mylan PharmaceuticalsSK-65 APAP Smith, Kline & French Labs Mylan PharmaceuticalsPropoxyphene HCl w/APAP Regal Labs Mylan PharmaceuticalsPropoxyphene HCl w/APAP Murray Drug Mylan PharmaceuticalsPropoxyphene HCl w/APAP Texas Drug Reps Mylan PharmaceuticalsPropoxyphene HCl w/APAP Towne, Paulsen Mylan PharmaceuticalsPropoxyphene HCl w/APAP Vita Rx Mylan PharmaceuticalsLorcet UAD Labs Mylan PharmaceuticalsPancet Pan American Labs Mylan PharmaceuticalsDolagesic J M Dwyer Mylan PharmaceuticalsWygesic Wyeth Labs Wyeth LabsPropoxyphene HCl/

Acetaminophen Warner Chilcott Labs Mylan PharmaceuticalsPropoxyphene HCl/

Acetaminophen Best Generics Mylan Pharmaceuticals

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

25-29(202437) No. 253 Dec. 95

Page 32: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

ACETAMINOPHEN/PROPOXYPHENE NAPSYLATETablets

Brand Name/Generic Name Distributed By: Manufactured By:

Propoxyphene Napsylate andAcetaminophen Barr Labs Barr Labs

Propoxyphene Napsylate andAcetaminophen Zenith Labs Zenith Labs

Propoxyphene Napsylate andAcetaminophen Gen-King Products Zenith Labs

Propoxyphene Napsylate andAcetaminophen Harber Pharmaceutical Lemmon Co

Propoxyphene Napsylate andAcetaminophen Lemmon Co Lemmon Co

Propoxyphene Napsylate andAcetaminophen Interstate Drug Exchange Lemmon Co

Propoxyphene Napsylate andAcetaminophen Parmed Pharmaceuticals Lemmon Co

Propoxyphene Napsylate andAcetaminophen Purepac Pharmaceutical Lemmon Co

Propoxyphene Napsylate andAcetaminophen United Research Labs Lemmon Co

Propoxyphene Napsylate andAcetaminophen Mylan Pharmaceuticals Mylan Pharmaceuticals

Propoxyphene Napsylate andAcetaminophen Goldline Labs Mylan Pharmaceuticals

Propoxyphene Napsylate andAcetaminophen Henry Schein Mylan Pharmaceuticals

Propoxyphene Napsylate andAcetaminophen H L Moore Drug Exchange Mylan Pharmaceuticals

Propoxyphene Napsylate andAcetaminophen Regal Labs Mylan Pharmaceuticals

Propoxyphene Napsylate andAcetaminophen United Research Labs Mylan Pharmaceuticals

Propoxyphene Napsylate andAcetaminophen Bioline Labs Mylan Pharmaceuticals

Propoxyphene Napsylate andAcetaminophen Rugby Labs Mylan Pharmaceuticals

Propoxyphene Napsylate andAcetaminophen Purepac Pharmaceutical Mylan Pharmaceuticals

Propoxyphene Napsylate andAcetaminophen Parmed Pharmaceuticals Mylan Pharmaceuticals

Propoxyphene Napsylate andAcetaminophen Geneva Generics Mylan Pharmaceuticals

Propoxyphene Napsylate andAcetaminophen Qualitest Mylan Pharmaceuticals

Propoxyphene Napsylate andAcetaminophen Texas Drug Reps Mylan Pharmaceuticals

Propoxyphene Napsylate andAcetaminophen Glenlawn Labs Mylan Pharmaceuticals

Propoxyphene Napsylate andAcetaminophen Genetco Mylan Pharmaceuticals

Propoxyphene Napsylate andAcetaminophen Warner Chilcott Labs Mylan Pharmaceuticals

Propoxyphene Napsylate andAcetaminophen Schein Pharmaceutical Mylan Pharmaceuticals

Propoxyphene Napsylate andAcetaminophen Dixon-Shane Mylan Pharmaceuticals

Propoxyphene Napsylate andAcetaminophen Best Generics Barr Labs

Propoxyphene Napsylate andAcetaminophen Rugby Labs Chelsea Labs

Propoxyphene Napsylate andAcetaminophen Cord Labs Cord Labs

Propoxyphene Napsylate andAcetaminophen Geneva Generics Cord Labs

Propoxyphene Napsylate andAcetaminophen Superpharm Corp Superpharm Corp

Propoxyphene Napsylate andAcetaminophen Best Generics Mylan Pharmaceuticals

Propoxyphene Napsylate andAcetaminophen Lederle Labs Mylan Pharmaceuticals

Propoxyphene Napsylate andAcetaminophen Purepac Pharmaceutical Purepac Pharmaceutical

Propoxyphene Napsylate andAcetaminophen Halsey Drug Halsey Drug

ACETAZOLAMIDETablets

Acetazolamide Bolar Pharmaceutical Bolar PharmaceuticalAcetazolamide Rugby Labs Bolar Pharmaceutical

28 § 25.58 PREVENTION OF DISEASES Pt. III

25-30(202438) No. 253 Dec. 95 Copyright � 1995 Commonwealth of Pennsylvania

Page 33: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

ACETAZOLAMIDETablets—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Acetazolamide Glenlawn Labs Bolar PharmaceuticalAcetazolamide Geneva Generics Bolar PharmaceuticalAcetazolamide Bell Pharmacal Bolar PharmaceuticalAcetazolamide Parmed Pharmaceutical Bolar PharmaceuticalAcetazolamide Qualitest Bolar PharmaceuticalAcetazolamide Purepac Pharmaceutical Bolar PharmaceuticalAcetazolamide United Research Labs Bolar PharmaceuticalAcetazolamide Best Generics Bolar PharmaceuticalAcetazolamide Mutual Pharmaceutical Bolar PharmaceuticalAcetazolamide Goldline Labs Bolar PharmaceuticalAcetazolamide Bioline Labs Bolar PharmaceuticalAcetazolamide Danbury Pharmacal Danbury PharmacalAcetazolamide Lannett LannettAcetazolamide Mutual Pharmaceutical Mutual PharmaceuticalAcetazolamide United Research Labs Mutual PharmaceuticalAcetazolamide Genetco Mutual Pharmaceutical

ACETIC ACID - NONAQUEOUSOtic Solution

Acetic Acid Thames Pharmacal Thames PharmacalAcetic Acid Rugby Labs National PharmaceuticalAcetasol Qualitest National PharmaceuticalAcetasol Barre Drug National PharmaceuticalBio-Sol Biocraft Labs National PharmaceuticalAcetasol Goldline Labs Barre-National

ACETIC ACID - NONAQUEOUS/HYDROCORTISONEOtic Solution

Acetasol HC Barre Drug National PharmaceuticalAcetic Acid w/Hydro Rugby Labs National PharmaceuticalBio-Sol HC Bioline Labs National PharmaceuticalHydrocortisone/Acetic Acid Thames Pharmacal Thames PharmacalAcetasol HC Goldline Labs Barre National

ACETOHEXAMIDETablets

Acetohexamide Pharmaceutical Basics Pharmaceutical BasicsAcetohexamide Best Generics Pharmaceutical BasicsAcetohexamide Barr Labs Barr LabsAcetohexamide Danbury Pharmacal Danbury Pharmacal

ALLANTOIN/AMINACRINE HCL/SULFANILAMIDEVaginal Cream

Vaginal Sulfa Cream G & W Labs G & W LabsVaginal Sulfa Cream United Research Labs Clay-Park LabsVaginal Sulfa Cream Interstate Drug Exchange Clay-Park LabsVaginal Sulfa Cream Rugby Labs Clay-Park LabsVaginal Sulfa Cream J J Balan Clay-Park LabsVaginal Sulfa Cream Henry Schein Clay-Park LabsVaginal Sulfa Cream Bioline Labs Clay-Park LabsVaginal Sulfa Cream H L Moore Drug Exchange Clay-Park LabsVaginal Sulfa Cream Cooper Clay-Park LabsVaginal Sulfa Cream Goldline Labs Clay-Park LabsVaginal Sulfa Cream Regal Labs Clay-Park LabsVaginal Sulfa Cream Qualitest Clay-Park LabsVaginal Sulfa Cream Clay-Park Labs Clay-Park LabsPar Cream Parmed Pharmaceuticals Clay-Park Labs

ALLANTOIN/AMINACRINE HCL/SULFANILAMIDEVaginal Suppositories

AAS Rugby Labs PharmacapsCPB Crown Drug PharmacapsAsulam Cooper Pharmacaps

ALLOPURINOLTablets

Zyloprim Burroughs Wellcome Burroughs WellcomeLopurin Boots Labs Boots LabsAllopurinol Rugby Labs Boots LabsAllopurinol Goldline Labs Boots LabsAllopurinol Parmed Pharmaceuticals Boots LabsAllopurinol Geneva Generics Boots LabsAllopurinol Qualitest Boots LabsAllopurinol Purepac Pharmaceutical Boots Labs

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

25-31(202439) No. 253 Dec. 95

Page 34: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

ALLOPURINOLTablets—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Allopurinol United Research Labs Boots LabsAllopurinol Mutual Pharmaceutical Boots LabsAllopurinol Rugby Labs Chelsea LabsAllopurinol Danbury Pharmacal Danbury PharmacalAllopurinol Qualitest Danbury PharmacalAllopurinol Lederle Labs Danbury PharmacalAllopurinol Geneva Generics Danbury PharmacalAllopurinol Bolar Pharmaceutical Bolar PharmaceuticalAllopurinol United Research Labs Bolar PharmaceuticalAllopurinol Best Generics Bolar PharmaceuticalAllopurinol Purepac Pharmaceutical Purepac PharmaceuticalAllopurinol Par Pharmaceutical Par PharmaceuticalAllopurinol Mutual Pharmaceutical Mutual PharmaceuticalAllopurinol Schein Pharmaceutical Danbury PharmacalAllopurinol Superpharm Corp Superpharm CorpAllopurinol Cord Labs Cord LabsAllopurinol Geneva Generics Cord LabsAllopurinol United Research Labs Mutual PharmaceuticalAllopurinol Bioline Labs Mutual PharmaceuticalAllopurinol Genetco Mutual PharmaceuticalAllopurinol Goldline Labs Mutual PharmaceuticalAllopurinol Barr Labs Barr LabsAllopurinol Mylan Pharmaceuticals Mylan PharmaceuticalsAllopurinol Dixon-Shane Mutual PharmaceuticalAllopurinol Bioline Labs Mutual PharmaceuticalAllopurinol Towne, Paulsen Mutual PharmaceuticalAllopurinol Purepac Pharmaceuticals Mutual Pharmaceutical

ALUMINUM ACETATETopical Solution

Aluminum Acetate Halsey Drug Halsey Drug

ALUMINUM HYDROXIDESuspension

Aluminum Hydroxide Gel Barre Drug National PharmaceuticalAluminum Hydroxide Gel Rugby Labs National PharmaceuticalAluminum Hydroxide Gel Goldline Labs National PharmaceuticalAluminum Hydroxide Gel Henry Schein National PharmaceuticalAluminum Hydroxide Gel Ascot National PharmaceuticalAluminum Hydroxide Gel H L Moore Drug Exchange National PharmaceuticalAluminum Hydroxide Gel Bioline Labs National PharmaceuticalAluminum Hydroxide Gel Rugby Labs Naska PharmacalAluminum Hydroxide Gel Roxane Labs Roxane Labs

ALUMINUM HYDROXIDE/MAGNESIUM HYDROXIDESuspension

Rolox Purepac Pharmaceutical Purepac PharmaceuticalAntacid G & W Labs G & W LabsAntacid Rugby Labs Naska PharmacalMag-Drox Antacid Life Labs Life LabsKessadrox McKesson Labs MK LabsLiquid Antacid McKesson Labs MK LabsAlamag Barre Drug National PharmaceuticalAlamag H L Moore Drug Exchange National PharmaceuticalAlamag Richie Pharmacal National PharmaceuticalAlamag United Research Labs National PharmaceuticalAlamag Medical Supplies National PharmaceuticalAlamag Glenlawn Labs National PharmaceuticalAlamag Murray Drug National PharmaceuticalAlamag Virginia Pharmaceutical National PharmaceuticalM A H Liquid Interstate Drug Exchange National PharmaceuticalMag-Gel Syncon Pharmaceutical National PharmaceuticalMagnagel Mallard National PharmaceuticalGenemag Gel General Pharmaceutical National PharmaceuticalAntacid Cooper National PharmaceuticalAntacid Suspension Geneva Generics National PharmaceuticalAluminum/Magnesium Hydroxide Gel Ascot National Pharmaceutical

ALUMINUM HYDROXIDE/MAGNESIUM HYDROXIDE/SIMETHICONESuspension

Alma-Mag Rugby Labs Naska PharmacalNewtrogel Newtron Pharmaceuticals Newtron PharmaceuticalsMygel Geneva Generics Newtron Pharmaceuticals

28 § 25.58 PREVENTION OF DISEASES Pt. III

25-32(202440) No. 253 Dec. 95 Copyright � 1995 Commonwealth of Pennsylvania

Page 35: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

ALUMINUM HYDROXIDE/MAGNESIUM TRISILICATESuspension

Brand Name/Generic Name Distributed By: Manufactured By:

Aluminum Hydroxide Gel w/Magnesium Trisilicate Barre Drug National Pharmaceutical

Alma-Mag Rugby Labs National Pharmaceutical

AMANTADINE HCLCapsules

Amantadine HCl Chase Labs Chase LabsAmantadine HCl Pharmaceutical Basics Chase LabsAmantadine HCl Martec Pharmaceutical Chase LabsAmantadine HCl Best Generics Chase LabsAmantadine HCl Lemmon Co Chase LabsAmantadine HCl Bolar Pharmaceutical Pharmacaps

AMILORIDE HCLTablets

Amiloride HCl Par Pharmaceutical Par PharmaceuticalAmiloride HCl Qualitest Par PharmaceuticalAmiloride HCl Schein Pharmaceutical Par PharmaceuticalAmiloride HCl Goldline Labs Par Pharmaceutical

AMILORIDE HCL/HYDROCHLOROTHIAZIDETablets

Amiloride HCl andHydrochlorothiazide Biocraft Labs Biocraft Labs

AMINOPHYLLINESolution

Aminophylline Barre Drug National PharmaceuticalAminophylline Henry Schein National PharmaceuticalAminophylline Rugby Labs National PharmaceuticalAminophylline United Research Labs National PharmaceuticalAminophylline Roxane Labs Roxane LabsAminophylline DF My-K Labs My-K LabsAminophylline DF Pharmaceutical Basics Pharmaceutical Basics

AMINOPHYLLINETablets

Aminophylline Cord Labs Cord LabsAminophylline Geneva Generics Cord LabsAminophylline West-ward West-wardAminophylline Towne, Paulsen West-wardAminophylline Geneva Generics West-wardAminophylline Euclid Pharmaceutical West-wardAminophylline Henry Schein West-wardAminophylline Regal Labs West-wardAminophylline Bioline Labs West-wardAminophylline Vangard Labs West-wardAminophylline Rugby Labs West-wardAminophylline United Research Labs West-wardAminophylline Whiteworth Pharmaceuticals West-wardAminophylline Bioline Labs Duramed PharmaceuticalsAminophylline Major Pharmaceutical Corp Duramed PharmaceuticalsAminophylline Penta Products Duramed PharmaceuticalsAminophylline Regal Labs Duramed PharmaceuticalsAminophylline Richie Pharmacal Duramed PharmaceuticalsAminophylline Towne, Paulsen Duramed PharmaceuticalsAminophylline UDL Duramed PharmaceuticalsAminophylline Qualitest Duramed PharmaceuticalsAminophylline Purepac Pharmaceutical Duramed PharmaceuticalsAminophylline Duramed Pharmaceuticals Duramed PharmaceuticalsAminophylline Goldline Labs Duramed Pharmaceuticals

AMITRIPTYLINE HCLInjection

Elavil Merck, Sharpe & Dohme Merck, Sharpe & DohmeAmitriptyline HCl Steris Labs Steris Labs

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

25-33(202441) No. 253 Dec. 95

Page 36: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

AMITRIPTYLINE HCLTablets

Brand Name/Generic Name Distributed By: Manufactured By:

Elavil Merck, Sharpe & Dohme Merck, Sharpe & DohmeSK-Amitriptyline HCl Smith, Kline & French Labs Roxane LabsAmitriptyline HCl Roxane Labs Roxane LabsAmitriptyline HCl Biocraft Labs Biocraft LabsAmitriptyline HCl United Research Labs Biocraft LabsAmitriptyline HCl Lederle Labs Biocraft LabsAmitriptyline HCl Purepac Pharmaceutical Biocraft LabsAmitriptyline HCl Regal Labs Biocraft LabsAmitriptyline HCl Henry Schein Biocraft LabsAmitriptyline HCl ACA Biocraft LabsAmitriptyline HCl Whiteworth Pharmaceuticals Biocraft LabsAmitriptyline HCl Glenlawn Labs Biocraft LabsAmitriptyline HCl C S Ruckstuhl Biocraft LabsAmitriptyline HCl Murray Drug Biocraft LabsStabanil Winston Pharmaceuticals Biocraft LabsAmitriptyline HCl Rugby Labs Chelsea LabsAmitriptyline HCl Mylan Pharmaceuticals Mylan PharmaceuticalsAmitriptyline HCl Rugby Labs Mylan PharmaceuticalsAmitriptyline HCl Interstate Drug Exchange Mylan PharmaceuticalsAmitriptyline HCl H L Moore Drug Exchange Mylan PharmaceuticalsAmitriptyline HCl Henry Schein Mylan PharmaceuticalsAmitriptyline HCl United Research Labs Mylan PharmaceuticalsAmitriptyline HCl Euclid Pharmaceutical Mylan PharmaceuticalsAmitriptyline HCl Qualitest Mylan PharmaceuticalsAmitriptyline HCl Glenlawn Labs Mylan PharmaceuticalsAmitriptyline HCl Barr Labs Barr LabsAmitriptyline HCl Rugby Labs Barr LabsAmitriptyline HCl Henry Schein Barr LabsAmitriptyline HCl McKesson Labs Barr LabsAmitriptyline HCl Bell Pharmacal Barr LabsAmitriptyline HCl Skaggs Co Barr LabsAmitriptyline HCl Bioline Labs Barr LabsAmitriptyline HCl H L Moore Drug Exchange Barr LabsAmitriptyline HCl Harber Pharmaceutical Barr LabsAmitriptyline HCl United Research Labs Barr LabsAmitriptyline HCl Glenlawn Labs Barr LabsAmitriptyline HCl Interstate Drug Exchange Barr LabsEndep Roche Labs Roche LabsAmitriptyline HCl Geneva Generics Cord LabsAmitriptyline HCl Parke-Davis Parke-DavisAmitriptyline HCl Purepac Pharmaceutical Purepac PharmaceuticalAmitriptyline HCl Sidmak Labs Sidmak LabsAmitriptyline HCl United Research Labs Sidmak LabsAmitriptyline HCl Genetco Sidmak LabsAmitriptyline HCl Parmed Pharmaceuticals Sidmak LabsAmitriptyline HCl Mutual Pharmaceutical Sidmak LabsAmitriptyline HCl Major Pharmaceutical Corp Sidmak LabsAmitriptyline HCl MD Pharmaceutical MD PharmaceuticalAmitriptyline HCl Dixon-Shane MD PharmaceuticalAmitriptyline HCl H L Moore Drug Exchange MD PharmaceuticalAmitriptyline HCl Lemmon Co Teva PharmaceuticalAmitriptyline HCl Dixon-Shane Mylan PharmaceuticalsAmitriptyline HCl Mutual Pharmaceutical Mutual PharmaceuticalAmitriptyline HCl United Research Labs Mutual PharmaceuticalAmitriptyline HCl Genetco Mutual PharmaceuticalAmitriptyline HCl Goldline Labs Mutual PharmaceuticalAmitriptyline HCl Bioline Labs Mutual PharmaceuticalAmitriptyline HCl Purepac Pharmaceutical Mutual PharmaceuticalAmitriptyline Genetco Mylan Pharmaceuticals

AMITRIPTYLINE HCL/CHLORDIAZEPOXIDETablets

Chlordiazepoxide andAmitriptyline HCl Mylan Pharmaceuticals Mylan Pharmaceuticals

Chlordiazepoxide andAmitriptyline HCl Geneva Generics Mylan Pharmaceuticals

Chlordiazepoxide andAmitriptyline HCl United Research Labs Mylan Pharmaceuticals

Chlordiazepoxide andAmitriptyline HCl Qualitest Mylan Pharmaceuticals

Chlordiazepoxide andAmitriptyline HCl Schein Pharmaceutical Mylan Pharmaceuticals

Chlordiazepoxide andAmitriptyline HCl H L Moore Drug Exchange Mylan Pharmaceuticals

Chlordiazepoxide andAmitriptyline HCl Goldline Labs Mylan Pharmaceuticals

Chlordiazepoxide andAmitriptyline HCl Glenlawn Labs Mylan Pharmaceuticals

28 § 25.58 PREVENTION OF DISEASES Pt. III

25-34(202442) No. 253 Dec. 95 Copyright � 1995 Commonwealth of Pennsylvania

Page 37: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

AMITRIPTYLINE HCL/CHLORDIAZEPOXIDETablets—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Chlordiazepoxide andAmitriptyline HCl Bioline Labs Mylan Pharmaceuticals

Chlordiazepoxide andAmitriptyline HCl Lemmon Co Mylan Pharmaceuticals

Chlordiazepoxide andAmitriptyline HCl Regal Labs Mylan Pharmaceuticals

Chlordiazepoxide andAmitriptyline HCl Texas Drug Reps Mylan Pharmaceuticals

Chlordiazepoxide andAmitriptyline HCl Lederle Labs Mylan Pharmaceuticals

Chlordiazepoxide andAmitriptyline HCl Parmed Pharmaceuticals Mylan Pharmaceuticals

Chlordiazepoxide andAmitriptyline HCl Best Generics Mylan Pharmaceuticals

Chlordiazepoxide andAmitriptyline HCl Barr Labs Barr Labs

Chlordiazepoxide andAmitriptyline HCl Goldline Labs Barr Labs

Chlordiazepoxide andAmitriptyline HCl Bioline Labs Barr Labs

Chlordiazepoxide andAmitriptyline HCl Rugby Labs Barr Labs

Chlordiazepoxide andAmitriptyline HCl Pharmaceutical Basics Pharmaceutical Basics

Chlordiazepoxide andAmitriptyline HCl Par Pharmaceutical Par Pharmaceutical

AMITRIPTYLINE HCL/PERPHENAZINETablets

Perphenazine andAmitriptyline HCl Rugby Labs Chelsea Labs

Perphenazine andAmitriptyline HCl Zenith Labs Zenith Labs

Perphenazine andAmitriptyline HCl Major Pharmaceutical Corp Zenith Labs

Perphenazine andAmitriptyline HCl Interstate Drug Exchange Zenith Labs

Perphenazine andAmitriptyline HCl Schein Pharmaceutical Zenith Labs

Perphenazine andAmitriptyline HCl Regal Labs Zenith Labs

Perphenazine andAmitriptyline HCl Purepac Pharmaceutical Zenith Labs

Perphenazine andAmitriptyline HCl H L Moore Drug Exchange Zenith Labs

Perphenazine andAmitriptyline HCl Glenlawn Labs Zenith Labs

Perphenazine andAmitriptyline HCl Goldline Labs Zenith Labs

Perphenazine andAmitriptyline HCl Bioline Labs Zenith Labs

Perphenazine andAmitriptyline HCl Par Pharmaceutical Par Pharmaceutical

Perphenazine andAmitriptyline HCl Schein Pharmaceutical Par Pharmaceutical

Perphenazine andAmitriptyline HCl Martec Pharmaceutical Par Pharmaceutical

Perphenazine andAmitriptyline HCl Lemmon Co Par Pharmaceutical

Perphenazine andAmitriptyline HCl Bolar Pharmaceutical Bolar Pharmaceutical

Perphenazine andAmitriptyline HCl Best Generics Bolar Pharmaceutical

Perphenazine andAmitriptyline HCl Barr Labs Barr Labs

Perphenazine andAmitriptyline HCl Geneva Generics Cord Labs

AMMONIUM CHLORIDE/CHLORPHENIRAMINE MALEATE/HYDROCODONE BITARTRATE/PHENINDAMINETARTRATE/PHENYLEPHRINE HCL/PYRILAMINE MALEATE

Syrup

Hexatussin My-K Labs My-K LabsHyfed LuChem Pharmaceuticals LuChem PharmaceuticalsHexatussin Pharmaceutical Basics Pharmaceutical Basics

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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AMOBARBITAL SODIUMCapsules

Brand Name/Generic Name Distributed By: Manufactured By:

Amobarbital Sodium Lannett Lannett

AMOXICILLINCapsules

Amoxil Beecham Labs Beecham LabsTrimox E R Squibb & Sons E R Squibb & SonsPolymox Bristol Labs Bristol LabsAmoxicillin Regal Labs Bristol LabsAmoxicillin Mylan Pharmaceuticals Mylan PharmaceuticalsAmoxicillin H L Moore Drug Exchange Mylan PharmaceuticalsAmoxicillin United Research Labs Mylan PharmaceuticalsAmoxicillin Rugby Labs Mylan PharmaceuticalsAmoxicillin Interstate Drug Exchange Mylan PharmaceuticalsQ-Mox Quality Pharmacal Mylan PharmaceuticalsAmoxicillin Bioline Labs Mylan PharmaceuticalsAmoxicillin Henry Schein Mylan PharmaceuticalsAmoxicillin Parmed Pharmaceuticals Mylan PharmaceuticalsAmoxicillin Genetco Mylan PharmaceuticalsAmoxicillin Biocraft Labs Biocraft LabsAmoxicillin Rugby Labs Biocraft LabsAmoxicillin Henry Schein Biocraft LabsAmoxicillin Glenlawn Labs Biocraft LabsAmoxicillin Interstate Drug Exchange Biocraft LabsAmoxicillin Skaggs Co Biocraft LabsAmoxicillin Geneva Generics Biocraft LabsAmoxicillin Bioline Labs Biocraft LabsAmoxicillin McKesson Labs Biocraft LabsAmoxicillin Qualitest Biocraft LabsAmoxicillin Purepac Pharmaceutical Biocraft LabsAmoxicillin Goldline Labs Biocraft LabsAmoxicillin H L Moore Drug Exchange Biocraft LabsUtimox Parke-Davis John D CopanosWymox Wyeth Labs Wyeth LabsAmoxicillin Goldline Labs Mylan PharmaceuticalsAmoxicillin Dixon-Shane Mylan PharmaceuticalsAmoxicillin Apothecon Bristol-MyersAmoxicillin Lyphomed/Novopharm Novopharm

AMOXICILLINFor Oral Suspension

Amoxil Beecham Labs Beecham LabsTrimox E R Squibb & Sons E R Squibb & SonsUtimox Parke-Davis Parke-DavisWymox Wyeth Labs Wyeth LabsAmoxicillin Mylan Pharmaceuticals Mylan PharmaceuticalsAmoxicillin Rugby Labs Mylan PharmaceuticalsAmoxicillin United Research Labs Mylan PharmaceuticalsAmoxicillin Henry Schein Mylan PharmaceuticalsAmoxicillin Parmed Pharmaceuticals Mylan PharmaceuticalsAmoxicillin Regal Labs Bristol LabsAmoxicillin Biocraft Labs Biocraft LabsAmoxicillin United Research Labs Biocraft LabsAmoxicillin Parmed Pharmaceuticals Biocraft LabsAmoxicillin H L Moore Drug Exchange Biocraft LabsAmoxicillin Interstate Drug Exchange Biocraft LabsAmoxicillin Rugby Labs Biocraft LabsAmoxicillin Bioline Labs Biocraft LabsAmoxicillin Henry Schein Biocraft LabsAmoxicillin Skaggs Co Biocraft LabsAmoxicillin McKesson Labs Biocraft LabsAmoxicillin Glenlawn Labs Biocraft LabsAmoxicillin Vangard Labs Biocraft LabsAmoxicillin Purepac Pharmaceutical Biocraft LabsAmoxicillin Goldline Labs Biocraft LabsAmoxicillin Goldline Labs Mylan PharmaceuticalsAmoxicillin Apothecom Bristol-Myers

AMPICILLINCapsules

Totacillin Beecham Labs Beecham LabsSK-Ampicillin Smith, Kline & French Labs Bristol LabsPolycillin Bristol Labs Bristol LabsAmpicillin Regal Labs Bristol LabsPrincipen E R Squibb & Sons E R Squibb & SonsAmcill Parke-Davis John D Copanos

28 § 25.58 PREVENTION OF DISEASES Pt. III

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Page 39: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

AMPICILLINCapsules—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Ampicillin Purepac Pharmaceutical Purepac PharmaceuticalAmpicillin Mylan Pharmaceuticals Mylan PharmaceuticalsAmpicillin Walgreen Mylan PharmaceuticalsAmpicillin Vangard Labs Mylan PharmaceuticalsAmpicillin H L Moore Drug Exchange Mylan PharmaceuticalsAmpicillin Interstate Drug Exchange Mylan PharmaceuticalsAmpicillin United Research Labs Mylan PharmaceuticalsAmpicillin Lederle Labs Mylan PharmaceuticalsAmpicillin Rugby Labs Mylan PharmaceuticalsAmpicillin Henry Schein Mylan PharmaceuticalsAmpicillin Murray Drug Mylan PharmaceuticalsAmpicillin Rexall Drug Mylan PharmaceuticalsAmpicillin Geneva Generics Mylan PharmaceuticalsAmpicillin Parmed Pharmaceuticals Mylan PharmaceuticalsAmpicillin Towne, Paulsen Mylan PharmaceuticalsAmpicillin Vangard Labs Biocraft LabsAmpicillin H L Moore Drug Exchange Biocraft LabsAmpicillin Rugby Labs Biocraft LabsAmpicillin Parmed Pharmaceuticals Biocraft LabsAmpicillin Artex Labs Biocraft LabsAmpicillin Atlas Pharmaceuticals Biocraft LabsAmpicillin Bioline Labs Biocraft LabsAmpicillin H R Cenci Labs Biocraft LabsAmpicillin Cenla Pharmaceutical Biocraft LabsAmpicillin Comer Pharmaceuticals Biocraft LabsAmpicillin Cooper Biocraft LabsAmpicillin Dixon-Shane Biocraft LabsAmpicillin Gen-King Products Biocraft LabsAmpicillin Glenlawn Labs Biocraft LabsAmpicillin Halsey Drug Biocraft LabsAmpicillin Harnel Pharmaceutical Biocraft LabsAmpicillin H & H Labs Biocraft LabsAmpicillin Interstate Drug Exchange Biocraft LabsAmpicillin McKesson Labs Biocraft LabsAmpicillin Michigan Pharmacal Biocraft LabsAmpicillin Murray Drug Biocraft LabsAmpicillin Pharmacist Choice Biocraft LabsAmpicillin Queen City Pharmacal Biocraft LabsAmpicillin Richie Pharmacal Biocraft LabsAmpicillin C S Ruckstuhl Biocraft LabsAmpicillin Henry Schein Biocraft LabsAmpicillin Vita-Rx Biocraft LabsAmpicillin Wasserotts Biocraft LabsAmpin Winston Pharmaceuticals Biocraft LabsSaramp Saron Pharmacal Biocraft LabsAmpicillin Purepac Pharmaceutical Biocraft LabsAmpicillin Qualitest Biocraft LabsAmpicillin Biocraft Labs Biocraft LabsAmpicillin Goldline Labs Biocraft LabsAmpicillin Laboratory A Mylan PharmaceuticalsAmpicillin Apothecon Bristol-MyersAmpicillin Best Generics Mylan Pharmaceuticals

AMPICILLINOral Suspension

Amcil Parke-Davis John D CompanosPrincipen E R Squibb & Sons E R Squibb & SonsSK-Ampicillin Smith, Kline & French Labs Bristol LabsPolycillin Bristol Labs Bristol LabsAmpicillin Regal Labs Bristol LabsAmpicillin Purepac Pharmaceutical Purepac PharmaceuticalAmpicillin Mylan Pharmaceuticals Mylan PharmaceuticalsAmpicillin Walgreen Mylan PharmaceuticalsAmpicillin Rugby Labs Mylan PharmaceuticalsAmpicillin United Research Labs Mylan PharmaceuticalsAmpicillin Interstate Drug Exchange Mylan PharmaceuticalsAmpicillin Lederle Labs Mylan PharmaceuticalsAmpicillin H L Moore Drug Exchange Mylan PharmaceuticalsAmpicillin Henry Schein Mylan PharmaceuticalsAmpicillin Biocraft Labs Biocraft LabsAmpicillin Rexall Drug Biocraft LabsAmpicillin Vangard Labs Biocraft LabsAmpicillin Rugby Labs Biocraft LabsAmpicillin Parmed Pharmaceuticals Biocraft LabsAmpicillin Artex Labs Biocraft LabsAmpicillin Atlas Pharmaceuticals Biocraft LabsAmpicillin Bioline Labs Biocraft LabsAmpicillin Cenla Pharmaceutical Biocraft LabsAmpicillin Comer Pharmaceuticals Biocraft Labs

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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Page 40: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

AMPICILLINOral Suspension—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Ampicillin Cooper Biocraft LabsAmpicillin Dixon-Shane Biocraft LabsAmpicillin Goldline Labs Biocraft LabsAmpicillin Gen-King Products Biocraft LabsAmpicillin Glenlawn Labs Biocraft LabsAmpicillin Halsey Drug Biocraft LabsAmpicillin Harnel Pharmaceutical Biocraft LabsAmpicillin Interstate Drug Exchange Biocraft LabsAmpicillin McKesson Labs Biocraft LabsAmpicillin Michigan Pharmacal Biocraft LabsAmpicillin H L Moore Drug Exchange Biocraft LabsAmpicillin Murray Drug Biocraft LabsAmpicillin Pharmacist Choice Biocraft LabsAmpicillin Queen City Pharmacal Biocraft LabsAmpicillin C S Ruckstuhl Biocraft LabsAmpicillin Henry Schein Biocraft LabsAmpicillin Winston Pharmaceuticals Biocraft LabsAmpicillin Towne, Paulsen Biocraft LabsAmpicillin Parmed Pharmaceuticals Mylan PharmaceuticalsAmpicillin Goldline Labs Mylan PharmaceuticalsAmpicillin Apothecon Bristol-Myers

AMPICILLIN SODIUMInjection

Totacillin-N Beecham Labs Beecham LabsPrincipen/N E R Squibb & Sons E R Squibb & SonsSK-Ampicillin-N Smith, Kline & French Labs Bristol Labs

AMPICILLIN/PROBENECIDFor Oral Suspension

Probampacin Biocraft Labs Biocraft LabsProbamparin Goldline Labs Biocraft Labs

ANISOTROPINE METHYLBROMIDETablets

Anisotropine Methylbromide Bolar Pharmaceutical Bolar PharmaceuticalAnisotropine Methylbromide United Research Labs Bolar PharmaceuticalAnisotropine Methylbromide Rugby Labs Bolar Pharmaceutical

ANTAZOLINE HCLTablets

Arithmin Lannett Lannett

ANTAZOLINE PHOSPHATE/NAPHAZOLINE HCLOphthalmic Solution

Abalon-A Allergan Pharmaceutical Allergan PharmaceuticalNaphazoline HCl/Antazoline

Phosphate Steris Labs Steris Labs

ANTIPYRINE/BENZOCAINEOtic Solution

Auroto Barre Drug National PharmaceuticalAuromid Vangard Labs National PharmaceuticalAura Queen Queen City Pharmacal National PharmaceuticalEar Drops Murray Drug National PharmaceuticalEar Drops Henry Schein National PharmaceuticalA/B Otic Drops Clay-Park Labs Clay-Park LabsA/B Otic Drops Qualitest Clay-Park LabsEar Drops Analgesic Rugby Labs Clay-Park LabsAnalgesic Ear Drops Bioline Labs Clay-Park LabsAllergen Ear Drops Goldline Labs Clay-Park LabsAurafair Pharmafair PharmafairRx-Otic Thames Pharmacal Thames Pharmacal

ASCORBIC ACIDInjection

Ascorbic Acid Steris Labs Steris LabsAscorbic Acid Schein Pharmaceutical Steris LabsAscorbic Acid H L Moore Drug Exchange Steris LabsAscorbic Acid Interstate Drug Exchange Steris Labs

28 § 25.58 PREVENTION OF DISEASES Pt. III

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Page 41: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

ASCORBIC ACIDSyrup

Brand Name/Generic Name Distributed By: Manufactured By:

Vitamin C Barre Drug National PharmaceuticalAscorbic Acid Towne, Paulsen National PharmaceuticalAscorbic Acid Rugby Labs National Pharmaceutical

ASCORBIC ACIDTablets

Ascorbic Acid Richlyn Labs Richlyn LabsAscorbic Acid ICN Pharmaceuticals ICN PharmaceuticalsAscorbic Acid United Research Labs Heather DrugAscorbic Acid Rugby Labs Chelsea LabsAscorbic Acid West-ward West-wardAscorbic Acid Lederle Labs KV PharmaceuticalAscorbic Acid McKesson Labs MK LabsAscorbic Acid Lannett LannettVitamin C Euclid Pharmaceutical West-wardVitamin C Geneva Generics Freshlabs

ASCORBIC ACID/FERROUS FUMARATETablets

Fe-O D Trimen Labs KV PharmaceuticalsVitron-C Fisons Corp Truett

ASCORBIC ACID/SODIUM ASCORBATEChewable Tablets

Ascorbic Acid Richlyn Labs Richlyn LabsUni-Cee-500 United Research Labs KalipharmaVitamin C ICN Pharmaceuticals ICN PharmaceuticalsVitamin C Lederle Labs KV PharmaceuticalsVitamin C Rugby Labs Chelsea LabsVitamin C Geneva Generics Freshlabs

ASCORBIC ACID/LIVER/VITAMIN B COMPLEXTablets

Allbee T A H Robins A H Robins

ASCORBIC ACID/VITAMIN B COMPLEXCapsules

Allbee w/C A H Robbins A H RobbinsVitamin B Complex plus C ICN Pharmaceuticals ICN PharmaceuticalsVitamin B w/Vitamin C Lederle Labs Mylan Pharmaceuticals

ASPIRINSuppositories

Aspirin Suppositoria Labs Suppositoria LabsAspirin Purepac Pharmaceutical Suppositoria LabsAspirin G & W Labs G & W LabsAspirin West-ward G & W LabsAspirin Rugby Labs G & W LabsAspirin United Research Labs G & W LabsAspirin Uniserts Upsher-Smith Upsher-SmithAspirin Great Southern Labs Great Southern Labs

ASPIRINTablets

Aspirin E R Squibb & Sons E R Squibb & SonsAspirin ICN Pharmaceuticals ICN PharmaceuticalsAspirin Parke-Davis Parke-DavisAspirin West-ward West-wardAspirin Purepac Pharmaceutical Purepac PharmaceuticalAspirin McKesson Labs MK LabsAspirin Lannett LannettAspirin Superpharm Corp Superpharm CorpAspirin Bioline Labs Superpharm CorpGenasec Goldline Labs Superpharm CorpAspirin Richlyn Labs Richlyn LabsAspirin-MLT Richlyn Labs Richlyn LabsAspirin-MLT United Research Labs Richlyn LabsAspirin United Research Labs B T ProductsAspirin Bowman Pharmaceuticals Bowman PharmaceuticalsAspirin United Research Labs Bowman Pharmaceuticals

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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ASPIRIN/BUTALBITAL/CAFFEINECapsules

Brand Name/Generic Name Distributed By: Manufactured By:

Isollyl Improved Rugby Labs Chelsea LabsButal Compound Cord Labs Cord Labs

ASPIRIN/BUTALBITAL/CAFFEINETablets

Isollyl Improved Rugby Labs Chelsea LabsButalbital/Aspirin/Caff. Purepac Pharmaceutical Purepac PharmaceuticalButalbital/Aspirin/Caff. Boots Labs Boots LabsButal Compound Parmed Pharmaceuticals Boots LabsFortabs United Research Labs Boots LabsFiorgen PF Goldline Labs Boots LabsButal Compound Cord Labs Cord LabsButalbital Compound Geneva Generics Cord LabsButalbital Compound Zenith Labs Zenith LabsButalbital Compound Whiteworth Pharmaceuticals Zenith LabsButalbital Compound Towne, Paulsen Zenith LabsButalbital Compound Geneva Generics Zenith LabsButalbital Compound Regal Labs Zenith LabsButalbital Compound United Research Labs Zenith LabsButalbital Compound Qualitest Zenith LabsButalbital Compound Gen-King Products Zenith LabsFiomor H L Moore Drug Exchange Zenith LabsIdenal Interstate Drug Exchange Zenith LabsButal Compound Cooper Zenith LabsIsobutyl Bioline Labs Zenith LabsButalgen Genetco Zenith LabsButalbital/Aspirin/Caff. West-ward West-wardButalbital/Aspirin/Caff. Lemmon Co West-wardButalbital/Aspirin/Caff. Harber Pharmaceutical West-wardFiormor H L Moore Drug Exchange West-wardHyosophen Rugby Labs West-wardButalbital with A & C Cooper West-wardButalbital with A & C Wesley Pharmacal West-wardButalbital with AC Towne, Paulsen West-wardButalbital Compound Dixon-Shane West-wardIsolin Glenlawn Labs West-wardIdenal Interstate Drug Exchange West-wardButalgen Genetco West-wardButalbital/Aspirin/Caff. Halsey Drug Halsey Drug

ASPIRIN/CAFFEINE/ORPHENADRINE CITRATETablets

Norgesic Riker Labs Riker LabsOrphengesic Par Pharmaceutical Par PharmaceuticalOrphengesic Martec Pharmaceutical Par Pharmaceutical

ASPIRIN/CAFFEINE/PROPOXYPHENE HCLCapsules

Propoxyphene Compound 65 Zenith Labs Zenith LabsPropoxyphene Compound 65 Murray Drug Zenith LabsPropoxyphene Compound 65 Henry Schein Zenith LabsPropoxyphene Compound 65 United Research Labs Zenith LabsPropoxyphene Compound 65 H L Moore Drug Exchange Zenith LabsPropoxyphene Compound 65 Regal Labs Zenith LabsPropoxyphene Compound 65 Glenlawn Labs Zenith LabsPropoxyphene Compound 65 Cooper Zenith LabsPropoxyphene Compound 65 Interstate Drug Exchange Zenith LabsPropoxyphene Compound 65 Gen-King Products Zenith LabsPropoxyphene Compound 65 Bioline Labs Zenith LabsPropoxyphene Compound 65 Whiteworth Pharmaceuticals Zenith LabsPropoxyphene Compound 65 Harber Pharmaceutical Zenith LabsPropoxyphene Compound 65 Geneva Generics Zenith LabsPropoxyphene Compound 65 Parmed Pharmaceuticals Zenith LabsPropoxyphene Compound 65 Towne, Paulsen Zenith LabsPropoxyphene Compound 65 Goldline Labs Zenith LabsPropoxyphene with Aspirin/Caffeine Rugby Labs Chelsea LabsK-65 Compound Smith, Kline & French Labs Smith, Kline & FrenchPropoxyphene HCl/Aspirin/Caffeine Vitarine Pharmaceuticals Vitarine PharmaceuticalPropoxyphene Compound 65 Parmed Pharmaceuticals Lemmon CoPropoxyphene Compound 65 Lemmon Co Lemmon CoPropoxyphene Compound United Research Labs Lemmon CoPropoxyphene HCl, Aspirin

and Caffeine Geneva Generics Cord Labs

28 § 25.58 PREVENTION OF DISEASES Pt. III

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ASPIRIN/CARISOPRODOLTablets

Brand Name/Generic Name Distributed By: Manufactured By:

Carisoprodol Compound Bolar Pharmaceutical Bolar PharmaceuticalCarisoprodol Compound Best Generics Bolar Pharmaceutical

ASPIRIN/CODEINE PHOSPHATETablets

Aspirin w/Codeine Barr Labs Barr LabsAspirin w/Codeine Bell Pharmacal Barr LabsAspirin w/Codeine Bioline Labs Barr LabsAspirin w/Codeine Rugby Labs Barr LabsAspirin w/Codeine Parke-Davis Parke-DavisAspirin with Codeine Qualitest Barr LabsAspirin with Codeine Whiteworth Pharmaceuticals Barr LabsAspirin with Codeine Purepac Pharmaceutical Barr LabsAspirin/Codeine Phosphate Zenith Labs Zenith LabsAspirin/Codeine Phosphate Gen-King Products Zenith LabsAspirin/Codeine Phosphate Murray Drug Zenith LabsAspirin/Codeine Phosphate Vangard Labs Zenith LabsAspirin/Codeine Phosphate Interstate Drug Exchange Zenith LabsAspirin/Codeine Phosphate H L Moore Drug Exchange Zenith LabsAspirin/Codeine Phosphate Regal Labs Zenith LabsAspirin/Codeine Phosphate Goldline Labs Zenith LabsAspirin/Codeine Phosphate Bioline Labs Zenith LabsAspirin/Codeine Phosphate Purepac Pharmaceutical Halsey DrugAspirin/Codeine Phosphate Halsey Drug Halsey DrugAspirin/Codeine Phosphate United Research Labs Halsey DrugAspirin/Codeine Phosphate Rugby Labs Halsey DrugAspirin/Codeine Phosphate Glenlawn Labs Halsey DrugAspirin/Codeine Phosphate Henry Schein Halsey DrugAspirin/Codeine Phosphate Interstate Drug Exchange Halsey DrugAspirin/Codeine Phosphate Geneva Generics Cord LabsEmcodeine Major Pharmaceutical Corp Zenith LabsAspirin with Codeine Best Generics Barr Labs

ASPIRIN/MEPROBAMATETablets

Meprogesic Q Quantum Pharmics Quantum PharmicsMeprogesic Q Parmed Pharmaceuticals Quantum PharmicsMepro-Compound Henry Schein Quantum PharmicsMepro-Analgesic United Research Labs Quantum PharmicsMeprogesic H L Moore Drug Exchange Quantum PharmicsMeprogesic Bioline Labs Quantum PharmicsEquazine M Rugby Labs Quantum PharmicsEpromate-M Major Pharmaceutical Corp Quantum PharmicsMeprobamate with Aspirin Goldline Labs Quantum PharmicsMeprobamate and Aspirin Purepac Pharmaceutical Quantum PharmicsMeprogesic Lemmon Co Quantum PharmicsMeprobamate and Aspirin Par Pharmaceutical Par Pharmaceutical

ASPIRIN/METHOCARBAMOLTablets

Robaxisal A H Robins A H RobinsMethocarbamol and Aspirin Par Pharmaceutical Par Pharmaceutical

ASPIRIN/OXYCODONE HCL/OXYCODONE TEREPHTHALATETablets

Oxycodone HCl/OxycodoneTerephthalate & Aspirin Roxane Labs Roxane Labs

SK-Oxycodone with Aspirin Smith, Kline & French Labs Roxane LabsCodoxy Halsey Drug Halsey DrugAspirin with Oxycodone Interstate Drug Exchange Halsey DrugAspirin with Oxycodone Purepac Pharmaceutical Halsey DrugAspirin with Oxycodone Henry Schein Halsey DrugOxycodone with Aspirin Glenlawn Labs Halsey DrugOxycodone with Aspirin Qualitest Halsey DrugAspirin and Oxycodone Goldline Labs Halsey DrugOxycodone w/Aspirin Barr Labs Barr LabsOxycodone w/Aspirin Rugby Labs Barr LabsAspirin and Oxycodone Goldline Labs Barr Labs

ATROPINE SULFATEOphthalmic Ointment

Atropine Sulfate Allergan Pharmaceutical Allergan PharmaceuticalAtropine Sulfate Pharmaderm AltanaAtropine Sulfate United Research Labs PharmafairAtropair Pharmafair Pharmafair

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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ATROPINE SULFATEOphthalmic Solution

Brand Name/Generic Name Distributed By: Manufactured By:

Isopto Atropine Alcon Labs Alcon LabsAtropair Pharmafair PharmafairAtropine Sulfate Allergan Pharmaceutical Allergan PharmaceuticalAtropine Sulfate Optopics Labs Optopics LabsAtropine Sulfate Hygeia Labs Carter-Glogau LabsAtropine Sulfate Orbis Pharmaceuticals Carter-Glogau LabsAtropine Sulfate Steris Labs Steris LabsAtropine Sulfate Schein Pharmaceutical Steris LabsOcu-Tropine Ocumed Ocumed

ATROPINE SULFATE/DIPHENOXYLATE HCLLiquid

Diphenoxylate HCl andAtropine Sulfate Roxane Labs Roxane Labs

Lo-Trol Vangard Labs National PharmaceuticalDiphenatol Rugby Labs National PharmaceuticalDimotal Mallard Inwood LabsNor-Mil North American Pharmacal Inwood LabsLomanate Bioline Labs National PharmaceuticalLomanate UDL Labs National PharmaceuticalEnoxa Reid-Provident Labs National PharmaceuticalDiphenoxylate HCl/Atropine Sulfate Interstate Drug Exchange National PharmaceuticalDiphenoxylate/Atropine Ascot Pharmaceuticals Barre-NationalDiphenoxylate/Atropine Henry Schein Barre-NationalLomanate Barre-National Barre-NationalLomanate Qualitest Barre-NationalLatropine Major Pharmaceutical Corp Barre-NationalLogen Goldline Labs Barre-National

ATROPINE SULFATE/DIPHENOXYLATE HCLTablets

Diphenatol Rugby Labs Chelsea LabsDiphenoxylate HCl and

Atropine Sulfate Interstate Drug Exchange Halsey DrugDiphenoxylate HCl and

Atropine Sulfate Henry Schein Halsey DrugDiphenoxylate HCl and

Atropine Sulfate Purepac Pharmaceutical Halsey DrugDiphenoxylate HCl and

Atropine Sulfate Glenlawn Labs Halsey DrugDiphenoxylate HCl and

Atropine Sulfate Qualitest Halsey DrugLow-Quel Halsey Drug Halsey DrugDi-Atro MD Pharmaceutical MD PharmaceuticalLo-Tabs Parmed Pharmaceuticals MD PharmaceuticalDiphenoxylate HCl and

Atropine Sulfate Mylan Pharmaceuticals Mylan PharmaceuticalsDiphenoxylate HCl and

Atropine Sulfate Regal Labs Mylan PharmaceuticalsDiphenoxylate HCl and

Atropine Sulfate Stayner Corp Mylan PharmaceuticalsDiphenoxylate HCl and

Atropine Sulfate Lederle Labs Mylan PharmaceuticalsDiatro Richie Pharmacal Mylan PharmaceuticalsDiphenoxylate HCl w/Atropine Sulfate Henry Schein Mylan PharmaceuticalsDiphenoxylate HCl w/Atropine Sulfate Interstate Drug Exchange Mylan PharmaceuticalsDiphenoxylate HCl w/Atropine Sulfate H L Moore Drug Exchange Mylan PharmaceuticalsDi-Atro Murray Drug Mylan PharmaceuticalsUni-Lom United Research Labs Mylan PharmaceuticalsUni-Lom United Research Labs Boots LabsUni-Lom United Research Labs Barr LabsDiphenoxylate HCl and

Atropine Sulfate Barr Labs Barr LabsDiphenoxylate HCl and

Atropine Sulfate Lederle Labs Barr LabsDiphenoxylate HCl and

Atropine Sulfate Bell Pharmacal Barr LabsDiphenoxylate HCl and

Atropine Sulfate Boots Labs Boots LabsLogen Superpharm Corp Superpharm CorpLogen Goldline Labs Superpharm CorpLomonate Bioline Labs Superpharm CorpDiphenoxylate HCl and

Atropine Sulfate Inwood Labs Inwood LabsDiphenoxylate HCl and

Atropine Sulfate American Pharmaceutical Inwood Labs

28 § 25.58 PREVENTION OF DISEASES Pt. III

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ATROPINE SULFATE/DIPHENOXYLATE HCLTablets—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Diphenoxylate HCl andAtropine Sulfate Henry Schein Inwood Labs

Diphenoxylate HCl andAtropine Sulfate Interstate Drug Exchange Inwood Labs

Diphenoxylate HCl andAtropine Sulfate Ascot Pharmaceuticals Inwood Labs

Lo-Tabs Parmed Pharmaceuticals Inwood LabsDimotal Mallard Inwood LabsNor-Mil North American Pharmacal Inwood LabsDiphenatol HCl Rugby Labs Inwood LabsAntiper Seneca Pharmaceuticals Inwood LabsDiphenoxylate HCl and

Atropine Sulfate Parke-Davis Parke-DavisDiphenoxylate HCl and

Atropine Sulfate Qualitest Zenith LabsDiphenoxylate HCl and

Atropine Sulfate Gen-King Products Zenith LabsDiphenoxylate HCl w/Atropine Sulfate Zenith Labs Zenith LabsDiphenoxylate HCl w/Atropine Sulfate Henry Schein Zenith LabsDiphenoxylate HCl w/Atropine Sulfate Cooper Zenith LabsDiphenoxylate HCl w/Atropine Sulfate Interstate Drug Exchange Zenith LabsDiphenoxylate HCl w/Atropine Sulfate H L Moore Drug Exchange Zenith LabsDi-Atro Murray Drug Zenith LabsLo-Trol Vangard Labs Zenith LabsLonox Geneva Generics Cord LabsDiphenoxylate HCl w/Atropine Sulfate KV Pharmaceutical KV PharmaceuticalDiphenoxylate HCl and

Atropine Sulfate Vitarine Pharmaceutical Vitarine PharmaceuticalDiphenoxylate HCl and

Atropine Sulfate Roxane Labs Roxane LabsLofene Lannett LannettDiphenoxylate HCl and

Atropine Sulfate West-ward West-wardDiphenoxylate HCl and

Atropine Sulfate Genetco West-wardDiphenoxylate HCl and

Atropine Sulfate Best Generics Mylan Pharmaceuticals

ATROPINE SULFATE/MORPHINE SULFATEInjection

Morphine Sulfate/Atropine Sulfate Beecham Labs Beecham Labs

BACITRACINInjection

Bacitracin McKesson Labs MK LabsBacitracin Biocraft Labs Biocraft LabsBacitracin United Research Labs Clay-Park LabsBacitracin Thames Pharmacal Thames Pharmacal

BACITRACINOintment

Bacitracin Rugby Labs Naska Pharmacal

BACITRACINOphthalmic Ointment

Bacitracin Pharmafair PharmafairBacitracin E Fougera AltanaBacitracin Pharmaderm Altana

BACITRACIN/NEOMYCIN SULFATE/POLYMYXIN-B SULFATEOintment

Mycitracin Upjohn Co Upjohn CoAntibiotic McKesson Labs MK LabsSpectro-Biotic American Pharmaceutical Biocraft LabsTriple Antibiotic Biocraft Labs Biocraft LabsBiothrycin Cooper Biocraft Labs

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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BACITRACIN/NEOMYCIN SULFATE/POLYMYXIN-B SULFATEOintment—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Triple Antibiotic Geneva Generics Biocraft LabsTriple Antibiotic Glenlawn Labs Biocraft LabsTriple Antibiotic Murray Drug Biocraft LabsTriple Antibiotic Wasserotts Biocraft LabsTriple Antibiotic West-ward Biocraft LabsTriple Antibiotic United Research Labs Clay-Park LabsTrio-Mycin Thames Pharmacal Thames PharmacalBacitracin/Neomycin

Polymyxin Pharmaderm AltanaTriple Antibiotic Goldline Labs Clay-Park Labs

BACITRACIN ZINC/HYDROCORTISONE/NEOMYCIN SULFATE/POLYMYXIN-B SULFATEOphthalmic Ointment

Ocusporin-HC Pharmafair Pharmafair

BACITRACIN ZINC/NEOMYCIN SULFATE/POLYMYXIN-B SULFATEOintment

Neosporin Burroughs Wellcome Burroughs WellcomeTopisporin Pharmafair PharmafairTriple Antibiotic Rugby Labs Naska Pharmacal

BACITRACIN ZINC/NEOMYCIN SULFATE/POLYMYXIN-B SULFATEOphthalmic Ointment

Neosporin Burroughs Wellcome Burroughs WellcomeOcutricin Pharmafair PharmafairOcutricin United Research Labs PharmafairBacitracin/Neomycin/Polymyxin Pharmaderm Altana

BACITRACIN ZINC/POLYMYXIN-B SULFATEOintment

Bacitracin/Polymyxin Rugby Labs Naska Pharmacal

BACITRACIN ZINC/POLYMYXIN-B SULFATEOphthalmic Ointment

Ocumycin Pharmafair Pharmafair

BACLOFENTablets

Baclofen Pharmaceutical Basics Pharmaceutical BasicsBaclofen Zenith Labs Zenith Labs

BALSAM of PERU/CASTOR OIL/TRYPSINAerosol

Granulderm Copley Pharmaceutical Copley Pharmaceutical

BELLADONNA ALKALOIDS/KAOLIN/PECTINSuspension

Donnagel A H Robins A H RobinsKapectolin Gel/Belladonna Barre Drug National PharmaceuticalKapectolin Gel/Belladonna Murray Drug National PharmaceuticalKapectolin Gel/Belladonna Henry Schein National PharmaceuticalKapectolin Gel/Belladonna Richie Pharmacal National PharmaceuticalKapectolin w/Belladonna Orbit Pharmaceutical National PharmaceuticalKaolin Pectin/Belladonna Purepac Pharmaceutical National PharmaceuticalQuiagel Rugby Labs National PharmaceuticalQuiagel Rugby Labs Naska Pharmacal

BELLADONNA ALKALOIDS/KAOLIN/PECTIN/POWDERED OPIUMSuspension

Donnagel-PG A H Robbins A H RobbinsKapectolin PG Barre Drug National PharmaceuticalKapectolin PG Cooper National PharmaceuticalKapectolin PG Murray Drug National PharmaceuticalKapectolin PG United Research Labs National Pharmaceutical

28 § 25.58 PREVENTION OF DISEASES Pt. III

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BELLADONNA ALKALOIDS/KAOLIN/PECTIN/POWDERED OPIUMSuspension—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Kapectolin PG Bell Pharmacal National PharmaceuticalKapectolin PG Goldline Labs National PharmaceuticalKaolin Pectin PG Mixture Henry Schein National PharmaceuticalParpectate PG Parmed Pharmaceuticals National PharmaceuticalKaodonna PG Vangard Labs National PharmaceuticalQuiagel PG Rugby Labs National PharmaceuticalKaotin PG Econo-Rx National Pharmaceutical

BELLADONNA ALKALOIDS/PHENOBARBITALCapsules

Donnatal A H Robbins A H Robbins

BELLADONNA ALKALOIDS/PHENOBARBITALElixir

Donnatal A H Robbins A H RobbinsElixir Susano Halsey Drug Halsey DrugAntispasmodic Henry Schein Halsey DrugHyosophen Rugby Labs Naska PharmacalMyphentol My-K Labs My-K LabsBelladonna Alkaloids w/Phenobarbital Purepac Pharmaceutical Purepac PharmaceuticalBelladonna Alkaloids w/Phenobarbital Purepac Pharmaceutical National PharmaceuticalBelladonna Alkaloids w/Phenobarbital American Pharmaceutical National PharmaceuticalBelladonna Alkaloids w/Phenobarbital Life Labs Life LabsVanatal Vangard Labs National PharmaceuticalBarophen American Pharmaceutical National PharmaceuticalHyoscyamine Compound Cooper National PharmaceuticalBellagen Grofton Pharmaceuticals National PharmaceuticalDonnamor H L Moore Drug Exchange National PharmaceuticalDon-A-Spas Richie Pharmacal National PharmaceuticalSedalix C S Ruckstuhl National PharmaceuticalHysophen Rugby Labs National PharmaceuticalAntispasmodic Henry Schein National PharmaceuticalSpastemms C O Truxton National PharmaceuticalBarophen United Research Labs National PharmaceuticalAntispasmodic Glenlawn Labs National PharmaceuticalAntispasmodic Ronda Pharmacal National PharmaceuticalConnatal Syncon Pharmaceutical National PharmaceuticalBarophen Harber Pharmaceutical National PharmaceuticalBarbacine Wayne Medical National PharmaceuticalMalatal Mallard National PharmaceuticalGenespas-PB General Pharmaceutical National PharmaceuticalSpastabon Bonco Labs National PharmaceuticalSpastolate Interstate Drug Exchange National PharmaceuticalArlatal Artex Labs National PharmaceuticalPalbar W E Hauck National PharmaceuticalVarophen Vita-Rx National PharmaceuticalW/W - Anti-Spas Whiteworth Pharmaceuticals National PharmaceuticalSpasdel Marlop Pharmaceuticals National PharmaceuticalBarophen Murray Drug National PharmaceuticalSpasquid Geneva Generics National PharmaceuticalAntispasmodic Goldline Labs Barre-National

BELLADONNA ALKALOIDS/PHENOBARBITALTablets

Donnatal A H Robbins A H RobbinsSpasmolin Richlyn Labs Richlyn LabsSpasmolin Danbury Pharmacal Danbury PharmacalHaponal United Research Labs Danbury PharmacalBelladonna Alkaloids w/Phenobarbital Regal Labs Danbury PharmacalBelladonna Alkaloids w/Phenobarbital Thrift Drug Danbury PharmacalBelladonna Alkaloids w/Phenobarbital West-ward West-wardBelladonna Alkaloids w/Phenobarbital Regal Labs West-wardBelladonna Alkaloids w/Phenobarbital Purepac Pharmaceutical Purepac PharmaceuticalBelladonna Alkaloids w/Phenobarbital Lemmon Co Lemmon CoRelaxadon Geneva Generics Lemmon CoHaponal United Research Labs Lemmon CoSedapar Parmed Pharmaceuticals KalipharmaHysophen Rugby Labs West-wardAntispasmodic Henry Schein West-wardAntispasmodic Bioline Labs West-wardAntispasmodic Penta Products Halsey DrugSusano Halsey Drug Halsey DrugRelaxadon Geneva Generics KalipharmaHyosophen Rugby Labs Chelsea LabsHybephen Beecham Labs Beecham Labs

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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BENZOYL PEROXIDEGel

Brand Name/Generic Name Distributed By: Manufactured By:

Panoxyl Stiefel Labs Stiefel LabsBenzoyl Peroxide Thames Pharmacal Thames Pharmacal

BENZOYL PEROXIDELotion

Benoxyl Stiefel Labs Stiefel LabsBenz 10 Treasury Drug Clay-Park LabsBenz 10 Revco Drug Clay-Park LabsBenzoyl Peroxide Bioline Labs Clay-Park LabsOxy-aid 10 Clay-Park Labs Clay-Park LabsB P Thames Pharmacal Thames Pharmacal

BENZTROPINE MESYLATETablets

Benztropine Mesylate Quantum Pharmics Quantum PharmicsBenztropine Mesylate Pharmaceutical Basics Pharmaceutical BasicsBenztropine Mesylate Sidmak Labs Sidmak Labs

BENZYL BENZOATEEmulsion

Benzyl Benzoate Lannett Lannett

BETAMETHASONE DIPROPIONATECream

Betamethasone Dipropionate E Fougera AltanaAlphatrex Savage Labs AltanaBetamethasone Dipropionate Pharmaderm AltanaBetamethasone Dipropionate Thames Pharmacal Thames PharmacalBetamethasone Dipropionate NMC Labs NMC LabsBetamethasone Dipropionate Lemmon Co Lemmon Co

BETAMETHASONE DIPROPIONATELotion

Alphatrex Savage Labs AltanaBetamethasone Dipropionate Pharmaderm AltanaBetamethasone Dipropionate E Fougera AltanaBetamethasone Dipropionate National Pharmaceutical National PharmaceuticalBetamethasone Dipropionate Bioline Labs National PharmaceuticalBetamethasone Dipropionate NMC Labs NMC LabsBetamethasone Dipropionate Lemmon Co Lemmon Co

BETAMETHASONE DIPROPIONATEOintment

Betamethasone Dipropionate Pharmaderm Altana

BETAMETHASONE DIPROPIONATEOintment—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Betamethasone Dipropionate NMC Labs NMC LabsBetamethasone Dipropionate Lemmon Co Lemmon Co

BETAMETHASONE SODIUM PHOSPHATEInjection

Betamethasone Sodium Phos. Steris Labs Steris LabsBetamethasone Sodium Phos. Rugby Labs Steris LabsBetamethasone Sodium Phos. Schein Pharmaceutical Steris LabsBetamethasone Sodium Phos. H L Moore Drug Exchange Steris LabsBetamethasone Sodium Phos. Interstate Drug Exchange Steris Labs

BETAMETHASONE VALERATECream

Betaderm K-Line Pharmaceuticals K-Line PharmaceuticalsBeta-Val Lemmon Co Lemmon CoValnac NMC Labs NMC Labs

28 § 25.58 PREVENTION OF DISEASES Pt. III

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Page 49: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

BETAMETHASONE VALERATECream—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Betatrex Savage Labs AltanaBetamethasone Valerate Pharmaderm AltanaBetamethasone Valerate E Fougera AltanaBetamethasone Valerate Thames Pharmacal Thames PharmacalBetamethasone Valerate Clay-Park Labs Clay-Park LabsDermabet Taro Pharmaceuticals Taro Pharmaceuticals

BETAMETHASONE VALERATELotion

Beta-Val Lemmon Co Lemmon CoBetatrex Savage Labs AltanaBetamethasone Valerate E Fougera AltanaBetamethasone Valerate National Pharmaceutical National PharmaceuticalBetamethasone Valerate Bioline Labs National PharmaceuticalBetamethasone Valerate Pharmaderm AltanaBetamethasone Valerate Goldline Labs Barre-National

BETAMETHASONE VALERATEOintment

Betamethasone Valerate Pharmaderm AltanaBetatrex Savage Labs AltanaValnac NMC Labs NMC LabsBeta-Val Lemmon Co Lemmon CoBetamethasone Valerate Clay-Park Labs Clay-Park Labs

BETHANECHOL CHLORIDETablets

Urecholine Merck, Sharpe & Dohme Merck, Sharpe & DohmeDuvoid Norwich-Eaton Norwich-EatonBethanechol Chloride Lannett LannettBethanechol Chloride Rugby Labs Chelsea LabsBethanechol Chloride Bolar Pharmaceutical Bolar PharmaceuticalBethanechol Chloride United Research Labs Bolar PharmaceuticalBethanechol Chloride Purepac Pharmaceutical Bolar PharmaceuticalBethanechol Chloride Glenlawn Labs Bolar PharmaceuticalBethanechol Chloride Geneva Generics Bolar PharmaceuticalBethanechol Chloride Bell Pharmacal Bolar PharmaceuticalBethanechol Chloride Parmed Pharmaceuticals Bolar PharmaceuticalBethanechol Chloride Mutual Pharmaceutical Bolar PharmaceuticalBethanechol Chloride Danbury Pharmacal Danbury PharmacalBethanechol Chloride McKesson Labs Danbury PharmacalBethanechol Chloride United Research Labs Danbury PharmacalBethanechol Chloride Interstate Drug Exchange Danbury PharmacalBethanechol Chloride Henry Schein Danbury PharmacalBethanechol Chloride Towne, Paulsen Danbury PharmacalBethanechol Chloride Regal Labs Danbury PharmacalBethanechol Chloride Rugby Labs Danbury PharmacalBethanechol Chloride Geneva Generics Danbury PharmacalBethanechol Chloride Qualitest Danbury PharmacalBethanechol Chloride Sidmak Labs Sidmak LabsBethanechol Chloride United Research Labs Sidmak LabsBethanechol Chloride Travenol Labs Sidmak LabsBethanechol Chloride Parmed Pharmaceuticals Sidmak LabsBethanechol Chloride Towne, Paulsen Sidmak LabsBethanechol Chloride Mutual Pharmaceutical Sidmak Labs

BISACODYLSuppositories

Bisacodyl Suppositoria Labs Suppositoria LabsBisacodyl Purepac Pharmaceutical Suppositoria LabsBisacodyl H L Moore Drug Exchange Suppositoria LabsBisacodyl Rugby Labs Suppositoria LabsBisacodyl Interstate Drug Exchange Suppositoria LabsBisacodyl Henry Schein Suppositoria LabsBisacodyl G & W Labs G & W LabsBisacodyl Geneva Generics G & W LabsBisacodyl Rugby Labs G & W LabsBisacodyl West-ward G & W LabsBisacodyl Upsher-Smith Upsher-SmithBisacodyl Geneva Generics L PerrigoBisacodyl United Research Labs Clay-Park LabsBisacodyl Roxane Labs Roxane LabsDeficol Vangard Labs R P SchererTheralax Beecham Labs Beecham LabsBisacodyl Great Southern Labs Great Southern Labs

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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BISACODYLEnteric Coated Tablets

Brand Name/Generic Name Distributed By: Manufactured By:

Bisacodyl Barr Labs Barr LabsBisacodyl West-ward Barr LabsBisacodyl Purepac Pharmaceutical Barr LabsBisacodyl Regal Labs Barr LabsBisacodyl McKesson Labs Barr LabsBisacodyl Richlyn Labs Richlyn LabsBisacodyl Parmed Pharmaceuticals Richlyn LabsBisacodyl Roxane Labs Roxane LabsBisacodyl ICN Pharmaceuticals ICN PharmaceuticalsBisacodyl Geneva Generics Cord LabsBisacodyl Rugby Labs Standard PharmacalBisacodyl Sidmak Labs Sidmak LabsBisacodyl Upsher-Smith Butler PharmaPacBisacodyl United Research Labs Ohm Labs

BORIC ACIDOintment

Boric Acid Clay-Park Labs Clay-Park LabsBoric Acid Rix Corp Clay-Park LabsBoric Acid Bioline Labs Clay-Park LabsBoric Acid Supermarkets General Clay-Park LabsBoric Acid Interstate Drug Exchange Clay-Park LabsBoric Acid Gen-King Products Clay-Park LabsBoric Acid Rugby Labs Clay-Park LabsBoric Acid CVS Clay-Park LabsBoric Acid Henry Schein Clay-Park LabsBoric Acid H L Moore Drug Exchange Clay-Park LabsBoric Acid Veratex Corp Clay-Park LabsBoric Acid United Research Labs Clay-Park Labs

BROMODIPHENHYDRAMINE HCL/CODEINE PHOSPHATESyrup

Bromnyl Cough Syrup Barre Drug National PharmaceuticalBromnyl Cough Syrup H L Moore Drug Exchange National PharmaceuticalBromnyl Cough Syrup Henry Schein National PharmaceuticalBromnyl Cough Syrup Bioline Labs National PharmaceuticalBromnyl Cough Syrup United Research Labs National PharmaceuticalBromnyl Cough Syrup Richie Pharmacal National PharmaceuticalBromnyl Cough Syrup Qualitest National PharmaceuticalBromnyl Cough Syrup Cooper National PharmaceuticalBromotuss with Codeine Rugby Labs National PharmaceuticalAmbophen Cough Syrup Major Pharmaceutical Corp National PharmaceuticalAmgenyl Cough Syrup Goldline Labs Barre-NationalMybanil Cough Syrup My-K Labs My-K LabsBromodiphenhydramine HCl

and Codeine Pharmaceutical Basics Pharmaceutical Basics

BROMPHENIRAMINE MALEATEElixir

Dimetane A H Robbins A H RobbinsMyphetane My-K Labs My-K LabsBromphen Rugby Labs National PharmaceuticalBromatane Glenlawn Labs National PharmaceuticalBrompheniramine Maleate United Research Labs National PharmaceuticalBrompheniramine Maleate Barre Drug National PharmaceuticalBromotane Thames Pharmacal Thames Pharmacal

BROMPHENIRAMINE MALEATEInjection

Brompheniramine Maleate Steris Labs Steris Labs

BROMPHENIRAMINE MALEATETablets

Dimetane A H Robbins A H RobbinsVeltane Lannett LannettBrompheniramine Maleate Rugby Labs Chelsea LabsBrompheniramine Maleate Henry Schein Phoenix LabsBrompheniramine Maleate United Research Labs Phoenix LabsBrompheniramine Maleate Rugby Labs Phoenix LabsBrompheniramine Maleate Danbury Pharmacal Danbury PharmacalBrompheniramine Maleate Pioneer Pharmaceuticals Pioneer Pharmaceuticals

28 § 25.58 PREVENTION OF DISEASES Pt. III

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BROMPHENIRAMINE MALEATE/CODEINE PHOSPHATE/PHENYLPROPANOLAMINE HCLSyrup

Brand Name/Generic Name Distributed By: Manufactured By:

Myphetane DC My-K Labs My-K LabsBromanate DC Barre Drug National PharmaceuticalBromanate DC H L Moore Drug Exchange National PharmaceuticalBromanate DC Bioline Labs National PharmaceuticalBromanate DC United Research Labs National PharmaceuticalBromphen DC w/Codeine Rugby Labs National PharmaceuticalBromatane DC Goldline Labs Barre-NationalMyphetane DC Pharmaceutical Basics Pharmaceutical Basics

BROMPHENIRAMINE MALEATE/DEXTROMETHORPHAN HBR/PSEUDOEPHEDRINE HCLSyrup

Myphetane DX My-K Labs My-K LabsMyphetane DX Pharmaceutical Basics Pharmaceutical Basics

BROMPHENIRAMINE MALEATE/PHENYLEPHRINE HCL/PHENYLPROPANOLAMINE HCLElixir

Veltap Lannett LannettBromopheniramine Decongest Life Labs Life LabsPhen Bro Phen Gentek Corp Gentek CorpBromtapp Halsey Drug Halsey DrugM-Hist R A McNeil National PharmaceuticalBromanate Barre Drug National PharmaceuticalBromanate Richie Pharmacal National PharmaceuticalBromanate United Research Labs National PharmaceuticalBromonate Ronda Pharmacal National PharmaceuticalBromonate Murray Drug National PharmaceuticalBromanate Jay Labs National PharmaceuticalBromanate Harber Pharmaceutical National PharmaceuticalBrompheniramine Compound H L Moore Drug Exchange National PharmaceuticalBrompheniramine Compound Lederle Labs National PharmaceuticalBrompheniramine Compound Ascot National PharmaceuticalBrompheniramine American Pharmaceutical National PharmaceuticalBrometap Bioline Labs National PharmaceuticalCo-Tapp Cooper National PharmaceuticalDimerex C S Ruckstuhl National PharmaceuticalBromphen Compound Henry Schein National PharmaceuticalMidatap Vangard Labs National PharmaceuticalBrom-Cortapp Interstate Drug Exchange National PharmaceuticalPurebrom Compound Purepac Pharmaceutical National PharmaceuticalBrotep Glenlawn National PharmaceuticalVitapp Vita-Rx National PharmaceuticalPenta-Tapp Penta Products National PharmaceuticalDime-Ott Wasserotts National PharmaceuticalArlatapp Artex Labs National PharmaceuticalKessotapp McKesson Labs National PharmaceuticalBromyne Whiteworth Pharmaceuticals National PharmaceuticalDimacon Syncon Pharmaceutical National PharmaceuticalTamine Geneva Generics National Pharmaceutical

BROMPHENIRAMINE MALEATE/PHENYLPROPANOLAMINE HCLElixir

Myphetapp My-K Labs My-K Labs

BUTABARBITAL SODIUMElixir

Butalan Lannett LannettElixir Sarisol Halsey Drug Halsey DrugButabarb Barre Drug National PharmaceuticalButabarb Henry Schein National PharmaceuticalSodium Butabarbital Vangard Labs National PharmaceuticalButabarbital Interstate Drug Exchange National PharmaceuticalPanbutal Pan American Labs National PharmaceuticalButabarbital Sodium United Research Labs National PharmaceuticalButabarbital Sodium Purepac Pharmaceutical National PharmaceuticalButabarbital Sodium Rugby Labs National PharmaceuticalButabarbital Sodium Bioline Labs National PharmaceuticalButabarbital Sodium C S Ruckstuhl National PharmaceuticalButabarbital Sodium Murray Drug National PharmaceuticalButabarbital Sodium Qualitest National PharmaceuticalButabarbital Sodium My-K Labs My-K LabsButabarb Goldline Labs Barre-National

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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BUTABARBITAL SODIUMTablets

Brand Name/Generic Name Distributed By: Manufactured By:

Sarisol Halsey Drug Halsey DrugButabarbital Sodium Bioline Labs Halsey DrugButabarbital Sodium Interstate Drug Exchange Halsey DrugButabarbital Sodium Wesley Pharmacal Halsey DrugButabarbital Sodium Henry Schein Halsey DrugButabarbital Sodium Mallard Halsey DrugButabarbital Sodium Towne, Paulsen Towne, PaulsenButabarbital Sodium Lannett LannettButabarbital Sodium West-ward West-wardButabarbital Sodium H L Moore Drug Exchange West-wardButabarbital Sodium Henry Schein West-wardButabarbital Sodium Rugby Labs West-wardButabarbital Sodium Lemmon Co Lemmon CoButabarbital Sodium United Research Labs Lemmon CoButabarbital Sodium Geneva Generics Cord LabsButabarbital Sodium Vitarine Pharmaceutical Vitarine Pharmaceutical

CAFFEINE/ERGOTAMINE TARTRATETablets

Cafergot Sandoz Pharmaceuticals Sandoz PharmaceuticalsErcaf Geneva Generics Cord Labs

CALCIUM CARBONATE/GLYCINETablets

Antacid # 6 Bowman Pharmaceuticals Bowman PharmaceuticalsAntacid # 6 Parmed Pharmaceuticals Bowman Pharmaceuticals

CALCIUM GLUCONATETablets

Calcium Gluconate Richlyn Labs Richlyn LabsCalcium Gluconate West-ward West-wardCalcium Gluconate United Research Labs Contract PharmacalCalcium Gluconate Lannett LannettCalcium Gluconate Rugby Labs Tishcon LabsCalcium Gluconate United Research Labs B T Products

CALCIUM LACTATETablets

Calcium Lactate Richlyn Labs Richlyn LabsCalcium Lactate Parke-Davis Parke-DavisCalcium Lactate West-ward West-wardCalcium Lactate H L Moore Drug Exchange West-wardCalcium Lactate Lannett LannettCalcium Lactate Geneva Generics Winning LabsCalcium Lactate Geneva Generics FreshlabsCalcium Lactate United Research Labs Ohm Labs

CARBACHOLOphthalmic Solution

Isopto Carbachol Alcon Labs Alcon LabsCarbachol Optopics Labs Optopics Labs

CARBAMAZEPINETablets

Epitol Lemmon Co Teva PharmaceuticalCarbamazepine Pharmaceutical Basics Pharmaceutical BasicsCarbamazepine Purepac Pharmaceutical Pharmaceutical BasicsCarbamazepine Mutual Pharmaceutical Pharmaceutical BasicsCarbamazepine Warner Chilcott Labs Warner Chilcott LabsCarbamazepine Purepac Pharmaceutical Purepac PharmaceuticalCarbamazepine Martec Pharmaceutical Pharmaceutical BasicsCarbamazepine Best Generics Pharmaceutical BasicsCarbamazepine Goldline Labs Pharmaceutical Basics

CARBENICILLIN DISODIUMInjection

Pyopen Beecham Labs Beecham Labs

28 § 25.58 PREVENTION OF DISEASES Pt. III

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Page 53: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

CARBINOXAMINE MALEATE/DEXTROMETHORPHAN HBR/PSEUDOEPHEDRINE HCLLiquid

Brand Name/Generic Name Distributed By: Manufactured By:

Cardec DM Henry Schein National PharmaceuticalCardec DM H L Moore Drug Exchange National PharmaceuticalCardec DM United Research Labs National PharmaceuticalCardec DM Goldline Labs Barre-NationalHarberdec DM Harber Pharmaceutical National PharmaceuticalPseudo-Car DM Geneva Generics National PharmaceuticalCardec DM Qualitest National PharmaceuticalMycadec Dm My-K Labs My-K LabsCardec DM Barre-National Barre-NationalCardec DM Qualitest Barre-NationalCardec DM Bioline Labs Barre-NationalCarbodec DM Rugby Labs Barre-NationalTussafed Everett Labs Barre-NationalRondamine DM Major Pharmaceutical Corp Barre-NationalCarbinoxamine Compound Pharmaceutical Basics Pharmaceutical Basics

CARBINOXAMINE MALEATE/PSEUDOEPHEDRINE HCLSyrup

Cardec-S Barre Drug National PharmaceuticalCarbodec Rugby Labs Barre-NationalRondamine Major Pharmaceutical Corp Barre-National

CARISOPRODOLTablets

Carisoprodol Rugby Labs Chelsea LabsCarisoprodol Geneva Generics Danbury PharmacalCarisoprodol Danbury Pharmacal Danbury PharmacalCarisoprodol Bolar Pharmaceutical Bolar PharmaceuticalCarisoprodol H L Moore Drug Exchange Bolar PharmaceuticalCarisoprodol United Research Labs Bolar PharmaceuticalCarisoprodol Rugby Labs Bolar PharmaceuticalCarisoprodol Goldline Labs Bolar PharmaceuticalCarisoprodol Henry Schein Bolar PharmaceuticalCarisoprodol Glenlawn Labs Bolar PharmaceuticalCarisoprodol Parmed Pharmaceuticals Bolar PharmaceuticalCarisoprodol Towne, Paulsen Bolar PharmaceuticalCarisoprodol Regal Labs Bolar PharmaceuticalCarisoprodol H R Cenci Labs Bolar PharmaceuticalCarisoprodol Bioline Labs Bolar PharmaceuticalCarisoprodol Whiteworth Pharmaceuticals Bolar PharmaceuticalCarisoprodol Gen-King Products Bolar PharmaceuticalCarisoprodol Murray Drug Bolar PharmaceuticalCarisoprodol Vita-Rx Bolar PharmaceuticalCarisoprodol Richie Pharmacal Bolar PharmaceuticalCarisoprodol Penta Products Bolar PharmaceuticalCarisoprodol Vangard Labs Bolar PharmaceuticalCarisoprodol Cooper Bolar PharmaceuticalCarisoprodol Bell Pharmacal Bolar PharmaceuticalCarisoprodol Qualitest Bolar PharmaceuticalCarisoprodol Purepac Pharmaceutical Bolar PharmaceuticalCarisoprodol Geneva Generics Bolar PharmaceuticalSoridol Interstate Drug Exchange Bolar PharmaceuticalCarisoprodol Vitarine Pharmaceutical Vitarine PharmaceuticalCarisoprodol Pioneer Pharmaceuticals Pioneer PharmaceuticalsCarisoprodol United Research Labs Pioneer PharmaceuticalsCarisoprodol Geneva Generics Cord Labs

CASANTHRANOL/DOCUSATE POTASSIUMCapsules

Docu-K Plus Newtron Pharmaceuticals Newtron PharmaceuticalsDSMC Plus Geneva Generics Newtron Pharmaceuticals

CASANTHRANOL/DOCUSATE SODIUMCapsules

Dioctyl Sodium Sulfosuccinate w/Casanthranol Danbury Pharmacal Danbury Pharmacal

Dioctyl Sodium Sulfosuccinate w/Casanthranol United Research Labs Danbury Pharmacal

Dioctyl Sodium Sulfosuccinate w/Casanthranol H L Moore Drug Exchange Danbury Pharmacal

Dioctyl Sodium Sulfosuccinate w/Casanthranol H L Moore Drug Exchange R P Scherer

Dioctyl Sodium Sulfosuccinate w/Casanthranol Geneva Generics R P Scherer

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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CASANTHRANOL/DOCUSATE SODIUMCapsules—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Dioctyl Sodium Sulfosuccinate w/Casanthranol Lederle Labs R P Scherer

Dioctyl Sodium Sulfosuccinate w/Casanthranol McKesson Labs R P Scherer

Dioctyl Sodium Sulfosuccinate w/Casanthranol Richlyn Labs Richlyn Labs

Dioctyl Sodium Sulfosuccinate w/Casanthranol United Research Labs Richlyn Labs

Docusate Sodium w/Casanthranol Geneva Generics Chase ChemicalDocusate Sodium w/Casanthranol Gen-King Products PharmacapsDocusate Sodium w/Casanthranol United Research Labs PharmacapsDossitol Plus Drug Guild Distributors PharmacapsLace-Copari Murray Drug PharmacapsConstiban Columbia Medical PharmacapsDioctanol Cooper PharmacapsCasa-Dicole Blue Cross Products PharmacapsD-D-S Parke-Davis Parke-DavisPro-Sof-Plus Vangard Labs R P SchererConstiban Columbia Medical R P SchererD S S with Casanthranol Towne, Paulsen R P SchererPerestan Interstate Drug Exchange R P SchererDoctase Purepac Pharmaceutical R P SchererDiocto-C J J Balan Encapsulations

CASANTHRANOL/DOCUSATE SODIUMSyrup

Dioctyl Sodium Sulfosuccinatew/Casanthranol Lederle Labs National Pharmaceutical

Docusate Sodium& Casanthranol Towne, Paulsen National Pharmaceutical

DSS w/Casanthranol Henry Schein National PharmaceuticalDSS w/Casanthranol Geneva Generics National PharmaceuticalDiocto-C Barre Drug National PharmaceuticalDiocto-C Rugby Labs National PharmaceuticalDiocto-C United Research Labs National PharmaceuticalDiocto-C Glenlawn Labs National PharmaceuticalDiocto-C Bioline Labs National PharmaceuticalDiocto-C H L Moore Drug Exchange National PharmaceuticalDiocto-C Cooper National PharmaceuticalDiocto-C Richie Pharmacal National PharmaceuticalDiocto-C Murray Drug National PharmaceuticalDiocto-C Rugby Labs Naska PharmacalDioctyl with Casanthranol West-ward West-wardDoss w/Casanthranol My-K Labs My-K LabsPeri Dos Goldline Labs Barre-National

CASCARA SAGRADA EXTRACTTablets

Cascara Sagrada Richlyn Labs Richlyn LabsCascara Sagrada Rugby Labs KalipharmaCascara Laxative Halsey Drug Halsey DrugCascara Laxative Henry Schein Halsey Drug

CEFAZOLIN SODIUMInjection

Cefazolin Sodium Lemmon Co Teva Pharmaceutical

CEPHALEXINFor Suspension

Cephalexin Biocraft Labs Biocraft LabsCephalexin Warner Chilcott Labs Biocraft LabsCephalexin E R Squibb & Sons Biocraft LabsCephalexin Barr Labs Barr LabsCephalexin LyphoMed/NovoPharm NovopharmCephalexin Danbury Pharmacal NovopharmCephalexin Geneva Generics NovopharmCephalexin Lemmon Co NovopharmCephalexin Schein Pharmaceutical NovopharmCephalexin Lemmon Co Teva Pharmaceutical

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CEPHALEXIN MONOHYDRATECapsules

Brand Name/Generic Name Distributed By: Manufactured By:

Cephalexin Vitarine Pharmaceutical Vitarine PharmaceuticalCephalexin Zenith Labs Zenith LabsCephalexin Bioline Labs Zenith LabsCephalexin Gen-King Products Zenith LabsCephalexin Major Pharmaceutical Corp Zenith LabsCephalexin Qualitest Zenith LabsCephalexin Biocraft Labs Biocraft LabsCephalexin E R Squibb & Sons Biocraft LabsCephalexin Martec Pharmaceutical Vitarine PharmaceuticalCephalexin Barr Labs Barr LabsCephalexin LyphoMed/NovoPharm NovopharmCephalexin Danbury Pharmacal NovopharmCephalexin Geneva Generics NovopharmCephalexin Laboratory A NovopharmCephalexin Schein Pharmaceutical NovopharmCephalexin Qualitest NovopharmCephalexin Purepac Pharmaceutical Institut Biochimique SACephalexin Par Pharmaceutical M J PharmaceuticalsCephalexin Jerome Stevens Pharm Jerome Stevens PharmCephalexin Lemmon Co Teva Pharmaceutical

CEPHALEXIN MONOHYDRATETablets

Cephalexin Barr Labs Barr Labs

CEPHRADINECapsules

Velosef E R Squibb & Sons E R Squibb & SonsAnspor Smith, Kline & French Smith, Kline & FrenchCephradine Zenith Labs Zenith LabsCephradine Bioline Labs Zenith LabsCephradine Gen-King Products Zenith LabsCephradine Glenlawn Labs Zenith LabsCephradine Goldline Labs Zenith LabsCephradine Qualitest Zenith LabsCephradine Rugby Labs Zenith LabsCephradine Biocraft Labs Biocraft LabsCephradine Lederle Labs Biocraft LabsCephradine Purepac Pharmaceutical Biocraft LabsCephradine Geneva Generics Biocraft LabsCephradine Warner Chilcott Labs Biocraft LabsCephradine Parmed Pharmaceuticals Biocraft LabsCephradine Barr Labs Barr Labs

CEPHRADINEFor Suspension

Velosef E R Squibb & Sons E R Squibb & SonsAnspor Smith, Kline & French Smith, Kline & FrenchCephradine Biocraft Labs Biocraft LabsCephradine Barr Labs Barr Labs

CHLORAL HYDRATECapsules

Chloral Hydrate J J Balan EncapsulationsChloral Hydrate Geneva Generics Banner Gelatin ProductsChloral Hydrate Purepac Pharmaceutical R P SchererChloral Hydrate Geneva Generics R P SchererChloral Hydrate Vangard Labs R P SchererChloral Hydrate Rexall Drug R P SchererChloral Hydrate United Research Labs R P SchererChloral Hydrate Zenith Labs R P SchererChloral Hydrate Pace-Bond Drug R P SchererChloral Hydrate Parke-Davis R P SchererChloral Hydrate Roxane Labs R P SchererChloral Hydrate Towne, Paulsen R P SchererChloral Hydrate H L Moore Drug Exchange R P SchererChloral Hydrate McKesson Labs R P SchererChloral Hydrate ICN Pharmaceuticals R P SchererChloral Hydrate West-ward R P SchererChloral Hydrate Interstate Drug Exchange R P SchererChloral Hydrate Rugby R P SchererChloral Hydrate Bioline Labs R P SchererChloral Hydrate Goldline Labs R P SchererChloral Hydrate Lederle Labs R P SchererNotec E R Squibb & Sons R P Scherer

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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CHLORAL HYDRATESyrup

Brand Name/Generic Name Distributed By: Manufactured By:

Notec E R Squibb & Sons E R Squibb & SonsChloral Hydrate Roxane Labs Roxane LabsChloral Hydrate My-K Labs My-K LabsChloral Hydrate Barre Drug National PharmaceuticalChloral Hydrate Purepac Pharmaceutical Purepac PharmaceuticalChloral Hydrate Henry Schein National PharmaceuticalChloral Hydrate Rugby Labs National PharmaceuticalChloral Hydrate United Research Labs National PharmaceuticalChloral Hydrate Geneva Generics National PharmaceuticalChloral Hydrate Qualitest National PharmaceuticalChloral Hydrate Pharmaceutical Basics Pharmaceutical Basics

CHLORAMPHENICOLCapsules

Mychel Rachelle Labs Rachelle LabsChloromycetin Parke-Davis Parke-DavisChloramphenicol Zenith Labs Zenith LabsChloramphenicol Henry Schein Zenith LabsChloramphenicol H L Moore Drug Exchange Zenith LabsChloramphenicol Rugby Labs Zenith LabsChloramphenicol Qualitest Zenith LabsChloramphenicol Major Pharmaceutical Corp Zenith LabsChloramphenicol Bioline Labs Zenith LabsChloramphenicol Goldline Labs Zenith LabsChloramphenicol Interstate Drug Exchange Zenith Labs

CHLORAMPHENICOLOphthalmic Ointment

Chloroptic Allergan Pharmaceutical Allergan PharmaceuticalChloromycetin Parke-Davis Parke-DavisChlorofair Pharmafair PharmafairChloramphenicol United Research Labs Pharmafair

CHLORAMPHENICOLOphthalmic Solution

Chloroptic Allergan Pharmaceutical Allergan PharmaceuticalOpthochlor Parke-Davis Parke-DavisChloromycetin Parke-Davis Parke-DavisOptomycin Optopics Labs Optopics LabsChlorofair Pharmafair PharmafairChloramphenicol Hygeia Labs Carter-Glogau LabsChloramphenicol Orbis Pharmaceuticals Carter-Glogau LabsChloramphenicol Steris Labs Steris LabsChloramphenicol Danbury Pharmacal Steris LabsChloramphenicol Schein Pharmaceutical Steris Labs

CHLORAMPHENICOL SODIUM SUCCINATEFor Injection

Mychel-S Rachelle Labs Rachelle LabsChloromycetin Parke-Davis Parke-Davis

CHLORDIAZEPOXIDE HCLCapsules

Librium Roche Labs Roche LabsChlordiazepoxide HCl Geneva Generics Cord LabsChlordiazepoxide HCl Rugby Labs Chelsea LabsChlordiazepoxide HCl McKesson Labs MK LabsChlordiazepoxide HCl Parke-Davis Parke-DavisChlordiazepoxide HCl Purepac Pharmaceutical Purepac PharmaceuticalChlordiazepoxide HCl Barr Labs Barr LabsChlordiazepoxide HCl United Research Labs Barr LabsChlordiazepoxide HCl Regal Labs Barr LabsChlordiazepoxide HCl Skaggs Co Barr LabsChlordiazepoxide HCl Rugby Labs Barr LabsChlordiazepoxide HCl Henry Schein Barr LabsChlordiazepoxide HCl Harber Pharmaceutical Barr LabsChlordiazepoxide HCl Murray Drug Barr LabsChlordiazepoxide HCl Bioline Labs Barr LabsChlordiazepoxide HCl Bell Pharmacal Barr LabsChlordiazepoxide HCl Qualitest Barr LabsChlordiazepoxide HCl Goldline Labs Barr LabsChlordiazepoxide HCl West-ward West-ward

28 § 25.58 PREVENTION OF DISEASES Pt. III

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Page 57: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

CHLORDIAZEPOXIDE HCLCapsules—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Chlordiazepoxide HCl H L Moore Drug Exchange West-wardChlordiazepoxide HCl Interstate Drug Exchange West-wardChlordiazepoxide HCl Henry Schein West-wardChlordiazepoxide HCl Towne, Paulsen West-wardSK - Lygen Smith, Kline & French Labs Smith, Kline & French LabsChlordiazepoxide HCl Halsey Drug Halsey DrugChlordiazepoxide HCl Interstate Drug Exchange Halsey DrugChlordiazepoxide HCl Glenlawn Labs Halsey DrugChlordiazepoxide HCl Henry Schein Halsey DrugChlordiazepoxide HCl United Research Labs Halsey DrugChlordiazepoxide HCl Gen-King Products Halsey DrugChlordiazepoxide HCl Cooper Halsey DrugChlordiazepoxide HCl Mallard Halsey DrugChlordiazepoxide HCl Qualitest Halsey DrugChlordiazepoxide HCl Zenith Labs Zenith LabsChlordiazepoxide HCl United Research Labs Zenith LabsChlordiazepoxide HCl Gen-King Products Zenith LabsChlordiazepoxide HCl Murray Drug Zenith LabsChlordiazepoxide HCl Interstate Drug Exchange Zenith LabsChlordiazepoxide HCl Mallard Zenith LabsChlordiazepoxide HCl Cooper Zenith LabsChlordiazepoxide HCl Vangard Labs Zenith LabsChlordiazepoxide HCl Pharmaceutical Basics Pharmaceutical BasicsChlordiazepoxide HCl H R Cenci Labs Pharmaceutical BasicsChlordiazepoxide HCl Richie Pharmacal Pharmaceutical BasicsChlordiazepoxide HCl Towne, Paulsen Pharmaceutical BasicsChlordiazepoxide HCl Lederle Labs Pharmaceutical BasicsChlordiazepoxide HCl Geneva Generics Pharmaceutical BasicsChlordiazepoxide HCl Goldline Labs Pharmaceutical BasicsChlordiazepoxide HCl Bioline Labs Pharmaceutical BasicsChlordiazepoxide HCl Vitarine Pharmaceutical Vitarine PharmaceuticalChlordiazepoxide HCl Major Pharmaceutical Corp Vitarine PharmaceuticalChlordiazepoxide HCl Henry Schein Vitarine Pharmaceutical

CHLOROQUINE PHOSPHATETablets

Chloroquine Phosphate Richlyn Labs Richlyn LabsChloroquine Phosphate Bioline Labs Richlyn LabsChloroquine Phosphate Consolidated Midland Richlyn LabsChloroquine Phosphate Interstate Drug Exchange Richlyn LabsChloroquine Phosphate H L Moore Drug Exchange Richlyn LabsChloroquine Phosphate Rugby Labs Richlyn LabsChloroquine Phosphate Penta Products Richlyn LabsChloroquine Phosphate Henry Schein Richlyn LabsChloroquine Phosphate Whiteworth Pharmaceuticals Richlyn LabsChloroquine Phosphate West-ward West-wardChloroquine Phosphate H L Moore Drug Exchange West-wardChloroquine Phosphate Henry Schein West-wardChloroquine Phosphate Geneva Generics West-wardChloroquine Phosphate United Research Labs West-wardChloroquine Phosphate Biocraft Labs Biocraft LabsChloroquine Phosphate Interstate Drug Exchange Biocraft LabsChloroquine Phosphate Danbury Pharmacal Danbury PharmacalChloroquine Phosphate Geneva Generics Danbury PharmacalChloroquine Phosphate Goldline Labs Biocraft Labs

CHLOROTHIAZIDETablets

Diuril Merck, Sharpe & Dohme Merck, Sharpe & DohmeChlorothiazide Rugby Labs Chelsea LabsChlorothiazide Bolar Pharmaceutical Bolar PharmaceuticalChlorothiazide Thrift Drug Bolar PharmaceuticalChlorothiazide Rugby Labs Bolar PharmaceuticalChlorothiazide Glenlawn Labs Bolar PharmaceuticalChlorothiazide Purepac Pharmaceutical Bolar PharmaceuticalChlorothiazide Geneva Generics Bolar PharmaceuticalChlorothiazide Bell Pharmacal Bolar PharmaceuticalChlorothiazide Parmed Pharmaceuticals Bolar PharmaceuticalChlorothiazide E R Squibb & Sons Mylan PharmaceuticalsChlorothiazide Lederle Labs Mylan PharmaceuticalsChlorothiazide United Research Labs Mylan PharmaceuticalsSK-Chlorothiazide Smith, Kline & French Labs Mylan PharmaceuticalsChlorothiazide Mylan Pharmaceuticals Mylan PharmaceuticalsChlorothiazide Rugby Labs Mylan PharmaceuticalsChlorothiazide Purepac Pharmaceutical Mylan PharmaceuticalsChlorothiazide Bioline Labs Mylan PharmaceuticalsChlorothiazide H L Moore Drug Exchange Mylan Pharmaceuticals

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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CHLOROTHIAZIDETablets—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Chlorothiazide Skaggs Co Mylan PharmaceuticalsChlorothiazide Murray Drug Mylan PharmaceuticalsChlorothiazide Geneva Generics Mylan PharmaceuticalsChlorothiazide Towne, Paulsen Mylan PharmaceuticalsChlorothiazide Interstate Drug Exchange Mylan PharmaceuticalsChlorothiazide McKesson Labs Mylan PharmaceuticalsChlorothiazide Regal Labs Mylan PharmaceuticalsChlorothiazide Henry Schein Mylan PharmaceuticalsChlorothiazide Bell Pharmacal Mylan PharmaceuticalsChlorothiazide Harber Pharmaceutical Mylan PharmaceuticalsChlorothiazide Parmed Pharmaceuticals Mylan PharmaceuticalsChlorothiazide Qualitest Mylan PharmaceuticalsChlorothiazide Glenlawn Labs West-wardChlorothiazide H L Moore Drug Exchange West-wardChlorothiazide Henry Schein West-wardChlorothiazide United Research Labs West-wardChlorothiazide Interstate Drug Exchange West-wardChlorothiazide Rugby Labs West-wardChlorothiazide West-ward West-wardDiurigen Goldline Labs Mylan Pharmaceuticals

CHLORPHENIRAMINE MALEATEInjection

Chlorpheniramine Maleate Steris Labs Steris LabsChlorpheniramine Maleate Rugby Labs Steris LabsChlorpheniramine Maleate H L Moore Drug Exchange Steris LabsChlor-Pro Schein Pharmaceutical Steris Labs

CHLORPHENIRAMINE MALEATESyrup

Chlor-Trimeton Schering Corp Schering CorpChlorpheniramine Maleate My-K Labs My-K LabsChlorpheniramine Maleate Rugby Labs National PharmaceuticalChlorpheniramine Maleate Henry Schein National PharmaceuticalChlorpheniramine Maleate Purepac Pharmaceutical National PharmaceuticalChlorpheniramine Maleate Whiteworth Pharmaceuticals National PharmaceuticalChlorpheniramine Syrup Interstate Drug Exchange National PharmaceuticalChloridamine Barre Drug National PharmaceuticalChloridamine Murray Drug National PharmaceuticalC P M Bioline Labs National PharmaceuticalChloranel Harnel Pharmaceutical National PharmaceuticalChlorpheniramine Maleate Pharmaceutical Basics Pharmaceutical Basics

CHLORPHENIRAMINE MALEATETablets

Chlor-Trimeton Schering Corp Schering CorpPanahist Panray Ormont Drug & ChemicalPhenetrom Lannett LannettChlro-Pro Henry Schein Phoenix LabsChlorpheniramine Maleate Phoenix Labs Phoenix LabsChlorpheniramine Maleate United Research Labs Phoenix LabsChlorpheniramine Maleate ICN Pharmaceuticals ICN PharmaceuticalsChlorpheniramine Maleate West-ward West-wardChlorpheniramine Maleate Richlyn Labs Richlyn LabsCloriton C S Ruckstuhl Richlyn LabsChlor-Maleate Caldwell & Bloor Richlyn LabsChlorpheniramine Maleate Dixon-Shane Richlyn LabsChlorpheniramine Maleate Murray Drug Richlyn LabsChlorpheniramine Maleate Danbury Pharmacal Danbury PharmacalChlorpheniramine Maleate Interstate Drug Exchange Danbury PharmacalChlor-Pro Henry Schein Danbury PharmacalChlorpheniramine Maleate Zenith Labs Zenith LabsChlorpheniramine Maleate Pace-Bond Drug Zenith LabsChlorpheniramine Maleate Geneva Generics Cord LabsChlorpheniramine Maleate Superpharm Corp Superpharm CorpCPM Bioline Labs Superpharm CorpCPM Goldline Labs Superpharm CorpChlorpheniramine Maleate Pioneer Pharmaceuticals Pioneer Pharmaceuticals

CHLORPHENIRAMINE MALEATE/CODEINE PHOSPHATE/PHENYLEPHRINE HCL/POTASSIUM IODIDESyrup

Pediatric Cough Life Labs Life Labs

28 § 25.58 PREVENTION OF DISEASES Pt. III

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Page 59: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

CHLORPHENIRAMINE MALEATE/CODEINE PHOSPHATE/PSEUDOEPHEDRINE HCLElixir

Dihistine DH Barre Drug National PharmaceuticalDihistine DH Bell Pharmacal National PharmaceuticalDihistine DH Cooper National PharmaceuticalDihistine DH Geneva Generics National PharmaceuticalDihistine DH United Research Labs National PharmaceuticalDihistine DH H L Moore Drug Exchange National PharmaceuticalDihistine DH Bioline Labs National PharmaceuticalDihistine DH Goldline Labs National PharmaceuticalAcahistine DH ACA National PharmaceuticalDecongestant Antitussive Henry Schein National PharmaceuticalPhenhist DH w/Codeine Rugby Labs National PharmaceuticalW/W-Histine DH Whiteworth Pharmaceuticals National PharmaceuticalNovagest DH Major Pharmaceutical Corp National PharmaceuticalPhenylhistine DH Life Labs Life LabsMyhistine DH My-K Labs My-K LabsNovadyne-DH LuChem Pharmaceuticals LuChem PharmaceuticalsDecohistine DH Pharmaceutical Basics Pharmaceutical Basics

CHLORPHENIRAMINE MALEATE/DEXTROMETHORPHAN HBR/PHENYLPROPANOLAMINE HCLSyrup

Myminicol My-K Labs My-K LabsMyminicol Pharmaceutical Basics Pharmaceutical Basics

CHLORPHENIRAMINE MALEATE/PHENYLEPHRINE HCLElixir

Dihistine Barre Drug National PharmaceuticalMyhistine My-K Labs My-K Labs

CHLORPHENIRAMINE MALEATE/PHENYLEPHRINE HCLSyrup

Decohist Barre Drug National PharmaceuticalDecohist Henry Schein National PharmaceuticalDecohist Murray Drug National PharmaceuticalDecohist Rugby Labs National PharmaceuticalBan-Tuss Plain LuChem Pharmaceuticals LuChem Pharmaceuticals

CHLORPHENIRAMINE MALEATE/PHENYLEPHRINE HCLPHENYLPROPANOLAMINE HCL/PHENYLTOLOXAMINE CITRATE

Drops

Naldecon Bristol Labs Bristol Labs

CHLORPHENIRAMINE MALEATE/PHENYLEPHRINE HCLPHENYLPROPANOLAMINE HCL/PHENYLTOLOXAMINE CITRATE

Syrup

Naldecon Bristol Labs Bristol LabsNaldelate Barre Drug National PharmaceuticalNaldelate Bell Pharmacal National PharmaceuticalNaldelate United Research Labs National PharmaceuticalNaldelate Qualitest National PharmaceuticalNaldelate Harber Pharmaceutical National PharmaceuticalNaldec Murray Drug National PharmaceuticalNaldec Bioline Labs National PharmaceuticalNaldec Richie Pharmacal National PharmaceuticalTri-Phen Chlor Rugby Labs National PharmaceuticalQuadrahist Henry Schein National PharmaceuticalNalgest Major Pharmaceutical Corp National PharmaceuticalNew Decongest Goldline Labs Barre-NationalPhentox Compound My-K Labs My-K LabsTri-Phen-Chlor Rugby Labs Naska Pharmacal

CHLORPHENIRAMINE MALEATE/PHENYLPROPANOLAMINE HCLSyrup

Myminic My-K Labs My-K Labs

CHLORPROMAZINE HCLInjection

Thorazine Smith, Kline & French Smith, Kline & FrenchChlorpromazine HCl Steris Labs Steris LabsChlorpromazine HCl Bioline Labs Steris LabsChlorpromazine HCl Interstate Drug Exchange Steris Labs

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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CHLORPROMAZINE HCLInjection—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Chlorpromazine HCl Rugby Labs Steris LabsChlorpromazine HCl Major Pharmaceutical Corp Steris LabsChlorpromazine HCl Geneva Generics Steris Labs

CHLORPROMAZINE HCLOral Liquid

Thorazine Smith, Kline & French Smith, Kline & FrenchSonazine Cord Labs Cord LabsChlorpromazine HCl Conc My-K Labs My-K LabsChlorpromazine HCl Conc Barre-National Barre-NationalChlorpromazine HCl Inten Roxane Labs Roxane LabsChlorpromazine HCl Conc Pharmaceutical Basics Pharmaceutical Basics

CHLORPROMAZINE HCLTablets

Thorazine Smith, Kline & French Smith, Kline & FrenchChlorpromazine HCl Geneva Generics Cord LabsChlorpromazine HCl McKesson Labs Zenith LabsChlorpromazine HCl Rugby Labs Zenith LabsChlorpromazine HCl United Research Labs Zenith LabsChlorpromazine HCl Zenith Labs Zenith LabsChlorpromazine HCl H L Moore Drug Exchange Zenith LabsChlorpromazine HCl Glenlawn Labs Zenith LabsChlorpromazine HCl Towne, Paulsen Zenith LabsChlorpromazine HCl Qualitest Zenith LabsChlorpromazine HCl Bell Pharmacal Zenith LabsChlorpromazine HCl Gen-King Products Zenith LabsChlorpromazine HCl Major Pharmaceutical Corp Zenith LabsChlorpromazine HCl Bioline Labs Zenith LabsChlorpromazine HCl Regal Labs Zenith LabsChlorpromazine HCl Interstate Drug Exchange Zenith LabsChlorpromazine HCl Goldline Labs Zenith LabsChlorpromazine HCl Pharmaceutical Basics Pharmaceutical BasicsChlorpromazine HCl Geneva Generics Pharmaceutical BasicsChlorpromazine HCl United Research Labs Pharmaceutical BasicsChlorpromazine HCl Richie Pharmacal Pharmaceutical BasicsChlorpromazine HCl Williams Generics Pharmaceutical BasicsChlorpromazine HCl Towne, Paulsen Pharmaceutical BasicsChlorpromazine HCl H R Cenci Labs Pharmaceutical BasicsChlorpromazine HCl Bioline Labs Pharmaceutical BasicsChlorpromazine HCl UDL Labs Pharmaceutical BasicsChlorpromazine HCl Goldline Labs Pharmaceutical BasicsChlorpromazine HCl Henry Schein Pharmaceutical BasicsChlorpromazine HCl Purepac Pharmaceutical Pharmaceutical BasicsChlorpromazine HCl Harber Pharmaceutical Pharmaceutical BasicsChlorpromazine HCl Glenlawn Labs Pharmaceutical BasicsChlorpromazine HCl Lederle Labs Pharmaceutical BasicsChlorpromazine HCl Parmed Pharmaceuticals Pharmaceutical BasicsChlorpromazine HCl Lannett Pharmaceutical BasicsChlorpromazine HCl Mutual Pharmaceutical Pharmaceutical BasicsChlorpromazine HCl Best Generics Pharmaceutical Basics

CHLORPROPAMIDETablets

Chlorpropamide Rugby Labs Chelsea LabsChlorpropamide Cord Labs Cord LabsChlorpropamide Geneva Generics Cord LabsChlorpropamide Lemmon Co Lemmon CoChlorpropamide Danbury Pharmacal Danbury PharmacalChlorpropamide Parmed Pharmaceuticals Danbury PharmacalChlorpropamide Duramed Pharmaceuticals Duramed PharmaceuticalsChlorpropamide Mylan Pharmaceuticals Mylan PharmaceuticalsChlorpropamide Sidmak Labs Sidmak LabsChlorpropamide Parmed Pharmaceuticals Sidmak LabsChlorpropamide Bioline Labs Superpharm CorpChlorpropamide Goldline Labs Superpharm CorpChlorpropamide Superpharm Corp Superpharm CorpChlorpropamide Bolar Pharmaceutical Bolar PharmaceuticalChlorpropamide Parmed Pharmaceuticals Bolar PharmaceuticalChlorpropamide Best Generics Bolar PharmaceuticalChlorpropamide Par Pharmaceutical Par PharmaceuticalChlorpropamide Dixon-Shane Par PharmaceuticalChlorpropamide Goldline Labs Par Pharmaceutical

28 § 25.58 PREVENTION OF DISEASES Pt. III

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Page 61: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

CHLORPROPAMIDETablets—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Chlorpropamide Harber Pharmaceutical Par PharmaceuticalChlorpropamide Interstate Drug Exchange Par PharmaceuticalChlorpropamide H L Moore Drug Exchange Par PharmaceuticalChlorpropamide Parmed Pharmaceuticals Par PharmaceuticalChlorpropamide Henry Schein Par PharmaceuticalChlorpropamide Texas Drug Reps Par PharmaceuticalChlorpropamide United Research Labs Par PharmaceuticalChlorpropamide Towne, Paulsen Par PharmaceuticalChlorpropamide Mutual Pharmaceutical Par PharmaceuticalChlorpropamide Pharmaceutical Basics Pharmaceutical BasicsChlorpropamide Richie Pharmacal Pharmaceutical BasicsChlorpropamide United Research Labs Pharmaceutical BasicsChlorpropamide Texas Drug Reps Pharmaceutical BasicsChlorpropamide General Generics Pharmaceutical BasicsGlucamide Lemmon Co Pharmaceutical BasicsChlorpropamide Zenith Labs Zenith LabsChlorpropamide Regal Labs Zenith LabsChlorpropamide Towne, Paulsen Zenith LabsChlorpropamide Bioline Labs Zenith LabsChlorpropamide Goldline Labs Zenith LabsChlorpropamide Halsey Drug Halsey DrugChlorpropamide E R Squibb & Sons Zenith LabsChlorpropamide Martec Pharmaceutical Par PharmaceuticalChlorpropamide Best Generics Pharmaceutical BasicsChlorpropamide Barr Labs Barr LabsChlorpropamide Texas Drug Reps Barr Labs

CHLORTHALIDONETablets

Chlorthalidone Mylan Pharmaceuticals Mylan PharmaceuticalsChlorthalidone Bioline Labs Mylan PharmaceuticalsChlorthalidone Rugby Labs Mylan PharmaceuticalsChlorthalidone Geneva Generics Mylan PharmaceuticalsChlorthalidone Interstate Drug Exchange Mylan PharmaceuticalsChlorthalidone Lederle Labs Mylan PharmaceuticalsChlorthalidone H L Moore Drug Exchange Mylan PharmaceuticalsChlorthalidone Regal Labs Mylan PharmaceuticalsChlorthalidone Henry Schein Mylan PharmaceuticalsChlorthalidone United Research Labs Mylan PharmaceuticalsChlorthalidone Skaggs Co Mylan PharmaceuticalsChlorthalidone Searle Mylan PharmaceuticalsChlorthalidone Purepac Pharmaceutical Mylan PharmaceuticalsChlorthalidone Danbury Pharmacal Danbury PharmacalChlorthalidone Bell Pharmacal Danbury PharmacalChlorthalidone Parmed Pharmaceuticals Danbury PharmacalChlorthalidone Bolar Pharmaceutical Bolar PharmaceuticalChlorthalidone Parmed Pharmaceuticals Bolar PharmaceuticalChlorthalidone Qualitest Bolar PharmaceuticalChlorthalidone Glenlawn Labs Bolar PharmaceuticalChlorthalidone United Research Labs Bolar PharmaceuticalChlorthalidone Goldline Labs Bolar PharmaceuticalBiogroton Bioline Labs Bolar PharmaceuticalChlorthalidone Geneva Generics Cord LabsChlorthalidone Zenith Labs Zenith LabsChlorthalidone H L Moore Drug Exchange Zenith LabsChlorthalidone Regal Labs Zenith LabsChlorthalidone Gen-King Products Zenith LabsChlorthalidone Cooper Zenith LabsChlorthalidone Interstate Drug Exchange Zenith LabsChlorthalidone Murray Drug Zenith LabsBiogroton Bioline Labs Zenith LabsChlorthalidone Purepac Parmaceutical Zenith LabsChlorthalidone Parmed Pharmaceuticals Zenith LabsChlorthalidone Towne, Paulsen Zenith LabsChlorthalidone Williams Generics Zenith LabsChlorthalidone Purepac Pharmaceutical Purepac PharmaceuticalChlorthalidone Superpharm Corp Superpharm CorpChlorthalidone Bioline Labs Superpharm CorpChlorthalidone Goldline Labs Superpharm CorpChlorthalidone Sidmak Labs Sidmak LabsChlorthalidone Parmed Pharmaceuticals Sidmak LabsChlorthalidone Genetco Sidmak LabsChlorthalidone Mutual Pharmaceutical Mutual PharmaceuticalChlorthalidone United Research Labs Mutual PharmaceuticalChlorthalidone Barr Labs Barr LabsChlorthalidone Towne, Paulsen Barr LabsChlorthalidone E R Squibb & Sons Zenith LabsChlorthalidone Genetco Mutual PharmaceuticalChlorthalidone Best Generics Mutual Pharmaceutical

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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CHLORTHALIDONETablets—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Chlorthalidone Warner Chilcott Labs Mutual PharmaceuticalChlorthalidone Parke-Davis Parke-Davis

CHLORTHALIDONE/CLONIDINE HCLTablets

Clonidine HCl and Chlorthalidone Mylan Pharmaceuticals Mylan PharmaceuticalsClonidine HCl and Chlorthalidone Geneva Generics Mylan PharmaceuticalsClonidine HCl and Chlorthalidone Major Pharmaceutical Corp Mylan PharmaceuticalsClonidine HCl and Chlorthalidone H L Moore Drug Exchange Mylan PharmaceuticalsClonidine HCl and Chlorthalidone Schein Pharmaceutical Mylan PharmaceuticalsClonidine HCl and Chlorthalidone Bioline Labs Mylan PharmaceuticalsClonidine HCl and Chlorthalidone Goldline Labs Mylan PharmaceuticalsClonidine HCl and Chlorthalidone Rugby Labs Mylan PharmaceuticalsClonidine HCl and Chlorthalidone Parmed Pharmaceuticals Mylan PharmaceuticalsClonidine HCl and Chlorthalidone Qualitest Mylan PharmaceuticalsClonidine HCl and Chlorthalidone Regal Labs Mylan PharmaceuticalsClonidine HCl and Chlorthalidone Texas Drug Reps Mylan PharmaceuticalsClonidine HCl and Chlorthalidone Warner Chilcott Labs Mylan PharmaceuticalsClonidine HCl and Chlorthalidone Lemmon Co Mylan PharmaceuticalsClonidine HCl and Chlorthalidone Par Pharmaceutical Par Pharmaceutical

CHLORZOXAZONETablets

Chlorzoxazone Par Pharmaceutical Par PharmaceuticalChlorzoxazone Geneva Generics Cord LabsChlorzoxazone Danbury Pharmacal Danbury PharmacalChlorzoxazone Barr Labs Barr LabsChlorzoxazone Lemmon Co Lemmon CoChlorzoxazone Goldline Labs Par PharmaceuticalChlorzoxazone Pioneer Pharmaceuticals Pioneer Pharmaceuticals

CHYMOTRYPSINOphthalmic Solution

Zolyse Alcon Labs Ben Venue Labs

CLINDAMYCIN PHOSPHATEInjection

Clindamycin Phosphate Lemmon Co Lemmon Co

CLOFIBRATECapsules

Clofibrate Chase Labs Chase LabsClofibrate Purepac Pharmaceutical Chase LabsClofibrate Martec Pharmaceutical Chase LabsClofibrate Best Generics Chase LabsClofibrate Rugby Labs PharmacapsClofibrate Geneva Generics Pharmacaps

CLOMIPHENE CITRATETablets

Serophene Serono Labs Ikapharm

CLONIDINE HCLTablets

Clonidine HCl Par Pharmaceutical Par PharmaceuticalClonidine HCl Qualitest Par PharmaceuticalClonidine HCl Mutual Pharmaceutical Par PharmaceuticalClonidine HCl Interpharm InterpharmClonidine HCl Duramed Pharmaceuticals Duramed PharmaceuticalsClonidine HCl Danbury Pharmacal Danbury PharmacalClonidine HCl Biocraft Labs Biocraft LabsClonidine HCl Lederle Labs Biocraft LabsClonidine HCl Parmed Pharmaceuticals Biocraft LabsClonidine HCl American Therapeutics American TherapeuticsClonidine HCl Warner Chilcott Labs American TherapeuticsClonidine HCl Martec Pharmaceutical Par PharmaceuticalClonidine HCl Parmed Pharmaceuticals American TherapeuticsClonidine HCl Lemmon Co Par PharmaceuticalClonidine HCl Goldline Labs Par Pharmaceutical

28 § 25.58 PREVENTION OF DISEASES Pt. III

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Page 63: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

CLONIDINE HCLTablets—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Clonidine HCl Purepac Pharmaceutical Purepac PharmaceuticalClonidine HCl Barr Labs Barr LabsClonidine HCl Bolar Pharmaceutical Bolar PharmaceuticalClonidine HCl Mylan Pharmaceuticals Mylan PharmaceuticalsClonidine HCl Geneva Generics Cord Labs

CLORAZEPATE DIPOTASSIUMCapsules

Clorazepate Dipotassium American Therapeutics American TherapeuticsClorazepate Dipotassium Martec Pharmaceutical American TherapeuticsClorazepate Dipotassium H L Moore Drug Exchange American TherapeuticsClorazepate Dipotassium United Research Labs American TherapeuticsClorazepate Dipotassium E R Squibb & Sons American TherapeuticsClorazepate Dipotassium Interstate Druge Exchange American TherapeuticsClorazepate Dipotassium Pharmaceutical Basics Pharmaceutical BasicsClorazepate Dipotassium Best Generics Pharmaceutical BasicsClorazepate Dipotassium Mylan Pharmaceuticals Mylan PharmaceuticalsClorazepate Dipotassium Bioline Labs Mylan PharmaceuticalsClorazepate Dipotassium Lederle Labs Lederle LabsClorazepate Dipotassium Geneva Generics Cord LabsClorazepate Dipotassium Rugby Labs Chelsea Labs

CLORAZEPATE DIPOTASSIUMTablets

Clorazepate Dipotassium American Therapeutics American TherapeuticsClorazepate Dipotassium Purepac Pharmaceutical American TherapeuticsClorazepate Dipotassium Interstate Drug Exchange American TherapeuticsClorazepate Dipotassium E R Squibb & Sons American TherapeuticsClorazepate Dipotassium Lemmon Co American TherapeuticsClorazepate Dipotassium Martec Pharmaceutical American TherapeuticsClorazepate Dipotassium H L Moore Drug Exchange American TherapeuticsClorazepate Dipotassium Parmed Pharmaceuticals American TherapeuticsClorazepate Dipotassium Qualitest American TherapeuticsClorazepate Dipotassium Regal Labs American TherapeuticsClorazepate Dipotassium Goldline Labs American TherapeuticsClorazepate Dipotassium Bioline Labs American TherapeuticsClorazepate Dipotassium Major Pharmaceutical Corp American TherapeuticsClorazepate Dipotassium Towne, Paulsen American TherapeuticsClorazepate Dipotassium Gen-King Products American TherapeuticsClorazepate Dipotassium Rugby Labs American TherapeuticsClorazepate Dipotassium Schein Pharmaceutical American TherapeuticsClorazepate Dipotassium Best Generics American TherapeuticsClorazepate Dipotassium Harber Pharmaceutical American TherapeuticsClorazepate Dipotassium Mylan Pharmaceuticals Mylan PharmaceuticalsClorazepate Dipotassium Goldline Labs Mylan PharmaceuticalsClorazepate Dipotassium Glenlawn Labs Mylan PharmaceuticalsClorazepate Dipotassium Schein Pharmaceutical Mylan PharmaceuticalsClorazepate Dipotassium Qualitest Mylan PharmaceuticalsClorazepate Dipotassium Rugby Labs Mylan PharmaceuticalsClorazepate Dipotassium Regal Labs Mylan PharmaceuticalsClorazepate Dipotassium Parmed Pharmaceuticals Mylan PharmaceuticalsClorazepate Dipotassium United Research Labs Mylan PharmaceuticalsClorazepate Dipotassium H L Moore Drug Exchange Mylan PharmaceuticalsClorazepate Dipotassium Watson Labs Watson LabsClorazepate Dipotassium Purepac Pharmaceutical Purepac PharmaceuticalGen-XENE Alra Labs Alra Labs

CLOTRIMAZOLECream

Mycelex Miles Pharmaceuticals Miles Pharmaceuticals

CLOTRIMAZOLESolution

Mycelex Miles Pharmaceuticals Miles Pharmaceuticals

CLOTRIMAZOLEVaginal Cream

Mycelex-G Miles Pharmaceuticals Miles Pharmaceuticals

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

25-61(202469) No. 253 Dec. 95

Page 64: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

CLOTRIMAZOLEVaginal Tablets

Brand Name/Generic Name Distributed By: Manufactured By:

Mycelex-G Miles Pharmaceuticals Miles Pharmaceuticals

CLOXACILLIN SODIUMCapsules

Tegopen Bristol Labs Bristol LabsCloxapen Beecham Labs Beecham LabsCloxacillin Biocraft Labs Biocraft LabsCloxacillin Rugby Labs Biocraft LabsCloxacillin Bioline Labs Biocraft LabsCloxacillin Skaggs Co Biocraft LabsCloxacillin Henry Schein Biocraft LabsCloxacillin Geneva Generics Biocraft LabsCloxacillin Qualitest Biocraft LabsCloxacillin United Research Labs Biocraft LabsCloxacillin E R Squibb & Sons Biocraft LabsCloxacillin Mutual Pharmaceutical Biocraft LabsCloxacillin Goldline Labs Biocraft Labs

CLOXACILLIN SODIUMFor Oral Solution

Tegopen Bristol Labs Bristol LabsCloxacillin Biocraft Labs Biocraft LabsCloxacillin Goldline Labs Biocraft Labs

COAL TAR SOLUTION/SALICYLIC ACID/SULFURShampoo

Vanseb-T Allergan Pharmaceutical Allergan Pharmaceutical

CODEINE/TERPIN HYDRATEElixir

Terpin Hydrate w/Codeine Rexall Drug Rexall DrugTerpin Hydrate w/Codeine Parke-Davis Parke-DavisTerpin Hydrate w/Codeine McKesson Labs MK LabsTerpin Hydrate w/Codeine Life Labs Life LabsTerpin Hydrate w/Codeine Roxane Labs Roxane LabsTerpin Hydrate w/Codeine Halsey Drug Halsey DrugTerpin Hydrate w/Codeine Rugby Labs Naska PharmacalTerpin Hydrate w/Codeine H R Cenci Labs H R Cenci LabsTerpin Hydrate w/Codeine Geneva Generics H R Cenci LabsTerpin Hydrate w/Codeine My-K Labs My-K LabsTerpin Hydrate w/Codeine Henry Schein KalipharmaTerpin Hydrate w/Codeine United Research Labs KalipharmaTerpin Hydrate w/Codeine Purepac Pharmaceutical Purepac PharmaceuticalTerpin Hydrate w/Codeine Barre Drug National PharmaceuticalTerpin Hydrate w/Codeine Interstate Drug Exchange National PharmaceuticalTerpin Hydrate w/Codeine Henry Schein National PharmaceuticalTerpin Hydrate w/Codeine United Research Labs National PharmaceuticalTerpin Hydrate w/Codeine Murray Drug National PharmaceuticalTerpin Hydrate w/Codeine Rugby Labs National PharmaceuticalTerpin Hydrate w/Codeine MacEslin National PharmaceuticalTerpin Hydrate w/Codeine Cooper National PharmaceuticalTerpin Hydrate w/Codeine Glenlawn Labs National PharmaceuticalTerpin Hydrate w/Codeine Wasserotts National PharmaceuticalTerpin Hydrate w/Codeine H L Moore Drug Exchange National PharmaceuticalTerpin Hydrate w/Codeine Penta Products National PharmaceuticalTerpin Hydrate w/Codeine Harber Pharmaceutical National PharmaceuticalTerpin Hydrate w/Codeine ACA National PharmaceuticalTerpin Hydrate w/Codeine Geneva Generics National PharmaceuticalTerpin Hydrate w/Codeine Qualitest National PharmaceuticalTerpin Hydrate w/Codeine Goldline Labs Barre-NationalTerpin Hydrate & Codeine Thames Pharmacal Thames Pharmacal

CODEINE PHOSPHATEInjection

Codeine Phosphate Knoll Pharmaceutical Knoll Pharmaceutical

CODEINE PHOSPHATE/GUAIFENESINSyrup

Robitussin AC A H Robins A H RobinsGuiatuss AC Barre Drug National PharmaceuticalGuiatuss AC Richie Pharmacal National Pharmaceutical

28 § 25.58 PREVENTION OF DISEASES Pt. III

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CODEINE PHOSPHATE/GUAIFENESINSyrup—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Guiatuss AC Henry Schein National PharmaceuticalGuiatuss AC United Research Labs National PharmaceuticalGuiatuss AC Murray Drug National PharmaceuticalGuiatuss AC H L Moore Drug Exchange National PharmaceuticalGuiatuss AC Bell Pharmacal National PharmaceuticalCotuss AC Cooper National PharmaceuticalGuiatussin with Codeine Rugby Labs National PharmaceuticalGuiamid AC Vangard Labs National PharmaceuticalGlydeine Geneva Generics National PharmaceuticalTussin AC Bioline Labs National PharmaceuticalGuiafenesin w/Codeine Interstate Drug Exchange National PharmaceuticalGuiatuss AC Goldline Labs Barre-NationalCheratussin AC Life Labs Life LabsGuiatussin with /Codeine Rugby Labs Naska PharmacalMytussin AC My-K Labs My-K LabsTusscidin AC H R Cenci Labs H R Cenci LabsMytussin AC Pharmaceutical Basics Pharmaceutical Basics

CODEINE PHOSPHATE/GUAIFENESIN/PSEUDOEPHEDRINE HCLElixir

Myhistine Expectorant My-K Labs My-K LabsPhenylhistine Expectorant Life Labs Life LabsDihistine Expectorant Barre Drug National PharmaceuticalDihistine Expectorant Bioline Labs National PharmaceuticalDihistine Expectorant H L Moore Drug Exchange National PharmaceuticalDihistine Expectorant United Research Labs National PharmaceuticalDihistine Expectorant Bell Pharmacal National PharmaceuticalDihistine Expectorant Goldline Labs National PharmaceuticalW/W Histine Expectorant Whiteworth Pharmaceuticals National PharmaceuticalDecongestant Expectorant Henry Schein National PharmaceuticalPhenhist Expectorant Rugby Labs National PharmaceuticalDeproist Expect w/Codeine Geneva Generics National PharmaceuticalHistanel Expectorant Harnel Pharmaceutical National PharmaceuticalNovadyne Expectorant LuChem Pharmaceuticals LuChem Pharmaceuticals

CODEINE PHOSPHATE/GUAIFENESIN/PSEUDOEPHEDRINE HCLSyrup

Guiatuss DAC Barre Drug National PharmaceuticalGuiatussin DAC Rugby Labs National PharmaceuticalGuiatuss DAC Goldline Labs National PharmaceuticalTussin DAC Bioline Labs National PharmaceuticalMytussin DAC My-K Labs My-K LabsGuiatuss DAC Schein Pharmaceutical Barre-NationalMytussin DAC Pharmaceutical Basics Pharmaceutical Basics

CODEINE PHOSPHATE/IODINATED GLYCEROLSolution

Iophen-C Barre Drug National PharmaceuticalIophen-C Henry Schein National PharmaceuticalIophen-C Rugby Labs National PharmaceuticalBio-Tuss C Bioline Labs National PharmaceuticalTussi-r-gen Goldline Labs Barre-NationalMyodine C My-K Labs My-K LabsOridol-C LuChem Pharmaceuticals LuChem PharmaceuticalsIodur with Codeine Duramed Pharmaceuticals Duramed PharmaceuticalsIodur with Codeine Mason Distributors Duramed PharmaceuticalsIophen-C Rugby Labs Duramed PharmaceuticalsIophen-C Qualitest Duramed Pharmaceuticals

CODEINE PHOSPHATE/PHENYLEPHRINE HCL/PROMETHAZINE HCLSyrup

Prometh VC with Codeine Barre Drug National PharmaceuticalPrometh VC with Codeine Qualitest National PharmaceuticalPrometh VC with Codeine Goldline Labs Barre-NationalPrometh VC with Codeine Bioline Labs Barre-NationalPromethazine VC w/Codeine My-K Labs My-K LabsPromethazine VC w/Codeine H R Cenci Labs H R Cenci LabsPherazine VC w/Codeine Halsey Drug Halsey Drug

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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CODEINE PHOSPHATE/PROMETHAZINE HCLSyrup

Promethazine w/Codeine H R Cenci Labs H R Cenci LabsPromethazine w/Codeine My-K Labs My-K LabsPromethazine w/Codeine Goldline Labs Barre-National

CODEINE PHOSPHATE/PSEUDOEPHEDRINE HCLSyrup

Nucofed Beecham Labs Beecham Labs

CODEINE PHOSPHATE/PSEUDOEPHEDRINE HCL/TRIPROLIDINE HCLSyrup

Triacin-C Barre Drug National PharmaceuticalTriacin-C Glenlawn Labs National PharmaceuticalTriacin-C United Research Labs National PharmaceuticalTriacin-C Bioline Labs National PharmaceuticalPseudodine C My-K Labs My-K LabsHistafed C Life Labs Life LabsActagen-C Goldline Labs Barre-National

CODEINE SULFATETablets

Codeine Sulfate ICN Pharmaceuticals ICN PharmaceuticalsCodeine Sulfate Knoll Pharmaceutical Knoll PharmaceuticalCodeine Sulfate Purepac Pharmaceutical Purepac PharmaceuticalCodeine Sulfate Roxane Labs Roxane Labs

COLCHICINETablets

Colchicine Zenith Labs Zenith LabsColchicine Cooper Zenith LabsColchicine Interstate Drug Exchange Zenith LabsColchicine H L Moore Drug Exchange Zenith LabsColchicine Henry Schein Zenith LabsColchicine United Research Labs Zenith LabsColchicine Geneva Generics Zenith LabsColchicine McKesson Labs Zenith LabsColchicine Murray Drug Zenith LabsColchicine Vangard Labs Zenith LabsColchicine Gen-King Products Zenith LabsColchicine Glenlawn Labs Zenith LabsColchicine Major Pharmaceutical Corp Zenith LabsColchicine Bioline Labs Zenith LabsColchicine Goldline Labs Zenith LabsColchicine Genetco Zenith LabsColchicine Danbury Pharmacal Danbury PharmacalColchicine Thrift Drug Danbury PharmacalColchicine Bell Pharmacal Danbury PharmacalColchicine Qualitest Danbury PharmacalColchicine West-ward West-wardColchicine Rugby Labs West-wardColchicine Rugby Labs Chelsea LabsColchicine Halsey Drug Halsey DrugColchicine Interstate Drug Exchange Halsey DrugColchicine Barr Labs Barr LabsColchicine Regal Labs Barr LabsColchicine Purepac Pharmaceutical Purepac Pharmaceutical

CORTICOTROPIN (ACTH)Injection

Corticotropin (ACTH) Parke-Davis Parke-DavisCorticotropin Steris Labs Steris Labs

CYANOCOBALAMINInjection

Redisol Merck, Sharpe & Dohme Merck, Sharpe & DohmeCyanocobalamin Steris Labs Steris LabsCyanocobalamin Purepac Pharmaceutical Steris LabsCyanocobalamin Purepac Pharmaceutical Carter-Glogau LabsCyanocobalamin E R Squibb & Sons E R Squibb & SonsCyanocobalamin Dell Labs Dell LabsCyanocobalamin United Research Labs Dell LabsCyanocobalamin Goldline Labs Steris LabsCyanocobalamin Qualitest Steris Labs

28 § 25.58 PREVENTION OF DISEASES Pt. III

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Page 67: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

CYANOCOBALAMINInjection—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Cyanocobalamin Geneva Generics Steris LabsCyanocobalamin H L Moore Drug Exchange Steris LabsCyanocobalamin Bioline Labs Steris LabsCyanocobalamin Genetco Steris LabsCyanocobalamin Travenol Labs Steris LabsCyanocobalamin Major Pharmaceutical Corp Steris LabsCyanocobalamin Regal Labs Steris LabsCyanocobalamin Towne, Paulsen Steris LabsCyanocobalamin Interstate Drug Exchange Steris LabsVitamin B-12 Rugby Labs Steris LabsVitamin B-12 Schein Pharmaceutical Steris Labs

CYANOCOBALAMINTablets

Redisol Merck, Sharpe & Dohme Merck, Sharpe & DohmeVitamin B-12 United Research Labs Contract PharmacalVitamin B-12 McKesson Labs MK LabsVitamin B-12 United Research Labs Heather DrugVitamin B-12 Richlyn Labs Richlyn LabsVitamin B-12 Geneva Generics Freshlabs

CYCLANDELATECapsules

Cyclandelate Rugby Labs Chelsea LabsCyclandelate Sidmak Labs Sidmak LabsCyclandelate Parmed Pharmaceuticals Sidmak LabsCyclandelate Inwood Labs Inwood LabsCyclandelate United Research Labs Inwood LabsCyclandelate Vangard Labs Inwood LabsCyclandelate Henry Schein Inwood LabsCyclandelate Interstate Drug Exchange Inwood LabsCyclorex C S Ruckstuhl Inwood LabsCyclandelate Murray Drug Inwood LabsCyclandelate Geneva Generics Inwood LabsCyclandelate American Pharmaceutical Inwood LabsCyclar Artex Labs Inwood LabsAcaspas ACA, Inc Inwood LabsCyclandelate Rugby Labs Inwood LabsCyclandelate Pharmecon Inwood LabsCyclandelate Parmed Pharmaceuticals Inwood LabsCyclandelate Econo-Rx Inwood LabsCyclandelate Par Pharmaceutical Par PharmaceuticalCyclandelate Henry Schein Par PharmaceuticalCyclandelate Interstate Drug Exchange Par PharmaceuticalCyclandelate Vangard Labs Par PharmaceuticalCyclandelate Pharmecon West Par PharmaceuticalCyclandelate American Pharmaceutical Par PharmaceuticalCyclandelate Rugby Labs Par PharmaceuticalCyclandelate Thrift Drug Par PharmaceuticalCyclandelate Towne, Paulsen Par PharmaceuticalCyclandelate Geneva Generics Par PharmaceuticalCyclandelate Whiteworth Pharmaceuticals Par PharmaceuticalCyclandelate Bioline Labs Par PharmaceuticalCyclandelate United Research Labs Par PharmaceuticalAcaspas ACA, Inc Par PharmaceuticalCyclar Artex Labs Par PharmaceuticalCyclandelate Parmed Pharmaceuticals Par PharmaceuticalCyclandelate Unit Dose Labs Par PharmaceuticalCyclandelate Cooper Par PharmaceuticalCyclandelate Harber Pharmaceutical Par PharmaceuticalCyclandelate Zenith Labs Zenith LabsCyclandelate Henry Schein Zenith LabsCyclandelate Murray Drug Zenith LabsCyclandelate Vangard Labs Zenith LabsCyclandelate Regal Labs Zenith LabsCyclandelate Glenlawn Labs Zenith LabsCyclandelate Qualitest Zenith LabsCyclandelate Goldline Labs Zenith LabsCyclandelate Geneva Generics Cord LabsCyclandelate Pioneer Pharmaceuticals Pioneer PharmaceuticalsCyclandelate Goldline Labs Pioneer PharmaceuticalsCyclandelate Bioline Labs Pioneer PharmaceuticalsCyclandelate Towne, Paulsen Zenith Labs

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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CYCLOBENZAPRINE HCLTablets

Brand Name/Generic Name Distributed By: Manufactured By:

Cyclobenzaprine HCl Danbury Pharmacal Danbury Pharmacal

CYCLOPENTOLATE HCLOphthalmic Solution

Cyclogyl Alcon Labs Alcon LabsPentolair Pharmafair PharmafairCyclopentolate HCl United Research Labs Pharmafair

CYPROHEPTADINE HCLSyrup

Cyproheptadine HCl Barre Drug National PharmaceuticalCyproheptadine HCl Henry Schein National PharmaceuticalCyproheptadine HCl Rugby Labs National PharmaceuticalCyproheptadine HCl Glenlawn Labs National PharmaceuticalCyproheptadine HCl Murray Drug National PharmaceuticalCyproheptadine HCl Halsey Drug National PharmaceuticalCyproheptadine HCl Qualitest National PharmaceuticalCyproheptadine HCl Goldline Labs Barre-NationalCyproheptadine HCl Halsey Drug Halsey DrugCyproheptadine HCl My-K Labs My-K LabsCyproheptadine HCl Rugby Labs Naska Pharmacal

CYPROHEPTADINE HCLTablets

Cyproheptadine HCl Mylan Pharmaceuticals Mylan PharmaceuticalsCyproheptadine HCl Interstate Drug Exchange Mylan PharmaceuticalsCyproheptadine HCl Murray Drug Mylan PharmaceuticalsCyproheptadine HCl United Research Labs Mylan PharmaceuticalsCyproheptadine HCl Stayner Corp Mylan PharmaceuticalsCyproheptadine HCl H L Moore Drug Exchange Mylan PharmaceuticalsCyproheptadine HCl Henry Schein Mylan PharmaceuticalsCyproheptadine HCl Regal Labs Mylan PharmaceuticalsCyproheptadine HCl Geneva Generics Mylan PharmaceuticalsCyproheptadine HCl Danbury Pharmacal Danbury PharmacalCyproheptadine HCl United Research Labs Bolar PharmaceuticalCyproheptadine HCl Purepac Pharmaceutical Bolar PharmaceuticalCyproheptadine HCl Glenlawn Labs Bolar PharmaceuticalCyproheptadine HCl Bell Pharmacal Bolar PharmaceuticalCyproheptadine HCl Par Pharmaceutical Par PharmaceuticalCyproheptadine HCl H L Moore Drug Exchange Par PharmaceuticalCyproheptadine HCl General Generics Par PharmaceuticalCyproheptadine HCl Henry Schein Par PharmaceuticalCyproheptadine HCl Interstate Drug Exchange Par PharmaceuticalCyproheptadine HCl Harber Pharmaceutical Par PharmaceuticalCyproheptadine HCl Rugby Labs Chelsea LabsCyproheptadine HCl Geneva Generics Cord LabsCyproheptadine HCl Duramed Pharmaceuticals Duramed PharmaceuticalsCyproheptadine HCl Superpharm Corp Superpharm CorpCyproheptadine HCl Bioline Labs Superpharm CorpCyproheptadine HCl Goldline Labs Superpharm CorpCyproheptadine HCl Halsey Drug Halsey DrugCyproheptadine HCl Zenith Labs Zenith LabsCyproheptadine HCl Gen-King Products Zenith LabsCyproheptadine HCl Vangard Labs Zenith LabsCyproheptadine HCl Regal Labs Zenith LabsCyproheptadine HCl Henry Schein Zenith LabsCyproheptadine HCl Murray Drug Zenith LabsCyproheptadine HCl Interstate Drug Exchange Zenith LabsCyproheptadine HCl H L Moore Drug Exchange Zenith LabsCyproheptadine HCl Glenlawn Labs Zenith LabsCyproheptadine HCl Qualitest Zenith LabsCyproheptadine HCl Camall Co Camall CoCyproheptadine HCl United Research Labs Camall CoCyproheptadine HCl Parmed Pharmaceuticals Camall CoCyproheptadine HCl Interstate Drug Exchange Camall CoCyproheptadine HCl Rugby Labs Camall CoCyproheptadine HCl Cooper Camall CoCyproheptadine HCl H L Moore Drug Exchange Camall CoCyproheptadine HCl Mutual Pharmaceutical Camall CoCyproheptadine HCl Sidmak Labs Sidmak LabsCyproheptadine HCl Parmed Pharmaceuticals Sidmak LabsCyproheptadine HCl American Therapeutics American TherapeuticsCyproheptadine HCl Pioneer Pharmaceuticals Pioneer PharmaceuticalsCyproheptadine HCl Bioline Labs Zenith LabsCyproheptadine HCl Goldline Labs Zenith LabsCyproheptadine HCl Genetco Duramed Pharmaceutical

28 § 25.58 PREVENTION OF DISEASES Pt. III

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Page 69: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

CYPROHEPTADINE HCLTablets—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Cyproheptadine HCl Harber Pharmaceutical Duramed PharmaceuticalCyproheptadine HCl Qualitest Duramed PharmaceuticalCyproheptadine HCl Purepac Pharmaceutical Duramed Pharmaceutical

DANAZOLCapsules

Danazol American Therapeutics American TherapeuticsDanazol Major Pharmaceutical Corp American TherapeuticsDanazol Geneva Generics American TherapeuticsDanazol Bioline Labs American TherapeuticsDanazol Martec Pharmaceutical American TherapeuticsDanazol Regal Labs American TherapeuticsDanazol Harber Pharmaceutical American TherapeuticsDanazol Schein Pharmaceutical American TherapeuticsDanazol Glenlawn Labs American TherapeuticsDanazol Best Generics American TherapeuticsDanazol Qualitest American TherapeuticsDanazol Lemmon Co American TherapeuticsDanazol United Research Labs American TherapeuticsDanazol H L Moore Drug Exchange American TherapeuticsDanazol Parmed Pharmaceuticals American TherapeuticsDanazol Warner Chilcott Labs American TherapeuticsDanazol Rugby Labs American Therapeutics

DEHYDROCHOLIC ACIDTablets

Dehydrocholic Acid Richlyn Labs Richlyn Labs

DESIPRAMINE HCLTablets

Desipramine HCl Pharmaceutical Basics Pharmaceutical BasicsDesipramine HCl Sidmak Labs Sidmak LabsDesipramine HCl Geneva Generics Cord Labs

DEXAMETHASONEElixir

Decadron Merck, Sharpe & Dohme Merck, Sharpe & DohmeDecarex C S Ruckstuhl National PharmaceuticalDexamethasone Barre Drug National PharmaceuticalDexamethasone Vangard Labs National PharmaceuticalDexamethasone Henry Schein National PharmaceuticalDexamethasone United Research Labs National PharmaceuticalDexamethasone Rugby Labs National PharmaceuticalDexamethasone Murray Drug National PharmaceuticalDexamethasone H L Moore Drug Exchange National PharmaceuticalDexamethasone Bioline Labs National PharmaceuticalDexamethasone Richie Pharmacal National PharmaceuticalDexamethasone Qualitest National PharmaceuticalDexamethasone Goldline Labs Barre-NationalDexamethasone Rugby Labs Naska PharmacalMymethasone My-K Labs My-K Labs

DEXAMETHASONEOphthalmic Suspension

Dexamethasone Steris Labs Steris Labs

DEXAMETHASONETopical Spray

Aeroseb-Dex Herbert Labs Allergan Pharmaceutical

DEXAMETHASONE/NEOMYCIN SULFATE/POLYMYXIN-B SULFATEOphthalmic Ointment

Dexasporin Pharmafair PharmafairDexasporin United Research Labs Pharmafair

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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Page 70: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

DEXAMETHASONE/NEOMYCIN SULFATE/POLYMYXIN-B SULFATEOphthalmic Suspension

Brand Name/Generic Name Distributed By: Manufactured By:

Dexasporin Pharmafair PharmafairDexasporin United Research Labs PharmafairNeomycin & Polymyxin-B

Sulfates & Dexamethasone Steris Labs Steris LabsNeomycin & Polymyxin-B

Sulfates & Dexamethasone Hygeia Labs Steris LabsNeomycin & Polymyxin-B

Sulfates & Dexamethasone Danbury Pharmacal Steris LabsMaxigen Genetco Steris LabsDexamycin Schein Pharmaceutical Steris Labs

DEXAMETHASONE SODIUM PHOSPHATEInjection

Decadron Merck, Sharpe & Dohme Merck, Sharpe & DohmeDexamethasone Sodium

Phosphate Steris Labs Steris LabsDexamethasone Sodium

Phosphate Schein Pharmaceutical Steris LabsDexamethasone Sodium

Phosphate Goldline Labs Steris LabsDexamethasone Sodium

Phosphate Major Pharmaceutical Corp Steris LabsDexamethasone Sodium

Phosphate Interstate Drug Exchange Steris LabsDexamethasone Sodium

Phosphate Bioline Labs Steris LabsDexamethasone Sodium

Phosphate Rugby Labs Steris LabsDexamethasone Sodium

Phosphate H L Moore Drug Exchange Steris LabsDexamethasone Sodium

Phosphate Towne, Paulsen Steris LabsDexamethasone Sodium

Phosphate United Research Labs Steris LabsDexamethasone Sodium

Phosphate Geneva Generics Steris LabsDexamethasone Sodium

Phosphate Travenol Labs Steris LabsAK-DEX Akorn Steris Labs

DEXAMETHASONE SODIUM PHOSPHATEOphthalmic Ointment

Maxidex Alcon Labs Alcon LabsDexair Pharmafair Pharmafair

DEXAMETHASONE SODIUM PHOSPHATEOphthalmic Solution

Dexair Pharmafair PharmafairDexamethasone Sodium

Phosphate United Research Labs PharmafairDexamethasone Sodium

Phosphate Orbis Pharmaceuticals Carter-Glogau LabsDexamethasone Sodium

Phosphate Hygeia Labs Carter-Glogau LabsDexamethasone Sodium

Phosphate Steris Labs Steris LabsDexamethasone Sodium

Phosphate Danbury Pharmacal Steris LabsDexamethasone Sodium

Phosphate Parnel Pharmaceuticals Steris LabsDexamethasone Sodium

Phosphate Schein Pharmaceutical Steris LabsDexamethasone Sodium

Phosphate Regal Labs Steris Labs

DEXAMETHASONE SODIUM PHOSPHATE/NEOMYCIN SULFATEOphthalmic Solution

Neomycin Sulfate/DexamethasoneSodium Phosphate Carter-Glogau Labs Carter-Glogau Labs

Neomycin Sulfate/DexamethasoneSodium Phosphate Hygeia Labs Carter-Glogau Labs

Neomycin Sulfate/DexamethasoneSodium Phosphate Orbis Pharmaceuticals Carter-Glogau Labs

28 § 25.58 PREVENTION OF DISEASES Pt. III

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Page 71: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

DEXAMETHASONE SODIUM PHOSPHATE/NEOMYCIN SULFATEOphthalmic Solution—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Neomycin Sulfate/DexamethasoneSodium Phosphate Steris Labs Steris Labs

Neomycin Sulfate/DexamethasoneSodium Phosphate Danbury Pharmacal Steris Labs

Neo Dexair Pharmafair PharmafairNeomycin-Dex Schein Pharmaceutical Steris Labs

DEXCHLORPHENIRAMINE MALEATETablets

Dexchlorpheniramine Maleate Sidmak Labs Sidmak Labs

DEXPANTHENOLInjection

Dexpanthenol Steris Labs Steris Labs

DEXTROAMPHETAMINE SULFATETablets

Dexedrine Smith, Kline & French Smith, Kline & FrenchDextro Amphetamine Sulfate Lannett LannettDextroamphetamine Sulfate Halsey Drug Halsey DrugDextroamphetamine Sulfate Henry Schein Halsey DrugDextroamphetamine Sulfate Interstate Drug Exchange Halsey Drug

DEXTROMETHORPHAN HBRSyrup

DM Cough Syrup My-K Labs My-K Labs

DEXTROMETHORPHAN HBR/GUAIFENESINSyrup

Robitussin - DM A H Robins A H RobinsCheratussin DM Life Labs Life LabsMytussin DM My-K Labs My-K LabsGuiatuss-DM Goldline Labs Barre-NationalGuaitussinw/Dextromethorphan Rugby Labs Naska PharmacalGuaituss-DM Barre Drug National PharmaceuticalGuaituss-DM Richie Pharmacal National PharmaceuticalGuaituss-DM Henry Schein National PharmaceuticalGuaituss-DM United Research Labs National PharmaceuticalGuaituss-DM Glenlawn Labs National PharmaceuticalGuaituss-DM H L Moore Drug Exchange National PharmaceuticalGuaituss-DM Murray Drug National PharmaceuticalGuiamid DM Vangard Labs National PharmaceuticalGuaifenesin/DM Lederle Labs National PharmaceuticalTussin DM Bioline Labs National PharmaceuticalAcatuss-DM ACA National PharmaceuticalPharm-A-Tussin DM Peoples Drug National PharmaceuticalCo-Tuss DM Pharmacist Choice National PharmaceuticalTussin DM Revco Drug National PharmaceuticalRome-Tuss DM American Pharmaceutical National PharmaceuticalTuss-Ott DM Wasserotts National PharmaceuticalGuaitussin DM Cooper National PharmaceuticalGuaitussinw/Dextromethorphan Rugby Labs National PharmaceuticalGuaitussinw/Dextromethorphan Interstate Drug Exchange National PharmaceuticalMcKesson Cough FormulaExpectorant DM McKesson Labs National PharmaceuticalT-Tussin DM Thames Pharmacal Thames PharmacalMytussin DM Pharmaceutical Basics Pharmaceutical Basics

DEXTROMETHORPHAN HBR/GUAIFENESIN/PHENYLPROPANOLAMINE HCLSyrup

Brand Name/Generic Name Distributed By: Manufactured By:

Robitussin-CF A H Robins A H Robins

DEXTROMETHORPHAN HBR/GUAIFENESIN/PSEUDOEPHEDRINE HCLCapsules

Dimacol A H Robins A H Robins

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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DEXTROMETHORPHAN HBR/GUAIFENESIN/PSEUDOEPHEDRINE HCLLiquid

Brand Name/Generic Name Distributed By: Manufactured By:

Dimacol A H Robins A H Robins

DEXTROMETHORPHAN HBR/IODINATED GLYCEROLSolution

Iophen DM United Research Labs National PharmaceuticalIophen DM Glenlawn Labs National PharmaceuticalMyodine DM My-K Labs My-K LabsBiotuss DM Bioline Labs Barre-NationalTussi-R-Gen DM Goldline Labs Barre-NationalTorganic-DM Major Pharmaceutical Corp Barre-NationalIophen DM Barre-National Barre-NationalIophen DM Parmed Pharmaceuticals Barre-NationalIophen DM Qualitest Barre-NationalIophen DM H L Moore Drug Exchange Barre-NationalIophen DM Schein Pharmaceutical Barre-NationalIophen DM Rugby Labs Barre-NationalOridol-DM LuChem Pharmaceuticals LuChem PharmaceuticalsIodinated Glycerol DM Pharmaceutical Basics Pharmaceutical BasicsIodur DM Duramed Pharmaceuticals Duramed PharmaceuticalsIodur DM Mason Distributors Duramed PharmaceuticalsIophen DM Rugby Labs Duramed PharmaceuticalsIophen DM Qualitest Duramed PharmaceuticalsGenophen DM Genetco Duramed Pharmaceuticals

DEXTROMETHORPHAN HBR/PROMETHAZINE HCLSyrup

Prometh w/Dextromethorphan Barre Drug National PharmaceuticalPrometh w/Dextromethorphan Qualitest National PharmaceuticalPrometh w/Dextromethorphan Goldline Labs Barre-NationalPrometh w/Dextromethorphan My-K Labs My-K LabsPherazine DM Halsey Drug Halsey Drug

DEXTROMETHORPHAN HBR/TERPIN HYDRATEElixir

Terpin Hydrate andDextromethorphan HBR My-K Labs My-K Labs

Terpin Hydrate andDextromethorphan Barre Drug National Pharmaceutical

Terpin Hydrate andDextromethorphan Caldwell & Bloor National Pharmaceutical

Terpin Hydrate andDextromethorphan MacEslin National Pharmaceutical

Terpin Hydrate andDextromethorphan Rugby Labs National Pharmaceutical

Terpin Hydrate andDextromethorphan Vangard Labs National Pharmaceutical

Terpin Hydrate w/Dextromethorphan Glenlawn Labs National Pharmaceutical

Terpin Hydrate w/Dextromethorphan Rugby Labs Naska Pharmacal

Terpin Hydrate DM Goldline Labs Barre-NationalTerpin Hydrate DW Pharmaceutical Basics Pharmaceutical Basics

DIAZEPAMInjection

Diazepam Steris Labs Steris LabsDiazepam Schein Pharmaceutical Steris LabsDiazepam Bioline Labs Steris LabsDiazepam Rugby Labs Steris LabsDiazepam Interstate Drug Exchange Steris LabsDiazepam H L Moore Drug Exchange Steris LabsDiazepam Major Pharmaceutical Corp Steris LabsDiazepam United Research Labs Steris LabsDiazepam Lemmon Co Lemmon Co

DIAZEPAMTablets

Diazepam Rugby Labs Chelsea LabsQ-Pam Quantum Pharmics ICN CanadaDiazepam Mylan Pharmaceuticals Mylan PharmaceuticalsDiazepam Rugby Labs Mylan PharmaceuticalsDiazepam Parmed Pharmaceuticals Mylan Pharmaceuticals

28 § 25.58 PREVENTION OF DISEASES Pt. III

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Page 73: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

DIAZEPAMTablets—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Diazepam Geneva Generics Mylan PharmaceuticalsDiazepam H L Moore Drug Exchange Mylan PharmaceuticalsDiazepam United Research Labs Mylan PharmaceuticalsDiazepam Bioline Labs Mylan PharmaceuticalsDiazepam Regal Labs Mylan PharmaceuticalsDiazepam Qualitest Mylan PharmaceuticalsDiazepam Henry Schein Mylan PharmaceuticalsDiazepam Zenith Labs Zenith LabsDiazepam Purepac Pharmaceutical Zenith LabsDiazepam Gen-King Products Zenith LabsDiazepam Parmed Pharmaceuticals Zenith LabsDiazepam Genetco Zenith LabsDiazepam Interstate Drug Exchange Zenith LabsDiazepam Parke-Davis Parke-DavisDiazepam Par Pharmaceutical Par PharmaceuticalDiazepam Barr Labs Barr LabsDiazepam Purepac Pharmaceutical Purepac PharmaceuticalDiazepam Rondex Labs KalipharmaDiazepam Superpharm Corp Superpharm CorpDiazepam Bioline Labs Superpharm CorpDiazepam Goldline Labs Superpharm CorpDiazepam Lederle Labs Lederle LabsDiazepam Halsey Drug Halsey DrugDiazepam Qualitest Halsey DrugDiazepam Duramed Pharmaceuticals Duramed PharmaceuticalsDiazepam E R Squibb & Sons Zenith LabsDiazepam Schein Pharmaceutical Par PharmaceuticalDiazepam Martec Pharmaceutical Par PharmaceuticalDiazepam Best Generics Barr LabsDiazepam Cord Labs Cord LabsDiazepam Geneva Generics Cord LabsDiazepam Danbury Pharmacal Danbury PharmacalDiazepam Pharmaceutical Basics Ferndale LabsDiazepam Best Generics Ferndale Labs

DIBUCAINEOintment

Dibucaine United Research Labs Clay-Park LabsDibucaine H L Moore Drug Exchange Clay-Park LabsDibucaine Gen-King Products Clay-Park LabsDibucaine Clay-Park Labs Clay-Park LabsDibucaine Interstate Drug Exchange Clay-Park LabsDibucaine Henry Schein Clay-Park LabsDibucaine Bioline Labs Clay-Park Labs

DICLOXACILLIN SODIUMCapsules

Dynapen Bristol Labs Bristol LabsDycill Beecham Labs Beecham LabsPathocil Wyeth Labs Wyeth LabsDicloxacillin Sodium Henry Schein Biocraft LabsDicloxacillin Sodium Qualitest Biocraft LabsDicloxacillin Sodium Geneva Generics Biocraft LabsDicloxacillin Sodium United Research Labs Biocraft LabsDicloxacillin Sodium Purepac Pharmaceutical Biocraft LabsDicloxacillin Sodium Mutual Pharmaceutical Biocraft LabsDicloxacillin Sodium Goldline Labs Biocraft LabsDicloxacillin Sodium E R Squibb & Sons Biocraft Labs

DICLOXACILLIN SODIUMOral Suspension

Dynapen Bristol Labs Bristol LabsPathocil Wyeth Labs Wyeth Labs

DICYCLOMINE HCLCapsules

Dicyclomine HCl Barr Labs Barr LabsDicyclomine HCl Geneva Generics Barr LabsDicyclomine HCl Towne, Paulsen Barr LabsDicyclomine HCl Rugby Labs Chelsea LabsDicyclomine HCl Bolar Pharmaceutical Bolar PharmaceuticalDicyclomine HCl United Research Labs Bolar PharmaceuticalDicyclomine HCl Interstate Drug Exchange Bolar PharmaceuticalDicyclomine HCl Rugby Labs Bolar Pharmaceutical

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

25-71(202479) No. 253 Dec. 95

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DICYCLOMINE HCLCapsules—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Dicyclomine HCl Bioline Labs Bolar PharmaceuticalDicyclomine HCl H L Moore Drug Exchange Bolar PharmaceuticalDicyclomine HCl Vangard Labs Bolar PharmaceuticalDicyclomine HCl Glenlawn Labs Bolar PharmaceuticalDicyclomine HCl Geneva Generics Bolar PharmaceuticalDicyclomine HCl Vita-Rx Bolar PharmaceuticalDicyclomine HCl Richie Pharmacal Bolar PharmaceuticalDicyclomine HCl Murray Drug Bolar PharmaceuticalDicyclomine HCl Regal Labs Bolar PharmaceuticalBenacol H R Cenci Labs Bolar PharmaceuticalDicyclomine HCl Parmed Pharmaceuticals Bolar PharmaceuticalDicyclomine HCl Qualitest Bolar PharmaceuticalDicyclomine HCl Goldline Labs Bolar PharmaceuticalDicyclomine HCl Schein Pharmaceutical Bolar Pharmaceutical

DICYCLOMINE HCLInjection

Dicyclomine HCl Steris Labs Steris LabsDicyclomine HCl Rugby Labs Steris LabsDicyclomine HCl Bioline Labs Steris LabsDicyclomine HCl Major Pharmaceutical Corp Steris LabsDicyclomine HCl Travenol Labs Steris Labs

DICYCLOMINE HCLSyrup

Dicyclomine HCl Barre Drug National PharmaceuticalDicyclomine HCl Henry Schein National PharmaceuticalDicyclomine HCl Vangard Labs National PharmaceuticalDicyclomine HCl Rugby Labs National PharmaceuticalDicyclomine HCl Bioline Labs National PharmaceuticalDicyclomine HCl Qualitest National PharmaceuticalDicyclomine HCl Goldline Labs Barre-National

DICYCLOMINE HCLTablets

Dicyclomine HCl Barr Labs Barr LabsDicyclomine HCl Geneva Generics Barr LabsDicyclomine HCl Towne, Paulsen Barr LabsDicyclomine HCl Goldline Labs Barr LabsDicyclomine HCl Rugby Labs Chelsea LabsDicyclomine HCl Bolar Pharmaceutical Bolar PharmaceuticalDicyclomine HCl United Research Labs Bolar PharmaceuticalDicyclomine HCl Henry Schein Bolar PharmaceuticalDicyclomine HCl H R Cenci Labs Bolar PharmaceuticalDicyclomine HCl Bioline Labs Bolar PharmaceuticalDicyclomine HCl Richie Pharmacal Bolar PharmaceuticalDicyclomine HCl Vita-Rx Bolar PharmaceuticalDicyclomine HCl H L Moore Drug Exchange Bolar PharmaceuticalDicyclomine HCl Glenlawn Labs Bolar PharmaceuticalDicyclomine HCl Interstate Drug Exchange Bolar PharmaceuticalDicyclomine HCl Veratex Corp Bolar PharmaceuticalDicyclomine HCl Murray Drug Bolar PharmaceuticalDicyclomine HCl Regal Labs Bolar PharmaceuticalDicyclomine HCl Cooper Bolar PharmaceuticalDicyclomine HCl Bell Pharmacal Bolar PharmaceuticalDicyclomine HCl Qualitest Bolar PharmaceuticalDicyclomine HCl Parmed Pharmaceuticals Bolar PharmaceuticalDicyclomine HCl Pioneer Pharmaceuticals Pioneer Pharmaceuticals

DIETHYLPROPION HCLTablets

Diethylpropion HCl MD Pharmaceutical MD PharmaceuticalDiethylpropion HCl United Research Labs MD PharmaceuticalDiethylpropion HCl Camall Co Camall CoNova Tabs R P Thomas Camall CoDiPro Calvin Scott Camall Co

DIMENHYDRINATEElixir

Hydrinate Barre Drug National PharmaceuticalHydrinate Qualitest National PharmaceuticalMotion-Aid Vangard Labs National Pharmaceutical

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DIMENHYDRINATEElixir—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Dimenhydrinate Henry Schein National PharmaceuticalDimenhydrinate Rugby Labs National Pharmaceutical

DIMENHYDRINATEInjection

Dimenhydrinate Steris Labs Steris LabsDimenhydrinate United Research Labs Steris LabsDimenhydrinate Rugby Labs Steris LabsDimenhydrinate Travenol Labs Steris Labs

DIMENHYDRINATETablets

Dimenhydrinate Purepac Pharmaceutical Purepac PharmaceuticalDimenhydrinate Heather Drug Heather DrugDimenhydrinate United Research Labs Heather DrugDimenhydrinate Richlyn Labs Richlyn LabsDimenhydrinate Rugby Labs Chelsea LabsDimenhydrinate Barr Labs Barr LabsDimenhydrinate H L Moore Drug Exchange Barr LabsDimenhydrinate Geneva Generics Barr LabsDimenhydrinate Regal Labs Barr LabsDimenhydrinate Towne, Paulsen Barr LabsDimenhydrinate Qualitest Barr LabsDimenhydrinate Danbury Pharmacal Danbury PharmacalDimenhydrinate McKesson Labs Danbury PharmacalDimenhydrinate H L Moore Drug Exchange Danbury PharmacalDimenhydrinate United Research Labs Danbury PharmacalDimenhydrinate Interstate Drug Exchange Danbury PharmacalDimenhydrinate Henry Schein Danbury PharmacalDimenhydrinate West-ward West-wardDimenhydrinate Lannett LannettDimenhydrinate Amide Pharmaceutical Amide PharmaceuticalDimenhydrinate Geneva Generics Cord LabsDimenhydrinate American Therapeutics American Therapeutics

DIPHENHYDRAMINE HCLCapsules

Benadryl Parke-Davis Parke-DavisDiphenhydramine HCl Purepac Pharmaceutical Purepac PharmaceuticalDiphenhydramine HCl Lannett LannettDiphenhydramine HCl Rugby Labs Chelsea LabsDiphenhydramine HCl Roxane Labs Roxane LabsDiphenhydramine HCl McKesson Labs MK LabsDiphenhydramine HCl ICN Pharmaceuticals ICN PharmaceuticalsDiphenhydramine HCl Towne, Paulsen Towne, PaulsenDiphenhydramine HCl Parmed Pharmaceuticals Towne, PaulsenDiphenhydramine HCl Geneva Generics Cord LabsDiphenhydramine HCl Lemmon Co Lemmon CoDiphenhydramine HCl Pioneer Pharmaceuticals Pioneer PharmaceuticalsDiphenhydramine HCl Mutual Pharmaceutical Mutual PharmaceuticalDiphenhydramine HCl Danbury Pharmacal Danbury PharmacalDiphenhydramine HCl Henry Schein Danbury PharmacalDiphenhydramine HCl Interstate Drug Exchange Danbury PharmacalDiphenhydramine HCl United Research Labs Danbury PharmacalDiphenhydramine HCl Gen-King Products Danbury PharmacalCumbedryl Cumberland Pharmacal Danbury PharmacalDiphenhydramine HCl H L Moore Drug Exchange Danbury PharmacalDiphenhydramine HCl Parmed Pharmaceuticals Danbury PharmacalDiphenhydramine HCl Bell Pharmacal Danbury PharmacalDiphenhydramine HCl Qualitest Danbury PharmacalDiphenhydramine HCl Zenith Labs Zenith LabsDiphenhydramine HCl Gen-King Products Zenith LabsDiphenhydramine HCl United Research Labs Zenith LabsDiphenhydramine HCl Barr Labs Barr LabsDiphenhydramine HCl Regal Labs Barr LabsDibenil H R Cenci Labs Barr LabsDiphenhydramine HCl Newtron Pharmaceuticals Newtron PharmaceuticalsDiphenhydramine HCl United Research Labs Newtron PharmaceuticalsDiphenhydramine HCl Halsey Drug Halsey DrugDiphenhydramine HCl Interstate Drug Exchange Halsey DrugDiphenhydramine HCl Superpharm Corp Superpharm CorpDiphenhydramine HCl Goldline Labs Superpharm CorpDiphenhydramine HCl Richlyn Labs Richlyn LabsDiphenhydramine HCl Medco Supply Richlyn LabsDiphenhydramine HCl United Research Labs Richlyn LabsDiphenhydramine HCl Penta Products Richlyn Labs

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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DIPHENHYDRAMINE HCLCapsules—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Diphenhydramine HCl Interstate Drug Exchange Richlyn LabsDiphenhydramine HCl Coast Labs Richlyn LabsDiphenhydramine HCl Dixon-Shane Richlyn LabsDiphenhydramine HCl Gen-King Products Richlyn LabsDiphenhydramine HCl Ronda Pharmacal Richlyn LabsDibenil H R Cenci Labs Richlyn LabsCalhistryl Caldwell & Bloor Richlyn LabsBen-Rex C S Ruckstuhl Richlyn LabsTrux-Adryl C O Truxton Richlyn LabsHydramine Wesley Pharmacal Richlyn LabsDiphenhydramine HCl West-ward West-wardDiphenhydramine HCl H L Moore Drug Exchange West-wardDiphenhydramine HCl Rugby Labs West-wardDiphenhydramine HCl Harber Pharmaceutical West-wardDiphenhydramine HCl United Research Labs Mutual PharmaceuticalDiphenhydramine HCl Genetco Mutual PharmaceuticalDiphenhydramine HCl Best Generics Mutual Pharmaceutical

DIPHENHYDRAMINE HCLElixir

Benadryl Parke-Davis Parke-DavisDiphenhydramine HCl McKesson Labs MK LabsDiphenhydramine HCl Purepac Pharmaceutical Purepac PharmaceuticalDiphenhydramine HCl Lannett LannettBelix Halsey Drug Halsey DrugDiphenhydramine HCl United Research Labs KalipharmaDiphen My-K Labs My-K LabsDiphenhydramine Life Labs Life LabsDiphenhydramine HCl Barre Drug National PharmaceuticalDiphenhydramine HCl Henry Schein National PharmaceuticalDiphenhydramine HCl Rugby Labs National PharmaceuticalDiphenhydramine HCl H L Moore Drug Exchange National PharmaceuticalDiphenhydramine HCl Lederle Labs National PharmaceuticalDiphenhydramine HCl Cooper National PharmaceuticalHydramine Richie Pharmacal National PharmaceuticalHydramine Murray National PharmaceuticalDiphenhydramine Vangard Labs National PharmaceuticalTruxadryl C O Truxton National PharmaceuticalDiphenhydramine HCl United Research Labs National PharmaceuticalDiphenhydramine HCl Purepac Pharmaceutical National PharmaceuticalDiphenhydramine HCl Glenlawn Labs National PharmaceuticalDiphenhydramine Interstate Drug Exchange National PharmaceuticalDiphenhydramine Ronda Pharmacal National PharmaceuticalDiphenhydramine American Pharmaceutical National PharmaceuticalDiphenhydramine HCl Bioline Labs National PharmaceuticalDiphenhydramine HCl Whiteworth Pharmaceuticals National PharmaceuticalHydramine Vita-Rx National PharmaceuticalHydramine Bell Pharmacal National PharmaceuticalBeldin Halsey Drug National PharmaceuticalSynadryl Syncon Pharmaceutical National PharmaceuticalBendyl-Ott Wasserotts National PharmaceuticalBen Rex C S Ruckstuhl National PharmaceuticalFenylhist Mallard National PharmaceuticalPenta-Diphon Penta Products National PharmaceuticalMedadryl Medco Supply National PharmaceuticalDiphenhydramine Geneva Generics National PharmaceuticalHydramine Goldline Labs Barre-NationalPhendryl LuChem Pharmaceuticals LuChem PharmaceuticalsDibenil H R Cenci Labs H R Cenci LabsDiphen Pharmaceutical Basics Pharmaceutical Basics

DIPHENHYDRAMINE HCLInjection

Benadryl Parke-Davis Parke-DavisDiphenhydramine HCl United Research Labs Carter-Glogau LabsDiphenhydramine HCl Steris Labs Steris LabsDiphenhydramine HCl Goldline Labs Steris LabsDiphenhydramine HCl Schein Pharmaceutical Steris LabsDiphenhydramine HCl Bioline Labs Steris LabsDiphenhydramine HCl Towne, Paulsen Steris LabsDiphenhydramine HCl Rugby Labs Steris LabsDiphenhydramine HCl Interstate Drug Exchange Steris Labs

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DIPHENHYDRAMINE HCLSyrup

Brand Name/Generic Name Distributed By: Manufactured By:

Hydramine Cough Syrup Goldline Labs National PharmaceuticalDiphenhydramine Cough Syr Rugby Labs National PharmaceuticalDiphenhydramine Cough Syr United Research Labs National PharmaceuticalDiphenhydramine Cough Syr Geneva Generics National PharmaceuticalHydramine Cough Syrup Barre Drug National PharmaceuticalDiphenhydramine HCl Expectorant Purepac Pharmaceutical Purepac PharmaceuticalDiphenhydramine HCl Life Labs Life LabsDiphen Cough Syrup My-K Labs My-K LabsBeldin Cough Syrup Halsey Drug Halsey DrugDiphenhydramine Cough Syr Harber Pharmaceutical Halsey Drug

DIPYRIDAMOLETablets

Dipyridamole Superpharm Corp Superpharm CorpDipyridamole Bioline Labs Superpharm CorpDipyridamole Goldline Labs Superpharm CorpDipyridamole Rugby Labs Chelsea LabsDipyridamole Danbury Pharmacal Danbury PharmacalDipyridamole Par Pharmaceutical Par PharmaceuticalDipyridamole Purepac Pharmaceutical Purepac PharmaceuticalDipyridamole Mutual Pharmaceutical Mutual PharmaceuticalDipyridamole Sidmak Labs Sidmak LabsDipyridamole United Research Labs Sidmak LabsDipyridamole Travenol Labs Sidmak LabsDipyridamole Dixon-Shane Sidmak LabsDipyridamole Genetco Sidmak LabsDipyridamole Parmed Pharmaceuticals Sidmak LabsDipyridamole Mutual Pharmaceutical Sidmak LabsDipyridamole Schein Pharmaceutical Par PharmaceuticalDipyridamole United Research Labs Mutual PharmaceuticalDipyridamole Genetco Mutual PharmaceuticalDipyridamole Cord Labs Cord LabsDipyridamole Geneva Generics Cord LabsDipyridamole Towne, Paulsen Mutual PharmaceuticalDipyridamole Goldline Labs Par PharmaceuticalDipyridamole Barr Labs Barr LabsDipyridamole Rugby Labs Barr LabsDipyridamole Glenlawn Labs Barr LabsDipyridamole Lederle Labs Barr LabsDipyridamole Purepac Pharmaceutical Mutual PharmaceuticalDipyridamole Pharmaceutical Basics Pharmaceutical Basics

DISOPYRAMIDE PHOSPHATECapsules

Disopyramide Phosphate Mylan Pharmaceuticals Mylan PharmaceuticalsDisopyramide Phosphate United Research Labs Mylan PharmaceuticalsDisopyramide Phosphate Danbury Pharmacal Danbury PharmacalDisopyramide Phosphate Parmed Pharmaceuticals Danbury PharmacalDisopyramide Phosphate Geneva Generics Danbury PharmacalDisopyramide Phosphate Biocraft Labs Biocraft LabsDisopyramide Phosphate Lederle Labs Biocraft LabsDisopyramide Phosphate Qualitest Biocraft LabsDisopyramide Phosphate H L Moore Drug Exchange Biocraft LabsDisopyramide Phosphate Zenith Labs Zenith LabsDisopyramide Phosphate Bolar Pharmaceutical Bolar PharmaceuticalDisopyramide Phosphate Rugby Labs Chelsea LabsDisopyramide Phosphate Cord Labs Cord LabsDisopyramide Phosphate Geneva Generics Cord LabsDisopyramide Phosphate Interpharm InterpharmDisopyramide Phosphate Superpharm Corp Superpharm CorpDisopyramide Phosphate Barr Labs Barr LabsDisopyramide Phosphate Bioline Labs Biocraft Labs

DOCUSATE CALCIUMCapsules

DCS J J Balan Chase ChemicalDocusate Calcium Geneva Generics Chase ChemicalDocusate Calcium Geneva Generics PharmacapsDocusate Calcium United Research Labs Pharmacaps

DOCUSATE POTASSIUMCapsules

Docu-K Newtron Pharmaceuticals Newtron PharmaceuticalsDSMC Geneva Generics Newtron Pharmaceuticals

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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DOCUSATE SODIUMCapsules

Brand Name/Generic Name Distributed By: Manufactured By:

Dioctyl Sodium Sulfosuccinate Rugby Labs Chelsea LabsDioctyl Sodium Sulfosuccinate Geneva Generics R P SchererDioctyl Sodium Sulfosuccinate Lederle Labs R P SchererDioctyl Sodium Sulfosuccinate West-ward R P SchererDioctyl Sodium Sulfosuccinate McKesson Labs R P SchererRegul-Aids Columbia Medical R P SchererDiocto Purepac Pharmaceutical R P SchererPro-Sof Vangard Labs R P SchererD S S Towne, Paulsen R P SchererD S S H L Moore Drug Exchange R P SchererDisonate Lannett R P SchererDionex Interstate Drug Exchange R P SchererDoxinate Hoechst-Roussel R P SchererD S S Parke-Davis R P SchererDi-Octo Softeze Richlyn Labs Richlyn LabsDossitol Drug Guild Distributors PharmacapsDioctyl Sodium Sulfosuccinate United Research Labs PharmacapsDocusate Sodium Gen-King Products PharmacapsDocusate Sodium Murray Drug PharmacapsDocusate Sodium Rugby Labs PharmacapsDocusate Sodium Cooper PharmacapsDocusate Sodium Henry Schein PharmacapsDocusate Sodium Geneva Generics PharmacapsDiocto Purepac Pharmaceutical PharmacapsDicole Halsey Drug PharmacapsRegul-Aids Columbia Medical PharmacapsDiocto J J Balan EncapsulationsDocusate Sodium Geneva Generics Chase ChemicalDocusate Sodium Vitarine Pharmaceutical Vitarine PharmaceuticalDocusate Sodium LuChem Pharmaceuticals LuChem Pharmaceuticals

DOCUSATE SODIUMSolution

Diocto Rugby Labs Naska Pharmacal

DOCUSATE SODIUMSyrup

Diocto Barre Drug National PharmaceuticalDiocto H L Moore Drug Exchange National PharmaceuticalDiocto United Research Labs National PharmaceuticalDiocto Murray Drug National PharmaceuticalDiocto Glenlawn Labs National PharmaceuticalDiocto Bioline Labs National PharmaceuticalDiocto Richie Pharmacal National PharmaceuticalDiocto Bell Pharmacal National PharmaceuticalDiocto Rugby Labs National PharmaceuticalDioctyl American Pharmaceutical National PharmaceuticalD S S Henry Schein National PharmaceuticalPro-Sof Vangard Labs National PharmaceuticalDioctal Cooper National PharmaceuticalDossitol Harber Pharmaceutical National PharmaceuticalDionex Interstate Drug Exchange National PharmaceuticalDicole Halsey Drug National PharmaceuticalDSS Geneva Generics National PharmaceuticalDioctyl Sodium Sulfosuccinate Lederle Labs National PharmaceuticalDioctyl Sodium Sulfosuccinate West-ward West-wardDisonate Lannett LannettDiocto Rugby Labs Naska PharmacalDSS Newtron Pharmaceuticals Newtron PharmaceuticalsDiocto United Research Labs Newtron PharmaceuticalsDoss My-K Labs My-K LabsDiocto Goldline Labs Barre-National

DOCUSATE SODIUMTablets

Docusate Sodium Rugby Labs Vitarine CoDocusate Sodium LuChem Pharmaceuticals LuChem Pharmaceuticals

DOXEPIN HCLCapsules

Brand Name/Generic Name Distributed By: Manufactured By:

Adapin Penwalt Corp Smith, Kline & FrenchDoxepin HCl Rugby Labs Chelsea LabsDoxepin HCl Danbury Pharmacal Danbury PharmacalDoxepin HCl Cord Labs Cord Labs

28 § 25.58 PREVENTION OF DISEASES Pt. III

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DOXEPIN HCLCapsules—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Doxepin HCl Geneva Generics Cord LabsDoxepin HCl Mylan Pharmaceuticals Mylan PharmaceuticalsDoxepin HCl Bioline Labs Mylan PharmaceuticalsDoxepin HCl Schein Pharmaceutical Mylan PharmaceuticalsDoxepin HCl Rugby Labs Mylan PharmaceuticalsDoxepin HCl H L Moore Drug Exchange Mylan PharmaceuticalsDoxepin HCl Purepac Pharmaceutical Mylan PharmaceuticalsDoxepin HCl United Research Labs Mylan PharmaceuticalsDoxepin HCl Goldline Labs Mylan PharmaceuticalsDoxepin HCl Regal Labs Mylan PharmaceuticalsDoxepin HCl Glenlawn Labs Mylan PharmaceuticalsDoxepin HCl Parmed Pharmaceuticals Mylan PharmaceuticalsDoxepin HCl Major Pharmaceutical Corp Mylan PharmaceuticalsDoxepin HCl Lemmon Co Mylan PharmaceuticalsDoxepin HCl Texas Drug Reps Mylan PharmaceuticalsDoxepin HCl Interstate Drug Exchange Mylan PharmaceuticalsDoxepin HCl Qualitest Mylan PharmaceuticalsDoxepin HCl Best Generics Mylan PharmaceuticalsDoxepin HCl Barr Labs Barr LabsDoxepin HCl Dixon-Shane Mylan PharmaceuticalsDoxepin HCl Baxter Healthcare Corp Mylan PharmaceuticalsDoxepin HCl Par Pharmaceutical Par PharmaceuticalDoxepin HCl Martec Pharmaceutical Par Pharmaceutical

DOXEPIN HCLOral Solution

Doxepin HCl (Concentrate) Copley Pharmaceutical Copley PharmaceuticalDoxepin HCl (Concentrate) Pharmaceutical Basics Pharmaceutical Basics

DOXYCYCLINEFor Suspension

Doxychel Rachelle Labs Rachelle Labs

DOXYCYCLINE HYCLATECapsules

Doxychel Hyclate Rachelle Labs Rachelle LabsDoxycycline Hyclate United Research Labs Rachelle LabsDoxycycline Hyclate Purepac Pharmaceutical Rachelle LabsDoxycycline Hyclate Rugby Labs Rachelle LabsDoxycycline Hyclate Geneva Generics Rachelle LabsDoxycycline Hyclate Bioline Labs Rachelle LabsDoxycycline Hyclate Cooper Rachelle LabsDoxycycline Hyclate Glenlawn Labs Rachelle LabsDoxycycline Hyclate Harber Pharmaceutical Rachelle LabsDoxycycline Hyclate Henry Schein Rachelle LabsDoxycycline Hyclate Interstate Drug Exchange Rachelle LabsDoxycycline Hyclate Major Pharmaceutical Corp Rachelle LabsDoxycycline Hyclate Murray Drug Rachelle LabsDoxycycline Hyclate Parmed Pharmaceuticals Rachelle LabsDoxycycline Hyclate Regal Labs Rachelle LabsDoxycycline Hyclate Richie Pharmacal Rachelle LabsDoxycycline Hyclate Towne, Paulsen Rachelle LabsDoxycycline Hyclate Unit Dose Labs Rachelle LabsDoxycycline Hyclate Vangard Labs Rachelle LabsDoxycycline Hyclate West-ward Rachelle LabsDoxycycline Hyclate Danbury Pharmacal Danbury PharmacalDoxycycline Hyclate Bell Pharmacal Danbury PharmacalDoxycycline Hyclate Parmed Pharmaceuticals Danbury PharmacalDoxycycline Hyclate Qualitest Danbury PharmacalDoxycycline Hyclate Geneva Generics Danbury PharmacalDoxycycline Hyclate United Research Labs Danbury PharmacalDoxycycline Hyclate Rugby Labs Chelsea LabsDoxycycline Hyclate Mylan Pharmaceuticals Mylan PharmaceuticalsDoxycycline Hyclate Lederle Labs Mylan PharmaceuticalsDoxycycline Hyclate United Research Labs Mylan PharmaceuticalsDoxycycline Hyclate Lemmon Co Lemmon CoDoxycycline Hyclate D-M Pharmaceuticals Lemmon CoDoxycycline Hyclate Parmed Pharmaceuticals Lemmon CoDoxycycline Hyclate Interstate Drug Exchange Lemmon CoDoxycycline Hyclate Major Pharmaceutical Corp Lemmon CoDoxycycline Hyclate Barr Labs Barr LabsDoxycycline Hyclate Regal Labs Barr LabsDoxycycline Hyclate Par Pharmaceutical Par PharmaceuticalDoxycycline Hyclate Purepac Pharmaceutical Purepac PharmaceuticalDoxycycline Hyclate Superpharm Corp Superpharm CorpDoxycycline Hyclate Bioline Labs Superpharm Corp

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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DOXYCYCLINE HYCLATECapsules—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Doxycycline Hyclate Goldline Labs Superpharm CorpDoxycycline Hyclate Zenith Labs Zenith LabsDoxycycline Hyclate Towne, Paulsen Zenith LabsDoxycycline Hyclate H L Moore Drug Exchange Zenith LabsDoxycycline Hyclate Vitarine Pharmaceutical Vitarine PharmaceuticalDoxycycline Hyclate Private Formulations Private FormulationsDoxycycline Hyclate Mutual Pharmaceutical Mutual PharmaceuticalDoxycycline Hyclate United Research Labs Mutual PharmaceuticalDoxycycline Hyclate Halsey Drug Halsey DrugDoxycycline Hyclate Rondex Labs KalipharmaDoxycycline Hyclate Heather Drug Heather DrugDoxycycline Hyclate Interstate Drug Exchange Zenith LabsDoxycycline Hyclate Major Pharmaceutical Corp Zenith LabsDoxycycline Hyclate Martec Pharmaceutical Par PharmaceuticalDoxycycline Hyclate Genetco Mutual PharmaceuticalDoxycycline Hyclate Dixon-Shane Mutual PharmaceuticalDoxycycline Hyclate Best Generics Mutual PharmaceuticalDoxycycline Hyclate Towne, Paulsen Mutual PharmaceuticalDoxycycline Hyclate J J Balan Mutual PharmaceuticalDoxycycline Hyclate Warner Chilcott Labs Mutual PharmaceuticalDoxycycline Hyclate Lemmon Co Par PharmaceuticalDoxycycline Hyclate Parke-Davis Parke-DavisDoxycycline Hyclate West-ward West-wardDoxycycline Hyclate H L Moore Drug Exchange West-wardDoxy-D Dunhall Pharmaceuticals West-wardDoxycycline Hyclate Interstate Drug Exchange West-ward

DOXYCYCLINE HYCLATETablets

Doxy-Tabs Rachelle Labs Rachelle LabsDoxycycline Hyclate Vangard Labs Rachelle LabsDoxycycline Hyclate United Research Labs Rachelle LabsDoxycycline Hyclate Geneva Generics Rachelle LabsDoxycycline Hyclate Henry Schein Rachelle LabsDoxycycline Hyclate Rugby Labs Rachelle LabsDoxycycline Hyclate Richie Pharmacal Rachelle LabsDoxycycline Hyclate Regal Labs Rachelle LabsDoxycycline Hyclate Bioline Labs Rachelle LabsDoxycycline Hyclate Parmed Pharmaceuticals Rachelle LabsDoxycycline Hyclate Murray Drug Rachelle LabsDoxycycline Hyclate Cooper Rachelle LabsDoxycycline Hyclate Harber Pharmaceutical Rachelle LabsDoxycycline Hyclate Major Pharmaceutical Corp Rachelle LabsDoxycycline Hyclate Towne, Paulsen Rachelle LabsDoxycycline Hyclate Unit Dose Labs Rachelle LabsDoxycycline Hyclate Barr Labs Barr LabsDoxycycline Hyclate Danbury Pharmacal Danbury PharmacalDoxycycline Hyclate Parmed Pharmaceuticals Danbury PharmacalDoxycycline Hyclate Geneva Generics Danbury PharmacalDoxycycline Hyclate United Research Labs Danbury PharmacalDoxycycline Hyclate Qualitest Danbury PharmacalDoxy-Lemmon Lemmon Co Danbury PharmacalDoxycycline Hyclate Mylan Pharmaceuticals Mylan PharmaceuticalsDoxycycline Hyclate United Research Labs Mylan PharmaceuticalsDoxycycline Hyclate Rugby Labs Chelsea LabsDoxycycline Hyclate Heather Drug Heather DrugDoxycycline Hyclate Zenith Labs Zenith LabsDoxycycline Hyclate H L Moore Drug Exchange Zenith LabsDoxycycline Hyclate Regal Labs Zenith LabsDoxycycline Hyclate Towne, Paulsen Zenith LabsDoxycycline Hyclate Purepac Pharmaceutical Zenith LabsDoxycycline Hyclate Mutual Pharmaceutical Mutual PharmaceuticalDoxy-Lemmon Lemmon Co Lemmon CoDoxycycline Hyclate Interstate Drug Exchange Zenith LabsDoxycycline Hyclate United Research Labs Mutual PharmaceuticalDoxycycline Hyclate Dixon-Shane Mutual PharmaceuticalDoxycycline Hyclate Best Generics Mutual PharmaceuticalDoxycycline Hyclate Towne, Paulsen Mutual PharmaceuticalDoxycycline Hyclate Warner Chilcott Labs Mutual PharmaceuticalDoxycycline Hyclate Pharbita B V PharbitaDoxycycline Hyclate Martec Pharmaceutical B V PharbitaDoxycycline Hyclate La Salle Labs B V PharbitaPoly V Poly Pharmaceuticals B V PharbitaDoxycycline Hyclate Parke-Davis Parke-DavisDoxycycline Hyclate Medicopharma B V Pharbita

28 § 25.58 PREVENTION OF DISEASES Pt. III

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DYPHYLLINE/GUAIFENESINElixir

Brand Name/Generic Name Distributed By: Manufactured By:

Diphylline GG Barre Drug National PharmaceuticalDiphylline GG Qualitest Barre-NationalDiphylline GG Bioline Labs Barre-NationalDiphylline GG Rugby Labs Barre-NationalDiphylline GG Goldline Labs Barre-NationalLufenesin-G Major Pharmaceutical Corp Barre-National

EPHEDRINE SULFATECapsules

Ephedrine Sulfate Richlyn Labs Richlyn LabsEphedrine Sulfate United Research Labs Richlyn LabsEphedrine Sulfate Rugby Labs Chelsea LabsEphedrine Sulfate West-ward West-wardEphedrine Sulfate Goldline Labs Richlyn LabsEphedrine Sulfate Towne, Paulsen Towne, Paulsen

EPHEDRINE SULFATE/GUAIFENESIN/PHENOBARBITAL/THEOPHYLLINEElixir

Guiaphed Rugby Labs National PharmaceuticalTussed Bioline Labs National PharmaceuticalGuiaphed Barre-National Barre-NationalGuiaphed Goldline Labs Barre-National

EPHEDRINE SULFATE/HYDROXYZINE HCL/THEOPHYLLINESyrup

Hydroxyzine Compound Barre Drug National PharmaceuticalHydroxyzine Compound Murray Drug National PharmaceuticalHydroxyzine Compound Vangard Labs National PharmaceuticalBrophed Bioline Labs National PharmaceuticalTheozine Henry Schein National PharmaceuticalHydrofed DF Rugby Labs National PharmaceuticalHydrofed DF Rugby Labs Naska PharmacalTheomax df Goldline Labs Barre-National

EPHEDRINE SULFATE/ISOPROTERENOL HCL/PHENOBARBITAL/POTASSIUM IODIDE/THEOPHYLLINEElixir

Isolate Compound Barre Drug National PharmaceuticalIsolate Compound Murray Drug National PharmaceuticalIsolate Compound C S Ruckstuhl National PharmaceuticalIsolate Compound Bioline Labs National PharmaceuticalIsolate Compound Qualitest National PharmaceuticalIsogen Compound Rugby Labs National PharmaceuticalIsolate Henry Schein National PharmaceuticalIsoproterenol Compound Vangard Labs National PharmaceuticalIsolate Compound Goldline Labs Barre-National

EPINEPHRINE/LIDOCAINE HCLInjection

Lidocaine HCl/Epinephrine Bel-Mar Labs Bel-Mar LabsLidocaine HCl/Epinephrine Rugby Labs Bel-Mar Labs

EPINEPHRINE BITARTRATEOphthalmic Solution

Mytrate Optopics Labs Optopics Labs

EPINEPHRINE BITARTRATE/PILOCARPINE HCLOphthalmic Solution

PE Alcon Labs Alcon Labs

EPINEPHRINE HCLFor Injection

Adrenalin Parke-Davis Parke-DavisEpinephrine Bel-Mar Labs Bel-Mar LabsEpinephrine Rugby Labs Bel-Mar Labs

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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EPINEPHRINE HCLOphthalmic Solution

Brand Name/Generic Name Distributed By: Manufactured By:

Glaucon Alcon Labs Alcon LabsEpifrin Allergan Pharmaceutical Allergan Pharmaceutical

EPINEPHRYL BORATEOphthalmic Solution

Epinal Alcon Labs Alcon Labs

ERGOCALCIFEROLCapsules

Vitamin D Richlyn Labs R P SchererVitamin D United Research Labs Pharmacaps

ERGOLOID MESYLATESSublingual Tablets

Deapril-ST Mead Johnson Lab Mead Johnson LabHydrogenated ErgotAlkaloids Bolar Pharmaceutical Bolar PharmaceuticalHydrogenated ErgotAlkaloids H L Moore Drug Exchange Bolar PharmaceuticalHydro-Ergoloid Henry Schein Bolar PharmaceuticalGerigene Rugby Labs Bolar PharmaceuticalHydro-Ergot Interstate Drug Exchange Bolar PharmaceuticalUni-gine United Research Labs Bolar PharmaceuticalErgoloid Mesylates Glenlawn Labs Bolar PharmaceuticalErgoloid Mesylates Geneva Generics Bolar PharmaceuticalErgoloid Mesylates Parmed Pharmaceuticals Bolar PharmaceuticalErgoloid Mesylates Cooper Bolar PharmaceuticalErgoloid Mesylates Richie Pharmacal Bolar PharmaceuticalErgoloid Mesylates H R Cenci Labs Bolar PharmaceuticalErgoloid Mesylates Murray Drug Bolar PharmaceuticalErgoloid Mesylates Vita-Rx Bolar PharmaceuticalErgoloid Mesylates Whiteworth Pharmaceuticals Bolar PharmaceuticalErgoloid Mesylates Gen-King Products Bolar PharmaceuticalErgoloid Mesylates Regal Labs Bolar PharmaceuticalErgoloid Mesylates Arkansas Cooperative Assn Bolar PharmaceuticalErgoloid Mesylates Ronda Pharmacal Bolar PharmaceuticalErgoloid Mesylates Penta Products Bolar PharmaceuticalErgoloid Mesylates Mutual Pharmaceutical Bolar PharmaceuticalErgoloid Mesylates Goldline Labs Bolar PharmaceuticalHydrogen Bioline Labs Bolar PharmaceuticalErgoloid Mesylates Superpharm Corp Superpharm CorpErgoloid Mesylates Bioline Labs Superpharm CorpErgoloid Mesylates Goldline Labs Superpharm CorpCircanol Riker Labs Riker LabsHydergine Sandoz Pharmaceuticals Sandoz PharmaceuticalsGerimal Rugby Labs Chelsea LabsErgoloid Mesylates KV Pharmaceutical KV PharmaceuticalErgoloid Mesylates Danbury Pharmacal Danbury PharmacalErgoloid Mesylates Qualitest Danbury PharmacalErgoloid Mesylates Bell Pharmacal Danbury PharmacalErgoloid Mesylates Geneva Generics Danbury PharmacalErgoloid Mesylates Parmed Pharmaceuticals Danbury Pharmacal

ERGOLOID MESYLATESTablets

Ergoloid Mesylates Danbury Pharmacal Danbury PharmacalErgoloid Mesylates Geneva Generics Danbury PharmacalErgoloid Mesylates Qualitest Danbury PharmacalErgoloid Mesylates Parmed Pharmaceuticals Danbury PharmacalErgoloid Mesylates Bell Pharmacal Danbury PharmacalErgoloid Mesylates Bolar Pharmaceutical Bolar PharmaceuticalErgoloid Mesylates Bell Pharmacal Bolar PharmaceuticalErgoloid Mesylates Parmed Pharmaceuticals Bolar PharmaceuticalErgoloid Mesylates Purepac Pharmaceutical Bolar PharmaceuticalErgoloid Mesylates Best Generics Bolar PharmaceuticalErgoloid Mesylates Mutual Pharmaceutical Bolar PharmaceuticalErgoloid Mesylates Goldline Labs Bolar PharmaceuticalGerimal Rugby Labs Bolar PharmaceuticalUni-Gene United Research Labs Bolar PharmaceuticalErgoloid Mesylates Rugby Labs Chelsea LabsHydro-Ergoloid Schein Pharmaceutical Danbury PharmacalErgoloid Mesylates Barr Labs Barr Labs

28 § 25.58 PREVENTION OF DISEASES Pt. III

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ERGOTAMINE TARTRATESublingual Tablets

Brand Name/Generic Name Distributed By: Manufactured By:

Ergostat Parke-Davis Parke-Davis

ERYTHROMYCINOphthalmic Ointment

Erythromycin Pharmafair PharmafairErythromycin United Research Labs PharmafairErythromycin E Fougera AltanaErythromycin Pharmaderm Altana

ERYTHROMYCINTopical Solution

EryDerm Abbott Labs Abbott LabsErythromycin Barre Drug National PharmaceuticalErythromycin Rugby Labs National PharmaceuticalErythromycin Bioline Labs National PharmaceuticalErythromycin Qualitest National PharmaceuticalErymax Herbert Labs National PharmaceuticalErythromycin Pharmafair PharmafairErythromycin Schein Pharmaceutical Barre-NationalMythromycin My-K Labs My-K LabsErythromycin Goldline Labs Barre-NationalErythromycin Rugby Labs Naska Pharmacal

ERYTHROMYCIN BASETablets

Erythromycin Base Filmtab Abbott Labs Abbott Labs

ERYTHROMYCIN BASEEnteric Coated Pellets in Capsules

Erythromycin Delayed-release Abbott Pharmaceuticals Abbott Pharmaceuticals

ERYTHROMYCIN BASEEnteric Coated Tablets

E-Mycin Upjohn Co Upjohn CoRobimycin A H Robins A H RobinsE-Base Barr Labs Barr Labs

ERYTHROMYCIN ESTOLATEOral Suspension

Erythromycin Estolate Barre Drug National PharmaceuticalErythromycin Estolate United Research Labs National PharmaceuticalErythromycin Estolate Bioline Labs National PharmaceuticalErythromycin Estolate H L Moore Drug Exchange National PharmaceuticalErythromycin Estolate Henry Schein National PharmaceuticalErythromycin Estolate Whiteworth Pharmaceuticals National PharmaceuticalErythromycin Estolate Rugby Labs National PharmaceuticalErythromycin Estolate Qualitest National PharmaceuticalErythromycin Estolate Goldline Labs Barre-NationalErythromycin Estolate Schein Pharmaceutical Barre-National

ERYTHROMYCIN ETHYLSUCCINATEOral Suspension

Erythromycin Barre Drug National PharmaceuticalErythromycin Bioline Labs National PharmaceuticalErythromycin Murray Drug National PharmaceuticalErythromycin Rugby Labs National PharmaceuticalErythromycin United Research Labs National PharmaceuticalErythromycin Ethylsuccinate Purepac Pharmaceutical National PharmaceuticalErythromycin Ethylsuccinate Qualitest National PharmaceuticalErythromycin Ethylsuccinate Goldline Labs Barre-NationalErythromycin Ethylsuccinate Barr Labs Barr LabsErythromycin Ethylsuccinate Rugby Labs Barr LabsErythromycin Ethylsuccinate Goldline Labs Barr LabsErythromycin Ethylsuccinate Pharmafair PharmafairErythromycin Ethylsuccinate Schein Pharmaceutical Barre-National

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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ERYTHROMYCIN ETHYLSUCCINATETablets

Brand Name/Generic Name Distributed By: Manufactured By:

EES Abbott Labs Abbott LabsErythromycin Ethylsuccinate Barr Labs Barr LabsErythromycin Ethylsuccinate Bell Pharmacal Barr LabsErythromycin Ethylsuccinate Qualitest Barr LabsErythromycin Ethylsuccinate Purepac Pharmaceutical Barr LabsErythromycin Ethylsuccinate Lederle Labs Barr LabsErythromycin Ethylsuccinate United Research Labs Barr LabsErythromycin Ethylsuccinate Goldline Labs Barr LabsErythromycin Ethylsuccinate Schein Pharmaceutical Barr LabsErythromycin Ethylsuccinate Best Generics Barr LabsErythromycin Ethylsuccinate Mylan Pharmaceuticals Mylan PharmaceuticalsErythromycin Ethylsuccinate Rugby Labs Mylan PharmaceuticalsErythromycin Ethylsuccinate H L Moore Drug Exchange Mylan PharmaceuticalsErythromycin Ethylsuccinate Major Pharmaceutical Corp Mylan PharmaceuticalsErythromycin Ethylsuccinate Lemmon Co Mylan PharmaceuticalsErythromycin Ethylsuccinate United Research Labs Mylan PharmaceuticalsErythromycin Ethylsuccinate Schein Pharmaceutical Mylan PharmaceuticalsErythromycin Ethylsuccinate Qualitest Mylan PharmaceuticalsErythromycin Ethylsuccinate Interstate Drug Exchange Mylan Pharmaceuticals

ERYTHROMYCIN ETHYLSUCCINATE/SULFISOXAZOLE ACETYLFor Suspension

Erythromycin Ethylsuccinate andSulfisoxazole Acetyl Barr Labs Barr Labs

ERYTHROMYCIN STEARATETablets

Erythromycin Stearate Zenith Labs Zenith LabsErythromycin Stearate H L Moore Drug Exchange Zenith LabsErythromycin Stearate Glenlawn Labs Zenith LabsErythromycin Stearate Purepac Pharmaceutical Zenith LabsErythromycin Stearate Gen-King Products Zenith LabsErythromycin Stearate Voluntary Hospitals Zenith LabsErythromycin Stearate Interstate Drug Exchange Zenith LabsErythromycin Stearate Rugby Labs Chelsea LabsErythromycin Stearate Barr Labs Barr LabsErythromycin Stearate Purepac Pharmaceutical Purepac PharmaceuticalErythromycin Stearate Mylan Pharmaceuticals Mylan PharmaceuticalsErythromycin Stearate Rexall Drug Mylan PharmaceuticalsErythromycin Stearate Geneva Generics Mylan PharmaceuticalsErythromycin Stearate Towne, Paulsen Mylan PharmaceuticalsErythromycin Stearate Interstate Drug Exchange Mylan PharmaceuticalsErythromycin Stearate Thrift Drug Mylan PharmaceuticalsErythromycin Stearate H L Moore Drug Exchange Mylan PharmaceuticalsErythromycin Stearate Walgreen Mylan PharmaceuticalsErythromycin Stearate United Research Labs Mylan PharmaceuticalsErythromycin Stearate Regal Labs Mylan PharmaceuticalsErythromycin Stearate Rugby Labs Mylan PharmaceuticalsErythromycin Stearate Henry Schein Mylan PharmaceuticalsErythromycin Stearate Bell Pharmacal Mylan PharmaceuticalsErythromycin Stearate McKesson Labs Mylan PharmaceuticalsErythromycin Stearate Lederle Labs Mylan PharmaceuticalsErythromycin Stearate Parmed Pharmaceuticals Mylan PharmaceuticalsErythromycin Stearate Skaggs Co Mylan PharmaceuticalsErythromycin Stearate Richie Pharmacal Mylan PharmaceuticalsErythromycin Stearate Murray Drug Mylan PharmaceuticalsErythromycin Stearate Comer Pharmaceuticals Mylan PharmaceuticalsErythromycin Stearate Halsey Drug Mylan PharmaceuticalsErythromycin Stearate Qualitest Mylan PharmaceuticalsErythromycin Stearate Glenlawn Labs Mylan PharmaceuticalsSK-Erythromycin Smith, Kline & French Mylan PharmaceuticalsRomycin Palmedico Mylan PharmaceuticalsErythrocin Stearate Abbott Labs Abbott LabsErypar Parke-Davis Parke-DavisEthril E R Squibb & Sons E R Squibb & SonsErythromycin Stearate Major Pharmaceutical Corp Mylan PharmaceuticalsErythromycin Stearate Laboratory A Mylan PharmaceuticalsErythromycin Stearate Lemmon Co Mylan PharmaceuticalsErythromycin Stearate C S Ruckstuhl Mylan PharmaceuticalsErythromycin Stearate Schein Pharmaceutical Mylan PharmaceuticalsD R Erycin D R Labs Mylan PharmaceuticalsErythromycin Stearate Towne, Paulsen Zenith LabsErythromycin Stearate Rugby Labs Zenith LabsErythromycin Stearate United Research Labs Zenith LabsErythromycin Stearate Goldline Labs Mylan PharmaceuticalsWyamycin S Wyeth Labs Mylan PharmaceuticalsErythromycin Stearate Best Generics Mylan Pharmaceuticals

28 § 25.58 PREVENTION OF DISEASES Pt. III

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ETHCHLORVYNOLCapsules

Brand Name/Generic Name Distributed By: Manufactured By:

Ethchlorvynol Pharmaceutical Basics Banner Gelatin Products

FENOPROFEN CALCIUMCapsules

Fenoprofen Calcium Geneva Generics Cord LabsFenoprofen Calcium Halsey Drug Halsey DrugFenoprofen Calcium Parmed Pharmaceuticals Halsey DrugFenoprofen Calcium Par Pharmaceutical Par PharmaceuticalFenoprofen Calcium Watson Labs Watson Labs

FENOPROFEN CALCIUMTablets

Fenoprofen Calcium American Therapeutics American TherapeuticsFenoprofen Calcium Geneva Generics Cord LabsFenoprofen Calcium Danbury Pharmacal Danbury PharmacalFenoprofen Calcium Halsey Drug Halsey DrugFenoprofen Calcium Parmed Pharmaceuticals Halsey DrugFenoprofen Calcium Lederle Labs Lederle LabsFenoprofen Calcium Mylan Pharmaceuticals Mylan PharmaceuticalsFenoprofen Calcium Qualitest Mylan PharmaceuticalsFenoprofen Calcium Glenlawn Labs Mylan PharmaceuticalsFenoprofen Calcium H L Moore Drug Exchange Mylan PharmaceuticalsFenoprofen Calcium Par Pharmaceutical Par PharmaceuticalFenoprofen Calcium Watson Labs Watson LabsFenoprofen Calcium Rugby Labs Chelsea LabsFenoprofen Calcium Purepac Pharmaceutical Purepac Pharmaceutical

FERROUS FUMARATETablets

Ferrous Fumarate Richlyn Labs Richlyn LabsFerrous Fumarate West-ward Richlyn LabsIrcon Key Pharmaceuticals Key Pharmaceuticals

FERROUS GLUCONATETablets

Ferrous Gluconate Richlyn Labs Richlyn LabsFerrous Gluconate ICN Pharmaceuticals ICN PharmaceuticalsFerrous Gluconate Purepac Pharmaceutical Purepac PharmaceuticalFerrous Gluconate Rugby Labs Chelsea LabsFerrous Gluconate Upsher-Smith KV PharmaceuticalFerrous Gluconate Bioline Labs Halsey DrugFerrous Gluconate Gen-King Products Halsey DrugFerrous Gluconate Blue Cross Products Halsey DrugFerrous Gluconate H L Moore Drug Exchange Halsey DrugFerrous Gluconate Pharmecon Halsey DrugFerrous Gluconate United Research Labs Halsey DrugFerrous Gluconate Interstate Drug Exchange Halsey DrugFerrous Gluconate Goldline Labs Halsey Drug

FERROUS SULFATEElixir

Ferrous Sulfate Liquid Roxane Labs Roxane LabsFerrous Sulfate Barre Drug National PharmaceuticalFerrous Sulfate Lederle Labs National PharmaceuticalFerrous Sulfate Rugby Labs National PharmaceuticalFerrous Sulfate Bioline Labs National PharmaceuticalFerrous Sulfate United Research Labs National PharmaceuticalFerrous Sulfate Glenlawn Labs National PharmaceuticalFerrous Sulfate Henry Schein National PharmaceuticalFerrous Sulfate Murray Drug National PharmaceuticalFerrous Sulfate H L Moore Drug Exchange National PharmaceuticalFerrous Sulfate Rugby Labs Naska PharmacalFerrous Sulfate My-K Labs My-K LabsFerrous Sulfate Goldline Labs Barre-National

FERROUS SULFATESolution

Ferrous Sulfate Drops Pharmaceutical Basics Pharmaceutical Basics

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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FERROUS SULFATETablets

Brand Name/Generic Name Distributed By: Manufactured By:

Ferrous Sulfate Lederle Labs K V PharmaceuticalsFerrous Sulfate Richlyn Labs Richlyn LabsFerrous Sulfate Roxane Labs Roxane LabsFerrous Sulfate Rugby Labs Chelsea LabsFerrous Sulfate Halsey Drug Halsey DrugFerrous Sulfate ICN Pharmaceuticals ICN PharmaceuticalsFerrous Sulfate Purepac Pharmaceutical Purepac PharmaceuticalFerrous Sulfate Penta Products Halsey DrugFerrous Sulfate Glenlawn Labs Halsey DrugFerrous Sulfate United Research Labs Halsey DrugFerrous Sulfate Parke-Davis Parke-DavisFerrous Sulfate Upsher-Smith Labs Hudson PharmaceuticalFerrous Sulfate United Research Labs Ohm Labs

FLUOCINOLONE ACETONIDECream

Synalar Syntex Labs Syntex LabsSynemol Syntex Labs Syntex LabsFluosyn Rugby Labs Clay-Park LabsFluocinolone Acetonide Clay-Park Labs Clay-Park LabsFluocinolone Acetonide United Research Labs Clay-Park LabsFluocinolone Acetonide Geneva Generics Clay-Park LabsFluocinolone Acetonide Interstate Drug Exchange Clay-Park LabsFluocinolone Acetonide Bioline Labs Clay-Park LabsFluocinolone Acetonide Gen-King Products Clay-Park LabsFluocinolone Acetonide Regal Labs Clay-Park LabsFluocinolone Acetonide Henry Schein Clay-Park LabsFluocinolone Acetonide Towne, Paulsen Clay-Park LabsFluocinolone Acetonide H L Moore Drug Exchange Clay-Park LabsFluocinolone Acetonide Qualitest Clay-Park LabsFluocinolone Acetonide Goldline Labs Clay-Park LabsFluocinolone Acetonide NMC Labs NMC LabsFluocinolone Acetonide Pharmafair PharmafairFluocinolone Acetonide Thames Pharmacal Thames PharmacalFluocinolone Acetonide E Fougera AltanaFluocinolone Acetonide Pharmaderm AltanaFluocinolene Acetonide G and W Labs G and W Labs

FLUOCINOLONE ACETONIDEOintment

Synalar Syntex Labs Syntex LabsFluocinolone Acetonide Pharmafair PharmafairFluocinolone Acetonide E Fougera AltanaFluocinolone Acetonide Pharmaderm AltanaFluocinolene Acetonide G and W Labs G and W Labs

FLUOCINOLONE ACETONIDETopical Solution

Synalar Syntex Labs Syntex LabsCinofair Pharmafair PharmafairFluocinolone Acetonide My-K Labs My-K LabsFluocinolone Acetonide E Fougera AltanaFluocinolone Acetonide Pharmaderm AltanaFluocinolone Acetonide Thames Pharmacal Thames PharmacalFluocinolone Acetonide Interstate Drug Exchange Thames PharmacalFluocinolone Acetonide Barre Drug National PharmaceuticalFluocinolone Acetonide Rugby Labs National PharmaceuticalFluocinolone Acetonide Bioline Labs National PharmaceuticalFluocinolone Acetonide United Research Labs National PharmaceuticalFluocinolone Acetonide Goldline Labs Barre-NationalFluocinolone Acetonide Schein Pharmaceutical Barre-NationalFluocinonide Thames Pharmacal Thames Pharmacal

FLUOCINONIDECream

Brand Name/Generic Name Distributed By: Manufactured By:

Fluocinonide Clay-Park Labs Clay-Park Labs

FLUORESCEIN SODIUMInjection

Fluorescite Alcon Labs Alcon Labs

28 § 25.58 PREVENTION OF DISEASES Pt. III

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FLUORESCEIN SODIUMOphthalmic Solution

Brand Name/Generic Name Distributed By: Manufactured By:

Sodium Fluorscein Alcon Labs Alcon Labs

FLUOROURACILCream

Fluroplex Herbert Labs Allergan Pharmaceutical

5-FLUOROURACILInjection

Fluorouracil Roche Labs Roche LabsFluorouracil Steris Labs Steris Labs

FLUOROURACILSolution

Fluoroplex Herbert Labs Allergan Pharmaceutical

FLUPHENAZINE HCLTablets

Fluphenazine HCl Bolar Pharmaceutical Bolar PharmaceuticalFluphenazine HCl Geneva Generics Cord LabsFluphenazine HCl Mylan Pharmaceuticals Mylan Pharmaceuticals

FLURANDRENOLIDELotion

Flurandrenolide Barre Drug National PharmaceuticalFlurandrenolide United Research Labs National PharmaceuticalFlurandrenolide Rugby Labs National PharmaceuticalFlurandrenolide Qualitest National Pharmaceutical

FLURAZEPAM HCLCapsules

Flurazepam HCl Mylan Pharmaceuticals Mylan PharmaceuticalsFlurazepam HCl Rugby Labs Mylan PharmaceuticalsFlurazepam HCl Geneva Generics Mylan PharmaceuticalsFlurazepam HCl United Research Labs Mylan PharmaceuticalsFlurazepam HCl H L Moore Drug Exchange Mylan PharmaceuticalsFlurazepam HCl Henry Schein Mylan PharmaceuticalsFlurazepam HCl Interstate Drug Exchange Mylan PharmaceuticalsFlurazepam HCl Bioline Labs Mylan PharmaceuticalsFlurazepam HCl Purepac Pharmaceutical Mylan PharmaceuticalsFlurazepam HCl Qualitest Mylan PharmaceuticalsFlurazepam HCl Parmed Pharmaceuticals Mylan PharmaceuticalsFlurazepam HCl Major Pharmaceutical Corp Mylan PharmaceuticalsFlurazepam HCl Lederle Labs Mylan PharmaceuticalsFlurazepam HCl Glenlawn Labs Mylan PharmaceuticalsFlurazepam HCl Voluntary Hospitals Mylan PharmaceuticalsFlurazepam HCl Lemmon Co Mylan PharmaceuticalsFlurazepam HCl Harber Pharmaceutical Mylan PharmaceuticalsFlurazepam HCl Par Pharmaceutical Par PharmaceuticalFlurazepam HCl Goldline Labs Par PharmaceuticalFlurazepam Barr Labs Barr LabsFlurazepam Danbury Pharmacal Danbury PharmacalFlurazepam Martec Pharmaceutical Par PharmaceuticalFlurazepam West-ward West-wardFlurazepam Best Generics Mylan PharmaceuticalsFlurazepam Dixon-Shane Mylan PharmaceuticalsFlurazepam HCl Halsey Drug Halsey DrugFlurazepam HCl Pharmaceutical Basics Pharmaceutical BasicsFlurazepam HCl Purepac Pharmaceutical Purepac PharmaceuticalFlurazepam HCl Warner Chilcott Labs Warner Chilcott LabsFlurazepam HCl Superpharm Corp Superpharm Corp

FOLIC ACIDTablets

Folic Acid Richlyn Labs Richlyn LabsFolic Acid Approved Pharmaceutical Richlyn LabsFolic Acid Arcum Pharmaceutical Richlyn LabsFolic Acid Barre Drug Richlyn LabsFolic Acid Cooper Richlyn LabsFolic Acid Bioline Labs Richlyn Labs

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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FOLIC ACIDTablets

Brand Name/Generic Name Distributed By: Manufactured By:

Folic Acid Gen-King Products Richlyn LabsFolic Acid H R Cenci Labs Richlyn LabsFolic Acid Coast Labs Richlyn LabsFolic Acid Dixon-Shane Richlyn LabsFolic Acid Halsey Drug Richlyn LabsFolic Acid Interstate Drug Exchange Richlyn LabsFolic Acid Murray Drug Richlyn LabsFolic Acid Parmed Pharmaceuticals Richlyn LabsFolic Acid Vangard Labs Richlyn LabsFoli-B Wesley Pharmacal Richlyn LabsFolic Acid Danbury Pharmacal Danbury PharmacalFolic Acid Dixon-Shane Danbury PharmacalFolic Acid Thrift Drug Danbury PharmacalFolic Acid Interstate Drug Exchange Danbury PharmacalFolic Acid Pharmecon Danbury PharmacalFolic Acid Regal Labs Danbury PharmacalFolic Acid Henry Schein Danbury PharmacalFolic Acid Geneva Generics Danbury PharmacalFolic Acid West-ward West-wardFolic Acid H L Moore Drug Exchange West-wardFolic Acid Harber Pharmaceutical West-wardFolic Acid Euclid Pharmaceutical West-wardFolic Acid United Research Labs West-wardFolic Acid Regal Labs West-wardFolic Acid ICN Pharmaceuticals ICN PharmaceuticalsFolic Acid Rugby Labs Chelsea LabsFolic Acid Purepac Pharmaceutical Purepac PharmaceuticalFolic Acid Geneva Generics KalipharmaFolic Acid United Research Labs KalipharmaFolic Acid Lannett LannettFolic Acid Private Formulations Private FormulationsFolic Acid Regal Labs Private FormulationsFolic Acid Pioneer Pharmaceuticals Pioneer PharmaceuticalsFolic Acid Vitarine Pharmaceutical Vitarine PharmaceuticalFolic Acid Glenlawn Labs Vitarine PharmaceuticalFolic Acid Barr Labs Barr LabsFolic Acid Halsey Drug Halsey DrugFolic Acid Qualitest Halsey DrugFolic Acid Rugby Labs Halsey DrugFolic Acid Medicopharma Charlotte Pharm

FUROSEMIDEInjection

Furosemide Steris Labs Steris LabsFurosemide Goldline Labs Steris LabsFurosemide Schein Pharmaceutical Steris LabsFurosemide Major Pharmaceutical Corp Steris LabsFurosemide Rugby Labs Steris LabsFurosemide Interstate Drug Exchange Steris Labs

FUROSEMIDESolution

Myrosemide My-K Labs My-K LabsFurosemide Roxane Labs Roxane LabsFurosemide Pharmaceutical Basics Pharmaceutical Basics

FUROSEMIDETablets

Furosemide Cord Labs Cord LabsFurosemide Geneva Generics Cord LabsFurosemide Superpharm Corp Superpharm CorpFurosemide Bioline Labs Superpharm CorpFurosemide Zenith Labs Zenith LabsFurosemide Interstate Drug Exchange Zenith LabsFurosemide H L Moore Drug Exchange Zenith LabsFurosemide Whiteworth Pharmaceuticals Zenith LabsFurosemide Cooper Zenith LabsFurosemide Mylan Pharmaceuticals Mylan PharmaceuticalsFurosemide Interstate Drug Exchange Mylan PharmaceuticalsFurosemide Bioline Labs Mylan PharmaceuticalsFurosemide United Research Labs Mylan PharmaceuticalsFurosemide Towne, Paulsen Mylan PharmaceuticalsFurosemide Henry Schein Mylan PharmaceuticalsFurosemide Richie Pharmacal Mylan PharmaceuticalsFurosemide Regal Labs Mylan PharmaceuticalsFurosemide Searle Mylan Pharmaceuticals

28 § 25.58 PREVENTION OF DISEASES Pt. III

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FUROSEMIDETablets—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Furosemide Purepac Pharmaceutical Mylan PharmaceuticalsFurosemide H L Moore Drug Exchange Mylan PharmaceuticalsFurosemide Parmed Pharmaceuticals Mylan PharmaceuticalsFurosemide Qualitest Mylan PharmaceuticalsFurosemide Glenlawn Labs Mylan PharmaceuticalsSK-Furosemide Smith, Kline & French Mylan PharmaceuticalsFurosemide Rugby Labs Mylan PharmaceuticalsFurosemide Major Pharmaceutical Corp Mylan PharmaceuticalsFurosemide Watson Labs Watson LabsFurosemide Texas Drug Reps Watson LabsFurosemide Major Pharmaceutical Corp Watson LabsFurosemide Parmed Pharmaceuticals Watson LabsFurosemide Purepac Pharmaceutical Watson LabsFurosemide Best Generics Watson LabsFurosemide Danbury Pharmacal Danbury PharmacalFurosemide Parke-Davis Parke-DavisFurosemide Barr Labs Barr LabsFurosemide Dixon-Shane Mylan Pharmaceutical

GENTAMICIN SULFATECream

Gentamicin Sulfate NMC Labs NMC LabsGentamicin Sulfate Thames Pharmacal Thames PharmacalGentamicin Sulfate E Fougera AltanaGentamicin Sulfate Pharmaderm AltanaGentafair Pharmafair PharmafairGentamicin Clay-Park Labs Clay-Park LabsGentamicin H L Moore Drug Exchange Clay-Park LabsGentamicin Interstate Drug Exchange Clay-Park LabsGentamicin Bioline Labs Clay-Park LabsGentamicin Henry Schein Clay-Park LabsGentamicin United Research Labs Clay-Park LabsGentamicin Rugby Labs Clay-Park LabsGentamicin Qualitest Clay-Park LabsGentamicin Schein Pharmaceutical Clay-Park LabsGentamicin Goldline Labs Clay-Park Labs

GENTAMICIN SULFATEInjection

Gentamicin Sulfate Steris Labs Steris LabsGentamicin Sulfate Schein Pharmaceutical Steris LabsGentamicin Sulfate Major Pharmaceutical Corp Steris LabsGentamicin Sulfate Rugby Labs Steris LabsGentamicin Sulfate Interstate Drug Exchange Steris LabsGentamicin Sulfate H L Moore Drug Exchange Steris LabsGentamicin Sulfate Bioline Labs Steris LabsGentamicin Sulfate Travenol Labs Steris Labs

GENTAMICIN SULFATEOintment

Gentamicin Sulfate NMC Labs NMC LabsGentamicin Sulfate Thames Pharmacal Thames PharmacalGentamicin Sulfate E Fougera AltanaGentamicin Sulfate Pharmaderm AltanaGentafair Pharmafair PharmafairGentamicin Clay-Park Labs Clay-Park LabsGentamicin H L Moore Drug Exchange Clay-Park LabsGentamicin Bioline Labs Clay-Park LabsGentamicin Henry Schein Clay-Park LabsGentamicin United Research Labs Clay-Park LabsGentamicin Rugby Labs Clay-Park LabsGentamicin Qualitest Clay-Park LabsGentamicin Goldline Labs Clay-Park Labs

GENTAMICIN SULFATEOphthalmic Ointment

Gentafair Pharmafair Pharmafair

GENTAMICIN SULFATEOphthalmic Solution

Gentafair Pharmafair PharmafairGentamicin Geneva Generics Pharmafair

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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GENTAMICIN SULFATEOphthalmic Solution—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Gentamicin Sulfate United Research Labs PharmafairGentamicin Sulfate Hygeia Labs Carter-Glogau LabsGentamicin Sulfate Orbis Pharmaceuticals Carter-Glogau LabsGentamicin Sulfate Danbury Pharmacal Steris LabsGentamicin Sulfate Steris Labs Steris LabsGentamicin Sulfate Regal Labs Steris LabsGent-AK Akorn Steris LabsGentamicin Sulfate Paco Pharmaceutical Ser Paco Pharmaceutical Ser

GLUTETHIMIDETablets

Glutethimide Rugby Labs Chelsea LabsGlutethimide Danbury Pharmacal Danbury PharmacalGlutethimide Interstate Drug Exchange Danbury PharmacalGlutethimide Bell Pharmacal Danbury PharmacalGlutethimide Parmed Pharmaceuticals Danbury PharmacalGlutethimide Qualitest Danbury PharmacalGlutethimide Lannett LannettGlutethimide Geneva Generics Cord LabsGlutethimide MD Pharmaceutical MD PharmaceuticalGlutethimide United Research Labs MD PharmaceuticalGlutethimide Halsey Drug Halsey DrugGlutethimide Qualitest Halsey Drug

GLYCERINSolution

Osmoglyn Alcon Labs Alcon Labs

GLYCERINSuppositories

Glycerin Suppositoria Labs Suppositoria LabsGlycerin Rugby Labs Suppositoria LabsGlycerin G & W Labs G & W LabsGlycerin United Research Labs Clay-Park Labs

GLYCOPYRROLATETablets

Robinul A H Robins A H RobinsGlycopyrrolate Bolar Pharmaceutical Bolar PharmaceuticalGlycopyrrolate Rugby Labs Bolar Pharmaceutical

GRISEOFULVIN MICROSIZETablets

Fulvicin U/F Schering Schering

GRISEOFULVIN ULTRAMICROSIZETablets

Fulvicin P/G Schering Schering

GRAMICIDIN/NEOMYCIN SULFATE/POLYMYXIN-B SULFATEOphthalmic Solution

Ocusporin Pharmafair PharmafairP N Geneva Generics PharmafairOcutricin United Research Labs PharmafairNeomycin & Polymyxin B

Sulfates & Gramicidin Steris Labs Steris Labs

GRAMICIDIN/NEOMYCIN SULFATE/NYSTATIN/TRIAMCINOLONE ACETONIDECream

Mykacet NMC Labs NMC LabsTri-Statin Rugby Labs NMC LabsMycobiotic H L Moore Drug Exchange NMC LabsMyco Triacet Lemmon Co Lemmon CoViaderm-KC K-Line Pharmaceuticals K-Line PharmaceuticalsNystatin/Neomycin Sulfate/Gramicidin/

Triamcinolone Acetonide Interstate Drug Exchange NMC Labs

28 § 25.58 PREVENTION OF DISEASES Pt. III

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Page 91: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

GRAMICIDIN/NEOMYCIN SULFATE/NYSTATIN/TRIAMCINOLONE ACETONIDECream—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Nystatin/Neomycin Sulfate/Gramicidin/Triamcinolone Acetonide Qualitest Clay-Park Labs

NNTG United Research Labs Clay-Park LabsMyco-Aricin Interstate Drug Exchange Clay-Park LabsTriamcinolone NNG Vangard Labs Clay-Park LabsMyco-Triacet H L Moore Drug Exchange Clay-Park LabsTri-Statin Rugby Labs Clay-Park LabsNyst-olone Henry Schein Clay-Park LabsRegal-Log Regal Labs Clay-Park Labs

GRAMICIDIN/NEOMYCIN SULFATE/NYSTATIN/TRIAMCINOLONE ACETONIDEOintment

Nystatin/Neomycin Sulfate/Gramicidin/Triamcinolone Acetonide Qualitest Clay-Park LabsMyco-Triacet H L Moore Drug Exchange Clay-Park LabsRegal-Log Regal Labs Clay-Park LabsMycoaricin Interstate Drug Exchange Clay-Park LabsTri-Statin Rugby Labs Clay-Park LabsNNGT United Research Labs Clay-Park LabsMyco Triacet Lemmon Co Lemmon Co

GUAIFENESINSyrup

Guiatuss H L Moore Drug Exchange National PharmaceuticalGuiatuss Murray Drug National PharmaceuticalGuiatuss Richie Pharmacal National PharmaceuticalGuiatuss Henry Schein National PharmaceuticalGuiatuss Veratex Corp National PharmaceuticalGuiatuss United Research Labs National PharmaceuticalGuiatuss Glenlawn Labs National PharmaceuticalGuiatuss Harber Pharmaceutical National PharmaceuticalGuiatuss Vita-Rx National PharmaceuticalGuiatuss Bell Pharmacal National PharmaceuticalKof-Quel Middlesex Medical National PharmaceuticalGuaidex Haberle Drug National PharmaceuticalGuiatuscon Consolidated Midland National PharmaceuticalE Tussin Econo-Rx National PharmaceuticalGenitussin Generic Pharmacal National PharmaceuticalTaspin Expectorant Philpharma Lab National PharmaceuticalPulatuss Pulse Drug National PharmaceuticalT L Tuss Thompson Lab National PharmaceuticalTussin Bioline Labs National PharmaceuticalG Tussin Columbia Medical National PharmaceuticalGenetuss Expectorant General Pharmaceutical National PharmaceuticalPartuss G Parmed Pharmaceuticals National PharmaceuticalCortuss Adco Pharmaceutics National PharmaceuticalM D Guaifenesin Medical District National PharmaceuticalOrbiqui Orbit Pharmaceuticals National PharmaceuticalParatussin Paramount Surgical National PharmaceuticalGlyatuss Dixon-Shane National PharmaceuticalE M G G Econo-Rx National PharmaceuticalCotuss Cooper National PharmaceuticalMalotuss Mallard National PharmaceuticalTuss-ott Wasserotts National PharmaceuticalCo-Tuss Pharmacists Choice National PharmaceuticalGlycogen Grafton Pharmaceutical National PharmaceuticalAcatuss ACA National PharmaceuticalTussin Revco Drug National PharmaceuticalSofatussin Southern First Aid Supply National PharmaceuticalPharm-A-Tussin Peoples Drug National PharmaceuticalMedcotussin Medco Supply National PharmaceuticalGlyate Geneva Generics National PharmaceuticalGuiatussin Rugby Labs National PharmaceuticalGuaifenesin Lederle Labs National PharmaceuticalGuaifenesin Interstate Drug Exchange National PharmaceuticalGuaifenesin Purepac Pharmaceutical National PharmaceuticalGuaifenesin Towne, Paulsen National PharmaceuticalGuaifenesin Ascot National PharmaceuticalMcKesson CoughFormula Expectorant McKesson Labs National PharmaceuticalGuaifenesin Roxane Labs Roxane LabsGuaifenesin Beecham Labs Beecham LabsGuaifenesin Rugby Labs Naska PharmacalRobitussin A H Robins A H RobinsCheratussin Life Labs Life LabsColrex Expectorant Reid-Rowell Reid-RowellMytussin My-K Labs My-K Labs

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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GUAIFENESINSyrup—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Guiatuss Goldline Labs Barre-NationalT-Tussin Thames Pharmacal Thames Pharmacal

GUAIFENESIN/HYDROCODONE BITARTRATE/PSEUDOEPHEDRINE HCLElixir

Detussin Expectorant Barre Drug National PharmaceuticalDetussin Expectorant Murray Drug National PharmaceuticalDetussin Expectorant Henry Schein National PharmaceuticalDetussin Expectorant Qualitest National PharmaceuticalTussafin Expectorant Rugby Labs National PharmaceuticalV-Tussin Expectorant Vangard Labs National PharmaceuticalMycotussin Expectorant My-K Labs My-K LabsPseudoephedrine HCl/Hydrocodone/

Guaifenesin Pharmaceutical Basics Pharmaceutical Basics

GUAIFENESIN/OXTRIPHYLLINEElixir

Oxyfenesin Rugby Labs National PharmaceuticalBrondelate Bioline Labs National PharmaceuticalBrondelate H L Moore Drug Exchange National PharmaceuticalBrondelate Barre-National Barre-NationalBrondelate Schein Pharmaceutical Barre-National

GUAIFENESIN/PHENYLEPHRINE HCL/PHENYLPROPANOLAMINE HCLCapsules

Duratex Duramed Pharmaceuticals Duramed Pharmaceuticals

GUAIFENESIN/PHENYLPROPANOLAMINE HCLSyrup

Myminic My-K Labs My-K Labs

GUAIFENESIN/PSEUDOEPHEDRINE HCLSyrup

Robitussin-PE A H Robins A H Robins

GUAIFENESIN/THEOPHYLLINELiquid

Theolate Barre Drug National PharmaceuticalTheolate Henry Schein National PharmaceuticalTheolate Qualitest National PharmaceuticalTheolate Liquid United Research Labs National PharmaceuticalTheolate Liquid Glenlawn Labs National PharmaceuticalQuelan Blue Cross Products National PharmaceuticalTheophylline w/Guaifenesin Vangard Labs National PharmaceuticalGlyceryl-T Rugby Labs National PharmaceuticalGlyceryl-T Rugby Labs Naska PharmacalTheolair-Plus Riker Labs Riker LabsTheocolate My-K Labs My-K LabsTheolate Goldline Labs Barre-National

HALOPERIDOLTablets

Haloperidol Mylan Pharmaceuticals Mylan PharmaceuticalsHaloperidol Qualitest Mylan PharmaceuticalsHaloperidol Goldline Labs Mylan PharmaceuticalsHaloperidol Bioline Labs Mylan PharmaceuticalsHaloperidol H L Moore Drug Exchange Mylan PharmaceuticalsHaloperidol Geneva Generics Mylan PharmaceuticalsHaloperidol Parmed Pharmaceuticals Mylan PharmaceuticalsHaloperidol Rugby Labs Mylan PharmaceuticalsHaloperidol Henry Schein Mylan PharmaceuticalsHaloperidol Major Pharmaceutical Corp Mylan PharmaceuticalsHaloperidol United Research Labs Mylan PharmaceuticalsHaloperidol Glenlawn Labs Mylan PharmaceuticalsHaloperidol Lemmon Co Mylan PharmaceuticalsHaloperidol Searle SearleHaloperidol Warner Chilcott Labs Mylan PharmaceuticalsHaloperidol Purepac Pharmaceutical Purepac PharmaceuticalHaloperidol Par Pharmaceutical Par Pharmaceutical

28 § 25.58 PREVENTION OF DISEASES Pt. III

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HALOPERIDOLTablets—Continued

Haloperidol Goldline Labs Par PharmaceuticalHaloperidol Genetco Par PharmaceuticalHaloperidol Bioline Labs Par PharmaceuticalHaloperidol H L Moore Drug Exchange Par PharmaceuticalHaloperidol Schein Pharmaceutical Par PharmaceuticalHaloperidol Martec Pharmaceutical Par PharmaceuticalHaloperidol Danbury Pharmacal Danbury PharmacalHaloperidol Duramed Pharmaceuticals Duramed PharmaceuticalsHaloperidol Qualitest Duramed PharmaceuticalsHaloperidol Texas Drug Reps Duramed PharmaceuticalsHaloperidol Best Generics Mylan PharmaceuticalsHaloperidol Lemmon Co Par PharmaceuticalHalperon Quantum Pharmics Quantum PharmicsHaloperidol Cord Labs Cord LabsHaloperidol Geneva Generics Cord LabsHaloperidol Barr Labs Barr LabsHaloperidol Lemmon Co Purepac PharmaceuticalHaloperidol Roxane Labs Roxane LabsHaloperidol Royce Labs Royce Labs

HALOPERIDOL LACTATEInjection

Haloperidol Lemmon Co Lemmon Co

HALOPERIDOL LACTATESolution

Haloperidol Concentrate My-K Labs My-K LabsHaloperidol Concentrate Barre-National Barre-NationalHaloperidol Concentrate Bioline Labs Barre-NationalHaloperidol Concentrate Goldline Labs Barre-NationalHaloperidol Concentrate Major Pharmaceutical Corp Barre-NationalHaloperidol Concentrate Rugby Labs Barre-NationalHaloperidol Concentrate Searle SearleHaloperidol (Concentrate) Lemmon Co Lemmon CoHaloperidol Intensol Roxane Labs Roxane LabsHaloperidol (Concentrate) Copley Pharmaceutical Copley Pharmaceutical

HOMATROPINE HBROphthalmic Solution

Isopto Homatropine Alcon Labs Alcon Labs

HOMATROPINE METHYLBROMIDE/HYDROCODONE BITARTRATESyrup

Hydrocodone Barre Drug National PharmaceuticalHydrocodone Glenlawn Labs National PharmaceuticalHydrocodone Geneva Generics National PharmaceuticalHydrotropine Rugby Labs National PharmaceuticalHydrocodone Compound Qualitest National PharmaceuticalMycodone My-K Labs My-K LabsHydropane Halsey Drug Halsey DrugHydrocodone Compound Goldline Labs Barre-National

HOMATROPINE METHYLBROMIDE/HYDROCODONE BITARTRATETablets

Tussigon Daniels Pharmaceuticals Daniels Pharmaceuticals

HYDRALAZINE HCLTablets

Hydralazine HCl Danbury Pharmacal Danbury PharmacalHydralazine HCl Interstate Drug Exchange Danbury PharmacalHydralazine HCl West-ward Danbury PharmacalHydralazine HCl Thrift Drug Danbury PharmacalHydralazine HCl Bell Pharmacal Danbury PharmacalHydralazine HCl Richlyn Labs Richlyn LabsHydralazine HCl Barr Labs Barr LabsHydralazine HCl Regal Labs Barr LabsHydralazine HCl Vangard Labs Barr LabsHydralazine HCl McKesson Labs Barr LabsHydralazine HCl Towne, Paulsen Barr LabsHydralazine HCl Rugby Labs Barr LabsHydralazine HCl Purepac Pharmaceutical Barr LabsHydralazine HCl Rexall Drug Barr Labs

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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HYDRALAZINE HCLTablets—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Hydralazine HCl Murray Drug Barr LabsHydralazine HCl Pharmecon Barr LabsHydralazine HCl Zenith Labs Zenith LabsHydralazine HCl Gen-King Products Zenith LabsHydralazine HCl Geneva Generics Zenith LabsHydralazine HCl Murray Drug Zenith LabsHydralazine HCl H L Moore Drug Exchange Zenith LabsHydralazine HCl United Research Labs Zenith LabsHydralazine HCl Cooper Zenith LabsHydralazine HCl Regal Labs Zenith LabsHydralazine HCl Glenlawn Labs Zenith LabsHydralazine HCl Rugby Labs Zenith LabsHydralazine HCl Qualitest Zenith LabsHydralazine HCl Bell Pharmacal Zenith LabsHydralazine HCl Parmed Pharmaceuticals Zenith LabsHydralazine HCl Towne, Paulsen Zenith LabsHydralazine HCl Interstate Drug Exchange Zenith LabsHydralazine HCl Par Pharmaceutical Par PharmaceuticalHydralazine HCl United Research Labs Par PharmaceuticalHydralazine HCl Dixon-Shane Par PharmaceuticalHydralazine HCl Glenlawn Labs Par PharmaceuticalHydralazine HCl Parmed Pharmaceuticals Par PharmaceuticalHydralazine HCl Goldline Labs Par PharmaceuticalHydralazine HCl Vita-Rx Par PharmaceuticalHydralazine HCl Williams Generics Par PharmaceuticalHydralazine HCl Harber Pharmaceutical Par PharmaceuticalHydralazine HCl Henry Schein Par PharmaceuticalHydralazine HCl H L Moore Drug Exchange Par PharmaceuticalHydralazine HCl Thrift Drug Par PharmaceuticalHydralazine HCl Bioline Labs Par PharmaceuticalHydralazine HCl General Generics Par PharmaceuticalHydralazine HCl Towne, Paulsen Par PharmaceuticalHydralazine HCl Rugby Labs Par PharmaceuticalHydralazine HCl Vangard Labs Par PharmaceuticalHydralazine HCl Interstate Drug Exchange Par PharmaceuticalHydralazine HCl Artex Labs Par PharmaceuticalHydralazine HCl Unit Dose Labs Par PharmaceuticalHydralazine HCl Texas Drug Reps Par PharmaceuticalHydralazine HCl Goldline Labs Par PharmaceuticalHydralazine HCl Mutual Pharmaceutical Par PharmaceuticalHydralazine HCl Rugby Labs Chelsea LabsHydralazine HCl Geneva Generics Cord LabsHydralazine HCl Purepac Pharmaceutical Purepac PharmaceuticalHydralazine HCl Lederle Labs Lederle LabsHydralazine HCl Sidmak Labs Sidmak LabsHydralazine HCl Travenol Labs Sidmak LabsHydralazine HCl Genetco Sidmak LabsHydralazine HCl Parmed Pharmaceuticals Sidmak LabsHydralazine HCl Towne, Paulsen Sidmak LabsHydralazine HCl Superpharm Corp Superpharm CorpHydralazine HCl Bioline Labs Superpharm CorpHydralazine HCl Goldline Labs Superpharm CorpHydralazine HCl Camall Co Camall CoHydralazine HCl United Research Labs Mutual PharmaceuticalHydralazine HCl Halsey Drug Halsey DrugHydralazine HCl Qualitest Halsey DrugHydralazine HCl Schein Pharmaceutical Danbury PharmacalHydralazine HCl Schein Pharmaceutical Par PharmaceuticalHydralazine HCl Mutual Pharmaceutical Mutual PharmaceuticalHydralazine HCl Vita-Rx Mutual PharmaceuticalHydralazine HCl Genetco Mutual PharmaceuticalHydralazine Towne, Paulsen Mutual PharmaceuticalHydralazine HCl Purepac Pharmaceutical Mutual Pharmaceutical

HYDRALAZINE HCL/HYDROCHLOROTHIAZIDECapsules

Hydralazine HCl/Hydrochlorothiazide Bolar Pharmaceutical Bolar PharmaceuticalHydralazine HCl/Hydrochlorothiazide Parmed Pharmaceuticals Bolar PharmaceuticalHydralazine HCl/Hydrochlorothiazide Qualitest Bolar PharmaceuticalHydralazine HCl/Hydrochlorothiazide Purepac Pharmaceutical Bolar PharmaceuticalHydralazine HCl/Hydrochlorothiazide United Research Labs Bolar PharmaceuticalHydralazine HCl/Hydrochlorothiazide Best Generics Bolar PharmaceuticalHydralazine HCl/Hydrochlorothiazide Zenith Labs Zenith LabsHydralazine HCl/Hydrochlorothiazide Superpharm Corp Superpharm CorpHydra-zide Par Pharmaceutical Par PharmaceuticalHydralazine-Thiazide Schein Pharmaceutical Par Pharmaceutical

28 § 25.58 PREVENTION OF DISEASES Pt. III

25-92(202500) No. 253 Dec. 95 Copyright � 1995 Commonwealth of Pennsylvania

Page 95: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

HYDROCHLOROTHIAZIDESolution

Brand Name/Generic Name Distributed By: Manufactured By:

Hydrochlorothiazide Pharmaceutical Basics Pharmaceutical Basics

HYDROCHLOROTHIAZIDETablets

Hydrodiuril Merck, Sharpe & Dohme Merck, Sharpe & DohmeEsidrix Ciba-Geigy Ciba-GeigyOretic Abbott Labs Abbott LabsThiuretic Parke-Davis Abbott LabsHydrochlorothiazide Barr Labs Barr LabsHydrochlorothiazide Regal Labs Barr LabsHydrochlorothiazide Bell Pharmacal Barr LabsHydrochlorothiazide Skaggs Co Barr LabsHydrochlorothiazide Geneva Generics Barr LabsHydrochlorothiazide Bioline Labs Barr LabsHydrochlorothiazide West-ward West-wardHydrochlorothiazide H L Moore Drug Exchange West-wardHydrochlorothiazide Interstate Drug Exchange West-wardHydrochlorothiazide Henry Schein West-wardHydrochlorothiazide Lederle Labs Lederle LabsHydrochlorothiazide Rugby Labs Chelsea LabsHydrochlorothiazide Richlyn Labs Richlyn LabsHydrochlorothiazide Roxane Labs Roxane LabsSK-Hydrochlorothiazide Smith, Kline & French Roxane LabsHydrochlorothiazide Camall Co Camall CoHydrochlorothiazide Henry Schein Camall CoHydrochlorothiazide Cooper Camall CoHydrochlorothiazide Harnel Pharmaceutical Camall CoHydrochlor R J Legere Camall CoAqwadril Wesley Pharmacal Camall CoHydrochlorothiazide Calvin Scott Co Camall CoHydrochlorothiazide H & H Labs Camall CoHydrochlorothiazide Caldwell & Bloor Camall CoHydrochlorothiazide Coast Labs Camall CoHydrochlorothiazide Queen City Pharmacal Camall CoHydrochlorothiazide Murray Drug Camall CoHCTZ Genco Camall CoHydrorex C S Ruckstuhl Camall CoHydrotabs Pharmacare Generic Drugs Camall CoHyclar Artex Labs Camall CoHydoril H R Cenci Labs Camall CoLoqua Columbia Drug Co Camall CoHy-Zide Wasserotts Camall CoHydromal Mallard Camall CoAquazide W F Baker Camall CoHyazide Quality Pharmacal Camall CoHydro-Par Parmed Pharmaceuticals Camall CoDiaqua W E Hauck Camall CoHydrochlorothiazide Harber Pharmaceutical Camall CoHydrochlorothiazide Mylan Pharmaceuticals Mylan PharmaceuticalsHydrochlorothiazide E R Squibb & Sons Mylan PharmaceuticalsHydrochlorothiazide Heather Drug Heather DrugHydrochlorothiazide United Research Labs Heather DrugHydrochlorothiazide Henry Schein Heather DrugHydrochlorothiazide Interstate Drug Exchange Heather DrugHydrochlorothiazide Cord Labs Cord LabsHydrochlorothiazide Geneva Generics Cord LabsHydrochlorothiazide Purepac Pharmaceutical Purepac PharmaceuticalHydrochlorothiazide Zenith Labs Zenith LabsHydrochlorothiazide Murray Drug Zenith LabsHydrochlorothiazide Richie Pharmacal Zenith LabsHydrochlorothiazide Vangard Labs Zenith LabsHydrochlorothiazide Cooper Zenith LabsHydrochlorothiazide H L Moore Drug Exchange Zenith LabsHydrochlorothiazide Regal Labs Zenith LabsHydrochlorothiazide Gen-King Products Zenith LabsHydrochlorothiazide Geneva Generics Zenith LabsHydrochlorothiazide United Research Labs Zenith LabsHydrochlorothiazide Seneca Pharmaceuticals Zenith LabsHydrochlorothiazide Interstate Drug Exchange Zenith LabsHydrochlorothiazide Qualitest Zenith LabsHydro-Par Parmed Pharmaceuticals Zenith LabsHydrochlorothiazide Williams Generics Zenith LabsHydrochlorothiazide Major Pharmaceutical Corp Zenith LabsHydrochlorothiazide Boots Labs Boots LabsHydrochlorothiazide United Research Labs Boots LabsHydrochlorothiazide Superpharm Corp Superpharm CorpHydrochlorothiazide Goldline Labs Superpharm CorpHydrochlorothiazide Bioline Labs Superpharm CorpHydrochlorothiazide Vitarine Pharmaceutical Vitarine PharmaceuticalHydrochlorothiazide Bioline Labs Zenith Labs

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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HYDROCHLOROTHIAZIDE/METHYLDOPATablets

Brand Name/Generic Name Distributed By: Manufactured By:

Methyldopa and Hydrochlorothiazide Purepac Pharmaceutical Purepac PharmaceuticalMethyldopa and Hydrochlorothiazide Rondex Labs KalipharmaMethyldopa and Hydrochlorothiazide Mylan Pharmaceuticals Mylan PharmaceuticalsMethyldopa and Hydrochlorothiazide Bioline Labs Mylan PharmaceuticalsMethyldopa and Hydrochlorothiazide Qualitest Mylan PharmaceuticalsMethyldopa and Hydrochlorothiazide Mutual Pharmaceutical Mylan PharmaceuticalsMethyldopa and Hydrochlorothiazide Goldline Labs Mylan PharmaceuticalsMethyldopa and Hydrochlorothiazide H L Moore Drug Exchange Mylan PharmaceuticalsMethyldopa and Hydrochlorothiazide Rugby Labs Mylan PharmaceuticalsMethyldopa and Hydrochlorothiazide United Research Labs Mylan PharmaceuticalsMethyldopa and Hydrochlorothiazide Major Pharmaceutical Corp Mylan PharmaceuticalsMethyldopa and Hydrochlorothiazide Henry Schein Mylan PharmaceuticalsMethyldopa and Hydrochlorothiazide Regal Labs Mylan PharmaceuticalsMethyldopa and Hydrochlorothiazide Parmed Pharmaceuticals Mylan PharmaceuticalsMethyldopa and Hydrochlorothiazide Texas Drug Reps Mylan PharmaceuticalsMethyldopa and Hydrochlorothiazide Lemmon Co Mylan PharmaceuticalsMethyldopa and Hydrochlorothiazide Glenlawn Labs Mylan PharmaceuticalsMethyldopa and Hydrochlorothiazide Warner Chilcott Labs Mylan PharmaceuticalsMethyldopa and Hydrochlorothiazide Cord Labs Cord LabsMethyldopa and Hydrochlorothiazide Geneva Generics Cord LabsMethyldopa and Hydrochlorothiazide LyphoMed/NovoPharm NovopharmMethyldopa and Hydrochlorothiazide Par Pharmaceutical Par PharmaceuticalMethyldopa and Hydrochlorothiazide Martec Pharmaceutical Par Pharmaceutical

HYDROCHLOROTHIAZIDE/PROPRANOLOL HCLTablets

Propranolol HCl andHydrochlorothiazide Purepac Pharmaceutical Purepac Pharmaceutical

Propranolol HCl andHydrochlorothiazide Parmed Pharmaceuticals Purepac Pharmaceutical

Propranolol HCl andHydrochlorothiazide Goldline Labs Purepac Pharmaceutical

Propranolol HCl andHydrochlorothiazide Bioline Labs Purepac Pharmaceutical

Propranolol HCl andHydrochlorothiazide Qualitest Purepac Pharmaceutical

Propranolol HCl andHydrochlorothiazide H L Moore Drug Exchange Kalipharma

Propranolol HCl andHydrochlorothiazide Schein Pharmaceutical Kalipharma

Propranolol HCl andHydrochlorothiazide Geneva Generics Kalipharma

Propranolol HCl andHydrochlorothiazide Rondex Labs Kalipharma

Propranolol HCl andHydrochlorothiazide United Research Labs Kalipharma

Propranolol HCl andHydrochlorothiazide Mutual Pharmaceutical Kalipharma

Propranolol HCl andHydrochlorothiazide Rugby Labs Chelsea Labs

Propranolol HCl andHydrochlorothiazide Barr Labs Barr Labs

Propranolol HCl andHydrochlorothiazide Duramed Pharmaceuticals Duramed Pharmaceuticals

Propranolol HCl andHydrochlorothiazide Qualitest Duramed Pharmaceuticals

Propranolol HCl andHydrochlorothiazide Mylan Pharmaceuticals Mylan Pharmaceuticals

Propranolol HCl andHydrochlorothiazide Goldline Labs Mylan Pharmaceuticals

Propranolol HCl andHydrochlorothiazide Bioline Labs Mylan Pharmaceuticals

Propranolol HCl andHydrochlorothiazide Geneva Generics Cord Labs

Propranolol HCl andHydrochlorothiazide Sidmak Labs Sidmak Labs

HYDROCHLOROTHIAZIDE/SPIRONOLACTONETablets

Spironolactone withHydrochlorothiazide Mylan Pharmaceuticals Mylan Pharmaceuticals

Spironolactone withHydrochlorothiazide H L Moore Drug Exchange Mylan Pharmaceuticals

Spironolactone withHydrochlorothiazide Interstate Drug Exchange Mylan Pharmaceuticals

Spironolactone withHydrochlorothiazide Richie Pharmacal Mylan Pharmaceuticals

28 § 25.58 PREVENTION OF DISEASES Pt. III

25-94(202502) No. 253 Dec. 95 Copyright � 1995 Commonwealth of Pennsylvania

Page 97: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

HYDROCHLOROTHIAZIDE/SPIRONOLACTONETablets—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Spironolactone withHydrochlorothiazide Murray Drug Mylan Pharmaceuticals

Spironolactone withHydrochlorothiazide Geneva Generics Mylan Pharmaceuticals

Spironolactone withHydrochlorothiazide Lederle Labs Mylan Pharmaceuticals

Spironolactone withHydrochlorothiazide United Research Labs Mylan Pharmaceuticals

Spironolactone withHydrochlorothiazide Henry Schein Mylan Pharmaceuticals

Spironolactone withHydrochlorothiazide Stayner Corp Mylan Pharmaceuticals

Spironolactone withHydrochlorothiazide Skaggs Co Mylan Pharmaceuticals

Spironolactone withHydrochlorothiazide Bioline Labs Mylan Pharmaceuticals

Spironolactone withHydrochlorothiazide Purepac Pharmaceutical Mylan Pharmaceuticals

Spirozide Rugby Labs Mylan PharmaceuticalsRonozide LuChem Pharmaceuticals Mylan PharmaceuticalsSpironolactone with

Hydrochlorothiazide Bolar Pharmaceutical Bolar PharmaceuticalSpironolactone with

Hydrochlorothiazide Purepac Pharmaceutical Bolar PharmaceuticalSpironolactone with

Hydrochlorothiazide Parmed Pharmaceuticals Bolar PharmaceuticalSpironolactone with

Hydrochlorothiazide Qualitest Bolar PharmaceuticalSpironolactone with

Hydrochlorothiazide Best Generics Bolar PharmaceuticalSpironolactone with

Hydrochlorothiazide Danbury Pharmacal Danbury PharmacalSpironolactone with

Hydrochlorothiazide Bell Pharmacal Danbury PharmacalSpironolactone with

Hydrochlorothiazide Rugby Labs Chelsea LabsSpironolactone with

Hydrochlorothiazide Zenith Labs Zenith LabsSpironolactone with

Hydrochlorothiazide Gen-King Products Zenith LabsSpironolactone with

Hydrochlorothiazide Parmed Pharmaceuticals Zenith LabsSpironolactone with

Hydrochlorothiazide Murray Drug Zenith LabsSpironolactone with

Hydrochlorothiazide Vangard Labs Zenith LabsSpironolactone with

Hydrochlorothiazide Cooper Zenith LabsSpironolactone with

Hydrochlorothiazide Interstate Drug Exchange Zenith LabsSpironolactone with

Hydrochlorothiazide H L Moore Drug Exchange Zenith LabsSpironolactone with

Hydrochlorothiazide Regal Labs Zenith LabsSpironolactone with

Hydrochlorothiazide Towne, Paulsen Zenith LabsSpironolactone with

Hydrochlorothiazide Williams Generics Zenith LabsSpirozide Glenlawn Labs Zenith LabsSpironazide Henry Schein Zenith LabsSpironolactone with

Hydrochlorothiazide Geneva Generics Cord LabsSpironolactone and

Hydrochlorothiazide Purepac Pharmaceutical Purepac PharmaceuticalSpironolactone and

Hydrochlorothiazide Superpharm Corp Superpharm CorpSpironolactone and

Hydrochlorothiazide Bioline Labs Superpharm CorpSpironolactone and

Hydrochlorothiazide Goldline Labs Superpharm CorpSpironolactone and

Hydrochlorothiazide Barr Labs Barr LabsSpironolactone and

Hydrochlorothiazide Towne, Paulsen Barr LabsSpironolactone and

Hydrochlorothiazide General Generics Barr LabsSpironolactone and

Hydrochlorothiazide Mutual Pharmaceutical Mutual PharmaceuticalSpironolactone and

Hydrochlorothiazide United Research Labs Mutual Pharmaceutical

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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HYDROCHLOROTHIAZIDE/SPIRONOLACTONETablets—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Spironolactone andHydrochlorothiazide Purepac Pharmaceutical Mutual Pharmaceutical

Spironolactone andHydrochlorothiazide Warner Chilcott Labs Mutual Pharmaceutical

HYDROCHLOROTHIAZIDE/TRIAMTERENECapsules

Triamterene and Hydrochlorothiazide Bolar Pharmaceutical Bolar PharmaceuticalTriamterene and Hydrochlorothiazide Schein Pharmaceutical Bolar Pharmaceutical

HYDROCHLOROTHIAZIDE/TRIAMTERENETablets

Triamterene andHydrochlorothiazide Vitarine Pharmaceutical Vitarine Pharmaceutical

Triamterene andHydrochlorothiazide Lemmon Co Vitarine Pharmaceutical

Triamterene andHydrochlorothiazide Purepac Pharmaceutical Vitarine Pharmaceutical

Triamterene andHydrochlorothiazide Martec Pharmaceutical Vitarine Pharmaceutical

Maxzide Lederle Labs Mylan PharmaceuticalsTriamterene and

Hydrochlorothiazide American Therapeutics American TherapeuticsTriamterene and

Hydrochlorothiazide Rugby Labs American TherapeuticsTriamterene and

Hydrochlorothiazide Qualitest American TherapeuticsTriamterene and

Hydrochlorothiazide Parmed Pharmaceuticals American TherapeuticsTriamterene and

Hydrochlorothiazide Martec Pharmaceutical American TherapeuticsTriamterene and

Hydrochlorothiazide Goldline Labs American TherapeuticsTriamterene and

Hydrochlorothiazide Glenlawn Labs American TherapeuticsTriamterene and

Hydrochlorothiazide Schein Pharmaceutical American TherapeuticsTriamterene and

Hydrochlorothiazide Bioline Labs American TherapeuticsTriamterene and

Hydrochlorothiazide Purepac Pharmaceutical American TherapeuticsTriamterene and

Hydrochlorothiazide Major Pharmaceutical Corp American TherapeuticsTriamterene and

Hydrochlorothiazide H L Moore Drug Exchange American TherapeuticsTriamterene and

Hydrochlorothiazide Best Generics American TherapeuticsTriamterene and

Hydrochlorothiazide Regal Labs American TherapeuticsTriamterene and

Hydrochlorothiazide Harber Pharmaceutical American TherapeuticsTriamazide Towne, Paulsen American TherapeuticsTriamterene and

Hydrochlorothiazide Barr Labs Barr LabsTriamterene and

Hydrochlorothiazide Interstate Drug Exchange Barr LabsTriamterene and

Hydrochlorothiazide Major Pharmaceutical Corp Barr LabsTriamterene and

Hydrochlorothiazide H L Moore Drug Exchange Barr LabsTriamterene and

Hydrochlorothiazide Qualitest Barr LabsTriamterene and

Hydrochlorothiazide Rugby Labs Barr LabsTriamterene and

Hydrochlorothiazide Best Generics Barr LabsTriamterene and

Hydrochlorothiazide Geneva Generics Cord LabsTriamterene and

Hydrochlorothiazide Danbury Pharmacal Danbury PharmacalTriamterene and

Hydrochlorothiazide Par Pharmaceutical Par Pharmaceutical

28 § 25.58 PREVENTION OF DISEASES Pt. III

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HYDROCODONE BITARTRATE/PHENYLPROPANOLAMINE HCLSyrup

Brand Name/Generic Name Distributed By: Manufactured By:

Codamine Barre Drug National PharmaceuticalCodamine Glenlawn Labs National PharmaceuticalCodamine Qualitest National PharmaceuticalHydrophen Rugby Labs National PharmaceuticalCodamine Goldline Labs Barre-NationalMyhydromine My-K Labs My-K LabsHydrocodone Bitartrate/

Phenylpropanolamine Pharmaceutical Basics Pharmaceutical Basics

HYDROCODONE BITARTRATE/PSEUDOEPHEDRINE HCLElixir

Detussin Barre Drug National PharmaceuticalDetussin Bioline Labs National PharmaceuticalDetussin Qualitest National PharmaceuticalDetussin Henry Schein National PharmaceuticalDetussin H L Moore Drug Exchange National PharmaceuticalTussafin Rugby Labs National PharmaceuticalTyrodone Major Pharmaceutical Corp National PharmaceuticalTussgen Goldline Labs Barre-NationalMycotussin My-K Labs My-K LabsPseudoephedrine HCl

and Hydrocodone Pharmaceutical Basics Pharmaceutical Basics

HYDROCORTISONECream

Hytone Dermik Labs Dermik LabsCortifair Pharmafair PharmafairDermacort Reid-Rowell Reid-RowellHydrocortisone NMC Labs NMC LabsHydrocortisone Geneva Generics NMC LabsHydrocortisone Thames Pharmacal Thames PharmacalHydrocortisone Biocraft Labs Biocraft LabsHydrocortisone Lemmon Co Lemmon CoHydrocortisone E Fougera AltanaHydrocortisone Pharmaderm AltanaHydrocortisone Clay-Park Labs Clay-Park LabsHydrocortisone Goldline Labs Clay-Park LabsHydrocortisone Interstate Drug Exchange Clay-Park LabsHydrocortisone Rugby Labs Clay-Park LabsHydrocortisone Parmed Pharmaceuticals Clay-Park LabsHydrocortisone Henry Schein Clay-Park LabsHydrocortisone Vangard Labs Clay-Park LabsHydrocortisone Gen-King Products Clay-Park LabsHydrocortisone United Research Labs Clay-Park LabsHydrocortisone H L Moore Drug Exchange Clay-Park LabsHydrocortisone Bioline Labs Clay-Park LabsHydrocortisone Regal Labs Clay-Park LabsHydrocortisone J J Balan Clay-Park LabsHydrocortisone Revco Drug Clay-Park LabsHydrocortisone Pharmacal Co Clay-Park LabsHydrocortisone Osco Drug Clay-Park LabsHydrocortisone Perry Drug Clay-Park LabsHydrocortisone Treasury Drug Clay-Park LabsHydrocortisone Rix Corp Clay-Park LabsHydrocortisone Geneva Generics Clay-Park LabsHydrocortisone Qualitest Clay-Park LabsHydrocortisone Rugby Labs Naska Pharmacal

HYDROCORTISONELotion

Hydrocortisone Clay-Park Labs Clay-Park LabsHydrocortisone United Research Labs Clay-Park LabsHydrocortisone H L Moore Drug Exchange Clay-Park LabsHydrocortisone Rugby Labs Clay-Park LabsHydrocortisone Bioline Labs Clay-Park LabsHydrocortisone Henry Schein Clay-Park LabsHydrocortisone Interstate Drug Exchange Clay-Park LabsHydrocortisone Revco Drug Clay-Park LabsHydrocortisone J J Balan Clay-Park LabsHydrocortisone Qualitest Clay-Park LabsHydrocortisone Goldline Labs Clay-Park LabsHydrocortisone Barre Drug National PharmaceuticalHydrocortisone Thames Pharmacal Thames PharmacalDermacort Reid-Rowell Reid-RowellHydrocortisone Rugby Labs Naska Pharmacal

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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HYDROCORTISONEOintment

Brand Name/Generic Name Distributed By: Manufactured By:

Hytone Dermik Labs Dermik LabsHydrocortisone NMC Labs NMC LabsHydrocortisone Thames Pharmacal Thames PharmacalHydrocortisone E Fougera AltanaHydrocortisone Pharmaderm AltanaHydrocortisone Rugby Labs Clay-Park LabsHydrocortisone Interstate Drug Exchange Clay-Park LabsHydrocortisone United Research Labs Clay-Park LabsHydrocortisone Goldline Labs Clay-Park LabsHydrocortisone Schein Pharmaceutical Clay-Park LabsHydrocortisone Rugby Labs Naska Pharmacal

HYDROCORTISONETopical Spray

Aeroseb - HC Herbert Labs Allergan Pharmaceutical

HYDROCORTISONE/DIIODOHYDROXYQUINCream

Vytone Dermik Labs Dermik Labs

HYDROCORTISONE/IODOCHLORHYDROXYQUINCream

Hydrocortisone/Iodochlorhydroxyquin Clay-Park Labs Clay-Park LabsHydrocortisone/Iodochlorhydroxyquin Rugby Labs Clay-Park LabsHydrocortisone/Iodochlorhydroxyquin Henry Schein Clay-Park LabsHydrocortisone/Iodochlorhydroxyquin United Research Labs Clay-Park LabsHydrocortisone/Iodochlorhydroxyquin Interstate Drug Exchange Clay-Park LabsHydrocortisone/Iodochlorhydroxyquin Regal Labs Clay-Park LabsHydrocortisone/Iodochlorhydroxyquin H L Moore Drug Exchange Clay-Park LabsHydrocortisone/Iodochlorhydroxyquin Bioline Labs Clay-Park LabsHydrocortisone/Iodochlorhydroxyquin Gen-King Products Clay-Park LabsHydrocortisone/Iodochlorhydroxyquin J J Balan Clay-Park LabsHydrocortisone/Iodochlorhydroxyquin Qualitest Clay-Park LabsHydrocortisone/Iodochlorhydroxyquin Goldline Labs Clay-Park LabsIodochlorhydroxyquin

w/Hydrocortisone Thames Pharmacal Thames PharmacalCorque Geneva Generics Thames PharmacalViodo HC NMC Labs NMC Labs

HYDROCORTISONE/NEOMYCIN SULFATE/POLYMYXIN-B SULFATEOphthalmic Suspension

Ocutricin HC Pharmafair PharmafairNeomycin & Polymyxin B

Sulfates & Hydrocortisone Steris Labs Steris Labs

HYDROCORTISONE/NEOMYCIN SULFATE/POLYMYXIN-B SULFATEOtic Solution

Otocort Sterile Lemmon Co Lemmon CoPolymyxin-B/Neomycin/Hydrocortisone Hygeia Labs Carter-Glogau LabsPolymyxin-B/Neomycin/Hydrocortisone Orbis Pharmaceuticals Carter-Glogau LabsAntibiotic Ear Drops Geneva Generics Carter-Glogau LabsOcticair Pharmafair PharmafairAntibiotic Ear Solution United Research Labs PharmafairAntibiotic Ear Solution Rugby Labs Steris LabsSterile Otic Solution Steris Labs Steris LabsSterile Otic Solution Hygeia Labs Steris LabsSterile Otic Solution Danbury Pharmacal Steris LabsAntibiotic Ear Solution H L Moore Drug Exchange Steris LabsAntibiotic Ear Solution United Research Labs Steris LabsSterile Otic Solution Richie Pharmacal Steris LabsSterile Otic Solution UDL Labs Steris LabsSterile Otic Solution Dixon-Shane Steris LabsSterile Otic Solution Lunsco Steris LabsSterile Otic Solution Regal Labs Steris LabsTexsporin-HC Texas Drug Reps Steris LabsOtimar Marlop Pharmaceuticals Steris LabsAntibiotic J J Balan Steris LabsOticrex C S Ruckstuhl Steris LabsAK-Spore Akorn Steris LabsAntibiOtic Parnel Pharmaceuticals Steris LabsEar Solution # 6 Schein Pharmaceutical Steris LabsAntibiotic/Hydrocortisone Qualitest Steris Labs

28 § 25.58 PREVENTION OF DISEASES Pt. III

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HYDROCORTISONE/NEOMYCIN SULFATE/POLYMYXIN-B SULFATEOtic Suspension

Brand Name/Generic Name Distributed By: Manufactured By:

Otocort Lemmon Co Lemmon CoOcticair Pharmafair PharmafairAntibiotic United Research Labs PharmafairNeomycin & Polymyxin B Sulfates &

Hydrocortisone Hygeia Labs Carter-Glogau LabsNeomycin & Polymyxin B Sulfates &

Hydrocortisone Orbis Pharmaceuticals Carter-Glogau LabsNeomycin & Polymyxin B Sulfates &

Hydrocortisone Steris Labs Steris LabsNeomycin & Polymyxin B Sulfates &

Hydrocortisone Hygeia Labs Steris LabsNeomycin & Polymyxin B Sulfates &

Hydrocortisone Danbury Pharmacal Steris LabsNeomycin & Polymyxin B Sulfates &

Hydrocortisone Richie Pharmacal Steris LabsNeomycin & Polymyxin B Sulfates &

Hydrocortisone Dixon-Shane Steris LabsOticair H L Moore Drug Exchange Steris LabsTexsporin-HC Texas Drug Reps Steris LabsAntibiotic Ear Suspension United Research Labs Steris LabsOtimar Marlop Pharmaceuticals Steris LabsSterile Otic Suspension UDL Labs Steris LabsSterile Otic Suspension Regal Labs Steris LabsAntibiOtic J J Balan Steris LabsOticrex C S Ruckstuhl Steris LabsAK-Trol Akorn Steris LabsAntibiOtic Parnel Pharmaceuticals Steris LabsHydromycin Schein Pharmaceutical Steris Labs

HYDROCORTISONE ACETATECream

Hydrocortisone Acetate Purepac Pharmaceutical Purepac PharmaceuticalHydrocortisone Acetate Life Labs Life LabsHydrocortisone Acetate Thames Pharmacal Thames Pharmacal

HYDROCORTISONE ACETATESuppositories

Cortisol Acetate G & W Labs G & W Labs

HYDROCORTISONE SODIUM SUCCINATEInjection

Hydrocortisone Sodium Succinate Steris Labs Steris LabsHydrocortisone Sodium Succinate Schein Pharmaceutical Steris LabsHydrocortisone Sodium Succinate Rugby Labs Steris Labs

HYDROFLUMETHIAZIDETablets

Hydroflumethiazide Bolar Pharmaceutical Bolar PharmaceuticalHydroflumethiazide Rugby Labs Chelsea LabsHydroflumethiazide Par Pharmaceutical Par Pharmaceutical

HYDROMORPHONE HCLTablets

Hydromorphone HCl Roxane Labs Roxane Labs

HYDROXOCOBALAMINInjection

Hydroxocobalamin Steris Labs Steris LabsHydroxocobalamin Rugby Labs Steris LabsHydroxocobalamin Major Pharmaceutical Corp Steris Labs

HYDROXYPROPYL METHYLCELLULOSEOphthalmic Solution

Lacril Artificial Tears Allergan Pharmaceutical Allergan PharmaceuticalUltra Tears Alcon Labs Alcon Labs

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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HYDROXYZINE HCLInjection

Brand Name/Generic Name Distributed By: Manufactured By:

Hydroxyzine HCl Steris Labs Steris LabsHydroxyzine HCl Schein Pharmaceutical Steris LabsHydroxyzine HCl H L Moore Drug Exchange Steris LabsHydroxyzine HCl Major Pharmaceutical Corp Steris LabsHydroxyzine HCl Rugby Labs Steris LabsHydroxyzine HCl Bioline Labs Steris Labs

HYDROXYZINE HCLSyrup

Hydroxyzine HCl KV Pharmaceutical KV PharmaceuticalHydroxyzine HCl My-K Labs My-K LabsHydroxyzine HCl Barre Drug National PharmaceuticalHydroxyzine HCl Henry Schein National PharmaceuticalHydroxyzine HCl Murray Drug National PharmaceuticalHydroxyzine HCl Rugby Labs National PharmaceuticalHydroxyzine HCl Bioline Labs National PharmaceuticalHydroxyzine HCl Geneva Generics National PharmaceuticalHydroxyzine HCl Qualitest National PharmaceuticalHydroxyzine HCl Goldline Labs Barre-NationalHydroxyzine HCl Rugby Labs Naska PharmacalHydroxyzine HCl Pharmaceutical Basics Pharmaceutical Basics

HYDROXYZINE HCLTablets

Hydroxyzine HCl Rugby Labs Chelsea LabsHydroxyzine HCl Zenith Labs Zenith LabsHydroxyzine HCl Interstate Drug Exchange Zenith LabsHydroxyzine HCl Rugby Labs Zenith LabsHydroxyzine HCl United Research Labs Zenith LabsHydroxyzine HCl Murray Drug Zenith LabsHydroxyzine HCl H L Moore Drug Exchange Zenith LabsHydroxyzine HCl Parmed Pharmaceuticals Zenith LabsHydroxyzine HCl Bioline Labs Zenith LabsHydroxyzine HCl Major Pharmaceutical Corp Zenith LabsHydroxyzine HCl Gen-King Products Zenith LabsHydroxyzine HCl Whiteworth Pharmaceuticals Zenith LabsHydroxyzine HCl Regal Labs Zenith LabsHydroxyzine HCl Bell Pharmacal Zenith LabsHydroxyzine HCl Purepac Pharmaceutical Zenith LabsHydroxyzine HCl Qualitest Zenith LabsTraxin Owens Labs Zenith LabsHydroxyzine HCl Ascot Zenith LabsHydroxyzine HCl Towne, Paulsen Zenith LabsHydroxyzine HCl Par Pharmaceutical Par PharmaceuticalHydroxyzine HCl Glenlawn Labs Par PharmaceuticalHydroxyzine HCl Whiteworth Pharmaceuticals Par PharmaceuticalHydroxyzine HCl United Research Labs Par PharmaceuticalHydroxyzine HCl Williams Generics Par PharmaceuticalHydroxyzine HCl Texas Drug Reps Par PharmaceuticalHydroxyzine HCl Unit Dose Labs Par PharmaceuticalHydroxyzine HCl Towne, Paulsen Par PharmaceuticalHydroxyzine HCl H L Moore Drug Exchange Par PharmaceuticalHydroxyzine HCl Parmed Pharmaceuticals Par PharmaceuticalHydroxyzine HCl Henry Schein Par PharmaceuticalHydroxyzine HCl Goldline Labs Par PharmaceuticalHydroxyzine HCl Harber Pharmaceutical Par PharmaceuticalHydroxyzine HCl Richie Pharmacal Par PharmaceuticalHydroxyzine HCl Geneva Generics Par PharmaceuticalHydroxyzine HCl General Generics Par PharmaceuticalHydroxyzine HCl Interstate Drug Exchange Par PharmaceuticalHydroxyzine HCl Ascot Pharmaceutical Par PharmaceuticalHydroxyzine HCl Dixon-Shane Par PharmaceuticalHydroxyzine HCl Bioline Labs Par PharmaceuticalHydroxyzine HCl Purepac Pharmaceutical Par PharmaceuticalHydroxyzine HCl Barr Labs Barr LabsHydroxyzine HCl Danbury Pharmacal Danbury PharmacalHydroxyzine HCl Bell Pharmacal Danbury PharmacalHydroxyzine HCl Cord Labs Cord LabsHydroxyzine HCl Geneva Generics Cord LabsHydroxyzine HCl KV Pharmaceutical KV PharmaceuticalHydroxyzine HCl Sidmak Labs Sidmak LabsHydroxyzine HCl Towne, Paulsen Sidmak LabsHydroxyzine HCl Genetco Sidmak LabsHydroxyzine HCl Parmed Pharmaceuticals Sidmak LabsHydroxyzine HCl Mutual Pharmaceutical Mutual PharmaceuticalHydroxyzine HCl Schein Pharmaceutical Danbury Pharmacal

28 § 25.58 PREVENTION OF DISEASES Pt. III

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Page 103: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

HYDROXYZINE HCLTablets—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Hydroxyzine HCl United Research Labs Mutual PharmaceuticalHydroxyzine HCl H L Moore Drug Exchange Mutual PharmaceuticalHydroxyzine HCl Genetco Mutual PharmaceuticalHydroxyzine HCl Purepac Pharmaceutical Mutual PharmaceuticalHydroxyzine HCl Towne, Paulsen Mutual PharmaceuticalHydroxyzine HCl Best Generics Mutual PharmaceuticalHydroxyzine HCl Halsey Drug Halsey DrugHydroxyzine HCl Pharmaceutical Basics Pharmaceutical BasicsHydroxyzine HCl Best Generics Pharmaceutical Basics

HYDROXYZINE PAMOATECapsules

Hydroxyzine Pamoate Rugby Labs Chelsea LabsHydroxyzine Pamoate Zenith Labs Zenith LabsHydroxyzine Pamoate Murray Drug Zenith LabsHydroxyzine Pamoate Geneva Generics Zenith LabsHy Pam Bioline Labs Zenith LabsHydroxyzine Pamoate Interstate Drug Exchange Zenith LabsHydroxyzine Pamoate Major Pharmaceutical Corp Zenith LabsHydroxyzine Pamoate Towne, Paulsen Zenith LabsHydroxyzine Pamoate Par Pharmaceutical Par PharmaceuticalHydroxyzine Pamoate Glenlawn Labs Par PharmaceuticalHydroxyzine Pamoate Geneva Generics Par PharmaceuticalHydroxyzine Pamoate Henry Schein Par PharmaceuticalHydroxyzine Pamoate Texas Drug Reps Par PharmaceuticalHydroxyzine Pamoate H L Moore Drug Exchange Par PharmaceuticalHydroxyzine Pamoate Towne, Paulsen Par PharmaceuticalHydroxyzine Pamoate United Research Labs Par PharmaceuticalHydroxyzine Pamoate Bioline Labs Par PharmaceuticalHydroxyzine Pamoate Interstate Drug Exchange Par PharmaceuticalHydroxyzine Pamoate Williams Generics Par PharmaceuticalHydroxyzine Pamoate Goldline Labs Par PharmaceuticalHydroxyzine Pamoate Unit Dose Labs Par PharmaceuticalHydroxyzine Pamoate Harber Pharmaceutical Par PharmaceuticalHydroxyzine Pamoate Mutual Pharmaceutical Par PharmaceuticalHydroxyzine Pamoate Duramed Pharmaceuticals Duramed PharmaceuticalsHydroxyzine Pamoate Parmed Pharmaceuticals Duramed PharmaceuticalsHydroxyzine Pamoate Towne, Paulsen Duramed PharmaceuticalsHydroxyzine Pamoate Vangard Labs Duramed PharmaceuticalsHydroxyzine Pamoate Vitarine Pharmaceutical Vitarine PharmaceuticalHydroxyzine Pamoate Danbury Pharmacal Danbury PharmacalHydroxyzine Pamoate Schein Pharmaceutical Par PharmaceuticalHydroxyzine Pamoate Superpharm Corp Superpharm CorpHydroxyzine Pamoate Barr Labs Barr LabsHydroxyzine Pamoate Regal Labs Barr Labs

L - HYOSCYAMINE SULFATEElixir

Levsin Kremers-Urban Kremers-Urban

L - HYOSCYAMINE SULFATETablets

Levsin Kremers-Urban Kremers-Urban

IBUPROFENTablets

Rufen Boots Pharmaceuticals Boots CoIbuprofen Interstate Drug Exchange Boots PharmaceuticalsIbuprofen Rugby Labs Boots PharmaceuticalsIbuprofen Purepac Pharmaceutical Boots PharmaceuticalsIbuprofen Parmed Pharmaceuticals Boots PharmaceuticalsIbuprofen United Research Labs Boots PharmaceuticalsIbuprofen Bioline Labs Boots PharmaceuticalsIbuprofen Henry Schein Boots PharmaceuticalsIbuprofen Major Pharmaceutical Corp Boots PharmaceuticalsIbuprofen Qualitest Boots PharmaceuticalsIbuprofen Glenlawn Labs Boots PharmaceuticalsIbuprofen H L Moore Drug Exchange Boots PharmaceuticalsIbuprofen Goldline Labs Boots PharmaceuticalsIbuprofen LuChem Pharmaceuticals Boots PharmaceuticalsHaltran Upjohn Co Upjohn CoIbuprofen Par Pharmaceutical Par PharmaceuticalIbuprofen Arkansas Cooperative Asso Par PharmaceuticalIbuprofen Bioline Labs Par Pharmaceutical

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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IBUPROFENTablets—Continued

Ibuprofen Dixon-Shane Par PharmaceuticalIbuprofen Geneva Generics Par PharmaceuticalIbuprofen Harber Pharmaceutical Par PharmaceuticalIbuprofen Interstate Drug Exchange Par PharmaceuticalIbuprofen Lederle Labs Par PharmaceuticalIbuprofen H L Moore Drug Exchange Par PharmaceuticalIbuprofen Regal Labs Par PharmaceuticalIbuprofen Rugby Labs Par PharmaceuticalIbuprofen Henry Schein Par PharmaceuticalI-Bu-Tex Texas Drug Reps Par PharmaceuticalIbuprofen United Research Labs Par PharmaceuticalIbuprofen Williams Generics Par PharmaceuticalIbuprofen Rugby Labs Chelsea LabsIbuprofen Mylan Pharmaceuticals Mylan PharmaceuticalsIbuprofen Parmed Pharmaceuticals Mylan PharmaceuticalsIbuprofen Lemmon Co Mylan PharmaceuticalsIbuprofen United Research Labs Mylan PharmaceuticalsIbuprofen Williams Generics Mylan PharmaceuticalsIbuprofen Glenlawn Labs Mylan PharmaceuticalsIbuprofen Superpharm Corp Superpharm CorpIbuprofen Goldline Labs Superpharm CorpIbuprofen Bioline Labs Superpharm CorpIbuprofen Private Formulations Private FormulationsIbuprofen Mutual Pharmaceutical Mutual PharmaceuticalIbuprofen Barr Labs Barr LabsIbuprofen Purepac Pharmaceutical Barr LabsIbuprofen Schein Pharmaceutical Par PharmaceuticalIbuprofen Martec Pharmaceutical Par PharmaceuticalIbuprofen Glenlawn Labs Barr LabsIbuprofen Purepac Pharmaceutical Purepac PharmaceuticalIbuprofen United Research Labs Mutual PharmaceuticalIbuprofen Vita-Rx Mutual PharmaceuticalIbuprofen Genetco Mutual PharmaceuticalIbuprofen Interpharm InterpharmIbuprofen Cord Labs Cord LabsIbuprofen Geneva Generics Cord LabsIbuprofen Towne, Paulsen Mutual PharmaceuticalIbuprofen Halsey Drug Halsey DrugIbuprofen LuChem Pharmaceuticals LuChem PharmaceuticalsIbuprofen Sidmak Labs Sidmak LabsIbuprofen Danbury Pharmacal Danbury PharmacalIbuprofen Schein Pharmaceutical Danbury PharmacalIbu-Tab Alra Labs Alra LabsIbuprofen Lederle Labs Lederle Arzneimittel

IDOXURIDINEOphthalmic Solution

Stoxil Smith, Kline & French Smith, Kline & FrenchHerplex Liquifilm Allergan Pharmaceutical Allergan Pharmaceutical

IMIPRAMINE HCLTablets

Tofranil Geigy Pharmaceutical Ciba-GeigySK-Pramine Smith, Kline & French Smith, Kline & FrenchJanimine Abbott Labs Abbott LabsImipramine HCl Bolar Pharmaceutical Bolar PharmaceuticalImipramine HCl United Research Labs Bolar PharmaceuticalImipramine HCl Purepac Pharmaceutical Bolar PharmaceuticalImipramine HCl Vangard Labs Bolar PharmaceuticalImipramine HCl Thrift Drug Bolar PharmaceuticalImipramine HCl Glenlawn Labs Bolar PharmaceuticalImipramine HCl Gen-King Products Bolar PharmaceuticalImipramine HCl Regal Labs Bolar PharmaceuticalImipramine HCl Vita-Rx Bolar PharmaceuticalImipramine HCl Ronda Pharmacal Bolar PharmaceuticalImipramine HCl Bioline Labs Bolar PharmaceuticalImipramine HCl H L Moore Drug Exchange Bolar PharmaceuticalImipramine HCl Towne, Paulsen Bolar PharmaceuticalImipramine HCl Rugby Labs Bolar PharmaceuticalImipramine HCl Whiteworth Pharmaceuticals Bolar PharmaceuticalImipramine HCl Murray Drug Bolar PharmaceuticalImipramine HCl Henry Schein Bolar PharmaceuticalImipramine HCl Interstate Drug Exchange Bolar PharmaceuticalImipramine HCl Richie Pharmacal Bolar PharmaceuticalImipramine HCl H R Cenci Labs Bolar PharmaceuticalImipramine HCl Parmed Pharmaceuticals Bolar PharmaceuticalImipramine HCl Qualitest Bolar PharmaceuticalImipramine HCl Best Generics Bolar PharmaceuticalImipramine HCl Biocraft Labs Biocraft Labs

28 § 25.58 PREVENTION OF DISEASES Pt. III

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Page 105: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

IMIPRAMINE HCLTablets—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Imipramine HCl Lederle Labs Biocraft LabsImipramine HCl Bell Pharmacal Biocraft LabsImipramine HCl West-ward Biocraft LabsImipramine HCl Geneva Generics Biocraft LabsImipramine HCl Rugby Labs Chelsea LabsImipramine HCl Geneva Generics Cord LabsImipramine HCl Vitarine Pharmaceutical Vitarine Pharmaceutical

INDOMETHACINCapsules

Indomethacin Mylan Pharmaceuticals Mylan PharmaceuticalsIndomethacin Regal Labs Mylan PharmaceuticalsIndomethacin Henry Schein Mylan PharmaceuticalsIndomethacin Interstate Drug Exchange Mylan PharmaceuticalsIndomethacin Parmed Pharmaceuticals Mylan PharmaceuticalsIndomethacin United Research Labs Mylan PharmaceuticalsIndomethacin H L Moore Drug Exchange Mylan PharmaceuticalsIndomethacin Rugby Labs Mylan PharmaceuticalsIndomethacin Geneva Generics Mylan PharmaceuticalsIndomethacin Bioline Labs Mylan PharmaceuticalsIndomethacin Purepac Pharmaceutical Mylan PharmaceuticalsIndomethacin Major Pharmaceutical Corp Mylan PharmaceuticalsIndomethacin Genetco Mylan PharmaceuticalsIndomethacin Zenith Labs Zenith LabsIndomethacin Bioline Labs Zenith LabsIndomethacin Glenlawn Labs Zenith LabsIndomethacin Goldline Labs Zenith LabsIndomethacin Purepac Pharmaceutical Zenith LabsIndomethacin Qualitest Zenith LabsIndomethacin Harber Pharmaceutical Zenith LabsIndomethacin Ascot Pharmaceutical Zenith LabsIndomethacin Towne, Paulsen Zenith LabsIndomethacin Geneva Generics Zenith LabsIndomethacin Major Pharmaceutical Corp Zenith LabsIndomethacin Interstate Drug Exchange Zenith LabsIndomethacin Par Pharmaceutical Par PharmaceuticalIndomethacin Bioline Labs Par PharmaceuticalIndomethacin Parmed Pharmaceuticals Par PharmaceuticalIndomethacin United Research Labs Par PharmaceuticalIndomethacin Geneva Generics Par PharmaceuticalIndomethacin Henry Schein Par PharmaceuticalIndomethacin H L Moore Drug Exchange Par PharmaceuticalIndomethacin Harber Pharmaceutical Par PharmaceuticalIndomethacin Interstate Drug Exchange Par PharmaceuticalIndomethacin Major Pharmaceutical Corp Par PharmaceuticalIndomethacin Arkansas Cooperative Asso Par PharmaceuticalIndomethacin Towne, Paulsen Par PharmaceuticalIndomethacin Texas Drug Reps Par PharmaceuticalIndomethacin General Generics Par PharmaceuticalIndomethacin Williams Generics Par PharmaceuticalIndomethacin Goldline Labs Par PharmaceuticalIndomethacin Rugby Labs Chelsea LabsIndomethacin Duramed Pharmaceuticals Duramed PharmaceuticalsIndomethacin Towne, Paulsen Duramed PharmaceuticalsIndomethacin Parmed Pharmaceuticals Duramed PharmaceuticalsIndomethacin Texas Drug Reps Duramed PharmaceuticalsIndomethacin Lederle Labs Lederle LabsIndomethacin Watson Labs Watson LabsIndomethacin Parmed Pharmaceuticals Watson LabsIndomethacin Texas Drug Reps Watson LabsIndomethacin Purepac Pharmaceutical Watson LabsIndomethacin Mutual Pharmaceutical Mutual PharmaceuticalIndomethacin Superpharm Corp Superpharm CorpIndomethacin Goldline Labs Superpharm CorpIndomethacin Bioline Labs Superpharm CorpIndo-Lemmon Lemmon Co Lemmon CoIndomethacin D-M Pharmaceuticals Lemmon CoIndomethacin Interstate Drug Exchange Lemmon CoIndomethacin United Research Labs Lemmon CoIndomethacin E R Squibb & Sons Zenith LabsIndomethacin Martec Pharmaceutical Par PharmaceuticalIndomethacin United Research Labs Mutual PharmaceuticalIndomethacin Purepac Pharmaceutical Mutual PharmaceuticalIndomethacin Genetco Mutual PharmaceuticalIndomethacin Best Generics Watson LabsIndomethacin Parke-Davis Parke-DavisIndomethacin Barr Labs Barr LabsIndomethacin Bolar Pharmaceutical Bolar PharmaceuticalIndomethacin Geneva Generics Cord Labs

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

25-103(202511) No. 253 Dec. 95

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INDOMETHACINCapsules—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Indomethacin Halsey Drug Halsey DrugIndomethacin Sidmak Labs Sidmak LabsIndomethacin Mason Distributors Mylan PharmaceuticalsIndomethacin LyphoMed/NovoPharm Novopharm

IODINATED GLYCEROLElixir

Iophen Barre Drug National PharmaceuticalBio-Phylline Bioline Labs National PharmaceuticalIophen Glenlawn Labs National PharmaceuticalIophen United Research Labs National PharmaceuticalIophen Rugby Labs National PharmaceuticalIophen H L Moore Drug Exchange National PharmaceuticalIophen Qualitest National PharmaceuticalOrganic-I Major Pharmaceutical Corp National PharmaceuticalMyodine My-K Labs My-K LabsOridol LuChem Pharmaceuticals LuChem PharmaceuticalsIodur Duramed Pharmaceuticals Duramed PharmaceuticalsIodur Mason Distributors Duramed PharmaceuticalsIophen Qualitest Duramed PharmaceuticalsIodinated Glycerol Pharmaceutical Basics Pharmaceutical Basics

IODINATED GLYCEROLSolution

Iophen Barre Drug National PharmaceuticalIophen Qualitest National PharmaceuticalOrgani-I Major Pharmaceutical Corp National PharmaceuticalIophen Goldline Labs Barre-NationalIophen Qualitest Barre-National

IODINATED GLYCEROL/THEOPHYLLINEElixir

Iophylline Barre Drug National PharmaceuticalIophylline Murray Drug National PharmaceuticalIophylline Rugby Labs National PharmaceuticalBio-Organidin Bioline Labs National PharmaceuticalIophylline Qualitest National PharmaceuticalOridol LuChem Pharmaceuticals LuChem Pharmaceuticals

IODOCHLORHYDROXYQUINCream

Iodo Plain Thames Pharmacal Thames Pharmacal

IPECAC ALKALOIDSSyrup

Ipecac Barre Drug National PharmaceuticalIpecac Rugby Labs National PharmaceuticalIpecac Roxane Labs Roxane Labs

IRON DEXTRANInjection

Iron Dextran Steris Labs Steris Labs

ISONIAZIDInjection

Nydrazid E R Squibb & Sons E R Squibb & Sons

ISONIAZIDTablets

Isoniazid Danbury Pharmacal Danbury PharmacalIsoniazid Interstate Drug Exchange Danbury PharmacalIsoniazid Henry Schein Danbury PharmacalIsoniazid McKesson Labs Danbury PharmacalIsoniazid Purepac Pharmaceutical Purepac PharmaceuticalPanzid Panray Ormont Drug & ChemicalIsoniazid Henry Schein Ormont Drug & ChemicalIsonicon Pharmecon Ormont Drug & Chemical

28 § 25.58 PREVENTION OF DISEASES Pt. III

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Page 107: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

ISONIAZIDTablets—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Isoniazid Richlyn Labs Richlyn LabsIsoniazid H R Cenci Labs Richlyn LabsIsoniazid West-ward West-wardIsoniazid Bolar Pharmaceutical Bolar PharmaceuticalIsoniazid Gen-King Products Bolar PharmaceuticalIsoniazid Bioline Labs Bolar PharmaceuticalIsoniazid United Research Labs Bolar PharmaceuticalIsoniazid Glenlawn Labs Bolar PharmaceuticalIsoniazid Geneva Generics Bolar PharmaceuticalIsoniazid H R Cenci Labs Bolar PharmaceuticalIsoniazid Towne, Paulsen Bolar PharmaceuticalIsoniazid Interstate Drug Exchange Bolar PharmaceuticalIsoniazid H L Moore Drug Exchange Bolar PharmaceuticalIsoniazid Penta Products Bolar PharmaceuticalIsoniazid Whiteworth Pharmaceuticals Bolar PharmaceuticalIsoniazid Ronda Pharmacal Bolar PharmaceuticalIsoniazid Murray Drug Bolar PharmaceuticalIsoniazid McKesson Labs Bolar PharmaceuticalIsoniazid Richie Pharmacal Bolar PharmaceuticalIsoniazid Goldline Labs Bolar PharmaceuticalIsoniazid Rugby Labs Chelsea LabsIsoniazid Towne, Paulsen Towne, PaulsenIsoniazid Phoenix Labs Phoenix LabsIsoniazid Henry Schein Phoenix LabsIsoniazid United Research Labs Phoenix LabsIsoniazid Rugby Labs Phoenix LabsIsoniazid American Quinine Phoenix LabsIsoniazid Halsey Drug Halsey DrugIsoniazid Lannett LannettIsoniazid Barr Labs Barr LabsIsoniazid Duramed Pharmaceuticals Duramed PharmaceuticalsIsoniazid Vitarine Pharmaceutical Vitarine Pharmaceutical

ISOSORBIDE DINITRATESublingual Tablets

Isosorbide Dinitrate Barr Labs Barr LabsIsosorbide Dinitrate H L Moore Drug Exchange Barr LabsIsosorbide Dinitrate Geneva Generics Barr LabsIsosorbide Dinitrate Glenlawn Labs Barr LabsIsosorbide Dinitrate Henry Schein Barr LabsIsosorbide Dinitrate Regal Labs Barr LabsIsosorbide Dinitrate Bell Pharmacal Barr LabsIsosorbide Dinitrate Qualitest Barr LabsIsosorbide Dinitrate Lederle Labs Barr LabsIsosorbide Dinitrate West-ward West-wardIsosorbide Dinitrate Best Generics Barr LabsIsosorbide Dinitrate Goldline Labs Barr LabsIsosorbide Dinitrate Danbury Pharmacal Danbury Pharmacal

ISOSORBIDE DINITRATETablets

Isosorbide Dinitrate Barr Labs Barr LabsIsosorbide Dinitrate Rugby Labs Barr LabsIsosorbide Dinitrate United Research Labs Barr LabsIsosorbide Dinitrate Geneva Generics Barr LabsIsosorbide Dinitrate Skaggs Co Barr LabsIsosorbide Dinitrate Regal Labs Barr LabsIsosorbide Dinitrate Glenlawn Labs Barr LabsIsosorbide Dinitrate Murray Drug Barr LabsIsosorbide Dinitrate Harber Pharmaceutical Barr LabsIsosorbide Dinitrate Henry Schein Barr LabsIsosorbide Dinitrate Bell Pharmacal Barr LabsIsosorbide Dinitrate Purepac Pharmaceutical Barr LabsIsosorbide Dinitrate Par Pharmaceutical Par PharmaceuticalIsosorbide Dinitrate Geneva Generics Par PharmaceuticalIsosorbide Dinitrate Parmed Pharmaceuticals Par PharmaceuticalIsosorbide Dinitrate Goldline Labs Par PharmaceuticalIsosorbide Dinitrate Texas Drug Reps Par PharmaceuticalIsosorbide Dinitrate Whiteworth Pharmaceuticals Par PharmaceuticalIsosorbide Dinitrate H L Moore Drug Exchange Par PharmaceuticalIsosorbide Dinitrate Dixon-Shane Par PharmaceuticalIsosorbide Dinitrate Quality Pharmacal Par PharmaceuticalIsosorbide Dinitrate United Research Labs Par PharmaceuticalIsosorbide Dinitrate Williams Generics Par PharmaceuticalIsosorbide Dinitrate Harber Pharmaceutical Par PharmaceuticalIsosorbide Dinitrate Henry Schein Par PharmaceuticalIsosorbide Dinitrate Bioline Labs Par Pharmaceutical

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

25-105(202513) No. 253 Dec. 95

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ISOSORBIDE DINITRATETablets—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Isosorbide Dinitrate Cooper Par PharmaceuticalIsosorbide Dinitrate General Generics Par PharmaceuticalIsosorbide Dinitrate Qualitest Par PharmaceuticalIsosorbide Dinitrate Artex Labs Par PharmaceuticalIsosorbide Dinitrate Towne, Paulsen Par PharmaceuticalIsosorbide Dinitrate Vangard Labs Par PharmaceuticalIsosorbide Dinitrate Interstate Drug Exchange Par PharmaceuticalIsosorbide Dinitrate Unit Dose Labs Par PharmaceuticalIsosorbide Dinitrate West-ward West-wardIsosorbide Dinitrate Schein Pharmaceutical Par PharmaceuticalIsosorbide Dinitrate Best Generics Barr LabsIsosorbide Dinitrate Superpharm Corp Superpharm CorpIsosorbide Dinitrate Geneva Generics Cord LabsIsosorbide Dinitrate Danbury Pharmacal Danbury Pharmacal

ISOXSUPRINE HCLTablets

Isoxsuprine HCl West-ward West-wardIsoxsuprine HCl H L Moore Drug Exchange West-wardIsoxsuprine HCl Par Pharmaceutical Par PharmaceuticalIsoxsuprine HCl United Research Labs Par PharmaceuticalIsoxsuprine HCl Danbury Pharmacal Danbury PharmacalIsoxsuprine HCl Henry Schein Danbury PharmacalIsoxsuprine HCl Interstate Drug Exchange Danbury PharmacalIsoxsuprine HCl Penta Products Danbury PharmacalIsoxsuprine HCl Stayner Corp Danbury PharmacalIsoxsuprine HCl Regal Labs Danbury PharmacalIsoxsuprine HCl United Research Labs Danbury PharmacalIsoxsuprine HCl Bell Pharmacal Danbury PharmacalIsoxsuprine HCl Purepac Pharmaceutical Danbury PharmacalIsoxsuprine HCl Halsey Drug Halsey DrugIsoxsuprine HCl Glenlawn Labs Halsey DrugIsoxsuprine HCl Purepac Pharmaceutical Halsey DrugIsoxsuprine HCl Interstate Drug Exchange Halsey DrugIsoxsuprine HCl Zenith Labs Zenith LabsIsoxsuprine HCl Gen-King Products Zenith LabsIsoxsuprine HCl Murray Drug Zenith LabsIsoxsuprine HCl Vangard Labs Zenith LabsIsoxsuprine HCl Cooper Zenith LabsIsoxsuprine HCl H L Moore Drug Exchange Zenith LabsIsoxsuprine HCl Regal Labs Zenith LabsIsoxsuprine HCl Henry Schein Zenith LabsIsoxsuprine HCl Qualitest Zenith LabsIsoxsuprine HCl Towne, Paulsen Zenith LabsIsoxsuprine HCl Rugby Labs Chelsea LabsIsoxsuprine HCl Geneva Generics Cord LabsIsoxsuprine HCl Amide Pharmaceutical Amide PharmaceuticalIsoxsuprine HCl Lemmon Co Lemmon CoIsoxsuprine HCl Parmed Pharmaceuticals Lemmon CoIsoxsuprine HCl Purepac Pharmaceutical Lemmon CoIsoxsuprine HCl Sidmak Labs Sidmak LabsIsoxsuprine HCl Parmed Pharmaceuticals Sidmak LabsIsoxsuprine HCl Lederle Labs Sidmak LabsIsoxsuprine HCl Bioline Labs Superpharm CorpIsoxsuprine HCl Vitarine Pharmaceutical Vitarine PharmaceuticalIsoxsuprine HCl Towne, Paulsen Vitarine PharmaceuticalIsoxsuprine HCl Parmed Pharmaceuticals Vitarine PharmaceuticalCitaprine Citation Labs Vitarine Pharmaceutical

KANAMYCIN SULFATEInjection

Kanamycin Sulfate Steris Labs Steris Labs

KAOLIN/PAREGORIC/PECTINSuspension

Kapectolin w/Paregoric Barre Drug National PharmaceuticalKapectolin w/Paregoric Murray Drug National PharmaceuticalKaolinpec w/Paregoric C O Truxton National PharmaceuticalKapectin w/Paregoric Approved Pharmaceutical National PharmaceuticalTanapec Cooper Drug National Pharmaceutical

28 § 25.58 PREVENTION OF DISEASES Pt. III

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Page 109: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

KAOLIN/PECTINSuspension

Brand Name/Generic Name Distributed By: Manufactured By:

Kapectolin Barre Drug National PharmaceuticalKapectolin Henry Schein National PharmaceuticalKapectolin United Research Labs National PharmaceuticalKapectolin Murray Drug National PharmaceuticalKaolin-Pectin Vangard Labs National PharmaceuticalKaolin-Pectin Purepac Pharmaceutical National PharmaceuticalKaolin-Pectin Glenlawn Labs National PharmaceuticalKaolin-Pectin Mallard National PharmaceuticalKaolin-Pectin Ascot National PharmaceuticalKaolin Pectin Mixture Towne, Paulsen National PharmaceuticalKaolin Mixture Bioline Labs National PharmaceuticalKaolinpec C O Truxton National PharmaceuticalTakolin Detroit First Aid National PharmaceuticalK-Pec Rugby Labs National PharmaceuticalKapectolin Goldline Labs National PharmaceuticalK-Pec Life Labs Life LabsK-Pek Rugby Labs Naska Pharmacal

LACTULOSESyrup

Cholac Alra Labs Alra LabsConstilac Alra Labs Alra LabsGenerlac Pharmaceutical Basics Pharmaceutical BasicsLactulose Pharmaceutical Basics Pharmaceutical BasicsLactulose Schiapparelli Searle Alra Labs

LEUCOVORIN CALCIUMTablets

Leucovorin Calcium Barr Labs Barr LabsLeucovorin Calcium Goldline Labs Barr LabsLeucovorin Calcium LyphoMed/NovoPharm Barr LabsLeucovorin Calcium Par Pharmaceutical Par Pharmaceutical

LEVORPHANOL TARTRATETablets

Levorphanol Tartrate Roxane Labs Roxane Labs

LIDOCAINEOintment

Lidocaine Thames Pharmacal Thames PharmacalLidocaine E Fougera Altana

LIDOCAINE HCLInjection

Lidocaine HCl Dell Labs Dell LabsLidocaine HCl United Research Labs Dell LabsLidocaine HCl Bel-Mar Labs Bel-Mar LabsLidocaine HCl Rugby Labs Bel-Mar LabsLidocaine HCl Rugby Labs Natcon ChemicalLidocaine HCl Steris Labs Steris LabsLidocaine HCl Goldline Labs Steris LabsLidocaine HCl Schein Pharmaceutical Steris LabsLidocaine HCl Major Pharmaceutical Corp Steris LabsLidocaine HCl Bioline Labs Steris LabsLidocaine HCl Interstate Drug Exchange Steris LabsLido HCl H L Moore Drug Exchange Steris Labs

LIDOCAINE HCLOral Solution

Lidocaine HCl Viscous Barre Drug National PharmaceuticalLidocaine HCl Viscous Rugby Labs National PharmaceuticalLidocaine HCl Viscous Qualitest National PharmaceuticalMylocaine Viscous My-K Labs My-K LabsLidocaine HCl Viscous Pharmaceutical Basics Pharmaceutical Basics

LIDOCAINE HCLTopical Solution

Mylocaine My-K Labs My-K LabsLidocaine HCl Roxane Labs Roxane Labs

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

25-107(202515) No. 253 Dec. 95

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LINDANELotion

Brand Name/Generic Name Distributed By: Manufactured By:

Lindane Barre Drug National PharmaceuticalLindane Geneva Generics National PharmaceuticalLindane Whiteworth Pharmaceuticals National PharmaceuticalLindane Richie Pharmacal National PharmaceuticalLindane Henry Schein National PharmaceuticalLindane H L Moore Drug Exchange National PharmaceuticalLindane Bioline Labs National PharmaceuticalLindane Rugby Labs National PharmaceuticalKwildane Major Pharmaceutical Corp National PharmaceuticalLindane Qualitest National PharmaceuticalLindane Goldline Labs Barre-NationalLindane My-K Labs My-K LabsG-Well Goldline Labs Barre-NationalLindane Schein Pharmaceutical Barre-National

LINDANEShampoo

Lindane Barre Drug National PharmaceuticalLindane Rugby Labs National PharmaceuticalLindane Geneva Generics National PharmaceuticalLindane Towne, Paulsen National PharmaceuticalLindane Henry Schein National PharmaceuticalLindane Whiteworth Pharmaceuticals National PharmaceuticalLindane Richie Pharmacal National PharmaceuticalLindane United Research Labs National PharmaceuticalLindane H L Moore Drug Exchange National PharmaceuticalLindane Bioline Labs National PharmaceuticalKwildane Major Pharmaceutical Corp National PharmaceuticalLindane Qualitest National PharmaceuticalG-Well Goldline Labs National PharmaceuticalLindane My-K Labs My-K LabsLindane Schein Pharmaceutical Barre-NationalLindane Pharmaceutical Basics Pharmaceutical Basics

LITHIUM CARBONATECapsules

Eskalith Smith, Kline & French Smith, Kline & FrenchLithonate Reid-Rowell Reid-RowellLithium Carbonate Bioline Labs Reid-RowellLithium Carbonate United Research Labs Reid-RowellLithium Carbonate International Labs Reid-RowellLithium Carbonate Major Pharmaceutical Corp Reid-RowellLithium Carbonate Geneva Generics Reid-RowellLithium Carbonate Goldline Labs Reid-RowellLithium Carbonate Williams Generics Reid-RowellLithium Carbonate Bolar Pharmaceutical Bolar Pharmaceutical

LITHIUM CARBONATETablets

Lithotabs Reid-Rowell Reid-Rowell

LITHIUM CITRATESyrup

Lithium Citrate Roxane Labs Roxane LabsLithium Citrate My-K Labs My-K Labs

LORAZEPAMTablets

Loraz Quantum Pharmics Quantum PharmicsLorazepam Bioline Labs Quantum PharmicsLorazepam H L Moore Drug Exchange Quantum PharmicsLorazepam Rugby Labs Quantum PharmicsLorazepam Interstate Drug Exchange Quantum PharmicsLorazepam Purepac Pharmaceutical Quantum PharmicsLorazepam United Research Labs Quantum PharmicsLorazepam Henry Schein Quantum PharmicsLorazepam Parmed Pharmaceuticals Quantum PharmicsLorazepam Geneva Generics Quantum PharmicsAlzapam Major Pharmaceutical Corp Quantum PharmicsLorazepam Lemmon Co Quantum PharmicsLorazepam Goldline Labs Quantum PharmicsLorazepam Barr Labs Barr Labs

28 § 25.58 PREVENTION OF DISEASES Pt. III

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LORAZEPAMTablets—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Lorazepam American Therapeutics American TherapeuticsLorazepam Zenith Labs American TherapeuticsLorazepam Colmed Labs Pharmaceutical BasicsLorazepam Best Generics Pharmaceutical BasicsLorazepam Danbury Pharmacal Danbury PharmacalLorazepam E R Squibb & Sons American TherapeuticsLorazepam Par Pharmaceutical Par PharmaceuticalLorazepam Martec Pharmaceutical Par PharmaceuticalLorazepam Superpharm Corp Superpharm CorpLorazepam Goldline Labs Superpharm CorpLorazepam Bioline Labs Superpharm CorpLorazepam Watson Labs Watson LabsLorazepam Major Pharmaceutical Corp American TherapeuticsLorazepam H L Moore Drug Exchange American TherapeuticsLorazepam Glenlawn Labs American TherapeuticsLorazepam United Research Labs American TherapeuticsLorazepam Texas Drug Reps American TherapeuticsLorazepam Genetco American TherapeuticsLorazepam Gen-King Products American TherapeuticsLorazepam Regal Labs American TherapeuticsLorazepam Mylan Pharmaceuticals Mylan PharmaceuticalsLorazepam Purepac Pharmaceutical Purepac PharmaceuticalLorazepam Halsey Drug Halsey DrugLorazepam Parmed Pharmaceuticals Halsey DrugLorazepam Geneva Generics Cord Labs

LOXAPINE SUCCINATECapsules

Loxitane Lederle Labs Lederle LabsLoxapine Succinate Watson Labs Watson Labs

MAGALDRATESuspension

Magaldrate Roxane Labs Roxane Labs

MANNITOLInjection

Mannitol Steris Labs Steris Labs

MAPROTILINE HCLTablets

Maprotiline HCl Bolar Pharmaceutical Bolar PharmaceuticalMaprotiline HCl American Therapeutics American TherapeuticsMaprotiline HCl Martec Pharmaceutical American TherapeuticsMaprotiline HCl H L Moore Drug Exchange American TherapeuticsMaprotiline HCl Major Pharmaceutical Corp American TherapeuticsMaprotiline HCl Rugby Labs American TherapeuticsMaprotiline HCl Bioline Labs American TherapeuticsMaprotiline HCl Harber Pharmaceutical American TherapeuticsMaprotiline HCl Goldline Labs American TherapeuticsMaprotiline HCl Parmed Pharmaceuticals American TherapeuticsMaprotiline HCl Best Generics American TherapeuticsMaprotiline HCl Glenlawn Labs American TherapeuticsMaprotiline HCl Qualitest American TherapeuticsMaprotiline HCl Regal Labs American TherapeuticsMaprotiline HCl Mylan Pharmaceuticals Mylan PharmaceuticalsMaprotiline HCl Watson Labs Watson Labs

MECLIZINE HCLChewable Tablets

Meclizine HCl Danbury Pharmacal Danbury PharmacalMeclizine HCl Interstate Drug Exchange Danbury PharmacalMeclizine HCl Henry Schein Danbury PharmacalMeclizine HCl United Research Labs Danbury PharmacalMeclizine HCl H L Moore Drug Exchange Danbury PharmacalMeclizine HCl Qualitest Danbury PharmacalMeclizine HCl Richlyn Labs Richlyn LabsMeclizine HCl Geneva Generics Richlyn LabsMeclizine HCl Interstate Drug Exchange Richlyn LabsMeclizine HCl Murray Drug Richlyn LabsMeclizine HCl Purepac Pharmaceutical Richlyn LabsMeclizine HCl Richie Pharmacal Richlyn Labs

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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MECLIZINE HCLChewable Tablets—Continued

Brand Name/Generic Name Distributed By: Manufactured By:Meclizine HCl Henry Schein Richlyn LabsMeclizine HCl United Research Labs Richlyn LabsMeclizine HCl Wesley Pharmacal Richlyn LabsMeclarex Chewable C S Ruckstuhl Richlyn LabsMeclizine HCl Boots Labs Boots LabsMeclizine HCl Geneva Generics Boots LabsMeclizine HCl Rugby Labs Boots LabsMeclizine HCl Sidmak Labs Sidmak LabsMeclizine HCl United Research Labs Sidmak Labs

MECLIZINE HCLTablets

Meclizine Zenith Labs Zenith LabsMeclizine United Research Labs Zenith LabsMeclizine Vangard Labs Zenith LabsMeclizine HCl H L Moore Drug Exchange Zenith LabsMeclizine HCl Glenlawn Labs Zenith LabsMeclizine HCl Bell Pharmacal Zenith LabsMeclizine HCl Major Pharmaceutical Corp Zenith LabsMeclizine HCl Purepac Pharmaceutical Zenith LabsMeclizine HCl Williams Generics Zenith LabsMeclizine HCl Towne, Paulsen Zenith LabsMeclizine HCl Gen-King Products Zenith LabsMeclizine Richlyn Labs Richlyn LabsMeclizine Interstate Drug Exchange Richlyn LabsMeclizine Rugby Labs Richlyn LabsMeclizine Henry Schein Richlyn LabsMeclizine HCl Purepac Pharmaceutical Richlyn LabsAntazine H R Cenci Labs Richlyn LabsMeclizine HCl Parmed Pharmaceuticals Richlyn LabsMeclizine Danbury Pharmacal Danbury PharmacalMeclizine Interstate Drug Exchange Danbury PharmacalMeclizine United Research Labs Danbury PharmacalMeclizine H L Moore Drug Exchange Danbury PharmacalMeclizine HCl Qualitest Danbury PharmacalMeclizine HCl Rugby Labs Chelsea LabsMeclizine HCl Camall Co Camall CoMeclizine HCl H & H Labs Camall CoMeclizine HCl Cooper Camall CoMeclizine HCl Coast Labs Camall CoArlavert Artex Labs Camall CoAbatezine Atlas Pharmaceuticals Camall CoMeclavert Quality Pharmacal Camall CoMeclicot C O Truxton Camall CoMeclarex C S Ruckstuhl Camall CoMeclizine HCl Lannett Camall CoMeclizine HCl Richie Pharmacal Camall CoMeclizine HCl Par Pharmaceutical Par PharmaceuticalMeclizine HCl Parmed Pharmaceuticals Par PharmaceuticalMeclizine HCl H L Moore Drug Exchange Par PharmaceuticalMeclizine HCl Henry Schein Par PharmaceuticalMeclizine HCl Interstate Drug Exchange Par PharmaceuticalMeclizine HCl Rugby Labs Par PharmaceuticalMeclizine HCl Towne, Paulsen Par PharmaceuticalMeclizine HCl Unit Dose Labs Par PharmaceuticalMeclizine HCl United Research Labs Par PharmaceuticalMeclizine HCl Glenlawn Labs Par PharmaceuticalMeclizine HCl Harber Pharmaceutical Par PharmaceuticalMeclizine HCl Whiteworth Pharmaceuticals Par PharmaceuticalAntazine H R Cenci Labs Par PharmaceuticalMeclizine HCl Williams Generics Par PharmaceuticalMeclizine HCl Dixon-Shane Par PharmaceuticalMeclizine HCl Bell Pharmacal Par PharmaceuticalMeclizine HCl Cooper Par PharmaceuticalMeclizine HCl General Generics Par PharmaceuticalMeclizine HCl Arkansas Cooperative Asso Par PharmaceuticalMeclizine HCl Ascot Pharmaceuticals Par PharmaceuticalMeclizine HCl Goldline Labs Par PharmaceuticalMeclizine HCl Bioline Labs Par PharmaceuticalMeclizine HCl Mutual Pharmaceutical Mutual PharmaceuticalMeclizine HCl KV Pharmaceutical KV PharmaceuticalMeclizine HCl Geneva Generics Cord LabsMeclizine HCl Sidmak Labs Sidmak LabsMeclizine HCl Genetco Sidmak LabsMeclizine HCl Parmed Pharmaceuticals Sidmak LabsMeclizine HCl Towne, Paulsen Sidmak LabsMeclizine HCl Superpharm Corp Superpharm CorpMeclizine HCl Bioline Labs Superpharm CorpMeclizine HCl Goldline Labs Superpharm CorpMeclizine HCl Goldline Labs Boots Labs

28 § 25.58 PREVENTION OF DISEASES Pt. III

25-110(202518) No. 253 Dec. 95 Copyright � 1995 Commonwealth of Pennsylvania

Page 113: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

MECLOFENAMATE SODIUMCapsules

Brand Name/Generic Name Distributed By: Manufactured By:

Meclofenamate Sodium Mylan Pharmaceuticals Mylan PharmaceuticalsMeclofenamate Sodium Qualitest Mylan PharmaceuticalsMeclofenamate Sodium United Research Labs Mylan PharmaceuticalsMeclofenamate Sodium Schein Pharmaceutical Mylan PharmaceuticalsMeclofenamate Sodium Regal Labs Mylan PharmaceuticalsMeclofenamate Sodium Glenlawn Labs Mylan PharmaceuticalsMeclofenamate Sodium Parmed Pharmaceuticals Mylan PharmaceuticalsMeclofenamate Sodium Lemmon Co Mylan PharmaceuticalsMeclofenamate Sodium Bolar Pharmaceutical Bolar PharmaceuticalMeclofenamate Sodium Best Generics Bolar PharmaceuticalMeclofenamate Sodium Danbury Pharmacal Danbury PharmacalMeclofenamate Sodium American Therapeutics American TherapeuticsMeclofenamate Sodium Martec Pharmaceutical American TherapeuticsMeclofenamate Sodium Purepac Pharmaceutical American TherapeuticsMeclofen Major Pharmaceutical Corp American TherapeuticsMeclodium Quantum Pharmics Quantum PharmicsMeclofenamate Sodium Rugby Labs Chelsea LabsMeclofenamate Sodium Geneva Generics Cord LabsMeclofenamate Sodium Par Pharmaceutical Par Pharmaceutical

MEDROXYPROGESTERONE ACETATETablets

Cycrin Ayerst Labs Ayerst Labs

MEPERIDINE HCLInjection

Meperidine HCl Knoll Pharmaceutical Knoll Pharmaceutical

MEPERIDINE HCLSyrup

Meperidine HCl Roxane Labs Roxane Labs

MEPERIDINE HCLTablets

Meperidine Barr Labs Barr LabsPethadol Halsey Drug Halsey DrugMeperidine HCl Interstate Drug Exchange Halsey DrugMeperidine HCl Glenlawn Labs Halsey DrugMeperidine HCl Schein Pharmaceutical Halsey DrugMeperidine HCl Goldline Labs Barr Labs

MEPROBAMATETablets

Equanil Wyeth Labs Wyeth LabsMeprobamate Parke-Davis Parke-DavisMeprobamate Zenith Labs Zenith LabsMeprobamate United Research Labs Zenith LabsMeprobamate Geneva Generics Zenith LabsMeprobamate Henry Schein Zenith LabsMeprobamate Qualitest Zenith LabsMeprobamate H L Moore Drug Exchange Zenith LabsMeprobamate Major Pharmaceutical Corp Zenith LabsMeprobamate Purepac Pharmaceutical Purepac PharmaceuticalMeprobamate Bioline Labs Purepac PharmaceuticalMeprobamate Henry Schein KalipharmaMeprobamate United Research Labs KalipharmaMeprobamate Interstate Drug Exchange KalipharmaMeprobamate Williams Generics KalipharmaMeprobamate Rondex Labs KalipharmaMeprobamate Barr Labs Barr LabsProtran Vangard Labs Barr LabsMeprobamate H L Moore Drug Exchange Barr LabsMeprobamate United Research Labs Barr LabsMeprobamate Skaggs Co Barr LabsMeprobamate Bioline Labs Barr LabsSK-Bamate Smith, Kline & French Barr LabsMeprobamate Goldline Labs Barr LabsMeprobamate Danbury Pharmacal Danbury PharmacalMeprobamate Interstate Drug Exchange Danbury PharmacalMeprobamate Henry Schein Danbury PharmacalMeprobamate United Research Labs Danbury PharmacalMeprobamate Bell Pharmacal Danbury Pharmacal

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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MEPROBAMATETablets—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Meprobamate McKesson Labs Danbury PharmacalMeprobamate H L Moore Drug Exchange Danbury PharmacalMeprobamate Geneva Generics Danbury PharmacalMeprobamate Richlyn Labs Richlyn LabsMeprobamate Medco Supply Richlyn LabsMeprobamate Parmed Pharmaceuticals Richlyn LabsMeprobamate Interstate Drug Exchange Richlyn LabsMeprobamate Henry Schein Richlyn LabsMeprobamate Wharton Lab Richlyn LabsMeprobamate Wesley Pharmacal Richlyn LabsMeprobamate Glenlawn Labs Richlyn LabsTrancot C O Truxton Richlyn LabsMeprobamate Gen-King Products Richlyn LabsMeprobamate H L Moore Drug Exchange Richlyn LabsMeprobamate C S Ruckstuhl Richlyn LabsMeprobamate Halsey Drug Halsey DrugMeprobamate Richie Pharmacal Halsey DrugMeprobamate Interstate Drug Exchange Halsey DrugMeprobamate Henry Schein Halsey DrugMeprobamate Whiteworth Pharmaceuticals Halsey DrugAcabamate Arkansas Cooperative Asso Halsey DrugMeprobamate ICN Pharmaceuticals ICN PharmaceuticalsMeprobamate Rugby Labs Chelsea LabsMeprobamate Lannett LannettMeprobamate Geneva Generics Cord LabsMeprobamate Best Generics Richlyn Labs

METAPROTERENOL SULFATESyrup

Metaprel Dorsey Labs Dorsey LabsMetaproterenol Sulfate My-K Labs My-K Labs

METAPROTERENOL SULFATETablets

Metaprel Dorsey Labs Dorsey LabsMetaproterenol Sulfate Pharmaceutical Basics Pharmaceutical BasicsMetaproterenol Sulfate American Therapeutics American TherapeuticsMetaproterenol Sulfate Par Pharmaceutical Par Pharmaceutical

METHADONE HCLTablets

Methadone HCl Roxane Labs Roxane Labs

METHENAMINE HIPPURATETablets

Urex Riker Labs Riker Labs

METHENAMINE MANDELATESuspension

Mandelamine Parke-Davis Parke-DavisMethenamine Mandelate Barre Drug National PharmaceuticalMethenamine Mandelate Vangard Labs National PharmaceuticalMethenamine Mandelate Rugby Labs National PharmaceuticalMethenamine Mandelate Henry Schein National PharmaceuticalMethenamine Mandelate Lederle Labs National PharmaceuticalMethenamine Mandelate United Research Labs National PharmaceuticalMethenamine Mandelate Murray Drug National PharmaceuticalMethenamine Mandelate Towne, Paulsen National PharmaceuticalMethenamine Mandelate H L Moore Drug Exchange National PharmaceuticalMethenamine Mandelate Bioline Labs National PharmaceuticalMethenamine Mandelate Goldline Labs Barre-National

METHENAMINE MANDELATETablets

Mandelamine Parke-Davis Parke-Davis

28 § 25.58 PREVENTION OF DISEASES Pt. III

25-112(202520) No. 253 Dec. 95 Copyright � 1995 Commonwealth of Pennsylvania

Page 115: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

METHENAMINE MANDELATEEnteric Coated Tablets

Brand Name/Generic Name Distributed By: Manufactured By:

Methenamine Mandelate Heather Drug Heather DrugMethenamine Mandelate United Research Labs Heather DrugMethenamine Mandelate Rugby Labs Heather DrugMethenamine Mandelate Geneva Generics Heather DrugMethenamine Mandelate Bioline Labs Heather DrugMethenamine Mandelate Goldline Labs Heather Drug

METHOCARBAMOLInjection

Methocarbamol Steris Labs Steris LabsMethocarbamol Schein Pharmaceutical Steris LabsMethocarbamol H L Moore Drug Exchange Steris LabsMethocarbamol Travenol Labs Steris Labs

METHOCARBAMOLTablets

Methocarbamol Richlyn Labs Richlyn LabsMethocarbamol Purepac Pharmaceutical Richlyn LabsMethocarbamol Interstate Drug Exchange Richlyn LabsMethocarbamol American Pharmaceutical Richlyn LabsMethocarbamol Dixon-Shane Richlyn LabsMethocarbamol Gen-King Products Richlyn LabsMethocarbamol Glenlawn Labs Richlyn LabsMethocarbamol West-ward West-wardMethocarbamol H L Moore Drug Exchange West-wardMethocarbamol Interstate Drug Exchange West-wardMethocarbamol Henry Schein West-wardMethocarbamol Bolar Pharmaceutical Bolar PharmaceuticalMethocarbamol Bioline Labs Bolar PharmaceuticalMethocarbamol Interstate Drug Exchange Bolar PharmaceuticalMethocarbamol Gen-King Products Bolar PharmaceuticalMethocarbamol Thrift Drug Bolar PharmaceuticalMethocarbamol Cooper Bolar PharmaceuticalMethocarbamol Whiteworth Pharmaceuticals Bolar PharmaceuticalRobamol H R Cenci Labs Bolar PharmaceuticalMethocarbamol Parmed Pharmaceuticals Bolar PharmaceuticalMethocarbamol Best Generics Bolar PharmaceuticalMethocarbamol Goldline Labs Bolar PharmaceuticalMethocarbamol Barr Labs Barr LabsMethocarbamol Rugby Labs Chelsea LabsMethocarbamol Zenith Labs Zenith LabsMethocarbamol United Research Labs Zenith LabsMethocarbamol Regal Labs Zenith LabsMethocarbamol Murray Drug Zenith LabsMethocarbamol Richie Pharmacal Zenith LabsMethocarbamol Vangard Labs Zenith LabsMethocarbamol Gen-King Products Zenith LabsMethocarbamol Glenlawn Labs Zenith LabsMethocarbamol Towne, Paulsen Zenith LabsMethocarbamol Major Pharmaceutical Corp Zenith LabsMethocarbamol Danbury Pharmacal Danbury PharmacalMethocarbamol Thrift Drug Danbury PharmacalMethocarbamol Interstate Drug Exchange Danbury PharmacalMethocarbamol Henry Schein Danbury PharmacalMethocarbamol Bell Pharmacal Danbury PharmacalMethocarbamol Qualitest Danbury PharmacalMethocarbamol Purepac Pharmaceutical Purepac PharmaceuticalMethocarbamol Lannett LannettMethocarbamol KV Pharmaceutical KV PharmaceuticalMethocarbamol Geneva Generics Cord LabsMethocarbamol Superpharm Corp Superpharm CorpMethocarbamol Goldline Labs Superpharm CorpMethocarbamol Lederle Labs Lederle LabsMethocarbamol Pioneer Pharmaceuticals Pioneer PharmaceuticalsMethocarbamol Vitarine Pharmaceutical Vitarine PharmaceuticalMethocarbamol Heather Drug Heather DrugMethocarbamol United Research Labs Heather DrugMethocarbamol American Therapeutics American TherapeuticsMethocarbamol Bioline Labs American TherapeuticsMethocarbamol Goldline Labs American TherapeuticsMethocarbamol United Research Labs American TherapeuticsMethocarbamol Qualitest American Therapeutics

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

25-113(202521) No. 253 Dec. 95

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METHYCLOTHIAZIDETablets

Brand Name/Generic Name Distributed By: Manufactured By:

Methyclothiazide Mylan Pharmaceuticals Mylan PharmaceuticalsMethyclothiazide Zenith Labs Zenith LabsMethyclothiazide Regal Labs Zenith LabsMethyclothiazide H L Moore Drug Exchange Zenith LabsMethyclothiazide Gen-King Products Zenith LabsMethyclothiazide Rugby Labs Chelsea LabsMethyclothiazide Bolar Pharmaceutical Bolar PharmaceuticalMethyclothiazide Geneva Generics Bolar PharmaceuticalMethyclothiazide Bell Pharmacal Bolar PharmaceuticalMethyclothiazide Qualitest Bolar PharmaceuticalMethyclothiazide Purepac Pharmaceutical Bolar PharmaceuticalMethyclothiazide United Research Labs Bolar PharmaceuticalMethyclothiazide Best Generics Bolar PharmaceuticalMethyclothiazide Goldline Labs Bolar PharmaceuticalMethyclothiazide Bioline Labs Bolar PharmaceuticalMethyclothiazide Colmed Labs Pharmaceutical BasicsMethyclothiazide Mutual Pharmaceutical Pharmaceutical BasicsMethyclothiazide Par Pharmaceutical Par PharmaceuticalMethyclothiazide Goldline Labs Pharmaceutical BasicsMethyclothiazide Geneva Generics Cord Labs

METHYLDOPATablets

Methyldopa Mylan Pharmaceuticals Mylan PharmaceuticalsMethyldopa United Research Labs Mylan PharmaceuticalsMethyldopa Henry Schein Mylan PharmaceuticalsMethyldopa H L Moore Drug Exchange Mylan PharmaceuticalsMethyldopa Regal Labs Mylan PharmaceuticalsMethyldopa Qualitest Mylan PharmaceuticalsMethyldopa Interstate Drug Exchange Mylan PharmaceuticalsMethyldopa Bioline Labs Mylan PharmaceuticalsMethyldopa Parmed Pharmaceuticals Mylan PharmaceuticalsMethyldopa Rugby Labs Mylan PharmaceuticalsMethyldopa Richie Pharmacal Mylan PharmaceuticalsMethyldopa Major Pharmaceutical Corp Mylan PharmaceuticalsMethyldopa Genetco Mylan PharmaceuticalsMethyldopa Lemmon Co Mylan PharmaceuticalsMethyldopa Mutual Pharmaceutical Mylan PharmaceuticalsMethyldopa Rugby Labs Chelsea LabsMethyldopa Cord Labs Cord LabsMethyldopa Geneva Generics Cord LabsMethyldopa Zenith Labs Zenith LabsMethyldopa Interstate Drug Exchange Zenith LabsMethyldopa Bioline Labs Zenith LabsMethyldopa Goldline Labs Zenith LabsMethyldopa Major Pharmaceutical Corp Zenith LabsMethyldopa H L Moore Drug Exchange Zenith LabsMethyldopa Regal Labs Zenith LabsMethyldopa Gen-King Products Zenith LabsMethyldopa Bolar Pharmaceutical Bolar PharmaceuticalMethyldopa Best Generics Bolar PharmaceuticalMethyldopa Danbury Pharmacal Danbury PharmacalMethyldopa Purepac Pharmaceutical Purepac PharmaceuticalMethyldopa Rondex Labs KalipharmaMethyldopa H L Moore Drug Exchange Mylan PharmaceuticalsMethyldopa E R Squibb & Sons Zenith LabsMethyldopa Barr Labs Barr LabsMethyldopa Duramed Pharmaceuticals Duramed PharmaceuticalsMethyldopa Qualitest Duramed PharmaceuticalsMethyldopa Parke-Davis Parke-DavisMethyldopa Par Pharmaceutical Par PharmaceuticalMethyldopa Martec Pharmaceutical Par PharmaceuticalMethyldopa Goldline Labs Mylan PharmaceuticalsMethyldopa LyphoMed/NovoPharm NovopharmMethyldopa Dixon-Shane Mylan PharmaceuticalsMethyldopa Sidmak Labs Sidmak LabsMethyldopa Halsey Drug Halsey DrugMethyldopa Lederle Labs Lederle Labs

METHYLPHENIDATE HCLTablets

Methylphenidate HCl MD Pharmaceutical MD PharmaceuticalMethylphenidate HCl Goldline Labs MD PharmaceuticalMethylphenidate HCl Rugby Labs MD PharmaceuticalMethylphenidate HCl Major Pharmaceutical Corp MD PharmaceuticalMethylphenidate HCl Regal Labs MD Pharmaceutical

28 § 25.58 PREVENTION OF DISEASES Pt. III

25-114(202522) No. 253 Dec. 95 Copyright � 1995 Commonwealth of Pennsylvania

Page 117: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

METHYLPREDNISOLONETablets

Brand Name/Generic Name Distributed By: Manufactured By:

Methylprednisolone Duramed Pharmaceuticals Duramed PharmaceuticalsMethylprednisolone Best Generics Duramed PharmaceuticalsMethylprednisolone Bioline Labs Duramed PharmaceuticalsMethylprednisolone Genetco Duramed PharmaceuticalsMethylprednisolone Geneva Generics Duramed PharmaceuticalsMethylprednisolone Goldline Labs Duramed PharmaceuticalsMethylprednisolone H L Moore Drug Exchange Duramed PharmaceuticalsMethylprednisolone Major Pharmaceutical Corp Duramed PharmaceuticalsMethylprednisolone Purepac Pharmaceutical Duramed PharmaceuticalsMethylprednisolone Qualitest Duramed PharmaceuticalsMethylprednisolone Regal Labs Duramed PharmaceuticalsMethylprednisolone Rugby Labs Duramed PharmaceuticalsMethylprednisolone Schein Pharmaceutical Duramed PharmaceuticalsMethylprednisolone Heather Drug Heather DrugMethylprednisolone Par Pharmaceutical Par Pharmaceutical

METHYLPREDNISOLONE SODIUM SUCCINATEInjection

Methylprednisolone SodiumSuccinate Steris Labs Steris Labs

METOCLOPRAMIDE HCLSyrup

Myclopramide My-K Labs My-K LabsMetoclopramide HCl Biocraft Labs Biocraft LabsMetoclopramide Barre-National Barre-NationalMetoclopramide Pharmaceutical Basics Pharmaceutical Basics

METOCLOPRAMIDE HCLTablets

Metoclopramide HCl Pharmaceutical Basics Pharmaceutical BasicsMetoclopramide HCl Mutual Pharmaceutical Pharmaceutical BasicsMetoclopramide HCl Purepac Pharmaceutical Purepac PharmaceuticalMetoclopramide HCl Rondex Labs KalipharmaClopra Quantum Pharmics Quantum PharmicsMetoclopramide HCl Bioline Labs Quantum PharmicsMetoclopramide HCl Rugby Labs Quantum PharmicsMetoclopramide HCl H L Moore Drug Exchange Quantum PharmicsMetoclopramide HCl Interstate Drug Exchange Quantum PharmicsMetoclopramide HCl Purepac Pharmaceutical Quantum PharmicsMetoclopramide HCl United Research Labs Quantum PharmicsMetoclopramide HCl Henry Schein Quantum PharmicsMetoclopramide HCl Parmed Pharmaceuticals Quantum PharmicsReclomide Major Pharmaceutical Corp Quantum PharmicsMetoclopramide HCl Danbury Pharmacal Danbury PharmacalMetoclopramide HCl Rugby Labs Chelsea LabsMetoclopramide HCl Par Pharmaceutical Par PharmaceuticalMetoclopramide HCl Interpharm InterpharmMetoclopramide HCl Biocraft Labs Biocraft LabsMetoclopramide HCl Qualitest Biocraft LabsMetoclopramide HCl Lederle Labs Biocraft LabsMetoclopramide HCl Parmed Pharmaceuticals Biocraft LabsMetoclopramide HCl Martec Pharmaceutical Par PharmaceuticalMetoclopramide HCl Halsey Drug Halsey DrugMetoclopramide HCl Qualitest Halsey DrugMetoclopramide HCl Martec Pharmaceutical ScheringMetoclopramide HCl Barr Labs Barr LabsMetoclopramide HCl Bolar Pharmaceutical Bolar PharmaceuticalMetoclopramide HCl Superpharm Corp Superpharm Corp

METOLAZONETablets

Zaroxolyn Pennwalt Corp Pennwalt CorpDiulo Searle Labs Pennwalt Corp

METRONIDAZOLEInjection

Metryl IV Lemmon Co Lemmon CoMetronidazole Steris Labs Steris Labs

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

25-115(202523) No. 253 Dec. 95

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METRONIDAZOLETablets

Brand Name/Generic Name Distributed By: Manufactured By:

Metronidazole Zenith Labs Zenith LabsSatric Savage Labs Zenith LabsMetronidazole Vangard Labs Zenith LabsMetronidazole Geneva Generics Zenith LabsMetronidazole Whiteworth Pharmaceuticals Zenith LabsMetronidazole Murray Drug Zenith LabsMetronidazole United Research Labs Zenith LabsMetronidazole Rugby Labs Zenith LabsMetronidazole H L Moore Drug Exchange Zenith LabsMetronidazole Bioline Labs Zenith LabsMetronidazole Henry Schein Zenith LabsMetronidazole Gen-King Products Zenith LabsMetronidazole Regal Labs Zenith LabsMetronidazole Interstate Drug Exchange Zenith LabsMetronidazole Lederle Labs Zenith LabsMetronidazole Parmed Pharmaceuticals Zenith LabsMetronidazole Qualitest Zenith LabsMetronidazole Purepac Pharmaceutical Zenith LabsMetronidazole Towne, Paulsen Zenith LabsMetronidazole Bell Pharmacal Zenith LabsMetronidazole Lemmon Co Lemmon CoMetronidazole D-M Pharmaceuticals Lemmon CoMetronidazole Parmed Pharmaceuticals Lemmon CoMetronidazole Barr Labs Barr LabsMetronidazole Danbury Pharmacal Danbury PharmacalMetronidazole Bell Pharmacal Danbury PharmacalMetronidazole Parmed Pharmaceuticals Danbury PharmacalMetronidazole United Research Labs Danbury PharmacalMetronidazole Cord Labs Cord LabsMetronidazole Geneva Generics Cord LabsMetronidazole Par Pharmaceutical Par PharmaceuticalMetronidazole Interstate Drug Exchange Par PharmaceuticalMetronidazole Rugby Labs Chelsea LabsMetronidazole Sidmak Labs Sidmak LabsMetronidazole United Research Labs Sidmak LabsMetronidazole Travenol Labs Sidmak LabsMetronidazole Genetco Sidmak LabsMetronidazole Parmed Pharmaceuticals Sidmak LabsMetronidazole Towne, Paulsen Sidmak LabsMetronidazole Superpharm Corp Superpharm CorpMetronidazole Bioline Labs Superpharm CorpMetronidazole Goldline Labs Superpharm CorpMetronidazole Major Pharmaceutical Corp Superpharm CorpMetronidazole Vitarine Pharmaceutical Vitarine PharmaceuticalMetronidazole Parmed Pharmaceuticals Vitarine PharmaceuticalMetronidazole Vangard Labs Vitarine PharmaceuticalMetronidazole Halsey Drug Halsey DrugMetronidazole Qualitest Halsey DrugMetronidazole Mutual Pharmaceutical Mutual PharmaceuticalMetronidazole E R Squibb & Sons Zenith LabsMetronidazole Martec Pharmaceutical Par PharmaceuticalMetronidazole United Research Labs Mutual PharmaceuticalMetronidazole Genetco Mutual PharmaceuticalMetronidazole Towne, Paulsen Mutual PharmaceuticalMetronidazole Purepac Pharmaceutical Mutual Pharmaceutical

MINERALS/MULTIPLE VITAMINSCapsules

Multicon C Par Pharmaceutical Par PharmaceuticalMulticon Forte Par Pharmaceutical Par Pharmaceutical

MINERALS/MULTIPLE VITAMINSTablets

Viopan T Trimen Labs KV PharmaceuticalVitamin and Minerals ICN Pharmaceuticals ICN PharmaceuticalsParnatal 1 + 60 Par Pharmaceutical Par PharmaceuticalRunatal Rugby Labs Par PharmaceuticalAmi-Natal Plus One Amide Pharmaceutical Amide PharmaceuticalAmi-Natal 60 Amide Pharmaceutical Amide PharmaceuticalPrenatal Rx Copley Pharmaceutical Copley PharmaceuticalPrenatal Rx Qualitest Copley PharmaceuticalPrenatal Rx Schein Pharmaceutical Copley PharmaceuticalPrenatal 1 mg + Iron Copley Pharmaceutical Copley PharmaceuticalPrenatal 1 mg + 1 Qualitest Copley PharmaceuticalPrenatal 1/60 Qualitest Copley PharmaceuticalB - Complex Plus Copley Pharmaceutical Copley PharmaceuticalTheravim M Geneva Generics Private Formulations

28 § 25.58 PREVENTION OF DISEASES Pt. III

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Page 119: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

MINERALS/MULTIPLE VITAMINSTablets—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Prenatal w/ Folic Acid Geneva Generics Private FormulationsThera Natal plus One American Therapeutics American TherapeuticsThera-Lins Rx American Therapeutics American TherapeuticsBio-Natal-S Bioline Labs American TherapeuticsPrenatal-S Goldline Labs American TherapeuticsB-Complex Vitamins Plus Best Generics Copley PharmaceuticalBerovite Plus Glenlawn Labs American Therapeutics

MINOXIDILTablets

Minoxidil Danbury Pharmacal Danbury PharmacalMinoxidil Quantum Pharmics Quantum PharmicsMinoxidil Bioline Labs Quantum PharmicsMinoxidil Goldline Labs Quantum PharmicsMinoxidil Geneva Generics Quantum PharmicsMinoxidil Major Pharmaceutical Corp Quantum PharmicsMinoxidil H L Moore Drug Exchange Quantum PharmicsMinoxidil Rugby Labs Quantum PharmicsMinoxidil Royce Labs Royce LabsMinoxidil Par Pharmaceutical Par Pharmaceutical

MORPHINE SULFATEInjection

Morphine Sulfate Knoll Pharmaceutical Knoll Pharmaceutical

MORPHINE SULFATETablets

Morphine Sulfate Roxane Labs Roxane Labs

MULTIPLE VITAMINChewable Tablets

Chewable Vitamins ICN Pharmaceuticals ICN Pharmaceuticals

MULTIPLE VITAMINTablets

Multiple Vitamins ICN Pharmaceuticals ICN PharmaceuticalsParplex Par Pharmaceutical Par PharmaceuticalB - C with Folic Acid Geneva Generics Par PharmaceuticalTherapeutic Vitamin American Therapeutics American TherapeuticsB-Plex Goldline Labs American TherapeuticsBioplex Bioline Labs American TherapeuticsFormula B Major Pharmaceutical Corp American TherapeuticsTherapeutic Vitamin Rugby Labs American TherapeuticsStrovite Everett Labs American Therapeutics

MULTIPLE VITAMINS/SODIUM FLUORIDESolution

Triple Vita Flor My-K Labs My-K LabsMulti Vita Drops/Fluoride My-K Labs My-K LabsTri-Vitamin w/Fluoride Rugby Labs HI-TECH PharmacalPolyvitamin w/Fluoride Rugby Labs HI-TECH PharmacalMulti-Vita Drops/Fluoride Pharmaceutical Basics Pharmaceutical Basics

MULTIPLE VITAMINS/SODIUM FLUORIDEChewable Tablets

Flura-Vite Kirkman Labs Kirkman LabsPoly-Vitamin Fluoride Danbury Pharmacal Danbury PharmacalADC-Vite-Flor Qualitest Par PharmaceuticalADC-Vite-Flor Par Pharmaceutical Par PharmaceuticalMulti-Vite-Flor Par Pharmaceutical Par PharmaceuticalChewable Vitamins/Fluoride Geneva Generics Par PharmaceuticalTri-Vite-F Glenlawn Labs Par PharmaceuticalPoly-Vite-F Glenlawn Labs Par PharmaceuticalTri Vita-Bets w/Fluoride Amide Pharmaceutical Amide PharmaceuticalMulti Vita-Bets/Fluoride Amide Pharmaceutical Amide PharmaceuticalMultiple Vitamins w/ Fluoride Copley Pharmaceutical Copley PharmaceuticalMultiple Vitamins w/ Fluoride Qualitest Copley PharmaceuticalMultiple Vitamins w/Fluoride & Iron Copley Pharmaceutical Copley PharmaceuticalPoly-Vitamin Fluoride American Therapeutics American Therapeutics

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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NALIDIXIC ACIDTablets

Brand Name/Generic Name Distributed By: Manufactured By:

Nalidixic Acid Barr Labs Barr LabsNalidixic Acid Danbury Pharmacal Danbury Pharmacal

NAPHAZOLINE HCLNasal Solution

Privine Ciba-Geigy Ciba-GeigyZoline Barre Drug National PharmaceuticalZoline-S United Research Labs National PharmaceuticalNaphazoline Henry Schein National Pharmaceutical

NAPHAZOLINE HCLOphthalmic Solution

Naphcon Alcon Labs Alcon LabsAlbalon Allergan Pharmaceutical Allergan PharmaceuticalNafazair Pharmafair PharmafairNaphazoline HCl United Research Labs Pharmafair

NAPHAZOLINE HCL/PHENIRAMINE MALEATEOphthalmic Solution

Naphazoline HCl andPheniramine Maleate Steris Labs Steris Labs

NEOMYCIN SULFATEOintment

Myciguent Upjohn Co Upjohn CoNeomycin Sulfate McKesson Labs MK LabsNeomycin Clay-Park Labs Clay-Park LabsNeomycin Bioline Labs Clay-Park LabsNeomycin H L Moore Drug Exchange Clay-Park LabsNeomycin Rugby Labs Clay-Park LabsNeomycin Henry Schein Clay-Park Labs

NEOMYCIN SULFATETablets

Mycifradin Upjohn Co Upjohn CoNeomycin Sulfate Biocraft Labs Biocraft LabsNeomycin Sulfate H L Moore Drug Exchange Biocraft LabsNeomycin Sulfate Lederle Labs Biocraft LabsNeomycin Sulfate Geneva Generics Biocraft LabsNeomycin Sulfate Henry Schein Biocraft LabsNeomycin Sulfate American Pharmaceutical Biocraft LabsNeomycin Sulfate Berry Withington Biocraft LabsNeomycin Sulfate Bioline Labs Biocraft LabsNeomycin Sulfate Cooper Biocraft LabsNeomycin Sulfate Dixon-Shane Biocraft LabsNeomycin Sulfate Glenlawn Labs Biocraft LabsNeomycin Sulfate Michigan Pharmacal Biocraft LabsNeomycin Sulfate Towne, Paulsen Biocraft LabsNeomycin Sulfate Tracy Pharmacal Biocraft LabsNeomycin Sulfate Vangard Labs Biocraft LabsNeomycin Sulfate Whiteworth Pharmaceuticals Biocraft LabsNeomycin Sulfate United Research Labs Biocraft LabsNeomycin Sulfate Goldline Labs Biocraft LabsNeomycin Sulfate Vitarine Pharmaceutical Vitarine PharmaceuticalNeomycin Sulfate Rugby Labs Vitarine Pharmaceutical

NEOMYCIN SULFATE/POLYMYXIN-B SULFATEIrrigating Solution

Neomycin & Polymyxin BSulfates Steris Labs Steris Labs

NEOMYCIN SULFATE/POLYMYXIN-B SULFATEOphthalmic Ointment

Statrol Alcon Labs Alcon Labs

28 § 25.58 PREVENTION OF DISEASES Pt. III

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Page 121: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

NEOMYCIN SULFATE/POLYMYXIN-B SULFATEOphthalmic Solution

Brand Name/Generic Name Distributed By: Manufactured By:

Statrol Alcon Labs Alcon Labs

NIACINTablets

Niacin Panray Ormont Drug & ChemicalNiacin Rugby Labs Chelsea LabsNiacin Richlyn Labs Richlyn LabsNiacin Cooper Richlyn LabsNiacin Interstate Drug Exchange Richlyn LabsNiacin Murray Drug Richlyn LabsNiacin Henry Schein Richlyn LabsNiacin C O Truxton Richlyn LabsNiacin Wesley Pharmacal Richlyn LabsNiacin West-ward West-wardNiacin ICN Pharmaceuticals ICN PharmaceuticalsNiacin Towne, Paulsen KV PharmaceuticalNiacin Purepac Pharmaceutical Purepac PharmaceuticalNiacin McKesson Labs MK LabsNiacin Geneva Generics Cord LabsNiacin Roxane Labs Roxane LabsNiacin United Research Labs B T ProductsNiacin Halsey Drug Halsey DrugNiacin Purepac Pharmaceutical Halsey Drug

NIACINAMIDETablets

Niacinamide Purepac Pharmaceutical Purepac PharmaceuticalNiacinamide Contract Pharmacal Contract PharmacalNiacinamide United Research Labs Contract Pharmacal

NITROFURANTOINCapsules

Nitrofurantoin Bolar Pharmaceutical Bolar PharmaceuticalNitrofurantoin United Research Labs Bolar PharmaceuticalNitrofurantoin Interstate Drug Exchange Bolar PharmaceuticalNitrofurantoin Veratex Corp Bolar PharmaceuticalNitrofurantoin Richie Pharmacal Bolar PharmaceuticalNitrofurantoin Henry Schein Bolar PharmaceuticalNitrofurantoin Rugby Labs Bolar PharmaceuticalNitrofurantoin Cooper Bolar PharmaceuticalNitrofurantoin H L Moore Drug Exchange Bolar PharmaceuticalNitrofurantoin Parmed Pharmaceuticals Bolar PharmaceuticalNitrofurantoin Pharmecon Bolar PharmaceuticalFuarex C S Ruckstuhl Bolar PharmaceuticalNitrofurantoin Geneva Generics Bolar PharmaceuticalNitrofurantoin Best Generics Bolar PharmaceuticalNitrofurantoin Goldline Labs Bolar Pharmaceutical

NITROFURANTOINTablets

Furadantin Norwich-Eaton Eaton LabsNitrofurantoin Bolar Pharmaceutical Bolar PharmaceuticalNitrofurantoin H L Moore Drug Exchange Bolar PharmaceuticalNitrofurantoin United Research Labs Bolar PharmaceuticalNitrofurantoin Purepac Pharmaceutical Bolar PharmaceuticalNitrofurantoin Glenlawn Labs Bolar PharmaceuticalNitrofurantoin Geneva Generics Bolar PharmaceuticalNitrofurantoin Parmed Pharmaceuticals Bolar PharmaceuticalNitrofurantoin Qualitest Bolar PharmaceuticalNitrofurantoin Best Generics Bolar PharmaceuticalNitrofurantoin Schein Pharmaceutical Bolar Pharmaceutical

NITROFURAZONEOintment

Nitrofurazone Lannett Lannett

NITROFURAZONESolution

Nitrofurazone Clay-Park Labs Clay-Park LabsNitrofurazone Interstate Drug Exchange Clay-Park LabsNitrofurazone Henry Schein Clay-Park LabsNitrofurazone Rugby Labs Clay-Park Labs

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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NITROFURAZONETopical Dressing

Brand Name/Generic Name Distributed By: Manufactured By:

Furacin Soluble Norwich-Eaton Norwich-EatonNitrofurazone Soluble Thames Pharmacal Thames Pharmacal

NITROGLYCERINOintment

Nitro-Bid Marion Labs Marion LabsNitrol Kremers-Urban Kremers-UrbanNitrostat Parke-Davis Parke-DavisNitrong Wharton Labs PharmafairNitroglycerin E Fougera Altana

NYLIDRIN HCLTablets

Nylidrin Zenith Labs Zenith LabsNylidrin Glenlawn Labs Zenith LabsNylidrin HCl United Research Labs Zenith LabsNylidrin HCl Bell Pharmacal Zenith LabsNylidrin HCl Regal Labs Zenith LabsNylidrin HCl Interstate Drug Exchange Zenith LabsNylidrin HCl Goldline Labs Zenith LabsNylidrin HCl Danbury Pharmacal Danbury PharmacalNylidrin HCl Lederle Labs Danbury PharmacalNylidrin HCl United Research Labs Danbury PharmacalNylidrin HCl Henry Schein Danbury PharmacalNylidrin HCl Interstate Drug Exchange Danbury PharmacalNylidrin HCl Qualitest Danbury PharmacalNylidrin Bell Pharmacal Danbury PharmacalNylidrin HCl Rugby Labs Chelsea LabsNylidrin Geneva Generics Cord LabsNylidrin HCl Sidmak Labs Sidmak LabsNylidrin HCl United Research Labs Sidmak LabsNylidrin HCl Genetco Sidmak LabsNylidrin HCl Mutual Pharmaceutical Sidmak LabsNylidrin HCl Lederle Labs Sidmak LabsNylidrin HCl Gen-King Products Zenith Labs

NYSTATINCream

Mycostatin E R Squibb & Sons E R Squibb & SonsNilstat Lederle Labs Lederle LabsMykinac NMC Labs NMC LabsNystatin Interstate Drug Exchange NMC LabsNystatin Henry Schein NMC LabsNystatin Clay-Park Labs Clay-Park LabsNystatin Rugby Labs Clay-Park LabsNystatin Henry Schein Clay-Park LabsNystatin Interstate Drug Exchange Clay-Park LabsNystatin Thrift Drug Clay-Park LabsNystatin United Research Labs Clay-Park LabsNystatin Bioline Labs Clay-Park LabsNystatin H L Moore Drug Exchange Clay-Park LabsNystatin Qualitest Clay-Park LabsNystatin Geneva Generics Clay-Park LabsNystatin Lemmon Co Lemmon CoNystatin E Fougera AltanaNystatin Thames Pharmacal Thames PharmacalNystatin Pharmaderm AltanaNystatin Goldline Labs Clay-Park LabsNystatin Rugby Labs Naska Pharmacal

NYSTATINOintment

Mycostatin E R Squibb & Sons E R Squibb & SonsNilstat Lederle Labs Lederle LabsNystatin Clay-Park Labs Clay-Park LabsNystatin Rugby Labs Clay-Park LabsNystatin Qualitest Clay-Park LabsNystatin Goldline Labs Clay-Park LabsNystatin E Fougera AltanaNystatin Pharmaderm AltanaNystex Savage Labs AltanaNystatin NMC Labs NMC LabsNystatin Schein Pharmaceutical Clay-Park LabsNystatin Topical Rugby Labs Naska Pharmacal

28 § 25.58 PREVENTION OF DISEASES Pt. III

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NYSTATINOral Suspension

Brand Name/Generic Name Distributed By: Manufactured By:

Mycostatin E R Squibb & Sons E R Squibb & SonsNilstat Lederle Labs Lederle LabsNystatin Barre Drug National PharmaceuticalNystatin Bioline Labs National PharmaceuticalNystatin Rugby Labs National PharmaceuticalNystatin Bell Pharmacal National PharmaceuticalNystatin Geneva Generics National PharmaceuticalNystatin Henry Schein National PharmaceuticalNystatin Parmed Pharmaceuticals National PharmaceuticalNystatin H L Moore Drug Exchange National PharmaceuticalNystatin United Research Labs National PharmaceuticalNystatin Major Pharmaceutical Corp National PharmaceuticalNystatin Qualitest National PharmaceuticalNystatin Goldline Labs Barre-NationalNystatin Pharmafair PharmafairNystatin United Research Labs PharmafairNystatin Rugby Labs Naska PharmacalNystatin My-K Labs My-K LabsNystatin Biocraft Labs Biocraft LabsNystatin Schein Pharmaceutical Barre-NationalNystatin Lemmon Co Lemmon CoNystatin Thames Pharmacal Thames PharmacalNystatin Pharmaderm AltanaNystatin Pharmaceutical Basics Pharmaceutical Basics

NYSTATINTablets

Mycostatin E R Squibb & Sons E R Squibb & SonsNilstat Lederle Labs Lederle LabsNystatin Rugby Labs Chelsea LabsNystatin Par Pharmaceutical Par PharmaceuticalNystatin Qualitest Par PharmaceuticalNystatin Bioline Labs Par PharmaceuticalNystatin Goldline Labs Par PharmaceuticalNystatin H L Moore Drug Exchange Par PharmaceuticalNystatin United Research Labs Par PharmaceuticalNystatin Williams Generics Par PharmaceuticalNystatin Quantum Pharmics Quantum PharmicsNystatin Parmed Pharmaceuticals Quantum PharmicsNystatin Lemmon Co Lemmon CoNystatin Parmed Pharmaceuticals Lemmon CoNystatin Interstate Drug Exchange Lemmon CoNystatin Rugby Labs Lemmon CoNystatin Major Pharmaceutical Corp Lemmon CoNystatin United Research Labs Lemmon CoNystatin Mutual Pharmaceutical Lemmon CoNystatin Vitarine Pharmaceutical Vitarine PharmaceuticalNystatin Geneva Generics Vitarine PharmaceuticalNystatin Pharmaceutical Basics Pharmaceutical BasicsNystatin Mutual Pharmaceutical Mutual Pharmaceutical

NYSTATINVaginal Tablets

Mycostatin E R Squibb & Sons E R Squibb & SonsNilstat Lederle Labs Lederle LabsNystatin Rugby Labs Chelsea LabsNystatin Quantum Pharmics Quantum PharmicsNystatin Sidmak Labs Sidmak LabsNystatin Vitarine Pharmaceutical Vitarine PharmaceuticalNystatin Geneva Generics Vitarine PharmaceuticalNystatin Lemmon Co Lemmon CoNystatin Purepac Pharmaceutical Lemmon CoNystatin Goldline Labs Lemmon CoNystatin E Fougera AltanaNystatin Pharmaderm Altana

NYSTATIN/TRIAMCINOLONE ACETONIDECream

Nystatin/Triamcinolone Acetonide Thames Pharmacal Thames PharmacalNystatin/Triamcinolone Acetonide Purepac Pharmaceutical NMC LabsMykacet NMC Labs NMC LabsNystatin/Triamcinolone Acetonide Clay-Park Labs Clay-Park LabsTri-Statin II Rugby Labs Clay-Park LabsTri-Statin II Glenlawn Labs Clay-Park LabsN T A United Research Labs Clay-Park LabsMyco II Bioline Labs Clay-Park Labs

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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NYSTATIN/TRIAMCINOLONE ACETONIDECream—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Myco-Aricin II Interstate Drug Exchange Clay-Park LabsMycobiotic II H L Moore Drug Exchange Clay-Park LabsNyst-Olone II Henry Schein Clay-Park LabsMycogen II Goldline Labs Clay-Park LabsMyco-Triacet II Lemmon Co Lemmon CoMytrex F Savage Labs AltanaNystatin/Triamcinolone Acetonide E Fougera AltanaNystatin/Triamcinolone Acetonide Pharmaderm AltanaNystatin and Triamcinolone

Acetonide Taro Pharmaceuticals Taro PharmaceuticalsTri-Statin II Rugby Labs Naska Pharmacal

NYSTATIN/TRIAMCINOLONE ACETONIDEOintment

Nystatin/Triamcinolone Acetonide NMC Labs NMC LabsNystatin/Triamcinolone Acetonide E Fougera AltanaNystatin/Triamcinolone Acetonide Pharmaderm AltanaMytrex F Savage Labs AltanaTri-Statin II Rugby Labs Clay-Park LabsN T A United Research Labs Clay-Park LabsMyco II Bioline Labs Clay-Park LabsMyco-Aricin II Interstate Drug Exchange Clay-Park LabsNyst-Olone II Henry Schein Clay-Park LabsMycogen II Goldline Labs Clay-Park LabsMyco-Triacet II Lemmon Co Lemmon Co

ORPHENADRINE CITRATEInjection

Norflex Riker Labs Riker LabsOrphenadrine Citrate Steris Labs Steris LabsOrphenadrine Citrate Schein Pharmaceutical Steris LabsOrphenadrine Citrate Rugby Labs Steris Labs

ORPHENADRINE CITRATETablets

Orphenadrine Citrate Bolar Pharmaceutical Bolar PharmaceuticalOrphenadrine Citrate United Research Labs Bolar PharmaceuticalOrphenadrine Citrate Rugby Labs Bolar PharmaceuticalOrphenadrine Citrate Murray Drug Bolar PharmaceuticalOrphenadrine Citrate Bioline Labs Bolar PharmaceuticalOrphenadrine Citrate Cooper Bolar PharmaceuticalOrphenadrine Citrate Geneva Generics Bolar PharmaceuticalOrphenadrine Citrate Henry Schein Bolar PharmaceuticalOrphenadrine Citrate Glenlawn Labs Bolar PharmaceuticalOrphenadrine Citrate Parmed Pharmaceuticals Bolar PharmaceuticalOrphenadrine Citrate Qualitest Bolar PharmaceuticalOrphenadrine Citrate Best Generics Bolar PharmaceuticalOrflagen Goldline Labs Bolar Pharmaceutical

OXACILLIN SODIUMCapsules

Prostaphlin Bristol Labs Bristol LabsBactocill Beecham Labs Beecham LabsOxacillin Sodium Biocraft Labs Biocraft LabsOxacillin Sodium Henry Schein Biocraft LabsOxacillin Sodium Geneva Generics Biocraft LabsOxacillin Sodium Qualitest Biocraft LabsOxacillin Sodium United Research Labs Biocraft LabsOxacillin Sodium Goldline Labs Biocraft Labs

OXACILLIN SODIUMInjection

Bactocill Beecham Labs Beecham Labs

OXACILLIN SODIUMFor Solution

Prostaphlin Bristol Labs Bristol LabsOxacillin Sodium Biocraft Labs Biocraft LabsOxacillin Sodium Goldline Labs Biocraft Labs

28 § 25.58 PREVENTION OF DISEASES Pt. III

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OXAZEPAMCapsules

Brand Name/Generic Name Distributed By: Manufactured By:

Oxazepam Rugby Labs Chelsea LabsOxazepam Purepac Pharmaceutical Purepac PharmaceuticalOxazepam American Therapeutics American TherapeuticsOxazepam Martec Pharmaceutical American TherapeuticsOxazepam Barr Labs Barr LabsOxazepam Parmed Pharmaceuticals Barr LabsOxazepam Geneva Generics Cord Labs

OXAZEPAMTablets

Oxazepam Danbury Pharmacal Danbury PharmacalOxazepam Warner Chilcott Labs Warner Chilcott LabsOxazepam Barr Labs Barr LabsOxazepam Bioline Labs Barr LabsOxazepam Goldline Labs Barr Labs

OXTRIPHYLLINEElixir

Oxtriphylline Barre Drug National PharmaceuticalOxtriphylline My-K Labs My-K LabsOxtriphylline Pharmaceutical Basics Pharmaceutical Basics

OXTRIPHYLLINESyrup

Oxtriphylline My-K Labs My-K LabsOxtriphylline Pediatric Pharmaceutical Basics Pharmaceutical Basics

OXTRIPHYLLINETablets

Oxtriphylline Bolar Pharmaceutical Bolar PharmaceuticalOxtriphylline Geneva Generics Bolar Pharmaceutical

OXYBUTYNIN CHLORIDETablets

Oxybutynin Chloride Pharmaceutical Basics Pharmaceutical Basics

OXYMETAZOLINE HCLNasal Spray

Oxytrin Thames Pharmacal Thames Pharmacal

OXYTETRACYCLINE HCLCapsules

Oxytetracycline Purepac Pharmaceutical Purepac PharmaceuticalOxytetracycline Geneva Generics KalipharmaOxytetracycline HCl United Research Labs KalipharmaOxytetracycline HCl Rugby Labs KalipharmaOxytetracycline HCl Glenlawn Labs KalipharmaOxytetracycline West-ward West-wardOxytetracycline HCl Rugby Labs West-wardOxytetracycline HCl Interstate Drug Exchange West-wardOxytetracycline HCl H L Moore Drug Exchange West-wardOxytetracycline HCl Henry Schein West-wardOxytetracycline HCl United Research Labs West-wardOxytetracycline Richlyn Labs Richlyn LabsOxytetracycline Bioline Labs Richlyn LabsOxytetracycline Interstate Drug Exchange Richlyn LabsOxytetracycline Rugby Labs Richlyn LabsOxytetracycline Henry Schein Richlyn LabsOxytetracycline HCl United Research Labs Richlyn LabsOxytetracycline HCl Glenlawn Labs Richlyn LabsOxytetracycline HCl Murray Drug Richlyn LabsOxytetracycline HCl Purepac Pharmaceutical Richlyn LabsOxytetracycline HCl McKesson Labs MK LabsOxytetracycline HCl Lederle Labs MK LabsOxytetracycline HCl American Urologicals MK Labs

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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OXYTOCINInjection

Brand Name/Generic Name Distributed By: Manufactured By:

Pitocin Parke-Davis Parke-Davis

PARACHLOROMETAXYLENOL/RESORCIN/SULFURLotion

Rezamid Dermik Labs Dermik Labs

PANCRELIPASECapsules

KU - ZYME HP Kremers-Urban Kremers-Urban

PAPAVERINE HCLTablets

Pavaren Rugby Labs Chelsea LabsPapaverine HCl Purepac Pharmaceutical Purepac PharmaceuticalPapaverine HCl Dixon-Shane Zenith LabsPapaverine HCl Danbury Pharmacal Danbury PharmacalPapaverine HCl Lederle Labs Danbury PharmacalPapaverine HCl H L Moore Drug Exchange Danbury PharmacalPapaverine HCl Henry Schein Danbury PharmacalPapaverine HCl Sidmak Labs Sidmak LabsPapaverine HCl United Research Labs Sidmak LabsPapaverine HCl Qualitest Sidmak LabsPapaverine HCl Mutual Pharmaceutical Sidmak LabsPapaverine HCl Major Pharmaceutical Corp Sidmak Labs

PAREGORICElixir

Paregoric Barre Drug National PharmaceuticalParegoric Vangard Labs National PharmaceuticalParegoric Interstate Drug Exchange National PharmaceuticalParegoric Murray Drug National PharmaceuticalParegoric Rugby Labs National PharmaceuticalParegoric United Research Labs National PharmaceuticalParegoric Glenlawn Labs National PharmaceuticalParegoric Mallard National PharmaceuticalParegoric Whiteworth Pharmaceuticals National PharmaceuticalParegoric Harber Pharmaceutical National PharmaceuticalParegoric Bioline Labs National PharmaceuticalParegoric Geneva Generics National PharmaceuticalParegoric Goldline Labs Barre-NationalParegoric Rexall Drug Rexall DrugParegoric Purepac Pharmaceutical Purepac PharmaceuticalParegoric United Research Labs KalipharmaParegoric McKesson Labs MK LabsParegoric Life Labs Life LabsParegoric My-K Labs My-K LabsParegoric Schein Pharmaceutical Barre-National

PENICILLIN G POTASSIUMFor Solution

Pentids for Syrup E R Squibb & Sons E R Squibb & SonsPenicillin G Potassium Purepac Pharmaceutical Purepac PharmaceuticalPenicillin G Potassium Biocraft Labs Biocraft LabsPenicillin G Potassium United Research Labs Biocraft LabsPenicillin G Potassium Rugby Labs Biocraft LabsPenicillin Cooper Biocraft LabsPenicillin Veratex Corp Biocraft LabsPenicillin Harnel Pharmaceutical Biocraft LabsPenicillin Interstate Drug Exchange Biocraft LabsPenicillin Henry Schein Biocraft LabsRexcillin C S Ruckstuhl Biocraft LabsTruxcillin C O Truxton Biocraft LabsWincillin Winston Pharmaceuticals Biocraft Labs

PENICILLIN G POTASSIUMTablets

Pentids E R Squibb & Sons E R Squibb & SonsPenicillin G Potassium Geneva Generics KalipharmaPenicillin G Potassium Purepac Pharmaceutical Purepac PharmaceuticalPenicillin G Potassium Mylan Pharmaceuticals Mylan PharmaceuticalsPenicillin G Potassium Lederle Labs Mylan Pharmaceuticals

28 § 25.58 PREVENTION OF DISEASES Pt. III

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PENICILLIN G POTASSIUMTablets—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Penicillin G Potassium Geneva Generics Mylan PharmaceuticalsSK-Penicillin G Smith Kline & French Mylan PharmaceuticalsPenicillin G Potassium McKesson Labs Mylan PharmaceuticalsPenicillin G Potassium Walgreen Mylan PharmaceuticalsPenicillin G Potassium United Research Labs Mylan PharmaceuticalsPenicillin G Potassium Bell Pharmacal Mylan PharmaceuticalsPenicillin G Potassium Rugby Labs Mylan PharmaceuticalsPenicillin G Potassium H L Moore Drug Exchange Mylan PharmaceuticalsPenicillin G Potassium Interstate Drug Exchange Mylan PharmaceuticalsPenicillin G Potassium Rexall Drug Mylan PharmaceuticalsPenicillin G Potassium Henry Schein Mylan PharmaceuticalsPenicillin G Potassium Towne, Paulsen Mylan PharmaceuticalsPenicillin G Potassium Thrift Drug Mylan PharmaceuticalsPenicillin G Potassium Murray Drug Mylan PharmaceuticalsPen-G Bioline Labs Mylan PharmaceuticalsPenicillin G Potassium Biocraft Labs Biocraft LabsPenicillin G Potassium Rugby Labs Biocraft LabsPenicillin G Potassium Cooper Biocraft LabsPenicillin G Potassium Dixon-Shane Biocraft LabsPenicillin G Potassium Gen-King Products Biocraft LabsPenicillin G Potassium Glenlawn Labs Biocraft LabsPenicillin G Potassium Halsey Drug Biocraft LabsPenicillin G Potassium Harnel Pharmaceutical Biocraft LabsPenicillin G Potassium Interstate Drug Exchange Biocraft LabsPenicillin G Potassium H L Moore Drug Exchange Biocraft LabsPenicillin G Potassium Parmed Pharmaceuticals Biocraft LabsPenicillin G Potassium Purepac Pharmaceutical Biocraft LabsPenicillin G Potassium Queen City Pharmacal Biocraft LabsPenicillin G Potassium C S Ruckstuhl Biocraft LabsPenicillin G Potassium Wasserotts Biocraft LabsPenicillin G Potassium Towne, Paulsen Biocraft LabsPenicillin G Potassium Qualitest Biocraft LabsPenicillin G Potassium United Research Labs Biocraft LabsPen-G Bioline Labs Biocraft LabsPenicillin-G Goldline Labs Biocraft Labs

PENICILLIN V POTASSIUMFor Solution

V-Cillin K Eli Lilly Eli LillyVeetids E R Squibb & Sons E R Squibb & SonsBetapen-VK Bristol Labs Bristol LabsLedercillin VK Lederle Labs Lederle LabsBeepen-VK Beecham Labs Beecham LabsPenicillin VK Purepac Pharmaceutical Purepac PharmaceuticalPenicillin V Potassium Mylan Pharmaceuticals Mylan PharmaceuticalsSK-Penicillin-VK Smith Kline & French Mylan PharmaceuticalsPenicillin V Potassium Walgreen Mylan PharmaceuticalsPenicillin V Potassium United Research Labs Mylan PharmaceuticalsPenicillin V Potassium H L Moore Drug Exchange Mylan PharmaceuticalsPenicillin V Potassium Rugby Labs Mylan PharmaceuticalsPenicillin V Potassium Henry Schein Mylan PharmaceuticalsPenicillin VK Biocraft Labs Biocraft LabsVan-Pen-VK Vangard Labs Biocraft LabsDeltapen-VK Trimen Labs Biocraft LabsPenicillin V Potassium Rugby Labs Biocraft LabsPenicillin VK Dixon-Shane Biocraft LabsPenicillin VK Comer Pharmaceuticals Biocraft LabsPenicillin VK Gen-King Products Biocraft LabsPenicillin VK Glenlawn Labs Biocraft LabsPenicillin VK Halsey Drug Biocraft LabsPenicillin VK Harnel Pharmaceutical Biocraft LabsPenicillin VK Interstate Drug Exchange Biocraft LabsPenicillin VK Mallard Biocraft LabsPenicillin VK Marnel Pharmaceuticals Biocraft LabsPenicillin VK Michigan Pharmacal Biocraft LabsPenicillin VK Murray Drug Biocraft LabsPenicillin VK H L Moore Drug Exchange Biocraft LabsPenicillin VK Pharmacist Choice Biocraft LabsPenicillin VK Queen City Pharmacal Biocraft LabsPenicillin VK C S Ruckstuhl Biocraft LabsPenicillin VK Henry Schein Biocraft LabsPenicillin VK Purepac Pharmaceutical Biocraft LabsPenicillin VK Goldline Labs Biocraft LabsPen-V Bioline Labs Biocraft LabsCen-Pen-V Cenla Pharmaceutical Biocraft LabsSuspen Circle Pharmaceuticals Biocraft LabsM-Cillin VK R A McNeil Biocraft LabsParcillin-V Parmed Pharmaceuticals Biocraft LabsPenicillin V McKesson Labs Biocraft Labs

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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PENICILLIN V POTASSIUMFor Solution—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Ledercillin VK Lederle Labs Biocraft LabsPenapar VK Parke-Davis John D CopanosPenicillin V Potassium Goldline Labs Mylan PharmaceuticalsPenicillin V Potassium Apothecan Bristol-Myers

PENICILLIN V POTASSIUMTablets

V-Cillin K Eli Lilly Eli LillyVeetids E R Squibb & Sons E R Squibb & SonsBetapen VK Bristol Labs Bristol LabsBeepen-VK Beecham Labs Beecham LabsPenicillin V Potassium Regal Labs Bristol LabsPenicillin V Potassium Mylan Pharmaceuticals Mylan PharmaceuticalsPenicillin V Potassium Vangard Labs Mylan PharmaceuticalsPenicillin V Potassium Geneva Generics Mylan PharmaceuticalsPenicillin V Potassium Walgreen Mylan PharmaceuticalsPenicillin V Potassium United Research Labs Mylan PharmaceuticalsPenicillin V Potassium H L Moore Drug Exchange Mylan PharmaceuticalsPenicillin V Potassium Rugby Labs Mylan PharmaceuticalsPenicillin V Potassium Henry Schein Mylan PharmaceuticalsPenicillin V Potassium Interstate Drug Exchange Mylan PharmaceuticalsPen-V Bioline Labs Mylan PharmaceuticalsPenicillin V Potassium Glenlawn Labs Mylan PharmaceuticalsPenicillin V Potassium Richie Pharmacal Mylan PharmaceuticalsPenicillin V Potassium Murray Drug Mylan PharmaceuticalsPenicillin V Potassium Parmed Pharmaceuticals Mylan PharmaceuticalsPenicillin V Potassium Harber Pharmaceutical Mylan PharmaceuticalsPenicillin VK Towne, Paulsen Mylan PharmaceuticalsSK-Penicillin VK Smith Kline & French Mylan PharmaceuticalsPenicillin V Potassium Purepac Pharmaceutical Purepac PharmaceuticalPenicillin V Potassium Glenlawn Labs KalipharmaLedercillin VK Lederle Labs Lederle LabsUticillin VK Upjohn Co Upjohn CoPenicillin VK Biocraft Labs Biocraft LabsPenicillin V Potassium Purepac Pharmaceutical Biocraft LabsPenicillin VK Towne, Paulsen Biocraft LabsRobicillin VK A H Robins Biocraft LabsPenicillin V Potassium Rugby Labs Biocraft LabsPenicillin VK Parmed Pharmaceuticals Biocraft LabsPenicillin VK Wasserotts Biocraft LabsPenicillin VK Atlas Pharmaceuticals Biocraft LabsPenicillin VK Henry Schein Biocraft LabsPenicillin VK C S Ruckstuhl Biocraft LabsPenicillin VK Queen City Pharmacal Biocraft LabsPenicillin VK Vita-Rx Biocraft LabsPenicillin VK Murray Drug Biocraft LabsPenicillin VK Interstate Drug Exchange Biocraft LabsPenicillin VK Harnel Pharmaceutical Biocraft LabsPenicillin VK Halsey Drug Biocraft LabsPenicillin VK Glenlawn Labs Biocraft LabsPenicillin VK Gen-King Products Biocraft LabsPenicillin VK Dixon-Shane Biocraft LabsPenicillin VK Cooper Biocraft LabsPenicillin V Potassium Mallard Biocraft LabsPenicillin V Potassium McKesson Labs Biocraft LabsPenicillin V Potassium Pharmacist Choice Biocraft LabsPenicillin V Potassium Vangard Labs Biocraft LabsPen-V Bioline Labs Biocraft LabsCen-Pen-VK Cenla Pharmaceutical Biocraft LabsCaropen-VK Seneca Pharmaceuticals Biocraft LabsWincillin-VK Winston Pharmaceuticals Biocraft LabsM-Cillin VK R A McNeil Biocraft LabsPenicillin-VK Qualitest Biocraft LabsPenicillin-VK H L Moore Drug Exchange Biocraft LabsLedercillin VK Lederle Labs Biocraft LabsPen-V Goldline Labs Biocraft LabsPenapar VK Parke-Davis John D CopanosPenicillin VK Laboratory A Mylan PharmaceuticalsPenicillin V Potassium Apothecon Bristol-Myers

PENTAERYTHRITOL TETRANITRATETablets

Peritrate Parke-Davis Parke-DavisPentaerythritol Tetranitrate Bolar Pharmaceutical Bolar PharmaceuticalPentaerythritol Tetranitrate Rugby Labs Bolar PharmaceuticalPentaerythritol Tetranitrate Henry Schein Bolar PharmaceuticalPentaerythritol Tetranitrate United Research Labs Bolar Pharmaceutical

28 § 25.58 PREVENTION OF DISEASES Pt. III

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PENTAERYTHRITOL TETRANITRATETablets—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Pentaerythritol Tetranitrate Interstate Drug Exchange Bolar PharmaceuticalPentaerythritol Tetranitrate Bioline Labs Bolar PharmaceuticalPentaerythritol Tetranitrate H L Moore Drug Exchange Bolar PharmaceuticalPentaerythritol Tetranitrate Gen-King Products Bolar PharmaceuticalPentaerythritol Tetranitrate Veratex Corp Bolar PharmaceuticalPentaerythritol Tetranitrate Wesley Pharmacal Bolar PharmaceuticalPentaerythritol Tetranitrate Purepac Pharmaceutical Bolar PharmaceuticalPentaerythritol Tetranitrate Glenlawn Labs Bolar PharmaceuticalPentaerythritol Tetranitrate Geneva Generics Bolar PharmaceuticalPentaerythritol Tetranitrate M M Mast Bolar PharmaceuticalPentaerythritol Tetranitrate Richie Pharmacal Bolar PharmaceuticalPentaerythritol Tetranitrate McKesson Labs Bolar PharmaceuticalPentaerythritol Tetranitrate Coast Labs Bolar PharmaceuticalPentaerythritol Tetranitrate H R Cenci Labs Bolar PharmaceuticalPentaerythritol Tetranitrate Penta Products Bolar PharmaceuticalPentaerythritol Tetranitrate Vangard Labs Bolar PharmaceuticalPentaerythritol Tetranitrate Cooper Bolar PharmaceuticalPentaerythritol Tetranitrate Ronda Pharmacal Bolar PharmaceuticalPentaerythritol Tetranitrate Bell Pharmacal Bolar PharmaceuticalPentaerythritol Tetranitrate Parmed Pharmaceuticals Bolar PharmaceuticalPentaerythritol Tetranitrate Qualitest Bolar PharmaceuticalPentaerythritol Tetranitrate Goldline Labs Bolar PharmaceuticalAntrate C S Ruckstuhl Bolar PharmaceuticalPentet C O Truxton Bolar PharmaceuticalBlaintrate Blaine Co Bolar PharmaceuticalPentaerythritol Tetranitrate Zenith Labs Zenith LabsPentaerythritol Tetranitrate United Research Labs Zenith Labs

PENTOBARBITAL SODIUMCapsules

Pentobarbital Purepac Pharmaceutical Purepac PharmaceuticalPentobarbital Sodium Lannett LannettPentobarbital Sodium ICN Pharmaceuticals ICN PharmaceuticalsPentobarbital Sodium Halsey Drug Halsey DrugPentobarbital Sodium Rugby Labs Halsey DrugSodium Pentobarbital Interstate Drug Exchange Halsey DrugSodium Pentobarbital Henry Schein Halsey Drug

PERPHENAZINETablets

Perphenazine Rugby Labs Chelsea LabsPerphenazine Zenith Labs Zenith LabsPerphenazine Bioline Labs Zenith LabsPerphenazine Goldline Labs Zenith LabsPerphenazine Lemmon Co Zenith LabsPerphenazine Qualitest Zenith LabsPerphenazine Parmed Pharmaceuticals Zenith LabsPerphenazine Glenlawn Labs Zenith Labs

PHENAZOPYRIDINE HCLTablets

Pyridium Parke-Davis Parke-DavisPyridiate Richlyn Labs Richlyn LabsPyridiate Rugby Labs Richlyn LabsPyridiate Bioline Labs Richlyn LabsPyridiate Glenlawn Labs Richlyn LabsPyridiate Murray Drug Richlyn LabsPyridiate Ronda Pharmacal Richlyn LabsPyrazodine H R Cenci Labs Richlyn LabsPhenylazo American Pharmaceutical Richlyn LabsPyridamor H L Moore Drug Exchange Richlyn LabsE-Ridium Econo-Rx Richlyn LabsPhenazodine Lannett Richlyn LabsPyridian Medco Supply Richlyn LabsUro-Pyridine Raway Pharmacal Richlyn LabsPyridin C S Ruckstuhl Richlyn LabsPhenazopyridine HCl Interstate Drug Exchange Richlyn LabsPhenazopyridine HCl Geneva Generics Richlyn LabsPhenazopyridine HCl Parmed Pharmaceuticals Richlyn LabsPhenazopyridine HCl Penta Products Richlyn LabsPhenazopyridine HCl Richie Pharmacal Richlyn LabsPhenazopyridine HCl United Research Labs Richlyn LabsPhenazopyridine HCl Vangard Labs Richlyn LabsPhenazopyridine HCl Amide Pharmaceutical Amide PharmaceuticalPhenazopyridine HCl Copley Pharmaceutical Copley PharmaceuticalPhenazopyridine HCl Qualitest Copley Pharmaceutical

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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PHENAZOPYRIDINE HCLTablets—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Phenazopyridine HCl Geneva Generics Copley PharmaceuticalPhenazopyridine HCl Purepac Pharmaceutical Copley PharmaceuticalPhenazopyridine HCl United Research Labs American TherapeuticsPhenazopyridine HCl Quantum Pharmics Quantum Pharmics

PHENDIMETRAZINE TARTRATETablets

Phendimetrazine Tartrate Rugby Labs Chelsea LabsCam-Metrazine Camall Co Camall CoPhendimetrazine Tartrate Elder Pharmaceuticals Camall CoPhendimetrazine Tartrate Parmed Pharmaceuticals Camall CoPhendimetrazine Tartrate Rugby Labs Camall CoPhendimetrazine Tartrate Henry Schein Camall CoPhendimetrazine Tartrate C O Truxton Camall CoPhendimetrazine Tartrate Veratex Corp Camall CoPhendimetrazine Tartrate Harnel Pharmaceutical Camall CoPhendimetrazine Tartrate Kraft Pharmaceutical Camall CoPhendimetrazine Tartrate Wesley Pharmacal Camall CoPhendimetrazine Tartrate Calvin Scott Camall CoPhendimetrazine Tartrate Cooper Camall CoPhendimetrazine H L Moore Drug Exchange Camall CoPhendimetrazine Bioline Labs Camall CoPhendimetrazine Coast Labs Camall CoNeocurb Pasadena Research Labs Camall CoDitrate R P Thomas Camall CoUni-Trim United Research Labs Camall CoTrim-Tabs United Research Labs Camall CoPhenazine R J Legere Camall CoAppatide Atlas Pharmaceuticals Camall CoP D M Lannett Camall CoDietrene Merit Pharmaceuticals Camall CoPanrexin-M Pan American Labs Camall CoPhendimet Parmed Pharmaceuticals Camall CoObrex Caldwell & Bloor Camall CoPhen 35 H & H Labs Camall CoResolve Bonco Labs Camall CoTrimtabs MayRand Pharmaceuticals Camall CoPhenazine Mallard Camall CoSpan-RD Metro Med Camall CoPhendimetrazine Tartrate Pharmaceutical Basics Pharmaceutical BasicsPhendimetrazine Tartrate Vitarine Pharmaceutical Vitarine Pharmaceutical

PHENIRAMINE MALEATE/PHENYLEPHRINE HCLOphthalmic Solution

Fenacel Optopics Labs Optopics Labs

PHENOBARBITALElixir

Phenobarbital Rexall Drug Rexall DrugPhenobarbital Barre Drug National PharmaceuticalPhenobarbital Generic Pharmacal National PharmaceuticalPhenobarbital Econo-Rx National PharmaceuticalPhenobarbital Medco Supply National PharmaceuticalPhenobarbital Midway Medical National PharmaceuticalPhenobarbital Richie Pharmacal National PharmaceuticalPhenobarbital Lederle Labs National PharmaceuticalPhenobarbital Vangard Labs National PharmaceuticalPhenobarbital Parmed Pharmaceuticals National PharmaceuticalPhenobarbital Glenlawn Labs National PharmaceuticalPhenobarbital Rugby Labs National PharmaceuticalPhenobarbital United Research Labs National PharmaceuticalPhenobarbital Harber Pharmaceutical National PharmaceuticalPhenobarbital Murray Drug National PharmaceuticalPhenobarbital Henry Schein National PharmaceuticalPhenobarbital Bioline Labs National PharmaceuticalPhenobarbital H L Moore Drug Exchange National PharmaceuticalPhenobarbital Cooper National PharmaceuticalPhenobarbital Goldline Labs Barre-NationalPhenobarbital Purepac Pharmaceutical Purepac PharmaceuticalPhenobarbital McKesson Labs MK LabsPhenobarbital Life Labs Life LabsPhenobarbital Halsey Drug Halsey DrugPhenobarbital Rugby Labs Halsey DrugPhenobarbital Rugby Labs Naska PharmacalPhenobarbital My-K Labs My-K LabsPhenobarbital H R Cenci Labs H R Cenci LabsPhenobarbital Pharmaceutical Basics Pharmaceutical Basics

28 § 25.58 PREVENTION OF DISEASES Pt. III

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PHENOBARBITALTablets

Brand Name/Generic Name Distributed By: Manufactured By:

Phenobarbital Parke-Davis Parke-DavisPhenobarbital Purepac Pharmaceutical Purepac PharmaceuticalPhenobarbital Geneva Generics KalipharmaPhenobarbital Richlyn Labs Richlyn LabsPhenobarbital Parmed Pharmaceuticals Richlyn LabsPhenobarbital Danbury Pharmacal Danbury PharmacalPhenobarbital Henry Schein Danbury PharmacalPhenobarbital Interstate Drug Exchange Danbury PharmacalPhenobarbital H L Moore Drug Exchange Danbury PharmacalPhenobarbital Glenlawn Labs Danbury PharmacalPhenobarbital Bell Pharmacal Danbury PharmacalPhenobarbital Qualitest Danbury PharmacalPhenobarbital ICN Pharmaceuticals ICN PharmaceuticalsPhenobarbital West-ward West-wardPhenobarbital Rugby Labs West-wardPhenobarbital Regal Labs West-wardPhenobarbital Towne, Paulsen Towne, PaulsenPhenobarbital McKesson Labs MK LabsPhenobarbital Roxane Labs Roxane LabsPhenobarbital Lemmon Co Lemmon CoPhenobarbital Major Pharmaceutical Corp Lemmon CoPhenobarbital Geneva Generics Lemmon CoPhenobarbital Parmed Pharmaceuticals Lemmon CoPhenobarbital Goldline Labs Lemmon CoPhenobarbital Barr Labs Barr LabsPhenobarbital Goldline Labs Barr LabsPhenobarbital Pioneer Pharmaceuticals Pioneer PharmaceuticalsPhenobarbital Bowman Pharmaceuticals Bowman PharmaceuticalsPhenobarbital United Research Labs Bowman PharmaceuticalsPhenobarbital Vitarine Pharmaceutical Vitarine PharmaceuticalPhenobarbital JMI-Canton JMI-Canton

PHENTERMINE HCLCapsules

Fastin Beechman Labs Beechman LabsPhentermine HCl Zenith Labs Zenith LabsPhentermine HCl United Research Labs Zenith LabsPhentermine HCl Bell Pharmacal Zenith LabsPhentermine HCl Qualitest Zenith LabsPhentermine HCl Interstate Drug Exchange Zenith LabsPhentermine HCl Towne, Paulsen Zenith LabsPhentermine HCl Goldline Labs Zenith LabsPhentermine HCl Geneva Generics Zenith LabsPhentermine HCl Lemmon Co Lemmon CoPhentermine HCl United Research Labs Lemmon CoPhentermine HCl Parmed Pharmaceuticals Lemmon CoPhentermine HCl Rugby Labs Chelsea LabsPhentermine HCl Vitarine Pharmaceutical Vitarine PharmaceuticalPhentermine HCl Parmed Pharmaceuticals Vitarine PharmaceuticalPhentermine HCl Duramed Pharmaceuticals Duramed PharmaceuticalsPhentermine HCl Camall Co Camall CoPhentermine HCl Rugby Labs Camall CoPhentermine HCl Lannett Camall CoPhentermine HCl Henry Schein Camall CoPhentermine HCl United Research Labs Camall CoPhentermine HCl H L Moore Drug Exchange Camall CoPhentermine HCl Cooper Camall CoPhentermine HCl Veratex Corp Camall CoPhentermine HCl Interstate Drug Exchange Camall CoPhentermine HCl Mallard Camall CoPhentercot C O Truxton Camall CoTeramine R J Legere Camall CoObecaps R P Thomas Camall CoKraftobese-GR Kraft Pharmaceutical Camall CoTermene Calvin Scott Co Camall CoPhenterspan Wesley Pharmacal Camall CoSuper-Fast Bari-Medical Co Camall CoPhentermine HCl Pharmaceutical Basics Pharmaceutical Basics

PHENTERMINE HCLTablets

Phentermine HCl Rugby Labs Chelsea LabsPhentermine HCl United Research Labs Camall CoPhentermine HCl Wesley Pharmacal Camall CoPhentermine HCl H L Moore Drug Exchange Camall CoPhentermine HCl Merit Pharmaceuticals Camall CoPhentermine HCl Lannett Camall Co

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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PHENTERMINE HCLTablets—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Obetab R P Thomas Camall CoTermene Calvin Scott Co Camall CoLo Ap-T J M Dwyer Camall CoKraftobese-HP Kraft Pharmaceutical Camall CoPhentermine HCl Camall Co Camall Co

PHENYLBUTAZONECapsules

Phenylbutazone Cord Labs Cord LabsPhenylbutazone Geneva Generics Cord LabsPhenylbutazone Rugby Labs Chelsea LabsPhenylbutazone Zenith Labs Zenith LabsPhenylbutazone Towne, Paulsen Zenith LabsPhenylbutazone Qualitest Zenith LabsPhenylbutazone Genetco Zenith LabsPhenylbutazone Barr Labs Barr LabsPhenylbutazone Best Generics Barr LabsPhenylbutazone Rugby Labs Barr LabsPhenylbutazone United Research Labs Barr Labs

PHENYLBUTAZONETablets

Butazolidin Geigy Pharmaceutical Ciba-GeigyPhenylbutazone Danbury Pharmacal Danbury PharmacalPhenylbutazone Bell Pharmacal Danbury PharmacalPhenylbutazone Qualitest Danbury PharmacalPhenylbutazone United Research Labs Danbury PharmacalPhenylbutazone Barr Labs Barr LabsPhenylbutazone Best Generics Barr LabsPhenylbutazone H L Moore Drug Exchange Barr LabsPhenylbutazone United Research Labs Barr LabsPhenylbutazone Quality Research Pharm Barr LabsPhenylbutazone Major Pharmaceutical Corp Barr LabsPhenylbutazone Glenlawn Labs Barr LabsPhenylbutazone Gen-King Products Barr LabsPhenylbutazone Genetco Barr LabsPhenylbutazone Harber Pharmaceutical Barr LabsPhenylbutazone Rugby Labs Barr Labs

PHENYLEPHRINE HCLNasal Solution

Phenylephrine HCl Barre Drug National PharmaceuticalPhenylephrine HCl Bioline Labs National PharmaceuticalPhenylephrine HCl Rugby Labs National PharmaceuticalPhenylephrine HCl Henry Schein National PharmaceuticalPhenylephrine HCl Vangard Labs National PharmaceuticalPhenylephrine HCl Interstate Drug Exchange National PharmaceuticalPhenylephrine HCl United Research Labs National PharmaceuticalPhenylephrine HCl Murray Drug National PharmaceuticalPhenylephrine HCl Geneva Generics National PharmaceuticalPhenylephrine HCl Goldline Labs Barre-NationalPhenylephrine HCl Rugby Labs Naska PharmacalMynephrine My-K Labs My-K LabsPhenylephrine HCl Pharmaceutical Basics Pharmaceutical Basics

PHENYLEPHRINE HCLOphthalmic Solution

Isopto Frin Alcon Labs Alcon LabsTearaid Optopics Labs Optopics LabsEfricel Optopics Labs Optopics LabsDilatair Pharmafair PharmafairPhenylephrine HCl Steris Labs Steris LabsPhenylephrine HCl Hygeia Labs Steris Labs

PHENYLEPHRINE HCL/PROMETHAZINE HCLSyrup

Prometh VC Plain Barre Drug National PharmaceuticalPrometh VC Plain Qualitest National PharmaceuticalPrometh VC Plain Goldline Labs Barre-NationalPromethazine VC Plain My-K Labs My-K LabsPromethazine VC Plain H R Cenci Labs H R Cenci LabsPherazine VC Halsey Drug Halsey Drug

28 § 25.58 PREVENTION OF DISEASES Pt. III

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PHENYLEPHRINE HCL/ZINC SULFATEOphthalmic Solution

Brand Name/Generic Name Distributed By: Manufactured By:

Zincfrin Alcon Labs Alcon Labs

PHENYTOIN SODIUMInjection

Phenytoin Sodium Steris Labs Steris LabsPhenytoin Sodium Travenol Labs Steris Labs

PHYSOSTIGMINE SALICYLATE/PILOCARPINE HCLOphthalmic Solution

Isopto P-ES Alcon Labs Alcon LabsMyiocel Optopics Labs Optopics Labs

PILOCARPINE HCLOphthalmic Solution

Isopto Carpine Alcon Labs Alcon LabsPiloptic Optopics Labs Optopics LabsPilokair Pharmafair PharmafairPilocarpine HCl Henry Schein PharmafairPilocarpine HCl H L Moore Drug Exchange PharmafairPilocarpine HCl United Research Labs PharmafairPilocarpine HCl Rugby Labs PharmafairPilocarpine HCl Bioline Labs PharmafairPilocarpine HCl Geneva Generics PharmafairPilocarpine HCl Steris Labs Steris LabsPilocarpine HCl Paco Pharmaceutical Ser Paco Pharmaceutical SerOcu-Carpine Ocumed Ocumed

PIPERAZINE CITRATESyrup

Piperazine Citrate Barre Drug National PharmaceuticalPiperazine Citrate Henry Schein National PharmaceuticalPiperazine Citrate Vangard Labs National PharmaceuticalPiperazine Citrate Rugby Labs National PharmaceuticalPiperazine Citrate Murray Drug National PharmaceuticalPiperazine Citrate Lannett Lannett

PIPERAZINE CITRATETablets

Piperazine Citrate Richlyn Labs Richlyn LabsPiperazine Citrate Henry Schein Richlyn LabsEffervescent Potassium Bajamar Chemical Tower Labs

POTASSIUM BICARBONATEEffervescent Tablets

Potassium Effervescent Copley Pharmaceutical Copley PharmaceuticalK + Care ET Alra Labs Alra LabsEffervescent Potassium Cima Labs Cima Labs

POTASSIUM CHLORIDELiquid

Potassium Chloride Purepac Pharmaceutical Purepac PharmaceuticalPotassium Chloride Barre Drug National PharmaceuticalPotassium Chloride A C A National PharmaceuticalPotassium Chloride American Pharmaceutical National PharmaceuticalPotassium Chloride Cooper National PharmaceuticalPotassium Chloride Rugby Labs National PharmaceuticalPotassium Chloride Henry Schein National PharmaceuticalPotassium Chloride Vangard Labs National PharmaceuticalPotassium Chloride Lederle Labs National PharmaceuticalPotassium Chloride Alto Pharmaceutical National PharmaceuticalPotassium Chloride Bioline Labs National PharmaceuticalPotassium Chloride Blue Cross Products National PharmaceuticalPotassium Chloride H L Moore Drug Exchange National PharmaceuticalPotassium Chloride Richie Pharmacal National PharmaceuticalPotassium Chloride Interstate Drug Exchange National PharmaceuticalPotassium Chloride United Research Labs National PharmaceuticalPotassium Chloride Glenlawn Labs National PharmaceuticalPotassium Chloride McKesson Labs National PharmaceuticalPotassium Chloride Ascot National Pharmaceutical

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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POTASSIUM CHLORIDELiquid—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Potassium Chloride Murray Drug National PharmaceuticalPotassium Chloride Harber Pharmaceutical National PharmaceuticalPotassium Chloride Vita Rx National PharmaceuticalPotassium Chloride Salem Labs National PharmaceuticalPotassium Chloride Bell Pharmacal National PharmaceuticalPotassium Chloride Geneva Generics National PharmaceuticalEM-K Econo-Med National PharmaceuticalK-Chlor-Rex C S Ruckstuhl National PharmaceuticalArchlor Artex Labs National PharmaceuticalK-Ten Pharmacist Choice National PharmaceuticalPotassium Chloride Goldline Labs Barre-NationalKloride Amfre-Grant Ormont Drug & ChemicalPan-Kloride Panray Ormont Drug & ChemicalPotassium Chloride Life Labs Life LabsPotassium Chloride Gentek Corp Gentek CorpPotassium Chloride Superpharm Corp Superpharm CorpPotassium Chloride Rugby Labs Superpharm CorpPotassium Chloride Halsey Drug Halsey DrugPotassium Chloride Rugby Labs Naska PharmacalPotassium Chloride Upsher-Smith Labs Upsher-Smith LabsPotassium Chloride Towne, Paulsen Towne, PaulsenPotassium Chloride Roxane Labs Roxane LabsPotachlor My-K Labs My-K LabsKlorvess Dorsey Labs Dorsey LabsPotassium Chloride LuChem Pharmaceuticals LuChem PharmaceuticalsK-10 H R Cenci Labs H R Cenci Labs

POTASSIUM CHLORIDEPowder

K-Lor Abbott Labs Abbott LabsKlor-Con Upsher-Smith Labs Upsher-Smith LabsK-potassium Chlor Copley Pharmaceutical Copley PharmaceuticalK + Care Alra Labs Alra LabsPotassium Chloride Best Generics Copley Pharmaceutical

POTASSIUM CHLORIDEEffervescent Tablets

Klorvess Dorsey Labs Dorsey LabsK-Electrolyte/CL Copley Pharmaceutical Copley Pharmaceutical

POTASSIUM CHLORIDE/POTASSIUM GLUCONATELiquid

Duo-K Barre Drug National PharmaceuticalDuo-K Rugby Labs National PharmaceuticalDuo-K Henry Schein National PharmaceuticalDuo-K Murray Drug National PharmaceuticalDuo-K Cooper National Pharmaceutical

POTASSIUM CITRATE/POTASSIUM GLUCONATELiquid

Kem-K LuChem Pharmaceuticals LuChem Pharmaceuticals

POTASSIUM GLUCONATEElixir

Potassium Gluconate Barre Drug National PharmaceuticalPotassium Gluconate Henry Schein National PharmaceuticalPotassium Gluconate Cooper National PharmaceuticalPotassium Gluconate Rugby Labs National PharmaceuticalPotassium Gluconate Vangard Labs National PharmaceuticalPotassium Gluconate Lederle Labs National PharmaceuticalPotassium Gluconate United Research Labs National PharmaceuticalPotassium Gluconate Bioline Labs National PharmaceuticalPotassium Gluconate Vita-Rx National PharmaceuticalPotassium Gluconate Richie Pharmacal National PharmaceuticalPotassium Gluconate H L Moore Drug Exchange National PharmaceuticalPotassium Gluconate Murray Drug National PharmaceuticalPotassium Gluconate Bell Pharmacal National PharmaceuticalK-Rex C S Ruckstuhl National PharmaceuticalK-G Geneva Generics National PharmaceuticalPotassium Gluconate Goldline Labs Barre-NationalPotassium Gluconate Roxane Labs Roxane LabsPotassium Gluconate Rugby Labs Naska Pharmacal

28 § 25.58 PREVENTION OF DISEASES Pt. III

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Page 135: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

POTASSIUM GLUCONATEElixir—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

My-K My-K Labs My-K LabsPotassium Gluconate LuChem Pharmaceuticals LuChem PharmaceuticalsPotassium Gluconate Pharmaceutical Basics Pharmaceutical Basics

POTASSIUM IODIDESaturated Solution

Potassium Iodide Solution Barre Drug National PharmaceuticalPotassium Iodide Solution Vangard Labs National PharmaceuticalPotassium Iodide Solution Murray Drug National PharmaceuticalPotassium Iodide Sat Soln Rugby Labs National PharmaceuticalSSKI Upsher-Smith Labs Upsher-Smith Labs

POTASSIUM IODIDE/THEOPHYLLINEElixir

Theophylline K-I Barre Drug National PharmaceuticalTheophylline K-I Cooper National PharmaceuticalTheophylline K-I Rugby Labs National PharmaceuticalTheophylline K-I Vangard Labs National PharmaceuticalTheophylline K-I Bioline Labs National PharmaceuticalTheophylline K-I H L Moore Drug Exchange National PharmaceuticalTheophylline K-I Henry Schein National PharmaceuticalTheophylline K-I Murray Drug National PharmaceuticalTheophylline K-I Qualitest National PharmaceuticalAsmicone KI Philpharma Labs National PharmaceuticalTheophylline K-I Rugby Labs Naska PharmacalTheophylline K-I My-K Labs My-K Labs

POVIDONE - IODINEOintment

Povidone - Iodine United Research Labs Clay-Park LabsPovidone - Iodine Thames Pharmacal Thames Pharmacal

POVIDONE - IODINESolution

Povidone - Iodine Thames Pharmacal Thames PharmacalPovidine Solution Barre Drug National PharmaceuticalPovidine Solution ABCO Dealers National PharmaceuticalPovidine Solution Rugby Labs National PharmaceuticalPovidine Solution Henry Schein National PharmaceuticalPovidone - Iodine Vangard Labs National PharmaceuticalSofa - Dine Solution Southern First Aid National PharmaceuticalMedaine Solution Med-Tech National PharmaceuticalPovine AMCO Drug National PharmaceuticalPovidone United Research Labs National PharmaceuticalPovidone Topical Solution Glenlawn Labs National PharmaceuticalPovidine Topical Solution Halsey Drug National PharmaceuticalMallisol Mallard National PharmaceuticalVidine Syncon Pharmaceutical National PharmaceuticalWebadine J A Webster National PharmaceuticalPovidine Bioline Labs National PharmaceuticalPovidine Murray Drug National PharmaceuticalPovidine H L Moore Drug Exchange National PharmaceuticalPovidine Ascot National PharmaceuticalBetagen Goldline Labs National PharmaceuticalPovidone Iodine Camall Co Camall CoPovidine Rugby Labs Camall Co

POVIDONE - IODINESurgical Scrub

Povidine Scrub Barre Drug National PharmaceuticalSofa-Dine Surgical Scrub Southern First Aid Supply National PharmaceuticalPovidine Surgical Scrub Rugby Labs National PharmaceuticalPovidine Surgical Scrub Henry Schein National PharmaceuticalPovidine Surgical Scrub United Research Labs National PharmaceuticalPovidine Surgical Scrub Murray Drug National PharmaceuticalPovidine Surgical Scrub Ascot National PharmaceuticalPovidine Surgical Scrub Bioline Labs National PharmaceuticalPovidine Surgical Scrub H L Moore Drug Exchange National PharmaceuticalPovidine Surgical Scrub Interstate Drug Exchange National PharmaceuticalMallisol Mallard National PharmaceuticalSurgi-Dyne A J Buck & Son National PharmaceuticalPovine Surgical Scrub Amco Drug Products National Pharmaceutical

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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POVIDONE - IODINESurgical Scrub—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Betagen Surgical Scrub Goldline Labs National PharmaceuticalPovidone-Iodine Camall Co Camall CoPovidone-Iodine Thames Pharmacal Thames Pharmacal

PRAZEPAMCapsules

Prazepam Pharmaceutical Basics Pharmaceutical BasicsPrazepam Martec Pharmaceutical Pharmaceutical BasicsPrazepam Best Generics Pharmaceutical Basics

PRAZOSIN HCLCapsules

Prazosin HCl Zenith Labs Zenith Labs

PREDNISOLONE ACETATEOphthalmic Suspension

Pred Mild Allergan Pharmaceutical Allergan PharmaceuticalPred Forte Allergan Pharmaceutical Allergan PharmaceuticalEconopred Alcon Labs Alcon LabsPredulose Optopics Labs Optopics Labs

PREDNISOLONE ACETATE/SULFACETAMIDE SODIUMOphthalmic Ointment

Blephamide SOP Allergan Pharmaceutical Allergan PharmaceuticalCetapred Alcon Labs Alcon LabsPredsulfair Pharmafair Pharmafair

PREDNISOLONE ACETATE/SULFACETAMIDE SODIUMOphthalmic Suspension

Isopto Cetapred Alcon Labs Alcon LabsBlephamide Allergan Pharmaceutical Allergan PharmaceuticalSulpred Pharmafair PharmafairPrednisolone Acetate/

Sulfacetamide Sodium United Research Labs Pharmafair

PREDNISOLONE SODIUM PHOSPHATEInjection

Prednisolone Sodium Phos. Steris Labs Steris Labs

PREDNISOLONE SODIUM PHOSPHATEOphthalmic Solution

Predfair Pharmafair PharmafairPrednisolone Sodium Phosphate United Research Labs Pharmafair

PREDNISONETablets

Deltasone Upjohn Co Upjohn CoOrasone Reid-Rowell Reid-RowellPrednisone Roxane Labs Roxane LabsPrednisone Mutual Pharmaceutical Mutual PharmaceuticalPrednisone United Research Labs Mutual PharmaceuticalPrednisone Private Formulations Private FormulationsPrednisone Duramed Pharmaceuticals Duramed PharmaceuticalsPrednisone Genetco Duramed PharmaceuticalsPrednisone Major Pharmaceutical Corp Duramed PharmaceuticalsPrednisone C S Ruckstuhl Duramed PharmaceuticalsPrednisone H L Moore Drug Exchange Duramed PharmaceuticalsPrednisone Richie Pharmacal Duramed PharmaceuticalsPrednisone American Therapeutics American TherapeuticsPrednisone Cord Labs Cord LabsPrednisone Geneva Generics Cord LabsPrednisone Harber Pharmaceutical American TherapeuticsPrednisone Dixon-Shane American TherapeuticsPrednisone Genetco Mutual PharmaceuticalPrednisone Dixon-Shane Mutual Pharmaceutical

28 § 25.58 PREVENTION OF DISEASES Pt. III

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Page 137: CHAPTER 25. CONTROLLED SUBSTANCES, DRUGS, DEVICES, AND COSMETICS

PREDNISONETablets—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Prednisone Purepac Pharmaceutical Mutual PharmaceuticalPrednisone Best Generics Mutual PharmaceuticalPrednisone Interpharm InterpharmPrednisone West-ward West-wardPrednisone H L Moore Drug Exchange West-wardPrednisone Harber Pharmaceutical West-wardPrednisone Heather Drug Heather DrugPrednisone Danbury Pharmacal Danbury PharmacalPrednisone Purepac Pharmaceutical Purepac PharmaceuticalPrednisone Rugby Labs Chelsea Labs

PRIMIDONETablets

Primidone Bolar Pharmaceutical Bolar PharmaceuticalPrimidone Glenlawn Labs Bolar PharmaceuticalPrimidone Geneva Generics Bolar PharmaceuticalPrimidone Parmed Pharmaceuticals Bolar PharmaceuticalPrimidone Qualitest Bolar PharmaceuticalPrimidone United Research Labs Bolar PharmaceuticalPrimidone Goldline Labs Bolar PharmaceuticalPrimidone Bioline Labs Bolar PharmaceuticalPrimidone Danbury Pharmacal Danbury PharmacalPrimidone Bell Pharmacal Danbury PharmacalPrimidone Geneva Generics Danbury PharmacalPrimidone United Research Labs Danbury PharmacalPrimidone Schein Pharmaceutical Danbury Pharmacal

PROBENECIDTablets

Benemid Merck Sharpe & Dohme Merck Sharpe & DohmeProbalan Lannett LannettProbenecid Mylan Pharmaceuticals Mylan PharmaceuticalsProbenecid Lederle Labs Mylan PharmaceuticalsProbenecid United Research Labs Mylan PharmaceuticalsProbenecid Purepac Pharmaceutical Mylan PharmaceuticalsProbenecid Geneva Generics Mylan PharmaceuticalsProbenecid Interstate Drug Exchange Mylan PharmaceuticalsProbenecid H L Moore Drug Exchange Mylan PharmaceuticalsProbenecid Murray Drug Mylan PharmaceuticalsProbenecid McKesson Labs Mylan PharmaceuticalsProbenecid Stayner Corp Mylan PharmaceuticalsProbenecid Rugby Labs Mylan PharmaceuticalsProbenecid Rexall Drug Mylan PharmaceuticalsProbenecid Bioline Labs Mylan PharmaceuticalsProbenecid Henry Schein Mylan PharmaceuticalsProbenecid Parmed Pharmaceuticals Mylan PharmaceuticalsProbenecid Major Pharmaceutical Corp Mylan PharmaceuticalsProbenecid Genetco Mylan PharmaceuticalsProbenecid Harber Pharmaceutical Mylan PharmaceuticalsSK-Probenecid Smith, Kline & French Mylan PharmaceuticalsProbenecid Danbury Pharmacal Danbury PharmacalProbenecid Interstate Drug Exchange Danbury PharmacalProbenecid Henry Schein Danbury PharmacalProbenecid Bell Pharmacal Danbury PharmacalProbenecid Regal Labs Danbury PharmacalProbenecid McKesson Labs Danbury PharmacalProbenecid Whiteworth Pharmaceuticals Danbury PharmacalProbenecid Qualitest Danbury PharmacalProbenecid Geneva Generics Danbury PharmacalProbenecid Purepac Pharmaceutical Danbury PharmacalProbenecid Rugby Labs Chelsea LabsProbenecid Goldline Labs Mylan Pharmaceuticals

PROCAINAMIDE HCLCapsules

Pronestyl E R Squibb & Sons E R Squibb & SonsProcainamide HCl Bolar Pharmaceutical Bolar PharmaceuticalProcainamide HCl Glenlawn Labs Bolar PharmaceuticalProcainamide HCl Geneva Generics Bolar PharmaceuticalProcainamide HCl Parmed Pharmaceuticals Bolar PharmaceuticalProcainamide HCl Purepac Pharmaceutical Bolar PharmaceuticalProcainamide HCl United Research Labs Bolar PharmaceuticalProcainamide HCl Best Generics Bolar PharmaceuticalProcainamide HCl Mutual Pharmaceutical Bolar PharmaceuticalProcainamide HCl Rugby Labs Chelsea LabsProcainamide HCl Danbury Pharmacal Danbury Pharmacal

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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PROCAINAMIDE HCLCapsules—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Procainamide HCl Lederle Labs Danbury PharmacalProcainamide HCl Bell Pharmacal Danbury PharmacalProcainamide HCl Geneva Generics Danbury PharmacalProcainamide HCl United Research Labs Danbury PharmacalProcainamide HCl Purepac Pharmaceutical Danbury PharmacalProcainamide HCl Zenith Labs Zenith LabsProcainamide HCl Bioline Labs Zenith LabsProcainamide HCl Cooper Zenith LabsProcainamide HCl Gen-King Products Zenith LabsProcainamide HCl Geneva Generics Zenith LabsProcainamide HCl H L Moore Drug Exchange Zenith LabsProcainamide HCl Harber Pharmaceutical Zenith LabsProcainamide HCl Henry Schein Zenith LabsProcainamide HCl Interstate Drug Exchange Zenith LabsProcainamide HCl McKesson Labs Zenith LabsProcainamide HCl Murray Drug Zenith LabsProcainamide HCl Regal Labs Zenith LabsProcainamide HCl United Research Labs Zenith LabsProcainamide HCl Vangard Labs Zenith LabsProcainamide HCl West-ward Zenith LabsProcainamide HCl Whiteworth Pharmaceuticals Zenith LabsProcainamide HCl Qualitest Zenith LabsProcainamide HCl Towne, Paulsen Zenith LabsProcainamide HCl Rugby Labs Zenith LabsProcainamide HCl Goldline Labs Zenith LabsProcainamide HCl Cord Labs Cord LabsProcainamide HCl Geneva Generics Cord Labs

PROCAINE HCLInjection

Procaine HCl Bel-Mar Labs Bel-Mar LabsProcaine HCl Rugby Labs Bel-Mar LabsProcaine HCl Steris Labs Steris LabsProcaine HCl Rugby Labs Steris Labs

PROCHLORPERAZINE EDISYLATEInjection

Prochlorperazine Edisylate Steris Labs Steris Labs

PROCHLORPERAZINE EDISYLATESyrup

Compazine Smith, Kline & French Smith, Kline & French

PROCHLORPERAZINE MALEATETablets

Compazine Smith, Kline & French Smith, Kline & FrenchProchlorperazine Maleate Duramed Pharmaceuticals Duramed Pharmaceuticals

PROMAZINE HCLInjection

Promazine HCl Steris Labs Steris LabsPromazine HCl Schein Pharmaceutical Steris LabsPromazine HCl H L Moore Drug Exchange Steris LabsPromazine HCl Interstate Drug Exchange Steris LabsPromazine HCl Rugby Labs Steris Labs

PROMETHAZINE HCLInjection

Promethazine HCl Knoll Pharmaceutical Knoll PharmaceuticalPromethazine HCl Steris Labs Steris LabsPromethazine HCl Schein Pharmaceutical Steris LabsPromethazine HCl Geneva Generics Steris LabsPromethazine HCl H L Moore Drug Exchange Steris LabsPromethazine HCl Travenol Labs Steris LabsPromethazine HCl Interstate Drug Exchange Steris LabsPromethazine HCl Major Pharmaceutical Corp Steris LabsPromethazine HCl Rugby Labs Steris LabsPromethazine HCl Bioline Labs Steris Labs

28 § 25.58 PREVENTION OF DISEASES Pt. III

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PROMETHAZINE HCLSyrup

Brand Name/Generic Name Distributed By: Manufactured By:

Prometh Barre Drug National PharmaceuticalPromethazine Vangard Labs National PharmaceuticalPromethazine Rugby Labs National PharmaceuticalPromethazine Plain United Research Labs National PharmaceuticalPrometh Plain Goldline Labs Barre-NationalPromethazine Plain My-K Labs My-K LabsPromethazine Plain Life Labs Life Labs

PROPANTHELINE BROMIDETablets

Propantheline Bromide Danbury Pharmacal Danbury PharmacalPropantheline Bromide Henry Schein Danbury PharmacalPropantheline Bromide H L Moore Drug Exchange Danbury PharmacalPropantheline Bromide Interstate Drug Exchange Danbury PharmacalPropantheline Bromide West-ward Danbury PharmacalPropantheline Bromide McKesson Labs Danbury PharmacalPropantheline Bromide Rugby Labs Danbury PharmacalPropantheline Bromide Bell Pharmacal Danbury PharmacalPropantheline Bromide Bioline Labs Danbury PharmacalPropantheline Bromide Glenlawn Labs Danbury PharmacalPropantheline Bromide Towne, Paulsen Danbury PharmacalPropantheline Bromide Purepac Pharmaceutical Danbury PharmacalUni-Prob United Research Labs Danbury PharmacalPropantheline Bromide Richlyn Labs Richlyn LabsPropantheline Bromide H R Cenci Labs Richlyn LabsPropantheline Bromide Interstate Drug Exchange Richlyn LabsPropantheline Bromide Glenlawn Labs Richlyn LabsPropantheline Bromide Ronda Pharmacal Richlyn LabsPropantheline Bromide Towne, Paulsen Richlyn LabsPropantheline Bromide Whiteworth Pharmaceuticals Richlyn LabsNorpanth North American Pharmacal Richlyn LabsPropantheline Bromide Roxane Labs Roxane LabsSK-Propantheline Bromide Smith, Kline & French Roxane LabsPropantheline Bromide Par Pharmaceutical Par Pharmaceutical

PROPARACAINE HCLOphthalmic Solution

Opthaine E R Squibb & Sons E R Squibb & SonsOpthetic Allergan Pharmaceutical Allergan PharmaceuticalAlcaine Alcon Labs Alcon LabsKainair Pharmafair Pharmafair

PROPOXYPHENE HCLCapsules

Dolene Lederle Labs Lederle LabsSK-65 Smith, Kline & French Smith, Kline & FrenchPropoxyphene HCl Zenith Labs Zenith LabsVandar Vangard Labs Zenith LabsPropoxyphene HCl United Research Labs Zenith LabsPropoxyphene HCl H L Moore Drug Exchange Zenith LabsPropoxyphene HCl Towne, Paulsen Zenith LabsPropoxyphene HCl Qualitest Zenith LabsPropoxyphene HCl Regal Labs Zenith LabsPropoxyphene HCl Bioline Labs Zenith LabsPropoxyphene HCl Gen-King Products Zenith LabsPropoxyphene HCl Goldline Labs Zenith LabsPropoxyphene HCl Parke-Davis Parke-DavisPropoxyphene HCl Purepac Pharmaceutical Purepac PharmaceuticalPropoxyphene HCl Richlyn Labs Richlyn LabsPropoxyphene HCl Dixon-Shane Richlyn LabsPropoxyphene HCl Grofton Pharmaceutical Richlyn LabsPropoxyphene HCl Interstate Drug Exchange Richlyn LabsPropoxyphene HCl Henry Schein Richlyn LabsPropoxyphene HCl Geneva Generics Richlyn LabsPropoxyphene HCl Glenlawn Labs Richlyn LabsProphene Halsey Drug Richlyn LabsDoraphen HCl H R Cenci Labs Richlyn LabsPropoxyphene HCl Rugby Labs Chelsea LabsPropoxyphene HCl ICN Pharmaceuticals ICN PharmaceuticalsPropoxyphene HCl Mylan Pharmaceuticals Mylan PharmaceuticalsPropoxyphene HCl Walgreen Mylan PharmaceuticalsPropoxyphene HCl Towne, Paulsen Mylan PharmaceuticalsPropoxyphene HCl United Research Labs Mylan PharmaceuticalsPropoxyphene HCl Bell Pharmacal Mylan PharmaceuticalsPropoxyphene HCl E R Squibb & Sons Mylan PharmaceuticalsPropoxyphene HCl Skaggs Co Mylan Pharmaceuticals

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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PROPOXYPHENE HCLCapsules—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Propoxyphene HCl Thrift Drug Mylan PharmaceuticalsPropoxyphene HCl West-ward West-wardPropoxyphene HCl Interstate Drug Exchange West-wardPropoxyphene HCl H L Moore Drug Exchange West-wardPropoxyphene HCl Whiteworth Pharmaceuticals West-wardPropoxyphene HCl Henry Schein West-wardProphene Halsey Drug Halsey DrugPropoxyphene HCl Qualitest Halsey DrugPropoxyphene HCl Geneva Generics Cord LabsPropoxyphene HCl Lemmon Co Lemmon CoPropoxyphene HCl Interstate Drug Exchange Lemmon CoPropoxyphene HCl United Research Labs Lemmon Co

PROPRANOLOL HCLSolution

Propranolol HCl Pharmaceutical Basics Pharmaceutical Basics

PROPRANOLOL HCLTablets

Propranolol HCl Rugby Labs Chelsea LabsPropranolol HCl Bioline Labs Chelsea LabsPropranolol HCl Duramed Pharmaceuticals Duramed PharmaceuticalsPropranolol HCl Purepac Pharmaceutical Duramed PharmaceuticalsPropranolol HCl Qualitest Duramed PharmaceuticalsPropranolol HCl Richie Pharmacal Duramed PharmaceuticalsPropranolol HCl United Research Labs Duramed PharmaceuticalsPropranolol HCl Geneva Generics Duramed PharmaceuticalsPropranolol HCl H & H Labs Duramed PharmaceuticalsPropranolol HCl Parmed Pharmaceuticals Duramed PharmaceuticalsPropranolol HCl Towne, Paulsen Duramed PharmaceuticalsPropranolol HCl Texas Drug Reps Duramed PharmaceuticalsPropranolol HCl Zenith Labs Schering CorpPropranolol HCl Glenlawn Labs Schering CorpPropranolol HCl Interstate Drug Exchange Schering CorpPropranolol HCl Major Pharmaceutical Corp Schering CorpPropranolol HCl H L Moore Drug Exchange Schering CorpPropranolol HCl Regal Labs Schering CorpPropranolol HCl Henry Schein Schering CorpPropranolol HCl United Research Labs Schering CorpPropranolol HCl Watson Labs Watson LabsPropranolol HCl Mylan Pharmaceuticals Mylan PharmaceuticalsPropranolol HCl Genetco Mylan PharmaceuticalsPropranolol HCl Lemmon Co Mylan PharmaceuticalsPropranolol HCl Danbury Pharmacal Danbury PharmacalPropranolol HCl Barr Labs Barr LabsPropranolol HCl Lemmon Co Mylan PharmaceuticalsPropranolol HCl Interstate Drug Exchange Mylan PharmaceuticalsPropranolol HCl Martec Pharmaceutical Schering CorpPropranolol HCl Par Pharmaceutical Par PharmaceuticalPropranolol HCl Purepac Pharmaceutical Purepac PharmaceuticalPropranolol HCl Cord Labs Cord LabsPropranolol HCl Geneva Generics Cord LabsPropranolol HCl Interpharm InterpharmPropranolol HCl Lederle Labs Lederle LabsPropranolol HCl Bolar Pharmaceutical Bolar PharmaceuticalPropranolol HCl Lemmon Co Lemmon CoPropranolol HCl Superpharm Corp Superpharm CorpPropranolol HCl Goldline Labs Superpharm CorpPropranolol HCl Bioline Labs Superpharm CorpPropranolol HCl United Research Labs Superpharm CorpPropranolol HCl Roxane Labs Roxane LabsPropranolol HCl Sidmak Labs Sidmak Labs

PSEUDOEPHEDRINE HCLSyrup

Sudafed Burroughs-Wellcome Burroughs-WellcomeDecofed Barre Drug National PharmaceuticalPseudoephedrine HCl Rugby Labs National PharmaceuticalPseudoephedrine HCl Henry Schein National PharmaceuticalPseudoephedrine HCl Vangard Labs National PharmaceuticalPseudoephedrine HCl Lederle Labs National PharmaceuticalPseudoephedrine HCl Geneva Generics National PharmaceuticalPseudoephedrine HCl Glenlawn Labs National PharmaceuticalPseudoephedrine HCl Bioline Labs National PharmaceuticalPseudoephedrine HCl Interstate Drug Exchange National PharmaceuticalPseudoephedrine HCl Richie Pharmacal National Pharmaceutical

28 § 25.58 PREVENTION OF DISEASES Pt. III

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PSEUDOEPHEDRINE HCLSyrup—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Pseudoephedrine HCl Qualitest National PharmaceuticalPharm-A-Fed Peoples Drug National PharmaceuticalUni-sed United Research Labs National PharmaceuticalPseudoephedrine HCl Life Labs Life LabsPseudoephedrine HCl Halsey Drug Halsey DrugPseudoephedrine HCl Rugby Labs Halsey DrugPseudoephedrine HCl Rugby Labs Naska PharmacalMyfedrine My-K Labs My-K LabsSuperfed Thames Pharmacal Thames PharmacalPseudoephedrine HCl Goldline Labs Barre-NationalMyfedrine Pediatric Pharmaceutical Basics Pharmaceutical Basics

PSEUDOEPHEDRINE HCLTablets

Sudafed Burroughs-Wellcome Burroughs-WellcomeNovafed Dow Pharmaceutical KV PharmaceuticalPseudoephedrine HCl H L Moore Drug Exchange Bolar PharmaceuticalPseudoephedrine HCl Bioline Labs Bolar PharmaceuticalPseudoephedrine HCl Vita-Rx Bolar PharmaceuticalPseudoephedrine HCl H R Cenci Labs Bolar PharmaceuticalPseudoephedrine HCl Gen-King Products Bolar PharmaceuticalPseudoephedrine HCl Rugby Labs Bolar PharmaceuticalPseudoephedrine HCl Richlyn Labs Richlyn LabsPseudoephedrine HCl Columbia Medical Richlyn LabsPseudoephedrine HCl Rugby Labs Richlyn LabsPseudoephedrine HCl Danbury Pharmacal Danbury PharmacalPseudoephedrine HCl United Research Labs Danbury PharmacalPseudoephedrine HCl Bell Pharmacal Danbury PharmacalPseudoephedrine HCl Qualitest Danbury PharmacalPseudoephedrine HCl Henry Schein Danbury PharmacalPseudoephedrine HCl Geneva Generics Danbury PharmacalPseudoephedrine HCl West-ward West-wardPseudoephedrine HCl Interstate Drug Exchange West-wardPseudoephedrine HCl Regal Labs West-wardPseudoephedrine HCl Rugby Labs Chelsea LabsPseudoephedrine HCl Par Pharmaceutical Par PharmaceuticalPseudoephedrine HCl H L Moore Drug Exchange Par PharmaceuticalPseudoephedrine HCl Henry Schein Par PharmaceuticalPseudoephedrine HCl Vangard Labs Par PharmaceuticalPseudoephedrine HCl Towne, Paulsen Par PharmaceuticalPseudoephedrine HCl American Pharmaceutical Par PharmaceuticalPseudoephedrine HCl Whiteworth Pharmaceuticals Par PharmaceuticalPseudoephedrine HCl United Research Labs Par PharmaceuticalPseudoephedrine HCl Regal Labs Par PharmaceuticalPseudoephedrine HCl Ronda Pharmacal Par PharmaceuticalPseudoephedrine HCl Geneva Generics Cord LabsPseudoephedrine HCl Halsey Drug Halsey DrugPseudoephedrine HCl Glenlawn Labs Halsey DrugPseudoephedrine HCl Bioline Labs Halsey DrugPseudoephedrine HCl Henry Schein Halsey DrugPseudoephedrine HCl Pharmaceutical Services Halsey DrugPseudoephedrine HCl Amide Pharmaceutical Amide PharmaceuticalPseudoephedrine HCl Superpharm Corp Superpharm CorpPseudoephedrine HCl Goldline Labs Superpharm CorpPseudoephedrine HCl Lemmon Co Lemmon CoNasal Decongestant Rugby Labs Lemmon CoPentafed Decongestant Penta Products Lemmon CoAllerfed Long Drug Stores Lemmon CoSudagest Major Pharmaceutical Corp Lemmon CoDecongestant American Therapeutics American TherapeuticsPseudoephedrine HCl United Research Labs Ohm LabsPseudoephedrine HCl Ascot American TherapeuticsCongestion Relief Schein Pharmaceutical American Therapeutics

PSEUDOEPHEDRINE HCL/TRIPROLIDINE HCLSyrup

Actifed Burroughs-Wellcome Burroughs-WellcomeTriposed Halsey Drug Halsey DrugTriofed Barre Drug National PharmaceuticalTriofed United Research Labs National PharmaceuticalTriofed Henry Schein National PharmaceuticalTriofed H L Moore Drug Exchange National PharmaceuticalIsocap Cooper National PharmaceuticalUnifed United Research Labs National PharmaceuticalTriacin Glenlawn Labs National PharmaceuticalTriacin Bioline Labs National PharmaceuticalAllerfrin OTC Rugby Labs National Pharmaceutical

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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PSEUDOEPHEDRINE HCL/TRIPROLIDINE HCLSyrup—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Valuphed H L Moore Drug Exchange National PharmaceuticalTriprolidine HCl and Pseudoephedrine

HCl Purepac Pharmaceutical National PharmaceuticalTriprolidine HCl and Pseudoephedrine

HCl Pharmafair PharmafairMyfed My-K Labs My-K LabsHistafed Life Labs Life LabsActagen Goldline Labs Barre-NationalTriprolidine HCl &

Pseudoephedrine HCl H R Cenci Labs H R Cenci LabsTriprolidine HCl &

Pseudoephedrine HCl Ascot American TherapeuticsTriprolidine and

Pseudoephedrine HCl Pharmaceutical Basics Pharmaceutical Basics

PSEUDOEPHEDRINE HCL/TRIPROLIDINE HCLTablets

Actifed Burroughs-Wellcome Burroughs-WellcomeAllerfrin Rugby Labs Chelsea LabsTriposed Halsey Drug Halsey DrugTriprodrine Danbury Pharmacal Danbury PharmacalTriprolidine HCl/Pseudoephedrine HCl Bell Pharmacal Danbury PharmacalTriprolidine HCl/Pseudoephedrine HCl Zenith Labs Zenith LabsTriprolidine w/Pseudoephedrine Dixon-Shane West-wardActamine H L Moore Drug Exchange West-wardTherafed American Therapeutics American TherapeuticsAllerfed Private Formulations Private FormulationsTrilitron Newtron Pharmaceuticals Newtron PharmaceuticalsUni-Fed United Research Labs Newtron PharmaceuticalsTriafed Schein Pharmaceutical West-wardAllergy Cold Tablets Geneva Generics Cord Labs

PYRIDOXINE HCLInjection

Pyridoxine HCl Steris Labs Steris LabsPyridoxine HCl Bioline Labs Steris LabsPyridoxine HCl Rugby Labs Steris LabsPyridoxine HCl Purepac Pharmaceutical Steris LabsPyridoxine HCl H L Moore Drug Exchange Steris LabsPyridoxine HCl Major Pharmaceutical Corp Steris LabsPyridoxine HCl Towne, Paulsen Steris LabsVitamin B6 Schein Pharmaceutical Steris Labs

PYRIDOXINE HCLTablets

Pyridoxine HCl Richlyn Labs Richlyn LabsPyridoxine HCl West-ward West-wardPyridoxine HCl Lederle Labs KV PharmaceuticalVitamin B-6 Contract Pharmacal Contract PharmacalVitamin B-6 United Research Labs Contract PharmacalVitamin B-6 Geneva Generics FreshlabsVitamin B-6 Bowman Pharmaceuticals Bowman PharmaceuticalsVitamin B-6 United Research Labs Bowman Pharmaceuticals

PYRILAMINE MALEATETablets

Pyrilamine Maleate Rugby Labs Chelsea Labs

QUINIDINE SULFATETablets

Cin-Quin Reid-Rowell Reid-RowellQuinidine Sulfate Danbury Pharmacal Danbury PharmacalQuinidine Sulfate Rugby Labs Danbury PharmacalQuinidine Sulfate H L Moore Drug Exchange Danbury PharmacalQuinidine Sulfate United Research Labs Danbury PharmacalQuinidine Sulfate Interstate Drug Exchange Danbury PharmacalQuinidine Sulfate Henry Schein Danbury PharmacalQuinidine Sulfate McKesson Labs Danbury PharmacalQuinidine Sulfate Geneva Generics Danbury PharmacalQuinidine Sulfate Bell Pharmacal Danbury PharmacalQuinidine Sulfate Glenlawn Labs Danbury PharmacalQuinidine Sulfate Skaggs Co Danbury Pharmacal

28 § 25.58 PREVENTION OF DISEASES Pt. III

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QUINIDINE SULFATETablets—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Quinidine Sulfate Whiteworth Pharmaceuticals Danbury PharmacalQuinidine Sulfate Parmed Pharmaceuticals Danbury PharmacalQuinidine Sulfate Qualitest Danbury PharmacalQuinidine Sulfate Parke-Davis Parke-DavisQuinidine Sulfate Purepac Pharmaceutical Purepac PharmaceuticalQuinidine Sulfate Richlyn Labs Richlyn LabsQuinidine Sulfate Cooper Richlyn LabsQuinidine Sulfate Parmed Pharmaceuticals Richlyn LabsQuinidine Sulfate C S Ruckstuhl Richlyn LabsQuinidine Sulfate Gen-King Products Richlyn LabsQuinidine Sulfate Glenlawn Labs Richlyn LabsQuinidine Sulfate Interstate Drug Exchange Richlyn LabsQuinidine Sulfate West-ward West-wardQuinidine Sulfate H L Moore Drug Exchange West-wardQuinidine Sulfate Euclid Pharmaceutical West-wardQuinidine Sulfate Lannett LannettQuinidine Sulfate Roxane Labs Roxane LabsSK-Quinidine Sulfate Smith, Kline & French Roxane LabsQuinidine Sulfate Halsey Drug Halsey DrugQuinidine Sulfate Glenlawn Labs Halsey DrugQuinidine Sulfate Interstate Drug Exchange Halsey DrugQuinidine Sulfate Rugby Labs Chelsea LabsQuinidine Sulfate Barr Labs Barr LabsQuinidine Sulfate ICN Pharmaceuticals ICN PharmaceuticalsQuinidine Sulfate Zenith Labs Zenith LabsQuinidine Sulfate United Research Labs Zenith LabsQuinidine Sulfate Glenlawn Labs Zenith LabsQuinidine Sulfate Interstate Drug Exchange Zenith LabsQuinidine Sulfate Parmed Pharmaeuticals Zenith LabsQuinidine Sulfate Lederle Labs Lederle LabsQuinidine Sulfate United Research Labs Mutual PharmaceuticalQuinidine Sulfate Geneva Generics Cord Labs

QUININE SULFATECapsules

Quine Reid-Rowell Reid-RowellQuinine Sulfate ICN Pharmaceuticals ICN PharmaceuticalsQuinine Sulfate Towne, Paulsen Towne, PaulsenQuinine Sulfate Parmed Pharmaceuticals Towne, PaulsenQuinine Sulfate Danbury Pharmacal Danbury PharmacalQuinine Sulfate Interstate Drug Exchange Danbury PharmacalQuinine Sulfate United Research Labs Danbury PharmacalQuinine Sulfate Bell Pharmacal Danbury PharmacalQuinine Sulfate Geneva Generics Danbury PharmacalQuinine Sulfate Richlyn Labs Richlyn LabsQuinine Sulfate Interstate Drug Exchange Richlyn LabsQuinine Sulfate American Pharmaceutical Richlyn LabsQuinine Sulfate Gen-King Products Richlyn LabsQuinine Sulfate Zenith Labs Zenith LabsQuinine Sulfate Cooper Zenith LabsQuinine Sulfate H L Moore Drug Exchange Zenith LabsQuinine Sulfate Regal Labs Zenith LabsQuinine Sulfate Geneva Generics Zenith LabsQuinine Sulfate Murray Drug Zenith LabsQuinine Sulfate Gen-King Products Zenith LabsQuinine Sulfate Glenlawn Labs Zenith LabsQuinine Sulfate Qualitest Zenith LabsQuinine Sulfate United Research Labs Zenith LabsQuinine Sulfate Major Pharmaceutical Corp Zenith LabsQuinine Sulfate Parke-Davis Parke-DavisQuinine Sulfate Purepac Pharmaceutical Purepac PharmaceuticalQuinine Sulfate Geneva Generics KalipharmaQuinine Sulfate Rugby Labs Chelsea LabsQuinine Sulfate West-ward West-wardQuinine Sulfate H L Moore Drug Exchange West-wardQuinine Sulfate LuChem Pharmaceuticals LuChem PharmaceuticalsQuinine Sulfate Halsey Drug Halsey DrugQuinine Sulfate Goldline Labs Halsey DrugQuinine Sulfate Gen-King Products Halsey DrugQuinine Sulfate Bioline Labs Halsey DrugQuinine Sulfate Qualitest Halsey Drug

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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QUININE SULFATECapsules—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Quinine Sulfate Mutual Pharmaceutical Mutual PharmaceuticalQuinine Sulfate United Research Labs Mutual PharmaceuticalQuinine Sulfate Vita-Rx Mutual PharmaceuticalQuinine Sulfate Genetco Mutual PharmaceuticalQuinine Sulfate Geneva Generics Cord Labs

QUININE SULFATETablets

Quinine Sulfate Bolar Pharmaceutical Bolar PharmaceuticalQuinine Sulfate Best Generics Bolar PharmaceuticalQuinine Sulfate American Therapeutics American TherapeuticsQuinine Sulfate Parmed Pharmaceuticals American TherapeuticsQuinine Sulfate LuChem Pharmaceuticals LuChem PharmaceuticalsQuinine Sulfate United Research Labs American TherapeuticsQuinine Sulfate Mutual Pharmaceutical American TherapeuticsQuinine Sulfate H L Moore Drug Exchange American TherapeuticsQuinine Sulfate Harber Pharmaceutical American TherapeuticsQuinlan Danbury Pharmacal Danbury PharmacalQuinine Sulfate Geneva Generics Cord Labs

SCOPOLAMINE HBROphthalmic Solution

Scopolamine Allergan Pharmaceutical Allergan PharmaceuticalIsopto Hyoscine Alcon Labs Alcon Labs

SECOBARBITAL SODIUMCapsules

Secobarbital Sodium Rugby Labs Chelsea LabsSecobarbital Sodium Halsey Drug Halsey DrugSecobarbital Sodium Interstate Drug Exchange Halsey DrugSecobarbital Sodium Rugby Labs Halsey DrugSecobarbital Sodium Henry Schein Halsey DrugSecobarbital Sodium Lannett Lannett

SELENIUM SULFIDELotion

Selsun Abbott Labs Abbott LabsSelenium Sulfide Barre Drug National PharmaceuticalSelenium Sulfide Interstate Drug Exchange National PharmaceuticalSelenium Sulfide Rugby Labs National PharmaceuticalSelenium Sulfide Vangard Labs National PharmaceuticalSelenium Sulfide Henry Schein National PharmaceuticalSelenium Sulfide United Research Labs National PharmaceuticalSelenium Sulfide Towne, Paulsen National PharmaceuticalSelenium Sulfide Whiteworth Pharmaceuticals National PharmaceuticalSelenium Sulfide Murray Drug National PharmaceuticalSelenium Sulfide Bioline Labs National PharmaceuticalSelenium Sulfide H L Moore Drug Exchange National PharmaceuticalSelenium Sulfide Bell Pharmacal National PharmaceuticalSelenium Sulfide Geneva Generics National PharmaceuticalSelenium Sulfide My-K Labs My-K LabsSelenium Sulfide Thames Pharmacal Thames PharmacalExsel Herbert Labs Allergan PharmaceuticalSelenium Sulfide Pharmaceutical Basics Pharmaceutical Basics

SIMETHICONETablets

Silain A H Robins A H Robins

SODIUM AMINOBENZOATE/SODIUM SALICYLATETablets

Pabalate A H Robins A H Robins

28 § 25.58 PREVENTION OF DISEASES Pt. III

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SODIUM BICARBONATETablets

Brand Name/Generic Name Distributed By: Manufactured By:

Sodium Bicarbonate Richlyn Labs Richlyn LabsSodium Bicarbonate Vale Chemical Vale ChemicalSodium Bicarbonate Rugby Labs Vale Chemical

SODIUM FLUORIDESolution

Flura-Drops Kirkman Labs Kirkman LabsFluoritab Liquid Fluoritab Corp PMI Labs

SODIUM FLUORIDETablets

Flura-Tabs Kirkman Labs Kirkman LabsFluoritab Fluoritab Corp PMI LabsSodium Fluoride Richlyn Labs Richlyn LabsSodium Fluoride Rugby Labs Chelsea LabsSodium Fluoride Copley Pharmaceutical Copley PharmaceuticalSodium Fluoride Boots Labs Boots LabsSodium Fluoride United Research Labs Boots LabsSodium Fluoride Henry Schein Boots LabsSodium Fluoride Rugby Labs Boots LabsSodium Fluoride Bioline Labs Boots LabsSodium Fluoride Geneva Generics Boots LabsSodium Fluoride Bowman Pharmaceuticals Bowman PharmaceuticalsSodium Fluoride United Research Labs Bowman Pharmaceuticals

SODIUM POLYSTYRENE SULFONATEPowder

Sodium Polystyrene Sulfonate My-K Labs My-K Labs

SODIUM POLYSTYRENE SULFONATESuspension

Sodium Polystyrene Sulfonate My-K Labs My-K Labs

SPIRONOLACTONETablets

Spironolactone Bolar Pharmaceutical Bolar PharmaceuticalSpironolactone H L Moore Drug Exchange Bolar PharmaceuticalSpironolactone Rugby Labs Bolar PharmaceuticalSpironolactone Towne, Paulsen Bolar PharmaceuticalSpironolactone Vangard Labs Bolar PharmaceuticalSpironolactone United Research Labs Bolar PharmaceuticalSpironolactone Purepac Pharmaceutical Bolar PharmaceuticalSpironolactone Gen-King Products Bolar PharmaceuticalSpironolactone Ronda Pharmacal Bolar PharmaceuticalSpironolactone Interstate Drug Exchange Bolar PharmaceuticalSpironolactone Glenlawn Labs Bolar PharmaceuticalSpironolactone Murray Drug Bolar PharmaceuticalSpironolactone Coast Labs Bolar PharmaceuticalSpironolactone Bioline Labs Bolar PharmaceuticalSpironolactone Stayner Corp Bolar PharmaceuticalSpironolactone Henry Schein Bolar PharmaceuticalSpironolactone Cooper Bolar PharmaceuticalSpironolactone Geneva Generics Bolar PharmaceuticalSpironolactone Richie Pharmacal Bolar PharmaceuticalSpironolactone Bell Pharmacal Bolar PharmaceuticalSpironolactone Parmed Pharmaceuticals Bolar PharmaceuticalSpironolactone Qualitest Bolar PharmaceuticalSpironolactone Best Generics Bolar PharmaceuticalSpironolactone Goldline Labs Bolar PharmaceuticalSpironolactone Mylan Pharmaceuticals Mylan PharmaceuticalsSpironolactone United Research Labs Mylan PharmaceuticalsSpironolactone Lederle Labs Mylan PharmaceuticalsSpironolactone H L Moore Drug Exchange Mylan PharmaceuticalsSpironolactone Purepac Pharmaceutical Mylan PharmaceuticalsSpironolactone Geneva Generics Mylan PharmaceuticalsSpironolactone Bioline Labs Mylan PharmaceuticalsSpironolactone Rugby Labs Chelsea LabsSpironolactone Bioline Labs Zenith LabsSpironolactone Glenlawn Labs Zenith LabsSpironolactone Cooper Zenith LabsSpironolactone Henry Schein Zenith LabsSpironolactone Regal Labs Zenith Labs

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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SPIRONOLACTONETablets—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Spironolactone Gen-King Products Zenith LabsSpironolactone Parmed Pharmaceuticals Zenith LabsSpironolactone Interstate Drug Exchange Zenith LabsSpironolactone Vangard Labs Zenith LabsSpironolactone H L Moore Drug Exchange Zenith LabsSpironolactone Murray Drug Zenith LabsSpironolactone Cooper Zenith LabsSpironolactone Williams Generics Zenith LabsSpironolactone Towne, Paulsen Zenith LabsSpironolactone Cord Labs Cord LabsSpironolactone Geneva Generics Cord LabsSpironolactone Purepac Pharmaceutical Purepac PharmaceuticalSpironolactone Mutual Pharmaceutical Mutual PharmaceuticalSpironolactone United Research Labs Mutual PharmaceuticalSpironolactone Superpharm Corp Superpharm CorpSpironolactone Goldline Labs Superpharm CorpSpironolactone Genetco Mutual PharmaceuticalSpironolactone Dixon-Shane Mutual PharmaceuticalSpironolactone Towne, Paulsen Mutual PharmaceuticalSpironolactone Goldline Labs Mutual PharmaceuticalSpironolactone Bioline Labs Mutual PharmaceuticalSpironolactone Warner-Chilcott Mutual PharmaceuticalSpironolactone Barr Labs Barr LabsSpironolactone Towne, Paulsen Barr LabsSpironolactone General Generics Barr Labs

SULFACETAMIDE SODIUMOphthalmic Ointment

Cetamide Alcon Labs Alcon LabsSulfair Pharmafair PharmafairSulfacetamide Sodium United Research Labs PharmafairSulfacetamide Sodium E Fougera AltanaSulfacetamide Sodium Pharmaderm Altana

SULFACETAMIDE SODIUMOphthalmic Solution

Isopto Cetamide Alcon Labs Alcon LabsBleph Liquifilm Allergan Pharmaceutical Allergan PharmaceuticalOcusulf Optopics Labs Optopics LabsSulfair Pharmafair PharmafairSodium Sulfacetamide Geneva Generics PharmafairSulfacetamide Sodium United Research Labs PharmafairSulfacetamide Sodium Steris Labs Steris Labs

SULFACETAMIDE/SULFABENZAMIDE/SULFATHIAZOLE/UREAVaginal Cream

Sulnac NMC Labs NMC LabsTriple Sulfa Geneva Generics NMC LabsTriple Sulfa Clay-Park Labs Clay-Park LabsTriple Sulfa Rugby Labs Clay-Park LabsTriple Sulfa Gen-King Products Clay-Park LabsTriple Sulfa J J Balan Clay-Park LabsTriple Sulfa United Research Labs Clay-Park LabsTriple Sulfa Regal Labs Clay-Park LabsTriple Sulfa Interstate Drug Exchange Clay-Park LabsTriple Sulfa Henry Schein Clay-Park LabsTriple Sulfa Bioline Labs Clay-Park LabsTriple Sulfa Vangard Labs Clay-Park LabsTriple Sulfa Qualitest Clay-Park LabsTriple Sulfa Goldline Labs Clay-Park LabsTriple Sulfa E Fougera AltanaTriple Sulfa Pharmaderm AltanaVagilia Lemmon Co Lemmon CoGyne-Sulf G & W Labs G & W Labs

SULFAMETHOXAZOLETablets

Gantanol Roche RocheSulfamethoxazole Bolar Pharmaceutical Bolar PharmaceuticalSulfamethoxazole Glenlawn Labs Bolar PharmaceuticalSulfamethoxazole Qualitest Bolar PharmaceuticalSulfamethoxazole Purepac Pharmaceutical Bolar PharmaceuticalSulfamethoxazole Heather Drug Heather DrugSulfamethoxazole Bioline Labs Heather Drug

28 § 25.58 PREVENTION OF DISEASES Pt. III

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SULFAMETHOXAZOLETablets—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Sulfamethoxazole United Research Labs Heather DrugSulfamethoxazole Rugby Labs Heather DrugSulfamethoxazole Goldline Labs Heather Drug

SULFAMETHOXAZOLE/TRIMETHOPRIMConcentrate for Injection

COTRIM I. V. Infusion Lemmon Co Lemmon Co

SULFAMETHOXAZOLE/TRIMETHOPRIMSuspension

Bactrim Roche RocheSeptra Burroughs-Wellcome Burroughs-WellcomeSulfatrim Barre Drug National PharmaceuticalSulfatrim H L Moore Drug Exchange National PharmaceuticalSulfatrim United Research Labs National PharmaceuticalSulfatrim Harber Pharmaceutical National PharmaceuticalSulfatrim Parmed Pharmaceuticals National PharmaceuticalSulfatrim Bioline Labs National PharmaceuticalSulfatrim Clark Surgical Corp National PharmaceuticalSulfatrim Henry Schein National PharmaceuticalSulfatrim Qualitest National PharmaceuticalSulfatrim Goldline Labs Barre-NationalCotrim Pediatric Lemmon Co National PharmaceuticalSulfatrim Pediatric Bell Pharmacal National PharmaceuticalBethaprim Major Pharmaceutical Corp National PharmaceuticalTrimeth/Sulfa Rugby Labs National PharmaceuticalSulfamethoxazole and Trimethoprim Lederle Labs National PharmaceuticalSulfamethoxazole and Trimethoprim Geneva Generics National PharmaceuticalSMZ-TMP Pediatric Biocraft Labs Biocraft LabsSMZ-TMP Pediatric Rugby Labs Biocraft LabsSMZ-TMP Pediatric Purepac Pharmaceutical Biocraft LabsSulmeprim My-K Labs My-K LabsCotrim Pediatric Lemmon Co Teva PharmaceuticalSulfamethoxazole and Trimethoprim D-M Pharmaceuticals Teva PharmaceuticalTrimeth/Sulfa Rugby Labs Naska Pharmacal

SULFAMETHOXAZOLE/TRIMETHOPRIMTablets

Bactrim Roche RocheSeptra Burroughs-Wellcome Burroughs-WellcomeSMZ-TMP Biocraft BiocraftSMZ-TMP Interstate Drug Exchange BiocraftSMZ-TMP H L Moore Drug Exchange BiocraftSMZ-TMP E R Squibb & Sons BiocraftSMZ-TMP Henry Schein BiocraftSMZ-TMP Rugby Labs BiocraftSMZ-TMP Skaggs Co BiocraftSMZ-TMP Whiteworth Pharmaceuticals BiocraftSMZ-TMP Purepac Pharmaceutical BiocraftSulfoxaprim Bioline Labs BiocraftCotrim Lemmon Co Lemmon CoTrimeth/Sulfa Rugby Labs Lemmon CoBethaprim Major Pharmaceutical Corp Lemmon CoSulfa-Trimethoprim Interstate Drug Exchange Lemmon CoSulfamethoxazole & Trimethoprim Parmed Pharmaceuticals Lemmon CoSulfamethoxazole & Trimethoprim D-M Pharmaceuticals Lemmon CoSulfamethoxazole & Trimethoprim United Research Labs Lemmon CoSulfamethoxazole & Trimethoprim Towne, Paulsen Lemmon CoSulfamethoxazole & Trimethoprim Danbury Pharmacal Danbury PharmacalSulfamethoxazole & Trimethoprim Bell Pharmacal Danbury PharmacalSulfamethoxazole & Trimethoprim Parmed Pharmaceuticals Danbury PharmacalSulfamethoxazole & Trimethoprim Geneva Generics Danbury PharmacalSulfamethoxazole & Trimethoprim Qualitest Danbury PharmacalSulfamethoxazole & Trimethoprim Purepac Pharmaceutical Danbury PharmacalSulfamethoxazole & Trimethoprim Vitarine Pharmaceutical Vitarine PharmaceuticalSulfamethoxazole & Trimethoprim Citation Labs Vitarine PharmaceuticalSulfamethoxazole & Trimethoprim Sidmak Labs Sidmak LabsSulfamethoxazole & Trimethoprim Dixon-Shane Sidmak LabsSulfamethoxazole & Trimethoprim Parmed Pharmaceuticals Sidmak LabsSulfamethoxazole & Trimethoprim Mutual Pharmaceutical Mutual PharmaceuticalTrimeth/Sulfa Rugby Labs Chelsea LabsSulfatrim Superpharm Corp Superpharm CorpSulfatrim Goldline Labs Superpharm CorpSulfoxaprim Bioline Labs Superpharm CorpSulfamethoprim Par Pharmaceutical Par PharmaceuticalSulfamethoxazole and Trimethoprim Martec Pharmaceutical Par Pharmaceutical

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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SULFAMETHOXAZOLE/TRIMETHOPRIMTablets–Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Sulfamethoxazole and Trimethoprim United Research Labs Mutual PharmaceuticalSulfamethoxazole and Trimethoprim Purepac Pharmaceutical Mutual PharmaceuticalSulfamethoxazole and Trimethoprim Vita-Rx Mutual PharmaceuticalSulfamethoxazole and Trimethoprim Genetco Mutual PharmaceuticalSulfamethoxazole and Trimethoprim Towne, Paulsen Mutual PharmaceuticalSulfamethoxazole and Trimethoprim J J Balan Mutual PharmaceuticalSulfamethoxazole and Trimethoprim Barr Labs Barr LabsSulfamethoxazole and Trimethoprim Purepac Pharmaceutical Barr LabsSulfamethoxazole and Trimethoprim J J Balan Barr LabsSulfamethoxazole and Trimethoprim Interpharm InterpharmSulfamethoxazole and Trimethoprim Pharmaceutical Basics Pharmaceutical BasicsSulfamethoxazole and Trimethoprim Best Generics Pharmaceutical BasicsSulfamethoxazole and Trimethoprim Cord Labs Cord LabsSulfamethoxazole and Trimethoprim Geneva Generics Cord LabsSulfamethoxazole and Trimethoprim Heather Drug Heather DrugSulfamethoxazole and Trimethoprim Harber Pharmaceutical Heather DrugSulfamethoxazole and Trimethoprim Parmed Pharmaceuticals Heather DrugSulfamethoxazole and Trimethoprim Texas Drug Reps Heather DrugSulfamethoxazole and Trimethoprim Genetco Heather DrugSulfamethoxazole and Trimethoprim Glenlawn Labs Heather DrugSulfamethoxazole and Trimethoprim Laboratory A Heather DrugSulfamethoxazole and Trimethoprim H L Moore Drug Exchange Heather Drug

SULFANILAMIDEVaginal Cream

Vagitrol Lemmon Co Lemmon Co

SULFASALAZINETablets

Sulfasalazine Danbury Pharmacal Danbury PharmacalSulfasalazine Bell Pharmacal Danbury PharmacalSulfasalazine Geneva Generics Danbury PharmacalSulfasalazine United Research Labs Danbury PharmacalSulfasalazine Rugby Labs Chelsea LabsSulfasalazine Bolar Pharmaceutical Bolar PharmaceuticalSulfasalazine Parmed Pharmaceuticals Bolar PharmaceuticalSulfasalazine Qualitest Bolar PharmaceuticalSulfasalazine Purepac Pharmaceutical Bolar PharmaceuticalSulfasalazine United Research Labs Bolar PharmaceuticalSulfasalazine Reid-Rowell Bolar PharmaceuticalSulfasalazine Mutual Pharmaceutical Mutual PharmaceuticalSulfasalazine United Research Labs Mutual PharmaceuticalSulfasalazine Genetco Mutual PharmaceuticalSulfasalazine Mason Distributors Mutual PharmaceuticalSulfasalazine Goldline Labs Mutual PharmaceuticalSulfasalazine Bioline Labs Mutual PharmaceuticalSulfasalazine Superpharm Corp Superpharm Corp

SULFINPYRAZONECapsules

Sulfinpyrazone Barr Labs Barr LabsSulfinpyrazone United Research Labs Barr LabsSulfinpyrazone Zenith Labs Zenith LabsSulfinpyrazone Rugby Labs Zenith LabsSulfinpyrazone Geneva Generics Zenith LabsSulfinpyrazone Qualitest Zenith LabsSulfinpyrazone Goldline Labs Zenith LabsSulfinpyrazone Interstate Drug Exchange Zenith LabsSulfinpyrazone Par Pharmaceutical Par PharmaceuticalSulfinpyrazone Mutual Pharmaceutical Par PharmaceuticalSulfinpyrazone Schein Pharmaceutical Barr LabsSulfinpyrazone Best Generics Barr Labs

SULFINPYRAZONETablets

Sulfinpyrazone Danbury Pharmacal Danbury PharmacalSulfinpyrazone United Research Labs Danbury PharmacalSulfinpyrazone Zenith Labs Zenith LabsSulfinpyrazone Geneva Generics Zenith LabsSulfinpyrazone Major Pharmaceutical Corp Zenith LabsSulfinpyrazone Goldline Labs Zenith LabsSulfinpyrazone Barr Labs Barr LabsSulfinpyrazone Rugby Labs Zenith Labs

28 § 25.58 PREVENTION OF DISEASES Pt. III

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SULFISOXAZOLETablets

Brand Name/Generic Name Distributed By: Manufactured By:

Gantrisin Roche RocheSulfisoxazole Heather Drug Heather DrugSulfisoxazole United Research Labs Heather DrugSulfisoxazole Roxane Labs Roxane LabsSulfisoxazole Barr Labs Barr LabsSulfisoxazole Richlyn Labs Richlyn LabsSulfisoxazole Zenith Labs Zenith LabsSulfisoxazole United Research Labs Zenith LabsSulfisoxazole Qualitest Zenith LabsSulfisoxazole Glenlawn Labs Zenith LabsSulfisoxazole Towne, Paulsen Zenith LabsSulfisoxazole West-ward West-wardSulfisoxazole H L Moore Drug Exchange West-wardSulfisoxazole Henry Schein West-wardSulfisoxazole Towne, Paulsen West-wardSulfisoxazole Interstate Drug Exchange Mylan PharmaceuticalsSulfisoxazole Henry Schein Mylan PharmaceuticalsSulfisoxazole Geneva Generics Cord LabsSulfisoxazole Purepac Pharmaceutical Purepac Pharmaceutical

SULINDACTablets

Sulindac Danbury Pharmacal Danbury PharmacalTemaz Quantum Pharmics Quantum PharmicsTemazepam Parmed Pharmaceuticals Quantum PharmicsTemazepam Goldline Labs Quantum PharmicsTemazepam Mylan Pharmaceuticals Mylan PharmaceuticalsTemazepam Schein Pharmaceutical Mylan PharmaceuticalsTemazepam Lederle Labs Mylan PharmaceuticalsTemazepam Texas Drug Reps Mylan PharmaceuticalsTemazepam Qualitest Mylan PharmaceuticalsTemazepam Warner Chilcott Labs Mylan PharmaceuticalsTemazepam Barr Labs Barr LabsTemazepam Par Pharmaceutical Par PharmaceuticalTemazepam Pharmaceutical Basics Pharmaceutical BasicsTemazepam Martec Pharmaceutical Pharmaceutical BasicsTemazepam Best Generics Pharmaceutical BasicsTemazepam Purepac Pharmaceutical Purepac PharmaceuticalTemazepam Bolar Pharmaceutical Bolar PharmaceuticalTemazepam Geneva Generics Cord Labs

TERPIN HYDRATEElixir

Terpin Hydrate Barre Drug National PharmaceuticalTerpin Hydrate Interstate Drug Exchange National PharmaceuticalTerpin Hydrate Murray Drug National PharmaceuticalTerpin Hydrate Southern First Aid Supply National PharmaceuticalTerpin Hydrate United Research Labs National PharmaceuticalTerpin Hydrate Vangard Labs National PharmaceuticalTerpin Hydrate Glenlawn Labs National PharmaceuticalTerpin Hydrate Rugby Labs Naska PharmacalTerpin Hydrate Purepac Pharmaceutical Purepac PharmaceuticalTerpin Hydrate United Research Labs KalipharmaTerpin Hydrate My-K Labs My-K LabsTerpin Hydrate Pharmaceutical Basics Pharmaceutical Basics

TETRACAINE HCLOphthalmic Solution

Tetracaine HCl Alcon Labs Alcon LabsTetracaine HCl Pharmafair PharmafairTetracaine Optopics Labs Optopics Labs

TETRACYCLINE HCLCapsules

Sumycin E R Squibb & Sons E R Squibb & SonsAchromycin V Lederle Labs Lederle LabsCyclopar Parke-Davis Parke-DavisTetracycline HCl Purepac Pharmaceutical Purepac PharmaceuticalTetracycline HCl Rondex Labs KalipharmaTetracycline HCl Heather Drug Heather DrugTetracycline HCl United Research Labs Heather DrugTetracycline HCl Geneva Generics Heather DrugTetracycline HCl Rugby Labs Heather DrugTetracycline HCl Parmed Pharmaceuticals Heather Drug

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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TETRACYCLINE HCLCapsules—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Tetracycline HCl Bioline Labs Heather DrugTetracycline HCl Goldline Labs Heather DrugTetracycline HCl Richlyn Labs Richlyn LabsTetracycline HCl Bioline Labs Richlyn LabsTetracycline HCl Gen-King Products Richlyn LabsTetracycline HCl H L Moore Drug Exchange Richlyn LabsTetracycline HCl Parmed Pharmaceuticals Richlyn LabsTetracycline HCl Henry Schein Richlyn LabsTetracycline HCl C S Ruckstuhl Richlyn LabsTetracycline HCl United Research Labs Richlyn LabsTetracycline HCl Interstate Drug Exchange Richlyn LabsTetracycline HCl Vita-Rx Richlyn LabsTetracycline HCl Glenlawn Labs Richlyn LabsTetracycline HCl Penta Products Richlyn LabsTetracycline HCl Mylan Pharmaceuticals Mylan PharmaceuticalsTetracycline HCl Rexall Drug Mylan PharmaceuticalsTetracycline HCl Bioline Labs Mylan PharmaceuticalsTetracycline HCl McKesson Labs Mylan PharmaceuticalsTetracycline HCl Walgreen Mylan PharmaceuticalsTetracycline HCl Regal Labs Mylan PharmaceuticalsTetracycline HCl H L Moore Drug Exchange Mylan PharmaceuticalsTetracycline HCl United Research Labs Mylan PharmaceuticalsTetracycline HCl Interstate Drug Exchange Mylan PharmaceuticalsTetracycline HCl Smith, Kline & French Mylan PharmaceuticalsTetracycline HCl Thrift Drug Mylan PharmaceuticalsTetracycline HCl Henry Schein Mylan PharmaceuticalsTetracycline HCl Euclid Pharmaceutical Mylan PharmaceuticalsTetracycline HCl Geneva Generics Mylan PharmaceuticalsTetracycline HCl Murray Drug Mylan PharmaceuticalsTetracycline HCl Skaggs Co Mylan PharmaceuticalsTetracycline HCl Purepac Pharmaceutical Mylan PharmaceuticalsCyclatet J M Dwyer Mylan PharmaceuticalsTetracycline HCl Parmed Pharmaceuticals Mylan PharmaceuticalsTetracycline HCl Halsey Drug Halsey DrugTetracycline HCl Bock Pharmaceutical Halsey DrugTetracycline HCl Interstate Drug Exchange Halsey DrugTetracycline HCl Caldwell & Bloor Halsey DrugPanmycin Upjohn Co Upjohn CoTetracycline HCl Zenith Labs Zenith LabsTetracycline HCl H L Moore Drug Exchange Zenith LabsTetracycline HCl Glenlawn Labs Zenith LabsTetracycline HCl Harber Pharmaceutical Zenith LabsTetracycline HCl Towne, Paulsen Zenith LabsTetracycline HCl Qualitest Zenith LabsTetracycline HCl Interstate Drug Exchange Zenith LabsTetracycline HCl Bioline Labs Zenith LabsTetracycline HCl Goldline Labs Zenith LabsTetracycline HCl Williams Generics Zenith LabsTetracycline HCl ICN Pharmaceuticals ICN PharmaceuticalsTetracycline HCl West-ward West-wardTetracycline HCl Rugby Labs Chelsea LabsTetracycline HCl Danbury Pharmacal Danbury PharmacalTetracycline HCl Bell Pharmacal Danbury PharmacalTetracycline HCl Parmed Pharmaceuticals Danbury PharmacalTetracycline HCl Wyeth Labs Wyeth LabsTetracycline HCl Lemmon Co Zenith LabsTetracycline HCl Private Formulations Private Formulations

TETRACYCLINE HCLSyrup

Sumycin E R Squibb & Sons E R Squibb & SonsAchromycin V Lederle Labs Lederle LabsTetracycline Barre Drug National PharmaceuticalTetracycline Geneva Generics National PharmaceuticalTetracycline Interstate Drug Exchange National PharmaceuticalTetracycline Rugby Labs National PharmaceuticalTetracycline Henry Schein National PharmaceuticalTetracycline Vangard Labs National PharmaceuticalTetracycline HCl United Research Labs National PharmaceuticalTetracycline Glenlawn Labs National PharmaceuticalTetracycline Towne, Paulsen National PharmaceuticalTetracycline Qualitest National PharmaceuticalBiocycline Murray Drug National PharmaceuticalBiocycline Bioline Labs National PharmaceuticalBiocycline Bell Pharmacal National PharmaceuticalTetracycline Goldline Labs Barre-NationalTetracycline Purepac Pharmaceutical Purepac Pharmaceutical

28 § 25.58 PREVENTION OF DISEASES Pt. III

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TETRACYCLINE HCLTablets

Brand Name/Generic Name Distributed By: Manufactured By:

Sumycin E R Squibb & Sons E R Squibb & Sons

THEOPHYLLINEElixir

Lanophyllin Lannett LannettTheophylline Barre Drug National PharmaceuticalTheophylline Cooper National PharmaceuticalTheophylline H L Moore Drug Exchange National PharmaceuticalTheophylline Penta Products National PharmaceuticalTheophylline Richie Pharmacal National PharmaceuticalTheophylline Rugby Labs National PharmaceuticalTheophylline Henry Schein National PharmaceuticalTheophylline Vangard Labs National PharmaceuticalTheophylline Bioline Labs National PharmaceuticalTheophylline Interstate Drug Exchange National PharmaceuticalTheophylline United Research Labs National PharmaceuticalTheophylline Purepac Pharmaceutical National PharmaceuticalTheophylline Glenlawn Labs National PharmaceuticalTheophylline Vita-Rx National PharmaceuticalTheophylline Ronda Pharmacal National PharmaceuticalTheophylline Murray Drug National PharmaceuticalTheophylline Whiteworth Pharmaceuticals National PharmaceuticalTheophylline McKesson Labs National PharmaceuticalTheophylline Penner & Welsch National PharmaceuticalTheophylline Towne, Paulsen National PharmaceuticalTheophylline Harber Pharmaceutical National PharmaceuticalTheophylline Bell Pharmacal National PharmaceuticalTheophylline Geneva Generics National PharmaceuticalLixolin Mallard National PharmaceuticalTheogen Grafton Pharmaceutical National PharmaceuticalTheostat Laser National PharmaceuticalTrux-Ophylline C O Truxton National PharmaceuticalTheophylline Life Labs Life LabsTheophylline Halsey Drug Halsey DrugTheophylline Whiteworth Pharmaceuticals Halsey DrugTheophylline My-K Labs My-K LabsTheophylline Goldline Labs Barre-NationalElixomin H R Cenci Labs H R Cenci LabsTheophylline Thames Pharmacal Thames PharmacalTheophylline Rugby Labs Naska Pharmacal

THEOPHYLLINESolution

Theophylline Roxane Labs Roxane Labs

THEOPHYLLINESyrup

Theolair Liquid Riker Labs Riker Labs

THIAMINE HCLInjection

Thiamine HCl Carter-Glogau Labs Carter-Glogau LabsThiamine HCl Steris Labs Steris LabsThiamine HCl H L Moore Drug Exchange Steris LabsThiamine HCl Towne, Paulsen Steris LabsThiamine HCl Rugby Labs Steris LabsThiamine HCl Major Pharmaceutical Corp Steris LabsB-1 Bioline Labs Steris LabsVitamin B-1 Schein Pharmaceutical Steris Labs

THIAMINE HCLTablets

Thiamine HCl ICN Pharmaceuticals ICN PharmaceuticalsThiamine HCl Richlyn Labs Richlyn LabsThiamine HCl United Research Labs Contract PharmaceuticalThiamine HCl Lederle Labs KV PharmaceuticalVitamim B-1 Geneva Generics FreshlabsVitamim B-1 United Research Labs Heather Drug

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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THIORIDAZINE HCLSolution

Brand Name/Generic Name Distributed By: Manufactured By:

Thioridazine My-K Labs My-K LabsThioridazine HCl Conc. Barre-National Barre-NationalThioridazine HCl Intensol Roxane Labs Roxane LabsThioridazine HCl (Conc) Copley Pharmaceutical Copley PharmaceuticalThioridazine HCl Goldline Labs Barre-NationalThioridazine HCl Pharmaceutical Basics Pharmaceutical Basics

THIORIDAZINE HCLTablets

Thioridazine HCl Mylan Pharmaceuticals Mylan PharmaceuticalsThioridazine HCl Regal Labs Mylan PharmaceuticalsThioridazine HCl Henry Schein Mylan PharmaceuticalsThioridazine HCl Rugby Labs Mylan PharmaceuticalsThioridazine HCl United Research Labs Mylan PharmaceuticalsThioridazine HCl H L Moore Drug Exchange Mylan PharmaceuticalsThioridazine HCl Bioline Labs Mylan PharmaceuticalsThioridazine HCl Parmed Pharmaceuticals Mylan PharmaceuticalsThioridazine HCl Lemmon Co Mylan PharmaceuticalsThioridazine HCl Interstate Drug Exchange Mylan PharmaceuticalsThioridazine HCl Texas Drug Reps Mylan PharmaceuticalsThioridazine HCl Qualitest Mylan PharmaceuticalsThioridazine HCl Zenith Labs Zenith LabsThioridazine HCl Bioline Labs Zenith LabsThioridazine HCl H L Moore Drug Exchange Zenith LabsThioridazine HCl Henry Schein Zenith LabsThioridazine HCl Towne, Paulsen Zenith LabsThioridazine HCl Gen-King Products Zenith LabsThioridazine HCl Bolar Pharmaceutical Bolar PharmaceuticalThioridazine HCl United Research Labs Bolar PharmaceuticalThioridazine HCl Parmed Pharmaceuticals Bolar PharmaceuticalThioridazine HCl Qualitest Bolar PharmaceuticalThioridazine HCl Danbury Pharmacal Danbury PharmacalThioridazine HCl Geneva Generics Danbury PharmacalThioridazine HCl Rugby Labs Chelsea LabsThioridazine HCl Cord Labs Cord LabsThioridazine HCl Geneva Generics Cord LabsThioridazine HCl Par Pharmaceutical Par PharmaceuticalThioridazine HCl Bioline Labs Par PharmaceuticalThioridazine HCl General Generics Par PharmaceuticalThioridazine HCl Goldline Labs Par PharmaceuticalThioridazine HCl Harber Pharmaceutical Par PharmaceuticalThioridazine HCl Texas Drug Reps Par PharmaceuticalThioridazine HCl Towne, Paulsen Par PharmaceuticalThioridazine HCl Unit Dose Labs Par PharmaceuticalThioridazine HCl United Research Labs Par PharmaceuticalThioridazine HCl Williams Generics Par PharmaceuticalThioridazine HCl Geneva Generics Par PharmaceuticalThioridazine HCl Mutual Pharmaceutical Mutual PharmaceuticalThioridazine HCl United Research Labs Mutual PharmaceuticalThioridazine HCl Warner Chilcott Labs Mylan PharmaceuticalsThioridazine HCl Goldline Labs Mylan PharmaceuticalsThioridazine HCl Superpharm Corp Superpharm CorpThioridazine HCl Goldline Labs Superpharm CorpThioridazine HCl Bioline Labs Superpharm CorpThioridazine HCl Barr Labs Barr LabsThioridazine HCl Ascot Pharmaceuticals Barr LabsThioridazine HCl Genetco Mutual PharmaceuticalThioridazine HCl Best Generics Mylan PharmaceuticalsThioridazine HCl Martec Pharmaceutical Par Pharmaceutical

THIOTHIXENECapsules

Thiothixene Rugby Labs Chelsea LabsThiothixene Mylan Pharmaceuticals Mylan PharmaceuticalsThiothixene Goldline Labs Mylan PharmaceuticalsThiothixene United Research Labs Mylan PharmaceuticalsThiothixene Major Pharmaceutical Corp Mylan PharmaceuticalsThiothixene Rugby Labs Mylan PharmaceuticalsThiothixene Texas Drug Reps Mylan PharmaceuticalsThiothixene Qualitest Mylan PharmaceuticalsThiothixene H L Moore Drug Exchange Mylan PharmaceuticalsThiothixene Bioline Labs Mylan PharmaceuticalsThiothixene Schein Pharmaceutical Mylan PharmaceuticalsThiothixene Genetco Mylan PharmaceuticalsThiothixene Regal Labs Mylan PharmaceuticalsThiothixene Warner Chilcott Labs Mylan PharmaceuticalsThiothixene Parmed Pharmaceuticals Mylan Pharmaceuticals

28 § 25.58 PREVENTION OF DISEASES Pt. III

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THIOTHIXENECapsules—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Thiothixene Best Generics Mylan PharmaceuticalsThiothixene Danbury Pharmacal Danbury PharmacalThiothixene American Therapeutics American TherapeuticsThiothixene Martec Pharmaceutical American TherapeuticsThiothixene Parmed Pharmaceutical American TherapeuticsThiothixene H L Moore Drug Exchange American TherapeuticsThiothixene Rugby Labs American TherapeuticsThiothixene Major Pharmaceutical Corp American TherapeuticsThiothixene Bioline Labs American TherapeuticsThiothixene Goldline Labs American TherapeuticsThiothixene Best Generics American TherapeuticsThiothixene Harber Pharmaceutical American TherapeuticsThiothixene Purepac Pharmaceutical American TherapeuticsThiothixene Cord Labs Cord Labs

THIOTHIXENE HCLOral Solution

Thiothixene HCl Lemmon Co Lemmon CoThiothixene HCl (Conc) Copley Pharmaceutical Copley PharmaceuticalThiothixene HCl (Conc) Barre-National Barre-National

TIMOLOL MALEATETablets

Timolol Maleate Pharmaceutical Basics Pharmaceutical Basics

TOLAZAMIDETablets

Tolazamide Rugby Labs Chelsea LabsTolazamide Mylan Pharmaceuticals Mylan PharmaceuticalsTolazamide United Research Labs Mylan PharmaceuticalsTolazamide Parmed Pharmaceuticals Mylan PharmaceuticalsTolazamide H L Moore Drug Exchange Mylan PharmaceuticalsTolazamide Lemmon Co Mylan PharmaceuticalsTolazamide Par Pharmaceutical Par PharmaceuticalTolazamide Mutual Pharmaceutical Par PharmaceuticalTolazamide Lederle Labs Par PharmaceuticalTolazamide Henry Schein Zenith LabsTolazamide H L Moore Drug Exchange Zenith LabsTolazamide Geneva Generics Zenith LabsTolazamide Purepac Pharmaceutical Zenith LabsTolazamide Qualitest Zenith LabsTolazamide Towne, Paulsen Zenith LabsTolazamide Regal Labs Zenith LabsTolazamide Interstate Drug Exchange Zenith LabsTolazamide Harber Pharmaceutical Zenith LabsTolazamide Rugby Labs Zenith LabsTolazamide United Research Labs Zenith LabsTolazamide Major Pharmaceutical Corp Zenith LabsTolazamide Goldline Labs Zenith LabsTolazamide Bioline Labs Zenith LabsTolazamide Colmed Labs Pharmaceutical BasicsTolazamide Duramed Pharmaceuticals Duramed PharmaceuticalsTolazamide Superpharm Corp Superpharm CorpTolazamide Goldline Labs Superpharm CorpTolazamide Bioline Labs Superpharm CorpTolazamide Bolar Pharmaceutical Bolar PharmaceuticalTolazamide Martec Pharmaceutical Par PharmaceuticalTolazamide Cord Labs Cord LabsTolazamide Geneva Generics Cord LabsTolazamide Danbury Pharmacal Danbury PharmacalTolazamide Barr Labs Barr LabsTolazamide Glenlawn Labs Barr LabsTolazamide Mutual Pharmaceutical Mutual PharmaceuticalTolazamide United Research Labs Mutual PharmaceuticalTolazamide Genetco Mutual PharmaceuticalTolazamide Purepac Pharmaceutical Mutual Pharmaceutical

TOLBUTAMIDETablets

Tolbutamide Mylan Pharmaceuticals Mylan PharmaceuticalsTolbutamide Geneva Generics Mylan PharmaceuticalsTolbutamide Interstate Drug Exchange Mylan PharmaceuticalsTolbutamide Lederle Labs Mylan PharmaceuticalsTolbutamide Murray Drug Mylan Pharmaceuticals

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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TOLBUTAMIDETablets—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Tolbutamide Purepac Pharmaceutical Mylan PharmaceuticalsTolbutamide Regal Labs Mylan PharmaceuticalsTolbutamide Henry Schein Mylan PharmaceuticalsTolbutamide Skaggs Co Mylan PharmaceuticalsTolbutamide E R Squibb & Sons Mylan PharmaceuticalsTolbutamide Towne, Paulsen Mylan PharmaceuticalsTolbutamide United Research Labs Mylan PharmaceuticalsTolbutamide H L Moore Drug Exchange Mylan PharmaceuticalsTolbutamide Rexall Drug Mylan PharmaceuticalsTolbutamide Stayner Corp Mylan PharmaceuticalsTolbutamide Richie Pharmacal Mylan PharmaceuticalsSK-Tolbutamide Smith, Kline & French Smith, Kline & FrenchTolbutamide Danbury Pharmacal Danbury PharmacalTolbutamide Bell Pharmacal Danbury PharmacalTolbutamide Parmed Pharmaceuticals Danbury PharmacalTolbutamide Qualitest Danbury PharmacalTolbutamide Geneva Generics Cord LabsTolbutamide Rugby Labs Chelsea LabsTolbutamide Superpharm Corp Superpharm CorpTolbutamide Bioline Labs Superpharm CorpTolbutamide Goldline Labs Superpharm CorpTolbutamide Vitarine Pharmaceutical Vitarine PharmaceuticalTolbutamide Lederle Labs Lederle LabsTolbutamide Purepac Pharmaceutical Purepac PharmaceuticalTolbutamide Qualitest Mylan PharmaceuticalsTolbutamide Barr Labs Barr LabsTolbutamide General Generics Barr LabsTolbutamide Towne, Paulsen Barr LabsTolbutamide Purepac Pharmaceutical Barr LabsTolbutamide Major Pharmaceutical Corp Mylan PharmaceuticalsTolbutamide Bolar Pharmaceutical Bolar Pharmaceutical

TRAZODONE HCLTablets

Trazodone HCl Danbury Pharmacal Danbury PharmacalTrazodone HCl Rugby Labs Chelsea LabsTrazodone HCl American Therapeutics American TherapeuticsTrazodone HCl Purepac Pharmaceutical American TherapeuticsTrazodone HCl Martec Pharmaceutical American TherapeuticsTrazodone HCl Towne, Paulsen American TherapeuticsTrialodine Quantum Pharmics Quantum PharmicsTrazodone HCl Goldline Labs Quantum PharmicsTrazodone HCl Major Pharmaceutical Corp Quantum PharmicsTrazodone HCl H L Moore Drug Exchange Quantum PharmicsTrazodone HCl Parmed Pharmaceuticals Quantum PharmicsTrazodone HCl Texas Drug Reps Quantum PharmicsTrazodone HCl Colmed Labs Pharmaceutical BasicsTrazodone HCl Best Generics Pharmaceutical BasicsTrazodone HCl Parmed Pharmaceuticals American TherapeuticsTrazodone HCl Bioline Labs American TherapeuticsTrazodone HCl Goldline Labs American TherapeuticsTrazodone HCl H L Moore Drug Exchange American TherapeuticsTrazodone HCl United Research Labs American TherapeuticsTrazodone HCl Major Pharmaceutical Corp American TherapeuticsTrazodone HCl Harber Pharmaceutical American TherapeuticsTrazodone HCl Warner Chilcott Labs American TherapeuticsTrazodone HCl Genetco American TherapeuticsTrazodone HCl Texas Drug Reps American TherapeuticsTrazodone HCl Gen-King Products American TherapeuticsTrazodone HCl Interstate Drug Exchange American TherapeuticsTrazodone HCl Bolar Pharmaceutical Bolar PharmaceuticalTrazodone HCl Barr Labs Barr LabsTrazodone HCl Purepac Pharmaceutical Purepac PharmaceuticalTrazodone HCl Sidmak Labs Sidmak Labs

TRIAMCINOLONE ACETONIDECream

Aristocort Lederle Labs Lederle LabsKenalog E R Squibb & Sons E R Squibb & SonsTriamcinolone Acetonide Johnson and Johnson E R Squibb & SonsTriamcinolone Acetonide Clay-Park Labs Clay-Park LabsTriamcinolone Acetonide Rugby Labs Clay-Park LabsTriamcinolone Acetonide United Research Labs Clay-Park LabsTriamcinolone Acetonide Bioline Labs Clay-Park LabsTriamcinolone Acetonide Vangard Labs Clay-Park LabsTriamcinolone Acetonide Henry Schein Clay-Park LabsTriamcinolone Acetonide Regal Labs Clay-Park Labs

28 § 25.58 PREVENTION OF DISEASES Pt. III

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TRIAMCINOLONE ACETONIDECream—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Triamcinolone Acetonide Gen-King Products Clay-Park LabsTriamcinolone Acetonide Qualitest Clay-Park LabsTriamcinolone Acetonide Goldline Labs Clay-Park LabsTriacet H L Moore Drug Exchange Clay-Park LabsAricin Interstate Drug Exchange Clay-Park LabsKenac NMC Labs NMC LabsTriamcinolone Acetonide Geneva Generics NMC LabsTriamcinolone Acetonide Purepac Pharmaceutical NMC LabsTriamcinair Pharmafair PharmafairTriamcinolone Acetonide Thames Pharmacal Thames PharmacalTriamcinolone Acetonide E Fougera AltanaTriamcinolone Acetonide Pharmaderm AltanaTrymex Savage Labs AltanaTriacet Lemmon Co Lemmon Co

TRIAMCINOLONE ACETONIDEDental Paste

Triamcinolone Acetonide Taro Pharmaceuticals K-Line PharmaceuticalsOralone Thames Pharmacal Thames Pharmacal

TRIAMCINOLONE ACETONIDELotion

Kenalog E R Squibb & Sons E R Squibb & SonsTriamcinolone Acetonide Barre Drug National PharmaceuticalTriamcinolone Acetonide Rugby Labs National PharmaceuticalTriamcinolone Acetonide Qualitest National PharmaceuticalTriamcinolone Acetonide My-K Labs My-K LabsTriamcinolone Acetonide Thames Pharmacal Thames PharmacalTriamcinolone Acetonide Glenlawn Labs Thames PharmacalAricin Interstate Drug Exchange Thames PharmacalTriamcinolone Acetonide Goldline Labs Barre-National

TRIAMCINOLONE ACETONIDEOintment

Brand Name/Generic Name Distributed By: Manufactured By:

Aristocort Lederle Labs Lederle LabsKenalog E R Squibb & Sons E R Squibb & SonsKenac NMC Labs NMC LabsTriamcinolone Acetonide Clay-Park Labs Clay-Park LabsTriamcinolone Acetonide Gen-King Products Clay-Park LabsTriamcinolone Acetonide Bioline Labs Clay-Park LabsTriamcinolone Acetonide Rugby Labs Clay-Park LabsTriamcinolone Acetonide Qualitest Clay-Park LabsTriamcinolone Acetonide United Research Labs Clay-Park LabsTriamcinolone Acetonide Goldline Labs Clay-Park LabsTriacet H L Moore Drug Exchange Clay-Park LabsTriamcinolone Acetonide Thames Pharmacal Thames PharmacalTriamcinolone Acetonide E Fougera AltanaTriamcinolone Acetonide Schein Pharmaceutical Clay-Park LabsTriamcinolone Acetonide Rugby Labs Naska Pharmacal

TRIFLUOPERAZINE HCLSyrup

Stelazine Smith, Kline & French Smith, Kline & FrenchTFP Concentrate Cord Labs Cord LabsTrifluoperazine HCl Conc. Geneva Generics Cord LabsTrifluoperazine HCl My-K Labs My-K Labs

TRIFLUOPERAZINE HCLTablets

Stelazine Smith, Kline & French Smith, Kline & FrenchTFP Cord Labs Cord LabsTrifluoperazine HCl Geneva Generics Cord LabsTrifluoperazine HCl Zenith Labs Zenith LabsTrifluoperazine HCl H L Moore Drug Exchange Zenith LabsTrifluoperazine HCl Murray Drug Zenith LabsTrifluoperazine HCl Qualitest Zenith LabsTrifluoperazine HCl Purepac Pharmaceutical Zenith LabsTrifluoperazine HCl United Research Labs Zenith LabsTrifluoperazine HCl Interstate Drug Exchange Zenith LabsTrifluoperazine HCl Major Pharmaceutical Corp Zenith LabsTrifluoperazine HCl Towne, Paulsen Zenith Labs

Ch. 25 DRUGS, DEVICES, COSMETICS 28 § 25.58

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TRIFLUOPERAZINE HCLTablets—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Trifluoperazine HCl Gen-King Products Zenith LabsTrifluoperazine HCl Glenlawn Labs Zenith LabsTrifluoperazine HCl Genetco Zenith LabsTrifluoperazine HCl Goldline Labs Zenith LabsTrifluoperazine HCl Regal Labs Zenith LabsTrifluoperazine HCl Ascot Pharmaceuticals Zenith LabsTrifluoperazine HCl Duramed Pharmaceuticals Duramed PharmaceuticalsTrifluoperazine HCl Parmed Pharmaceuticals Duramed PharmaceuticalsTrifluoperazine HCl Regal Labs Duramed PharmaceuticalsTrifluoperazine HCl Rugby Labs Duramed PharmaceuticalsTrifluoperazine HCl Henry Schein Duramed PharmaceuticalsTrifluoperazine HCl UDL Labs Duramed PharmaceuticalsTrifluoperazine HCl United Research Labs Duramed PharmaceuticalsTrifluoperazine HCl Dixon-Shane Duramed PharmaceuticalsTrifluoperazine HCl Purepac Pharmaceutical Duramed PharmaceuticalsTrifluoperazine HCl Towne, Paulsen Duramed PharmaceuticalsTrifluoperazine HCl H L Moore Drug Exchange Duramed PharmaceuticalsTrifluoperazine HCl Major Pharmaceutical Corp Duramed PharmaceuticalsTrifluoperazine HCl Mutual Pharmaceutical Duramed PharmaceuticalsTrifluoperazine HCl Bioline Labs Duramed PharmaceuticalsTrifluoperazine HCl Goldline Labs Duramed PharmaceuticalsTrifluoperazine HCl Genetco Duramed PharmaceuticalsTrifluoperazine HCl Rugby Labs Zenith Labs

TRIHEXYPHENIDYL HCLElixir

Artane Lederle Labs Lederle Labs

TRIHEXYPHENIDYL HCLTablets

Artane Lederle Labs Lederle LabsTrihexyphenidyl HCl Danbury Pharmacal Danbury PharmacalTrihexyphenidyl HCl Interstate Drug Exchange Danbury PharmacalTrihexyphenidyl HCl H L Moore Drug Exchange Danbury PharmacalTrihexyphenidyl HCl Rugby Labs Danbury PharmacalTrihexyphenidyl HCl McKesson Labs Danbury PharmacalTrihexyphenidyl HCl Bioline Labs Danbury PharmacalTrihexyphenidyl HCl Regal Labs Danbury PharmacalTrihexyphenidyl HCl Bell Pharmacal Danbury PharmacalTrihexyphenidyl HCl Qualitest Danbury PharmacalTrihexidyl Henry Schein Danbury PharmacalTrihexy Geneva Generics Danbury PharmacalTrihexyphenidyl HCl Bolar Pharmaceutical Bolar PharmaceuticalTrihexyphenidyl HCl Bioline Labs Bolar PharmaceuticalTrihexyphenidyl HCl Gen-King Products Bolar PharmaceuticalTrihexyphenidyl HCl Vangard Labs Bolar PharmaceuticalTrihexyphenidyl HCl Cooper Bolar PharmaceuticalTrihexyphenidyl HCl Rugby Labs Bolar PharmaceuticalTrihexyphenidyl HCl United Research Labs Bolar PharmaceuticalTrihexyphenidyl HCl Thrift Drug Bolar PharmaceuticalTrihexyphenidyl HCl Glenlawn Labs Bolar PharmaceuticalTrihexyphenidyl HCl Veratex Corp Bolar PharmaceuticalTrihexyphenidyl HCl Interstate Drug Exchange Bolar PharmaceuticalTrihexyphenidyl HCl Ronda Pharmacal Bolar PharmaceuticalTrihexyphenidyl HCl Whiteworth Pharmaceuticals Bolar PharmaceuticalTrihexyphenidyl HCl H L Moore Drug Exchange Bolar PharmaceuticalTrihexyphenidyl HCl Arkansas Cooperative Assn Bolar PharmaceuticalTrihexyphenidyl HCl Penta Products Bolar PharmaceuticalTrihexyphenidyl HCl Richie Pharmacal Bolar PharmaceuticalTrihexyphenidyl HCl Murray Drug Bolar PharmaceuticalTrihexyphenidyl HCl Towne, Paulsen Bolar PharmaceuticalTrihexyphenidyl HCl H R Cenci Labs Bolar PharmaceuticalTrihexyphenidyl HCl McKesson Labs Bolar PharmaceuticalTrihexyphenidyl HCl Parmed Pharmaceuticals Bolar PharmaceuticalTrihexyphenidyl HCl Goldline Labs Bolar PharmaceuticalTrihexy Geneva Generics Bolar Pharmaceutical

TRIMEPRAZINE TARTRATESyrup

Trimeprazine Tartrate Barre Drug National Pharmaceutical

28 § 25.58 PREVENTION OF DISEASES Pt. III

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TRIMETHOBENZAMIDE HCLInjection

Brand Name/Generic Name Distributed By: Manufactured By:

Tigan Beecham Labs Beecham LabsTrimethobenzamide HCl Steris Labs Steris LabsTrimethobenzamide HCl Schein Pharmaceutical Steris LabsTrimethobenzamide HCl Interstate Drug Exchange Steris LabsTrimethobenzamide HCl Travenol Labs Steris Labs

TRIMETHOPRIMTablets

Trimethoprim Biocraft Labs Biocraft LabsTrimethoprim Henry Schein Biocraft LabsTrimethoprim Geneva Generics Biocraft LabsTrimethoprim Danbury Pharmacal Danbury PharmacalTrimethoprim Barr Labs Barr LabsTrimethoprim Goldline Labs Biocraft Labs

TRIMIPRAMINE MALEATECapsules

Trimipramine Maleate Pharmaceutical Basics Pharmaceutical BasicsTrimipramine Maleate Best Generics Pharmaceutical Basics

TRIPELENNAMINE HCLTablets

Pyribenzamine HCl Ciba Pharmaceutical Ciba PharmaceuticalTripelennamine HCl Richlyn Labs Richlyn LabsTripelennamine HCl Caldwell & Bloor Richlyn LabsTripelennamine HCl Dixon-Shane Richlyn LabsTripelennamine HCl C O Truxton Richlyn LabsTripelennamine HCl Danbury Pharmacal Danbury PharmacalTripelennamine HCl Henry Schein Danbury PharmacalTripelennamine HCl Geneva Generics Danbury PharmacalTriplen Interstate Drug Exchange Danbury PharmacalTripelennamine HCl Bolar Pharmaceutical Bolar PharmaceuticalTripelennamine HCl Bioline Labs Bolar PharmaceuticalTripelennamine HCl United Research Labs Bolar PharmaceuticalTripelennamine HCl Rugby Labs Bolar PharmaceuticalTripelennamine HCl Interstate Drug Exchange Bolar PharmaceuticalTripelennamine HCl Glenlawn Labs Bolar PharmaceuticalTripelennamine HCl Henry Schein Bolar PharmaceuticalTripelennamine HCl Cooper Bolar PharmaceuticalTripelennamine HCl Ronda Pharmacal Bolar PharmaceuticalTripelennamine HCl H R Cenci Labs Bolar PharmaceuticalTripelennamine HCl Murray Drug Bolar PharmaceuticalTripelennamine HCl Gen-King Products Bolar PharmaceuticalTripelennamine HCl Veratex Corp Bolar PharmaceuticalTripelennamine HCl Parmed Pharmaceuticals Bolar PharmaceuticalTripelennamine HCl Qualitest Bolar PharmaceuticalTripelennamine HCl H L Moore Drug Exchange Bolar Pharmaceutical

TRIPROLIDINE HCLSyrup

Triprolidine HCl Barre Drug National PharmaceuticalTriprolidine HCl Rugby Labs National PharmaceuticalTriprolidine HCl Halsey Drug National PharmaceuticalTriprolidine HCl Qualitest National PharmaceuticalMyidyl My-K Labs My-K Labs

TRIPROLIDINE HCLTablets

Triprolidine HCl Geneva Generics Bolar Pharmaceutical

TRISULFAPYRAMIDINESSuspension

Triple Sulfa Barre Drug National Pharmaceutical

TROPICAMIDEOphthalmic—Solution

Mydriafair Pharmafair Pharmafair

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VALPROIC ACIDCapsules—Continued

Brand Name/Generic Name Distributed By: Manufactured By:

Valproic Acid Par Pharmaceutical Par PharmaceuticalValproic Acid Qualitest Par PharmaceuticalValproic Acid Purepac Pharmaceutical Par PharmaceuticalValproic Acid Schein Pharmaceutical Par PharmaceuticalValproic Acid Martec Pharmaceutical Par PharmaceuticalValproic Acid Goldline Labs Par PharmaceuticalValproic Acid Chase Labs Chase LabsValproic Acid Pharmaceutical Basics Chase Labs

VALPROIC ACIDSyrup

Myproic Acid My-K Labs My-K LabsValproic Acid Pharmaceutical Basics Pharmaceutical Basics

VANCOMYCINInjection

Vancoled Lederle Labs Lederle Labs

VERAPAMIL HCLTablets

Verapamil HCl Watson Labs Watson LabsVerapamil HCl Bioline Labs Watson LabsVerapamil HCl Harber Pharmaceutical Watson LabsVerapamil HCl Goldline Labs Watson LabsVerapamil HCl Genetco Watson LabsVerapamil HCl Interstate Drug Exchange Watson LabsVerapamil HCl Major Pharmaceutical Corp Watson LabsVerapamil HCl Parmed Pharmaceuticals Watson LabsVerapamil HCl Texas Drug Reps Watson LabsVerapamil HCl Purepac Pharmaceutical Purepac PharmaceuticalVerapamil HCl Parmed Pharmaceuticals Purepac PharmaceuticalVerapamil HCl Rondex Labs KalipharmaVerapamil HCl Mutual Pharmaceutical KalipharmaVerapamil HCl Danbury Pharmacal Danbury PharmacalVerapamil HCl Rugby Labs Chelsea LabsVerapamil HCl Best Generics Watson LabsVerapamil HCl Barr Labs Barr LabsVerapamil HCl Parke-Davis Parke-DavisVerapamil HCl Geneva Generics Cord LabsVerapamil HCl Mutual Pharmaceutical Mutual PharmaceuticalVerapamil HCl United Research Labs Mutual Pharmaceutical

VITAMIN A (FISH LIVER OIL)Capsules

Vitamin A Richlyn Labs R P SchererVitamin A Purepac Pharmaceutical R P SchererVitamin A Lederle Labs R P SchererVitamin A Cooper PharmacapsVitamin A Rugby Labs Pharmacaps

VITAMIN A PALMITATECapsules

Vitamin A Richlyn Labs R P SchererVitamin A McKesson Labs R P SchererVitamin A United Research Labs PharmacapsVitamin A Comer Pharmaceuticals Pharmacaps

VITAMIN A PALMITATE(Solubilized) Capsules

Vitamin A Richlyn Labs R P SchererVitamin A Cooper PharmacapsVitamin A DOFS Labs PharmacapsVitamin A United Research Labs PharmacapsVitamin A Rugby Labs PharmacapsVitamin A Henry Schein Pharmacaps

28 § 25.58 PREVENTION OF DISEASES Pt. III

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VITAMIN D (Irradiated Ergosterol)See Ergocalciferol

VITAMIN A/VITAMIN D/ZINC OXIDEOintment

Comfortine Dermik Labs Dermik Labs

WARFARIN SODIUMTablets

Brand Name/Generic Name Distributed By: Manufactured By:

Warfarin Sodium Colmed Labs Pharmaceutical BasicsSofarin Lemmon Co Pharmaceutical BasicsWarfarin Sodium Martec Pharmaceutical Pharmaceutical Basics

XYLOMETAZOLINE HCLSolution

Long Acting Nasal Spray Barre Drug National PharmaceuticalLong Acting Nasal Spray Peoples Drug National PharmaceuticalLong Acting Nasal Spray Vitamin Specialties National PharmaceuticalLong Acting Nasal Spray Pharmex National PharmaceuticalLong Acting Nasal Spray Southern First Aid Supply National PharmaceuticalNeo-Spray Blue Cross Products National PharmaceuticalMist-O-Zol Caldwell & Bloor National PharmaceuticalIsohalant L A Paul B Elder National PharmaceuticalChlorohist-LA Mallard National PharmaceuticalXylomet Henry Schein National PharmaceuticalNasal Mist Long Lasting Rugby Labs National PharmaceuticalLong Acting Nasal Spray Thames Pharmacal Thames Pharmacal

Authority

The provisions of this § 25.58 issued and amended under section 2102(g) of The AdministrativeCode of 1929 (71 P. S. § 532(g)); and section 5 of the act of November 24, 1976 (P. L. 1163, No.259) (35 P. S. § 960.5).

Source

The provisions of this § 25.58 amended September 12, 1986, effective September 13, 1986, 16Pa.B. 3397; amended April 17, 1987, effective April 18, 1987, 17 Pa.B. 1567; amended April 1, 1988,effective April 2, 1988, 18 Pa.B. 1489; amended April 7, 1989, effective April 8, 1989, 19 Pa.B. 1527;amended September 1, 1989, effective September 2, 1989, 19 Pa.B. 3760; amended June 8, 1990,effective June 9, 1990, 20 Pa.B. 3062. Immediately preceding text appears at serial pages (140369) to(140510).

Cross References

This section cited in 6 Pa. Code § 22.2 (relating to definitions); 28 Pa. Code § 25.55 (relating todispensing); 28 Pa. Code § 551.3 (relating to definitions); 49 Pa. Code § 18.158 (relating to prescrib-ing and dispensing drugs, pharmaceutical aids and devices); 49 Pa. Code § 25.177 (relating to dis-pensing drugs, pharmaceutical aids and devices); and 49 Pa. Code § 21.284a (relating to prescribingand dispensing drugs).

SECURITY REQUIREMENTS

§ 25.61. General provisions.(a) Persons maintaining stocks or having controlled substances in production

areas or on hand for distribution shall provide effective controls and proceduresto guard against theft and diversion of the substances.

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(b) Physical security controls shall be commensurate with the schedules andquantity of controlled substances on hand and required for normal business opera-tions. If a controlled substance is transferred to a different schedule or a noncon-trolled substance is listed on a schedule, or the quantity of controlled substanceson hand significantly increases, physical security controls shall be expanded andextended accordingly.

(c) Persons who receive or transfer substantial quantities of controlled sub-stances shall employ security procedures to guard against losses in transit.

Cross References

This section cited in 28 Pa. Code § 551.3 (relating to definitions); and 49 Pa. Code § 21.284a(relating to prescribing and dispensing drugs).

§ 25.62. Security controls for distributors.

(a) Before distributing a controlled substance to a person who is not knownto be registered to possess the controlled substance, the distributor shall make agood faith inquiry with the Federal Drug Enforcement Administration to deter-mine that the person is legally permitted to possess the controlled substance.

(b) No complimentary samples of controlled substances may be distributedexcept on the specific written request of a licensed practitioner.

Cross References

This section cited in 28 Pa. Code § 551.3 (relating to definitions); and 49 Pa. Code § 21.284a(relating to prescribing and dispensing drugs).

§ 25.63. Security controls for practitioners and research personnel.

(a) Controlled substances listed in Schedule I shall be stored in substantiallyconstructed, securely locked cabinets with access restricted to approved person-nel.

(b) Controlled substances listed in Schedules II, III, IV and V shall be storedin substantially constructed, securely locked cabinets. However, pharmacies andpractitioners as defined in section 2 of the act (35 P. S. § 780-102) may dispersethe substances throughout the stocks of noncontrolled substances in a manner asto obstruct the theft or diversion of the substances.

Source

The provisions of this § 25.63 amended August 20, 1976, effective August 21, 1976, 6 Pa.B. 1985.Immediately preceding text appears at serial page (24405).

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Cross References

This section cited in 28 Pa. Code § 551.3 (relating to definitions); 49 Pa. Code § 21.284a (relatingto prescribing and dispensing drugs); and 49 Pa. Code § 43b.7 (relating to schedule of civilpenalties—pharmacists and pharmacies).

SCHEDULES OF CONTROLLED SUBSTANCES

Source

The provisions of these §§ 25.72—25.76 amended February 23, 1979, 9 Pa.B. 611, unless other-wise noted.

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§ 25.72. Schedules of controlled substances.(a) General. In accordance with sections 3 and 4 of the act (35 P. S.

§§ 780-103 and 780-104), this section lists all controlled substances. Section 4of the act (35 P. S. § 780-104) designates specific substances for inclusion underthe five schedules. The substances listed in this section include those listed bysection 4 of the act (35 P. S. § 780-104) and those that have been added by theSecretary after consultation with the Drug, Device and Cosmetic Board.

(b) Schedule I. In determining that a substance comes within this schedule,the Secretary will find: a high potential for abuse; no currently accepted medicaluse in the United States; and a lack of accepted safety for use under medicalsupervision. The following controlled substances are included in this schedule:

(1) The following opiates, including their isomers, esters, ethers, salts, andsalts of isomers, esters, and ethers, unless specifically excepted whenever theexistence of the isomers, esters, ethers, and salts is possible within the specificchemical designation:

(i) [Reserved].(ii) Allylprodine.(iii) Alphacetylmethadol.(iv) Alphameprodine.(v) Alphamethadol.(v.1) Alpha-methylfentanyl.(vi) Benzethidine.(vii) Betacetylmethadol.(viii) Betameprodine.(ix) Betamethadol.(x) Betaprodine.(xi) Clonitazene.(xii) Dextromoramide.(xiii) Dextrorphan (except its methylether).(xiv) Diampromide.(xv) Diethylthiambutene.(xvi) Dimenoxadol.(xvii) Dimepheptanol.(xviii) Dimethylthiambutene.(xix) Dioxaphetyl butyrate.(xx) Dipipanone.(xxi) Ethylmethylthiambutene.(xxii) Etonitazene.(xxiii) Etoxeridine.(xxiv) Furethidine.(xxv) Hydroxypethidine.(xxvi) Ketobemidone.

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(xxvii) Levomoramide.(xxviii) Levophenacylmorphan.(xxix) Morpheridine.(xxx) Noracymethadol.(xxxi) Norlevorphanol.(xxxii) Normethadone.(xxxiii) Norpipanone.(xxxiv) Phenadoxone.(xxxv) Phenampromide.(xxxvi) Phenomorphan.(xxxvii) Phenoperidine.(xxxviii) Piritramide.(xxxix) Proheptazine.(xl) Properidine.(xli) Racemoramide.(xlii) Tilidine.(xliii) Trimeperidine.(xliv) [Reserved].(xlv) 3-Methylfentanyl.(xlvi) 1-Methyl-4-Phenyl-4-Propionoxypiperidine (MPPP).(xlvii) 1-(2-Phenylethyl)-4-Phenyl-4-etyloxypiperidine (PEPAP).(xlviii) Para-fluorofentanyl.(xlix) Acetyl-alpha-methylfentanyl.(l) Alph-methylthiofentanyl.(li) Beta-hydroxyfentanyl.(lii) 3 Methylthiofentanyl.(liii) Thiofentanyl.(liv) Beta-hydroxy-3-methylfentanyl.

(2) The following opium derivatives, their salts, isomers and salts of iso-mers, unless specifically excepted, whenever the existence of the salts, isomers,and salts of isomers is possible within the specific chemical designation:

(i) Acetorphine.(ii) Acetyldihydrocodeine.(iii) Benzylmorphine.(iv) Codeine methylbromide.(v) Codeine-N-Oxide.(vi) Cyprenorphine.(vii) Desomorphine.(viii) Dihydromorphine.(ix) Drotebanol (added August 6, 1978).(x) Etorphine.(xi) Heroin.(xii) Hydromorphinol.

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(xiii) Methyldesorphine.(xiv) Methylhydromorphine.(xv) Morphine methylbromide.(xvi) Morphine methylsulfonate.(xvii) Morphine-N-Oxide.(xviii) Myrophine.(xix) Nicocodeine.(xx) Nicomorphine.(xxi) Normorphine.(xxii) Pholcodine.(xxiii) Thebacon.

(3) A material, compound, mixture or preparation which contains anyquantity of the following hallucinogenic substances, their salts, isomers, andsalts of isomers, unless specifically excepted, whenever the existence of thesalts, isomers, and salts of isomers is possible within the specific chemical des-ignation:

(i) 3,4-methylenedioxy amphetamine.(ii) 5-methoxy-3, 4-methylenedioxy amphetamine.(iii) 3,4,5-trimethoxy amphetamine.(iv) Bufotenine.(v) Diethyltryptamine.(vi) Dimethyltryptamine.(vii) 4-methyl-2, 5-dimethoxyamphetamine.(viii) Ibogaine.(ix) Lysergic acid diethylamide.(x) Mescaline.(xi) Peyote.(xii) N-ethyl-3-piperidyl benzilate.(xiii) N-methyl-3-piperidyl benzilate.(xiv) Psilocybin.(xv) Psilocyn.(xvi) Tetrahydrocannabinols.(xvii) 3, 4-methylenedioxy-N-ethylamphetamine.(xviii) N-hydroxy-3, 4-methylenedioxyamphetamine.(xix) 2, 5-Dimethoxy-4-ethylamphetamine (DOET).(xx) 4 Bromo 2, 5 Dimethoxyphenethylamine.

(4) Marihuana.(5) 4-Bromo-2, 5 Dimethoxyamphetamine (4-Bromo, 2, 5 DMA) (added

October 17, 1975).(6) Unless specifically excepted or unless listed in another schedule, a

material, compound, mixture or preparation which contains any quantity of thefollowing substances including the salts, isomers and salts of isomers:

(i) Fenethylline.

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(ii) N-ethylamphetamine.(iii) Methaqualone.(iv) Bromazepam.(v) Camazepam.(vi) Clotiazepam.(vii) Cloxazolam.(viii) Delorazepam.(ix) Ethyl loflazepate.(x) Fludiazepam.(xi) Flunitrazepam.(xii) Haloxazolam.(xiii) Ketazolam.(xiv) Loprazolam.(xv) Lormetazepam.(xvi) Medazepam.(xvii) Nimetazepam.(xiii) Nitrazepam.(xix) Nordiazepam.(xx) Oxazolam.(xxi) Pinazepam.(xxii) Tetrazepam.(xxiiii) 3, 4-Methylenedioxymethamphetamine (MDMA)(xxiv) 4-methylaminorex.(xxv) Cathinone.(xxvi) Methcathinone HCL.(xxvii) Dimethylamphetamine.(xxiii) 1-(3-trifluoromethylphenyl) Piperazine (TFMPP)(xxix) N-Benzylpiperazine (BZP)(xxx) Alpha-Methyltryptamine (AMT)(xxxi) 2-5 Dimethoxy-4-(N)-Propylthiophenethylamine (2C-T-7)(xxxii) 5-Methoxy-N, N-Diisopropyltryptamine (5-MEO-DIPT)

(c) Schedule II. In determining that a substance comes within this schedule,the Secretary will find: a high potential for abuse; currently accepted medical usein the United States; or currently accepted medical use with severe restrictionsand abuse may lead to severe psychic or physical dependence. The followingcontrolled substances are included in this schedule:

(1) The following substances of any quantity, except those narcotics spe-cifically excepted or listed in other schedules, whether produced directly orindirectly by extraction from substances of vegetable origin, or independentlyby means of chemical synthesis, or by combination of extraction and chemicalsynthesis:

(i) Opium and opiate, and a salt, compound, derivative or preparationof opium or opiate.

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(ii) A salt, compound, derivative or preparation thereof which is chemi-cally equivalent or identical with the substances referred to in subparagraph(i) except that these substances may not include the isoquinoline alkaloids ofopium.

(iii) Opium poppy and poppy straw.(iv) Coca leaves and a salt, compound, derivative or preparation of coca

leaves, and a salt, compound, derivative or preparation thereof which ischemically equivalent or identical with these substances, but may not includedecocanized coca leaves or extracts of coca leaves, which extracts do notcontain cocaine or ecgonine.(2) The following opiates, including their isomers, esters, ethers, salts and

salts of isomers, esters and ethers, of any quantity, unless specifically exceptedor listed in another schedule, whenever the existence of the isomers, esters,ethers and salts is possible within the specific chemical designation:

(i) Alphaprodine.(ii) Anileridine.(iii) Bezitramide.(iv) Dihydrocodeine.(v) Diphenoxylate.(vi) Fentanyl.(vii) Isomethadone.(viii) Levomethorphan.(ix) Levorphanol.(x) Metazocine.(xi) Methadone.(xii) Methadone-Intermediate, 4-cyano-2-dimethylamino-4, 4-diphenyl

butane.(x i i i ) Moramide-Intermedia te , 2-methyl -3-morphol ino-1 ,

1-diphenylpropane-carboxylicacid.(xiv) Pethidine.(xv) Pethidine-Intermediate-A, 4-cyano-1-methyl-4-phenylpiperidine.(xvi) Pethidine-Intermediate-B, ethyl-4-phenylpiperidine-4-carboxylate.(xvii) Pethidine-Intermediate-C, 1-methyl-4-phenylpiperidine-4-

carboxylic acid.(xviii) Phenazocine.(xix) Piminodine.(xx) Propiram (added August 5, 1978).(xxi) Racemethorphan.(xxii) Racemorphan.(xxiii) Sufentanil.(xxiv) Alfentanil.(xxv) Carfentanil.(xxvi) Levo-Alpha Acetyl-Methadol.

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(3) Unless specifically excepted or unless listed in another schedule, amaterial, compound, mixture or preparation which contains any quantity of thefollowing substances:

(i) Amphetamine, its salts, optical isomers and salts of its optical iso-mers.

(ii) Phenmetrazine and its salts.(iii) Methylphenidate.(iv) Methamphetamine including its salts, isomers and salts of isomers.(v) Phenylacetone.(vi) Nabilone.(vii) Glutethimide.

(4) The phrase ‘‘opiates’’ as used in section 4 of the act (35 P. S.§ 780-104) and elsewhere throughout the act may not include the dextrorota-tory isomer of 3-methoxy-n-methylmorphinan and its salts, but does include itsracemic and levorotatory forms.

(5) A material, compound, mixture or preparation, unless specificallyexcepted, which contains a quantity of:

(i) Phencyclidine.(ii) 1-phenylcyclohexylamine.(iii) 1-piperidinocyclohexanecarbonitrile.(iv) Nabilone.

(6) Unless specifically excepted or unless listed in another schedule, anymaterial, compound, mixture or preparation which contains any quantity of thefollowing substances, including its salts, isomers and salts of isomers wheneverthe existence of the salts, isomers and salts of isomers is possible within thespecific chemical designation:

(i) Amobarbital (added August 21, 1976).(ii) Secobarbital (added August 21, 1976).(iii) Pentobarbital (added August 21, 1976).

(d) Schedule III. In determining that a substance comes within this schedule,the Secretary will find: a potential for abuse less than the substances listed inSchedules I and II; well documented and currently accepted medical use in theUnited States; and abuse may lead to moderate or low physical dependence. Thefollowing classes of controlled substances are included in this schedule:

(1) A material, compound, mixture or preparation unless specificallyexcepted or unless listed in another schedule which contains any quantity of thefollowing substances:

(i) A substance which contains any quantity of a derivative of barbitu-ric acid, or a salt of a derivative of barbituric acid.

(ii) Chorhexadol.(iii) Lysergic acid.(iv) Lysergic acid amide.(v) Methyprylon.

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(vi) Sulfondiethylmethane.(vii) Sulfonethylmethane.(viii) Sulfonmethane.

(2) Nalorphine.(3) A material, compound, mixture, or preparation containing limited quan-

tities of the following narcotic drugs, or salts thereof, unless specificallyexcepted or listed in other schedules.

(i) Not more than 1.8 grams of codeine per 100 milliliters or not morethan 90 milligrams per dosage unit, with an equal or greater quantity of anisoquinoline alkaloid of opium.

(ii) Not more than 1.8 grams of codeine per 100 milliliters or not morethan 90 milligrams per dosage unit, with one or more active, nonnarcoticingredients in recognized therapeutic amounts.

(iii) Not more than 300 milligrams of dihydrocodeinone per 100 millili-ters or not more than 15 milligrams per dosage unit, with a fourfold orgreater quantity of an isoquinolene alkaloid of opium.

(iv) Not more than 300 milligrams of dihydrocodeinone per 100 millili-ters or not more than 15 milligrams per dosage unit, with one or more active,nonnarcotic ingredients in recognized therapeutic amounts.

(v) Not more than 1.8 grams of dihydrocodeine per 100 milliliters ornot more than 90 milligrams per dosage unit, with one or more active, non-narcotic ingredients in recognized therapeutic amounts.

(vi) Not more than 300 milligrams of ethylmorphine per 100 millilitersor not more than 15 milligrams per dosage unit, with one or more active,nonnarcotic ingredients in recognized therapeutic amounts.

(vii) Not more than 500 milligrams of opium per 100 milliliters or per100 grams, or not more than 2.5 milligrams per dosage unit with one or moreactive, nonnarcotic ingredients in recognized therapeutic amounts.(4) Unless specifically excepted or unless listed in another schedule, a

material, compound, mixture, or preparation which contains any quantity of thefollowing substances including its salts, isomers, whether optical position orgeometric, and salts of the isomers whenever the existence of the salts, isomers,and salts of isomers is possible within the specific chemical designation,Schedule III shall include the following:

(i) Benzphetamine (added August 21, 1976).(ii) Chlorphentermine (added August 21, 1976).(iii) Clortermine (added August 21, 1976).(iv) [Reserved].(v) Phendimetrazine (added August 21, 1976).

(5) A compound, mixture or preparation or a salt thereof including one ormore other active medicinal ingredients which are not listed in a schedule con-taining the following:

(i) Amobarbital.

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(ii) Secobarbital.(iii) Pentobarbital.

(6) A suppository dosage form or a salt thereof approved by the Food andDrug Administration for marketing only as a suppository containing the follow-ing:

(i) Amobarbital.(ii) Secobarbital.(iii) Pentobarbital.

(7) The Secretary may, by regulation, except a compound, mixture, orpreparation containing a drug or controlled substance listed in this schedulefrom the application of those provisions of the act covering controlled sub-stances, if the compound, mixture, or preparation contains one or more activemedicinal ingredients not having a stimulant or depressant effect on the centralnervous system; provided, that the admixtures shall be included therein in thecombinations, quantity, proportion, or concentration as to vitiate the potentialfor abuse of the substances which do have a stimulant or depressant effect onthe central nervous system.

(8) The Secretary will, by regulation, exempt a nonnarcotic substance fromthe control under the act if the substance may, under the provisions of the Fed-eral Food, Drug, and Cosmetic Act (21 U.S.C.A. § 301 et seq.), be lawfullysold over the counter without a prescription.

(9) A material, compound, mixture or preparation, unless specificallyexcepted, which contains a quantity of Dronabinol—synthetic—in sesame oilencapsulated in a soft gelatin capsule but only those drug products approved bythe United States Food and Drug Administration.

(10) Buprenorphine.(e) Schedule IV. In determining that a substance comes within this schedule,

the Secretary will find: a low potential for abuse relative to substances in Sched-ule III; currently accepted medical use in the United States; and limited physicalor psychological dependence liability relative to the substances listed in ScheduleIII. The following controlled substances are included in this schedule:

(1) A material, compound, mixture or preparation, unless specificallyexcepted or unless listed in another schedule, which contains a quantity of thefollowing substances:

(i) Barbital.(ii) Chloral betaine.(iii) Chloral hydrate.(iv) Ethchlorvynol.(v) Ethinamate.(vi) Methohexital.(vii) Meprobamate.(viii) Methylphenobarbital.(ix) Paraldehyde.(x) Petrichloral.

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(xi) Phenobarbital.(xii) Chlordiazepoxide (added August 21, 1976).(xiii) Diazepam (added August 21, 1976).(xiv) Oxazepam (added August 21, 1976).(xv) Clorazepate (added August 21, 1976).(xvi) Flurazepam (added August 21, 1976).(xvii) Clonazepam (added August 21, 1976).(xviii) Mebutamate (added August 21, 1976).(xix) Temazepam.(xx) Alprazolam.(xxi) Halazepam.(xxii) Triazolam.(xxiii) Midazolam.(xxiv) Quazepam.(xxv) Estazolam.(xxvi) Zolpidem.(xxvii) Clobazam. (added March 27, 2012)

(2) A material, compound, mixture, or preparation which contains anyquantity of the following substance including its salts, isomers whether opticalposition or geometric, and salts of the isomers, whenever the existence of thesalts, isomers, and salts of isomers is possible:

(i) Fenfluramine (added August 21, 1976).(ii) Pentazocine (added January 19, 1980).(iii) Lorazepam (added January 19, 1980).(iv) Prazepam (added January 19, 1980).(v) Dextropropoxyphene (added January 19, 1980).

(3) Unless specifically excepted or unless listed in another schedule, amaterial, compound, mixture or preparation which contains any quantity of thefollowing substances including its salts, isomers whether optical position orgeometric, and salts of the isomers whenever the existence of the salts, isomersand salts of isomers is possible within the specific chemical designation:

(i) Diethylpropion (added August 21, 1976).(ii) Phentermine (added August 21, 1976).(iii) Pemoline (added August 21, 1976).(iv) Mazindol.(v) Pipradol.(vi) SPA (1-dimethylamino-1-2-diphenylethane).(vii) Cathine.(viii) Fencamfamin.(ix) Fenproporex.(x) Mefenorex.(xi) Butorphanol.(xii) Sibutramine.

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(4) The Secretary may, by regulation, except a compound, mixture, orpreparation containing a drug or controlled dangerous substance listed in para-graph (1) from the application of those provisions of the act, sections 3 and 4of the act (35 P. S. §§ 780-103 and 780-104), covering controlled drugs, if thecompound, mixture, or preparation contains one or more active medicinalingredients not having a stimulant or depressant effect on the central nervoussystem; provided that the admixtures shall be included therein in combinations,quantity, proportion, or concentration as to vitiate the potential for abuse of thesubstances which do have a stimulant or depressant effect on the central ner-vous system.

(5) The Secretary shall by regulation exempt a nonnarcotic substance fromthe control under the act if the substance may, under the provisions of the Fed-eral Food, Drug, and Cosmetic Act (21 U.S.C.A. § 301 et seq.) be lawfullysold over the counter without a prescription.

(6) A compound, mixture, or preparation which purports to have a coughsuppressant effect and which contains a limited quantity of the following nar-cotics or their salts, and which contains in addition one or more nonnarcoticactive medicinal ingredients in sufficient proportion to confer upon the com-pound, mixture, or preparation, valuable medicinal qualities other than thosepossessed by the narcotic alone shall be included under this schedule:

(i) Not more than 200 milligrams of codeine, or any of its salts, per 100milliliters or per 100 grams and not more than 10 milligrams per dosage unit.

(ii) Not more than 100 milligrams of dihydrocodeine, or any of its salts,per 100 milliliters or per 100 grams and not more than 5 milligrams per dos-age unit.

(iii) Not more than 100 milligrams of ethylmorphine, or any of its salts,per 100 milliliters or per 100 grams and not more than 5 milligrams per dos-age unit.

(f) Schedule V. In determining that a substance comes within this schedule,the Secretary will find: a low potential for abuse relative to the substances listedin Schedule IV; currently accepted medical use in the United States; and limitedphysical dependence or psychological dependence liability relative to the sub-stances listed in Schedule IV. The following controlled substances are included inthis schedule:

(1) A compound, mixture, or preparation containing limited quantities ofany of the following narcotics or any of their salts, which shall include one ormore nonnarcotic active medicinal ingredients in sufficient proportion to con-fer upon the compound, mixture, or preparation, valuable medicinal qualitiesother than those possessed by the narcotic alone:

(i) Not more than 200 milligrams of codeine, or any of its salts, per 100milliliters or per 100 grams and not more than 10 milligrams per dosage unit.

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(ii) Not more than 100 milligrams of dihydrocodeine or any of its salts,per 100 milliliters or per 100 grams and not more than 5 milligrams per dos-age unit.

(iii) Not more than 100 milligrams of ethylmorphine, or any of its salts,per 100 milliliters or per 100 grams and not more than 5 milligrams per dos-age unit.

(iv) Not more than 2.5 milligrams of diphenoxylate and not less than 25micrograms of altropine sulfate per dosage unit.

(v) Not more than 100 milligrams of opium per 100 milliliters or per100 grams, or not more than 5 milligrams per dosage unit.(2) Propylhexadrine, except when labeled for over-the-counter drug sale in

conformity with 21 CFR 1308.15 (relating to schedule V).(3) Pyrovalerone.

AuthorityThe provisions of this § 25.72 amended under section 2102(g) of The Administrative Code of 1929

(71 P. S. § 532(g)); sections 3(a) and (c) and 4 of The Controlled Substance, Drug, Device and Cos-metic Act (35 P. S. §§ 780-103(a) and (c) and 780-104); and section 2 of the Optometric Practice andLicensure Act (63 P. S. § 244.2).

SourceThe provisions of this § 25.72 amended February 23, 1979, effective February 24, 1979, 9 Pa.B.

611; amended January 18, 1980, effective January 19, 1980, 10 Pa.B. 216; amended August 13, 1982,effective August 14, 1982, 12 Pa.B. 2685; amended November 4, 1983, effective November 5, 1983,13 Pa.B. 3376; amended September 7, 1984, effective September 8, 1984, 14 Pa.B. 3250; amendedOctober 26, 1984, effective November 5, 1983, 14 Pa.B. 3909; amended March 15, 1986, effectiveMarch 16, 1986, 16 Pa.B. 812; amended August 29, 1986, effective August 30, 1986, 16 Pa.B. 3209;corrected February 13, 1987, 17 Pa.B. 717; amended April 17, 1987, effective April 18, 1987, 17Pa.B. 1567; amended May 20, 1988, effective May 21, 1988, 18 Pa.B. 2298; amended May 20, 1988,effective May 21, 1988, 18 Pa.B. 2299; corrected July 1, 1988, effective April 16, 1977, 18 Pa.B.2905; amended February 17, 1989, effective February 18, 1989, 19 Pa.B. 638; amended March 10,1989, effective March 11, 1989, 19 Pa.B. 997; amended November 21, 1997, effective November 22,1997, 27 Pa.B. 6088; amended May 4, 2001, effective May 5, 2001, 31 Pa.B. 2373; amended May21, 2004, effective May 22, 2004, 34 Pa.B. 2711; amended March 17, 2006, effective March 18, 2006,36 Pa.B. 1218; amended July 10, 2015, effective July 11, 2015, 45 Pa.B. 3708. Immediately preced-ing text appears at serial pages (236115) to (236116), (317777) to (317778), (279223) to (279224),(304185) to (304188) and (366337).

Notes of DecisionsA material containing the drug cathinone is a controlled substance under § 25.72(b)(6)(xxvi). The

language of the § 25.72(b)(6)(xxvi) plainly states that an unlisted material, when containing a con-trolled substance, is a controlled substance. Commonwealth v. Mohamud, 15 A.3d 80, 92 (Pa. Super.2010).

Cross ReferencesThis section cited in 28 Pa. Code § 551.3 (relating to definitions); and 49 Pa. Code § 21.284a

(relating to prescribing and dispensing drugs).

§ 25.73. [Reserved].

§ 25.74. [Reserved].

§ 25.75. Paregoric.Paregoric, otherwise known as camphorated tincture of opium, shall be

included under Schedule III of the act. No pharmacist shall sell, dispense or giveaway a paregoric except under an oral or written prescription order of a licensed

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practitioner; provided, however, that this section may not be construed to applyto paregoric in the combinations, quantity, proportion or concentration as to viti-ate the potential for abuse.

§ 25.76. [Reserved].

NONPROPRIETARY DRUGS

§ 25.81. Classification of nonproprietary drugs.Nonproprietary drugs are considered to be drugs which carry the following, or

similarly worded, legend as required by the Federal Food, Drug and Cosmetic Act(21 U.S.C.A. § 301 et seq.):

(1) ‘‘Caution: Federal law prohibits dispensing without a prescription.’’(2) ‘‘Warning: May be habit-forming.’’(3) ‘‘Caution: Federal law restricts this drug to sale by or on the order

of a licensed veterinarian.’’(4) ‘‘Caution: New Drug—Limited by Federal law to investigational

use.’’

Cross References

This section cited in 28 Pa. Code § 551.3 (relating to definitions); 49 Pa. Code § 18.6a (relatingto prescribing, dispensing and administering drugs); and 49 Pa. Code § 21.284a (relating to prescrib-ing and dispensing drugs).

LABELING OF DRUGS, DEVICES AND COSMETICS

§ 25.91. Labeling.No label, labeling or advertisement of a drug, device or cosmetic shall contain

the words ‘‘approved by the Pennsylvania Department of Health,’’ or a similarwording or reference thereto.

Cross References

This section cited in 28 Pa. Code § 551.3 (relating to definitions); 49 Pa. Code § 18.6a (relatingto prescribing, dispensing and administering drugs); and 49 Pa. Code § 18.158 (relating to prescrib-ing and dispensing drugs); 49 Pa. Code § 21.284a (relating to prescribing and dispensing drugs); and49 Pa. Code § 25.177 (relating to prescribing drugs, pharmaceutical aids and devices).

§ 25.92. Control numbers in labeling of controlled substances and otherdrugs but excluding prescription orders.

Each manufacturer and each distributor, as to material removed by it from themanufacturer’s original container and repackaged, shall insure that the label ofthe immediate container or the immediate container itself of a drug or controlledsubstance bears characteristic markings or numbers commonly referred to as‘‘lot’’ or ‘‘control’’ numbers, to make it possible to determine the completemanufacturing history of the package of the drug.

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Cross References

This section cited in 28 Pa. Code § 551.3 (relating to definitions); 49 Pa. Code § 18.6a (relatingto prescribing, dispensing and administering drugs); 49 Pa. Code § 18.158 (relating to prescribing anddispensing drugs); 49 Pa. Code § 21.284a (relating to prescribing and dispensing drugs); 49 Pa. Code§ 25.177 (relating to prescribing and dispensing drugs, pharmaceutical aids and devices); and 49Pa. Code § 43b.7 (relating to schedule of civil penalties—pharmacists and pharmacies).

§ 25.93. Labeling—drug code number.

The label on a dispensed drug container shall include the name of the drug,using abbreviations if necessary, the quantity, and the name of the manufacturerif the drug is a ‘‘generic’’ drug. In those situations where a practitioner specifi-cally indicates that the name of the drug should not appear on the label, the rec-ognized national drug code number should be placed on the label if such a num-ber is available for the product. When a drug is dispensed by a practitioner otherthan a pharmacist, the label shall also bear the name and address of the practitio-ner, the date dispensed, the name of the patient, and the directions for the use ofthe drug by the patient.

Source

The provisions of this § 25.93 amended June 24, 1977, 7 Pa.B. 1742. Immediately preceding textappears at serial page (24407).

Cross References

This section cited in 28 Pa. Code § 25.95 (relating to mandatory compliances); 28 Pa. Code§ 551.3 (relating to definitions); 49 Pa. Code § 18.6a (relating to prescribing, dispensing and admin-istering drugs); 49 Pa. Code § 18.158 (relating to prescribing and dispensing drugs); 49 Pa. Code§ 25.177 (relating to prescribing and dispensing drugs, pharmaceutical aids and devices); and 49Pa. Code § 21.284a (relating to prescribing and dispensing drugs).

§ 25.94. Expiration date of drug.

Drugs which at the time of their dispensing have full potency for less than oneyear, as determined by the expiration date placed on the original label by themanufacturer, may only be dispensed by a practitioner with a label that indicatessaid expiration date. The label should include the statement: ‘‘Do not use after(manufacturer’s expiration date)’’ or similar wording.

Cross References

This section cited in 28 Pa. Code § 25.95 (relating to mandatory compliances); 28 Pa. Code§ 551.3 (relating to definitions); 49 Pa. Code § 18.6a (relating to prescribing, dispensing and admin-istering drugs); 49 Pa. Code § 18.158 (relating to prescribing and dispensing drugs); 49 Pa. Code§ 21.284a (relating to prescribing and dispensing drugs); 49 Pa. Code § 25.177 (relating to prescrib-ing and dispensing drugs, pharmaceutical aids and devices); and 49 Pa. Code § 43b.7 (relating toschedule of civil penalties—pharmacists and pharmacies.).

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§ 25.95. Mandatory compliances.Any practitioner who is registered or licensed by the appropriate State Board

to dispense drugs to patients is required to comply with §§ 25.93 and 25.94(relating to labeling—drug code number; and expiration date of drug).

Cross References

This section cited in 28 Pa. Code § 551.3 (relating to definitions); 49 Pa. Code § 18.6a (relatingto prescribing, dispensing and administering drugs); 49 Pa. Code § 18.158 (relating to prescribing anddispensing drugs); and 49 Pa. Code § 21.284a (relating to prescribing and dispensing drugs); and 49Pa. Code § 25.177 (relating to prescribing and dispensing drugs, pharmaceutical aids and devices).

MISBRANDING

§ 25.101. Standards.(a) No drug, device, or cosmetic shall be deemed misbranded under the act if

such drug, device, or cosmetic would—if introduced into interstate commerce—comply with 21 U.S.C.A. § 352 and the rules, regulations, and interpretationsadopted thereunder relating to misbranding, except where the act or this chapterprovides otherwise.

(b) Any drug in a solid dosage form other than a nonproprietary drug thatcontains any quantity of caffeine, phenylpropanolamine, or pseudoephedrine orany of their salts or that contains any quantity of ingredients which have a stimu-lant or depressant effect on humans will be deemed misbranded—with all atten-dant criminal penalties found in the act—regardless of its label, labeling, orpackaging if its size, shape, and color or its imprinted symbols, numbers, or let-ters are substantially identical in appearance to a controlled substance as dis-played in the color product identification section of the current edition of thePhysician’s Desk Reference.

(c) Any solid dosage form which contains markings which bear a distinctivetrademark, trade name, brand name, or manufacturer’s name so as not to appearsubstantially identical to a controlled substance will not be in violation of thissection.

Authority

The provisions of this § 25.101 issued under sections 2102(g) and 2108 of The AdministrativeCode of 1929 (71 P. S. §§ 532(g) and 538).

Source

The provisions of this § 25.101 amended February 5, 1982, effective March 8, 1982, 12 Pa.B. 522.Immediately preceding text appears at serial page (37618).

Cross References

This section cited in 28 Pa. Code § 551.3 (relating to definitions).

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SALVAGE OF DISTRESSED DRUGS, DEVICES AND COSMETICS

§ 25.102. Definition.Distressed drugs, devices and cosmetics, as used in this section, shall mean

those items which have been subjected to damage by fire, flood, excessive heator cold or other conditions which affect or may have affected their fitness for useor consumption.

§ 25.103. Distressed drugs, devices or cosmetics.All persons knowingly having in their possession regardless of ownership, dis-

tressed drugs, devices or cosmetics, shall notify the Department of Health inorder that such items may be inspected to determine their fitness for use or con-sumption before they are sold or distributed.

§ 25.104. Prohibitions.No person shall sell, trade, auction or dispose of any distressed drugs, devices

or cosmetics, either as owner, agent or insurer, or in any other agent capacity,when such has been declared unfit for use by the Department of Health.

§ 25.105. Normal return for credit.Nothing in this section shall prevent the normal return for credit of drugs,

devices or cosmetics to distributors or manufacturers, or to prevent the absolutedestruction of unfit drugs, devices or cosmetics.

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REGISTRATION

§ 25.113. Requirements for registration.(a) Every person who manufactures, distributes or retails drugs or devices

within the Commonwealth or proposes to engage in the manufacture, distributionor retail sale of drugs or devices within the Commonwealth shall obtain annuallya registration unless exempted under § 25.114 (relating to persons exempt fromregistration).

(b) Only persons actually engaged in such activities are required to obtain aregistration; related or affiliated persons not engaged in such activities are notrequired to be registered. (For example, a stockholder or parent corporation of acorporation manufacturing drugs or devices is not required to obtain a registra-tion.)

(c) Any manufacturer or distributor of drugs or devices not operating anestablishment within the Commonwealth shall either obtain a registration ormaintain with the secretary an up-to-date listing of the names and addresses ofits representatives operating within the Commonwealth.

(d) Separate registration is required for each place where drugs or devices aremanufactured or sold. (For example, establishments whose locations are not con-tiguous are separate places.)

(e) Registration as a distributor is required by every person not exempt underthe act who sells or otherwise distributes any of the following:

(1) Controlled substances.(2) Nonproprietary drugs.(3) Devices which are labeled to require a physician’s order.(4) Any drug having a stimulant or depressant effect which is sold or oth-

erwise distributed to one person or address in quantities of a 1000 or moredoses within a given 30-day period.(f) The sales described in subsection (e) will be considered to be for resale

or redistribution and not for personal use.

Authority

The provisions of this § 25.113 issued under sections 2102(g) and 2108 of The AdministrativeCode of 1929 (71 P. S. §§ 532(g) and 538).

Source

The provisions of this § 25.113 amended February 5, 1982, effective March 8, 1982, 12 Pa.B. 522.Immediately preceding text appears at serial page (37619).

§ 25.114. Persons exempt from registration.The following persons are exempt from registration:(1) An official or agency of the United States Army, Navy, Marine Corps, Air

Force, Coast Guard, Veterans Administration or Public Health Service.

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(2) An official employe or other civil officer of an agency of the UnitedStates or of the Commonwealth or its political subdivisions, otherwise authorizedto manufacture, distribute, or retail drugs or devices in the course of his officialduties or employment.

(3) Practitioners licensed by law to prescribe, administer or dispense drugs ordevices when operating under the authority of the licensure. Registration isrequired if practitioners engage in the manufacture or distribution of drugs ordevices.

(4) An agent or employe of any registered manufacturer, distributor or retailerof drugs or devices when acting in the regular course of his business or employ-ment.

(5) A common or contract carrier or warehouseman, or an employe thereofwhose possession of drugs or devices is in the usual course of his business oremployment.

(6) An ultimate user who possesses drugs or devices for his own use whichhave been obtained in good faith from a practitioner licensed to prescribe or dis-pense.

(7) Exemption from registration requirements does not relieve persons fromcompliance with other requirements or duties prescribed by law.

(8) For purposes of registration, the term retailer shall not include a personwho sells external application drugs or devices as an independent direct seller ofthe drugs or devices, unless the person’s primary business is the sale of drugs ordevices, or the person sells controlled substances, nonproprietary drugs, ordevices required to be prescribed by a physician. For purposes of this section, theterm independent direct seller means a person engaged in a trade or business whoin the course of trade or business sells consumer products to a buyer not forresale—by the buyer or another person—and who does not sell from a perma-nently located retail business establishment, but who usually sells in the purchas-er’s home.

Authority

The provisions of this § 25.114 issued under section 2102(g) of The Administrative Code of 1929(71 P. S. § 532(g)); and sections 6 and 35 of the Controlled Substance, Drug, Device and CosmeticAct (35 P. S. §§ 780-106 and 780-135).

Source

The provisions of this § 25.114 amended April 27, 1984, effective April 28, 1984, 14 Pa.B. 1451.Immediately preceding text appears at serial page (59705).

Cross References

This section cited in 28 Pa. Code § 25.113 (relating to requirements for registration).

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§ 25.115. Registration fees.

(a) General. This subsection lists annual registration fees, applicable late reg-istration fees, and compulsory registration fees. All late fees shall accrue on acalendar month basis, the amount to be determined by multiplying the appropri-ate fee by the number of months—any portion of a month shall be considered afull month—by which the registrant is late. The late fee will commence from themonth a manufacturer, distributor, or retailer has been notified they are not reg-istered as required by law. The compulsory registration fees listed in subsection(d) are in addition to the fees listed in subsections (b) and (c). They shall applyto any of the unregistered categories upon the filing of any lawsuit to compelcompliance with the registration requirements of the act.

(b) Fees for controlled substances and nonproprietary drugs. The fees formanufacturing or distributing controlled substances and nonproprietary drugs areas follows:

(1) Manufacturer —Annual Fee $400—Late Fee $50

(2) Distributor —Annual Fee $100—Late Fee $10

(c) Fees for other drugs. The fees for manufacturing, distributing, or retail-ing other drugs are as follows:

(1) Manufacturer —Annual Fee $100—Late Fee $25

(2) Distributor —Annual Fee $25—Late Fee $5.00

(3) Retailer —Annual Fee $10—Late Fee $2.00

(d) Fees for devices. The fees for manufacturing, distributing, or retailingdevices for those persons not registered under subsections (b) or (c) are as fol-lows:

(1) Annual Fee $25.(2) Late fee $10.

(e) Compulsory registration fees. In the event that litigation is required toenforce the registration requirements of the act, the additional following compul-sory registration fee shall apply for all categories of establishments listed in thissection:

$250.

(f) Only the single highest fee will apply at a given location.

(g) Such fees shall not be required of organizations which qualify for exemp-tion under section 501(c)(3) of the Internal Revenue Code of 1954 as amended,26 U.S.C.A. § 501(c)(3).

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Authority

The provisions of this § 25.115 issued under sections 6 and 25 of the Controlled Substance, Drug,Device and Cosmetic Act (35 P. S. §§ 780-106 and 780-135); and section 2102(g) of The Adminis-trative Code of 1929 (71 P. S. § 532(g)).

Source

The provisions of this § 25.115 amended through November 4, 1983, effective January 4, 1984,13 Pa.B 3375. Immediately preceding text appears at serial pages (59705) and (59706).

§ 25.116. Time and method of payment; refund.Registration and renewal fees shall be paid at the time when the application for

registration or renewal is submitted for filing. Payment should be made in theform of a personal, certified or cashiers’ check or money order made payable tothe Commonwealth of Pennsylvania. Payments made in the form of stamps, for-eign currency or third party endorsed checks will not be accepted. In the eventthe application is not accepted for filing or is denied, the payment shall berefunded to the applicant.

SAMPLES

§ 25.121. Official samples for analysis.(a) When any officer or employe of the Department collects a sample of a

drug, device, or cosmetic for analysis under the act, the sample shall be desig-nated as an official sample if records or other evidence is obtained by him or anyother officer or employe of the Department indicating that the lot of the materialfrom which such sample was collected was introduced or delivered for introduc-tion into commerce or was offered for or otherwise held for sale. Only samplesso designated by an officer or employe of the Department shall be considered tobe official samples.

(b) For the purpose of determining whether or not a sample is collected foranalysis, the term ‘‘analysis’’ includes examination and tests.

(c) The owner of a drug, device or cosmetic of which an official sample iscollected is the person who owns the shipment or other lot of the article fromwhich the sample is collected.

§ 25.122. Quantity of sample.When an officer or employe of the Department collects an official sample of a

drug, device or cosmetic for analysis under the act, he shall collect at least twicethe quantity estimated by him to be sufficient for analysis, unless:

(1) The amount of the article available and reasonably accessible for sam-pling is less than twice the quantity so estimated.

(2) The cost of twice the quantity so estimated exceeds $20;(3) The article is perishable;

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(4) The sample is collected from a person named on the label of the article,or his agent, and such person is also the owner of the article;

(5) The sample is collected from the owner of the article or his agent, andsuch article bears no label or, if it bears a label, no person is named thereon;or

(6) The analysis consists principally of rapid, analytical procedures, orga-noleptic examination, or other field, inspection examination or tests, made atthe place where the sample is collected or in a mobile or temporary laboratory.In addition to the quantity of sample prescribed above, the officer or employeeshall, if practicable, collect as part of the sample such further amount of thearticle as he estimates to be sufficient for use as exhibits in the trial of any casethat may arise under the act based on the sample.

§ 25.123. Disposition of sample.After the Department has completed such analysis of an official sample of a

drug, device or cosmetic as it determines, in the course of analysis and interpre-tation of analytical results, to be adequate to establish the respects, if any, inwhich the article is adulterated or misbranded within the meaning of the act, orotherwise subject to the prohibitions of the act, and has reserved an amount ofthe article it estimates to be adequate for use as exhibits in the trial of any casethat may arise under the Act based on the sample, a part of the sample, if anyremains available, shall be provided for analysis, upon written request, by anyperson named on the label of the article, or the owner thereof, or the attorney oragent of such person or owner, except under the following circumstances:

(1) After collection, the sample or remaining part thereof has becomedecomposed or otherwise unfit for analysis, or

(2) The request is not made within a reasonable time before the trial of anycase under the act, based on the sample, to which such person or owner is aparty. The person, owner, attorney, or agent who requests the part of sampleshall specify the amount desired. A request from an owner shall be accompa-nied by a showing of ownership, and a request from an attorney or agent by ashowing of authority from such person or owner to receive the part of sample.When two or more requests for parts of the same sample are received therequests shall be complied with in the order in which they were received solong as any part of the sample remains available therefrom.

§ 25.124. Destruction of samples.The Department is authorized to destroy:

(1) Any official sample when it determines that no analysis of such samplewill be made.

(2) Any official sample or part thereof when it determines that no caseunder the act, is or will be based on such sample.

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(3) Any official sample of part thereof when the sample was the basis of acase under the act which has gone to final judgment, and when it determinesthat no other such case is or will be based on such sample.

(4) Any official sample or part thereof if the article is perishable.(5) Any official sample or part thereof, when, after collection, such sample

or part has become decomposed or otherwise unfit for analysis.(6) That part of any official sample which is in excess of three times the

quantity it estimates to be sufficient for analysis.

§ 25.125. Payment for samples.Compensation for the samples taken pursuant to the provisions of the act shall

be made under the following conditions:(1) When the samples are found to be in compliance with the provisions of

the act.(2) Upon presentation of proper billing to the Department.

REPORTS OF SCHEDULE II CONTROLLED SUBSTANCES

§ 25.131. Every dispensing practitioner.Every pharmacy shall, at the end of each month, on forms issued for this pur-

pose by the Office of the Attorney General of the Commonwealth, provide theOffice of the Attorney General of the Commonwealth with the name of each per-son to whom a drug or preparation, which is classified by the ComprehensiveDrug Abuse Prevention and Control Act of 1970, 21 U.S.C.A. § 3801 and the actas a controlled substance in Schedule II, was sold, dispensed, distributed or givenaway, except when used in anesthetic procedures, together with such other infor-mation as may be required, under the act.

Subchapter B. HEARING AID SALES AND REGISTRATION

25.201. Application.25.202. Definitions.25.203. Advisory Council.25.204. Application for and renewal of registration.25.205. Additional registration requirements.25.206. Examinations.25.207. Categories of registrations: fee schedule.25.208. Display of registration certificates; offices.25.209. Facilities, procedures and instrumentation.25.210. Receipt, disclosure agreement and money back guarantee to purchaser—

purchaser protection.25.211. Medical recommendations; waiver form.25.212. Medical recommendations by examining physicians.25.213. Consumer review.

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25.214. Recordkeeping.25.215. Denial, revocation or suspension of registrant’s certificate.25.216. Continuing education requirements.25.217. Approval of continuing education programs.25.218. Credit for continuing education.25.219. Responsibilities of persons offering continuing education programs.25.220. Rights to enter, inspect and obtain records.25.221. Exceptions.

Authority

The provisions of this Subchapter B issued under The Hearing Aid Sales Registration Law (35 P. S.§§ 6700-101—6700-802), unless otherwise noted.

Source

The provisions of this Subchapter B adopted August 25, 1978, 8 Pa.B. 2343; amended May 28,2004, effective May 29, 2004, 34 Pa.B. 2808, unless otherwise noted.

§ 25.201. Application.(a) Scope. This subchapter applies to all persons engaged in the business of

selling or fitting hearing aids in this Commonwealth; except that physicians andaudiologists are exempted from all provisions regarding hearing aid fitters.

(b) Authority. This subchapter is adopted under the act.

Notes of Decisions

Since the legislature obviously believes that the license already held by physicians and audiologistsis adequate proof of their competence to fit patients with hearing aids, they are not required to takea qualifying examination prior to obtaining a hearing aid dealers certificate. Pennsylvania Hearing AidDealers Association, Inc. v. Department of Health, 417 A.2d 1340 (Pa. Cmwlth. 1980); affirmed 430A.2d 1150 (Pa. 1981).

§ 25.202. Definitions.The following words and terms, when used in this subchapter, have the follow-

ing meanings, unless the context clearly indicates otherwise:Act—The Hearing Aid Sales Registration Law (35 P. S. §§ 6700-101—6700-

802).Advertise and any of its variants—The use of a newspaper, magazine or

other publication, book, notice, circular, pamphlet, letter, handbill, poster, sign,placard, label, tag, window display, store sign, radio, television announcement,Internet, or other means or methods employed to bring to the attention of thepublic the practice of selling or fitting hearing aids.

Audiologist—A person who holds a current license as an audiologist issuedby the State Board of Examiners in Speech-Language and Hearing, or a personwho is permitted to practice audiology pursuant to an exemption to the audi-ologist licensure requirement under section 6(b) of the Speech-Language andHearing Licensure Act (63 P. S. § 1706(b)).

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Authorized representative—A person who is authorized by law to make adecision, required pursuant to this subchapter, for a hearing aid user or prospec-tive hearing aid user.

Business of selling hearing aids—(i) Selling, leasing or offering for sale or lease new, used or recondi-

tioned hearing aids exclusive of parts, attachments or accessories, at retail,either as exact replacements for damaged or worn out units or written speci-fications provided by an audiologist, otologist or otolaryngologist.

(ii) The term does not include fitting or the practice of fitting and sell-ing hearing aids.Continuing education program—A program approved by the Department for

credit towards the continuing education requirements for the renewal of theregistration certificate of a hearing aid fitter.

Conviction—A plea or verdict of guilty, or a conviction following a plea ofnolo contendere to a charge of a crime involving moral turpitude.

Department—The Department of Health of the Commonwealth.Fitting—Includes the physical acts of adjusting the hearing aid to the indi-

vidual, taking audiograms, making ear molds, advising the individual withrespect to hearing aids, making audiogram interpretations and assisting in theselection of a suitable hearing aid to sell a hearing aid.

Hearing aid—A wearable instrument or device designed or offered to aid orcompensate for impaired human hearing together with any parts, attachmentsor accessories for those instruments or devices, including ear molds but exclud-ing batteries and cords.

Hearing aid dealer—A person engaged in the business of selling hearingaids.

Hearing aid fitter—An individual engaged in the practice of fitting and sell-ing hearing aids.

Hearing aid user—An individual who uses a hearing aid.Practice of fitting and selling hearing aids—Those practices used solely for

making selections, adaptations and sales of hearing aids.Prospective hearing aid user—An individual who is considering buying a

hearing aid or whose hearing is being evaluated by a registrant.Purchaser—An individual who has agreed to purchase a hearing aid from a

registrant.Registrant—A hearing aid dealer or fitter holding a current certificate of reg-

istration.Secretary—The Secretary of Health of the Commonwealth.Sponsor—An individual registered in this Commonwealth as a hearing aid

fitter who agrees to supervise an apprentice hearing aid fitter.Used hearing aid—

(i) A hearing aid that has been worn for any period of time by a user.

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(ii) A hearing aid is not a used hearing aid if it has been worn only bya prospective user as part of a bona fide hearing aid evaluation conducted inthe presence of the registrant or an individual selected by the registrant andauthorized by law to assist the prospective user in making such an evalua-tion.

§ 25.203. Advisory Council.(a) The Advisory Council (Council) will be composed as provided for under

section 201 of the act (35 P. S. § 6700-201).(b) It will be the duty of the Council to advise the Secretary, to the best of its

ability, on the administration of the act.(c) The Council will hold at least one annual meeting at a time and place

designated by the Secretary for the purpose of providing information and adviceto the Department.

(d) A Council member may convey the impression, either publicly or pri-vately, that the member is acting officially for the Council only with prior autho-rization from the Council.

§ 25.204. Application for and renewal of registration.(a) Application. An application for registration or renewal of registration as a

hearing aid dealer, hearing aid fitter, apprentice hearing aid fitter or temporaryhearing aid fitter can be obtained from the Division of Home Health, Pennsylva-nia Department of Health, 132 Kline Plaza, Suite A, Harrisburg, Pennsylvania17104.

(b) Apprentice hearing aid fitter. A completed application for registration asan apprentice hearing aid fitter shall be filed with the Department at least 30 daysbefore the fitter’s examination that the applicant intends to take, together with acheck, money order or other approved method of payment as the Departmentpublishes in a notice in the Pennsylvania Bulletin, in the amount of $50. Anadditional $150 shall be paid before taking the fitter’s examination. The applica-tion fee is not refundable, but the $150 fee for the examination will be refundedto an applicant who is found to be ineligible to take the examination.

(c) All other registrations. A completed application for any registration cer-tificate, other than a registration certificate as an apprentice hearing aid fitter, maybe filed at any time, together with a check, money order or other approvedmethod of payment as the Department publishes in a notice in the PennsylvaniaBulletin, in the amount of the appropriate application fee.

(d) Renewal of current certificate. A registrant shall apply to renew a currentregistration certificate by March 16 prior to the certificate’s expiration, by sub-mitting a completed renewal application, available from the Department, alongwith the renewal fee of $100. To renew a hearing aid fitter’s registration certifi-cate, the applicant shall also demonstrate satisfaction of the continuing educationrequirements under § 25.216 (relating to continuing education requirements).

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(e) Renewal of expired certificate. An expired registration certificate may berenewed within 5 years after its expiration or inactive date by filing an applica-tion for renewal, with payment of the renewal fee, and payment of the delin-quency fee if the application is received more than 30 days after the expirationdate. To renew an expired hearing aid fitter’s registration certificate, the applicantshall also demonstrate satisfaction of the continuing education requirementsunder § 25.216.

(f) Renewal of fitter’s temporary registration certificate and apprentice cer-tificate. Upon application, the Secretary may renew a temporary certificate orapprentice certificate for a period which shall expire 30 days after the next avail-able fitter’s qualifying examination has been given. The Secretary will not issuemore than two renewals of these certificates, except upon petition of an applicantfor good and sufficient cause shown. An applicant may petition the Departmentfor an additional renewal. The petition shall include the reasons for which theadditional renewal is requested. An applicant shall send a petition for additionalrenewal to the Division at the address given in subsection (a). The Departmentwill then decide whether to issue the renewal.

(g) Late application for renewal. A person who files for renewal of a regis-tration certificate after March 16 may not receive the renewal before the registra-tion certificate expires.

Cross References

This section cited in 28 Pa. Code § 25.205 (relating to additional registration requirements); 28Pa. Code § 25.206 (relating to examinations); and 28 Pa. Code § 25.208 (relating to display of reg-istration certificates; offices).

§ 25.205. Additional registration requirements.

(a) Hearing aid dealers. No requirement is imposed in addition to thoseimposed under § 25.204(c) (relating to application for and renewal of registra-tion).

(b) Hearing aid fitters. A hearing aid fitter shall pass the qualifying examina-tion as provided by the act.

(c) Reciprocal registration—certificate by endorsement.(1) An applicant for registration to practice as a hearing aid dealer or as a

hearing aid fitter who is licensed or registered in any other state, which hasrequirements equal to or greater than those in this Commonwealth for registra-tion as a hearing aid dealer or fitter and which maintains reciprocal practiceprivileges with this Commonwealth, may be granted a registration certificate byendorsement by the Secretary. Being qualified to apply for a hearing aid fitter’sregistration certificate by endorsement relieves the applicant from having totake the qualifying examination otherwise required under the act.

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(2) In all other respects, the applicant for a registration certificate byendorsement shall be registered in the same manner and meet the same require-ments as other registrants.

(3) If the Commonwealth does not maintain reciprocal practice privilegeswith a state in which a person is registered or otherwise authorized to functionas a hearing aid fitter or dealer, the person may apply for a temporary registra-tion certificate under subsection (e).(d) Apprentice registration. Apprentice registration shall conform to the fol-

lowing:(1) An applicant for registration as an apprentice hearing aid fitter shall

have a sponsor responsible for the training and supervision of the applicant.(2) An application shall be accompanied by a statement of the sponsor:

(i) Setting forth the type of supervision which shall be given the appli-cant.

(ii) Providing an outline of the training program to be followed in pre-paring the applicant for examination. The training program shall includeeducation and training in at least the following areas:

(A) The anatomy and physiology of the ear.(B) The function of hearing aids.(C) The grounds for revocation or suspension of a certificate of regis-

tration, or probation of a registrant, under the act.(D) The violations and penalties under the act.(E) The procedures and use of equipment established by the Depart-

ment for the fitting and selling of hearing aids.(F) The taking of ear mold impressions.(G) The medical and rehabilitation facilities for children and adults

that are available in the areas served.(H) The criteria for medical referral when found to exist either from

observation by the registrant or on the basis of information furnished bythe prospective hearing aid user, to include those criteria in § 25.211(d)(relating to medical recommendations; waiver forms).(iii) Providing the registration number of the sponsor.

(3) An apprentice hearing aid fitter desiring to change sponsors shall fur-nish the Department a sworn or affirmed request giving reasons for the changeand a sworn or affirmed statement from the new sponsor setting forth theinformation required by paragraph (2), and accompanied by the apprentice’scertificate of registration. An affirmed statement may be given in any form solong as it is in writing, signed, and contains a statement to the effect that it istruthful.

(4) A sponsor desiring to terminate responsibilities with regard to anapprentice shall give the apprentice 10 days written notice of the reasons forthe action and shall notify the Department at the same time by certified mail.

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(e) Temporary registration. Temporary registration shall conform to the fol-lowing:

(1) A temporary fitter’s registration certificate will be issued to an appli-cant who satisfactorily demonstrates having been engaged in the fitting andselling of hearing aids at an established place of business in a state other thanthis Commonwealth for 2 years within a 5-year period immediately beforemaking application and who otherwise fulfills the requirements of the act andthis subchapter.

(2) The temporary registrant shall take the hearing aid fitter’s examinationto qualify for a regular hearing aid fitter’s registration certificate.

(3) The temporary registration certificate shall expire 30 days after theadministration of the qualifying examination that the temporary registranttakes. The temporary registrant shall take the qualifying examination no earlierthan 90 days after the date the temporary registration certificate was issued, andno later than 1 year after the date the temporary registration certificate wasissued.

Notes of Decisions

Since the legislature obviously believes that the license already held by physicians and audiologistsis adequate proof of their competence to fit patients with hearing aids, they are not required to takea qualifying examination prior to obtaining a hearing aid dealers certificate. Pennsylvania Hearing AidDealers Association, Inc. v. Department of Health, 417 A.2d 1340 (Pa. Cmwlth. 1980); affirmed 430A.2d 1150 (Pa. 1981).

§ 25.206. Examinations.(a) An examination to obtain registration as a hearing aid fitter shall be held

at least twice each year, at a time and place to be fixed by the Secretary at least45 days before the examination date.

(b) The date of an examination may be obtained by writing to the Division atthe address given in § 25.204(a) (relating to application for and renewal of reg-istration), by checking the Department’s website at www.health.state.pa.us, or byphone or e-mail to the Division.

(c) The passing grade on an examination will be determined by the Secretary.

§ 25.207. Categories of registrations; fee schedule.(a) A registration certificate, other than a temporary or apprentice registration

certificate, shall expire at midnight of April 15 of each year, if not renewed.(b) For a hearing aid dealer, the initial registration fee is $200 if the Depart-

ment issues the registration certificate between April 15 and October 14, and$100 if the Department issues the registration certificate between October 15 andApril 14. The annual renewal fee is $100 for both dealers and fitters.

(c) For a hearing aid fitter’s registration certificate, the initial registration feeis $200, $150 of which will be refunded if the applicant is ineligible to take thequalifying fitter’s examination. The annual renewal fee is $100.

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(d) For a registration certificate by endorsement the fees shall be the same asin subsection (b).

(e) For a temporary hearing aid fitter’s registration certificate, the initial reg-istration fee is $200, $150 of which is for the examination. A refund of the $150will be made if the applicant is ineligible to take the qualifying examination fora fitter’s registration certificate. Instead of paying the full $200 when making theapplication, the applicant may pay $50 when making the initial application, and$150 before taking the examination for the first time. The renewal fee is $100.

(f) For an apprentice fitter’s registration certificate, the fee is $50 plus anadditional $150 before the apprentice takes the fitter’s examination. The renewalfee is $100.

(g) For a duplicate or replacement registration certificate, the fee is $10. Theregistrant shall obtain a duplicate certificate upon the loss of an original certifi-cate or for a branch office. The registrant shall obtain a replacement registrationcertificate upon a name change by the person holding a certificate.

(h) The fee to retake the fitter’s examination for an applicant who has previ-ously failed the examination is $50.

(i) A delinquency fee will be assessed if an applicant applies for renewal ofa registration certificate after May 15. The delinquency fee is $50.

(j) For renewal of a suspended registration certificate, the fee is $100 plusthe delinquency fee if one has otherwise accrued.

§ 25.208. Display of registration certificates; offices.(a) A registrant shall display the dealer’s or fitter’s registration certificate at

the place of business listed in the registrant’s application.(b) If a registrant maintains more than one place of business within this

Commonwealth, the registrant shall apply for a duplicate registration certificatefor each branch office. The registrant shall display the appropriate duplicate reg-istration certificate in each office.

(c) The place of business identified in a registrant’s application shall be anoffice at a fixed location. An office which is part of a building normally used asa residence shall be in a space set aside for office purposes only.

(d) A registrant shall file notice of a change in the registrant’s place of busi-ness with the Department at least 10 work days before the change by writing tothe Department at the address given in § 25.204(a) (relating to application forand renewal of registration).

(e) A registrant shall make the registration certificate available for inspectionon request of any client, prospective client, Department employee or law enforce-ment official.

§ 25.209. Facilities, procedures and instrumentation.(a) Facilities. A registrant shall engage in the practice of fitting or selling a

hearing aid only if the registrant provides:

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(1) An appropriate test area, the ambient noise level of which shall have adocumented readout of 55 dB or lower on the A scale of a sound level meter.

(2) A selection of hearing aid models, supplies and accessories to providefor the immediate needs of hearing aid users or prospective hearing aid users.(b) Procedures. A registrant shall satisfy the following:

(1) The registrant shall sell a hearing aid only if within 6 months before thesale an examination of the prospective hearing aid user was conducted usingpure tone air conduction, bone conduction and speech audiometry tests. Thisrequirement does not apply when the registrant is replacing a hearing aid withanother of the same make, model and response. The registrant shall sell a hear-ing aid replacing another of the same make, model and response only if within12 months before the sale an examination of the prospective hearing aid userwas conducted using pure tone air conduction, bone conduction and speechaudiometry tests. The registrant shall verify that the tests were performed by anindividual authorized by law to do so. The registrant may rely on a representa-tion by the physician, audiologist or fitter who performed or supervised thetests that the individual who performed the tests was authorized to do so.

(2) The registrant shall:(i) Perform air conduction tests for hearing level thresholds at frequen-

cies of 250 Hz, 500 Hz, 1,000 Hz, 2,000 Hz, 4,000 Hz and 6,000 Hz or 8,000Hz, with masking if necessary.

(ii) Perform bone conduction tests for hearing level thresholds at fre-quencies of 500 Hz, 1,000 Hz, 2,000 Hz and 4,000 Hz, with masking if nec-essary.

(iii) Maintain records of the test results for each ear for 7 years.(iv) Perform a speech reception or speech awareness threshold test using

an electronic speech audiometer with head or insert ear phones.(v) Perform a word discrimination or other speech intelligibility test for

conversational level speech using an electronic speech audiometer with heador insert ear phones.(3) The registrant shall sell a hearing aid only if the hearing aid is fitted to

the wearer to ensure physical and operational comfort and improvement inhearing function is demonstrated and documented in at least one of the follow-ing areas: speech detection, speech awareness levels, speech intelligibility, ori-entation or speech reception threshhold.(c) Instrumentation. A registrant shall satisfy the following:

(1) All test instruments shall be calibrated once each year or more often ifnecessary to meet current American National Standards Institute standards forpure tone and speech audiometry as identified by 1996 A.N.S.I. standards orapplicable succeeding A.N.S.I. standards.

(2) Instruments transported to test sites shall be calibrated to the standardset forth in paragraph (1) every 6 months, or more frequently as needed.

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(3) Calibration shall be performed by a qualified individual other than theowner.

(4) A signed certificate identifying the most recent date of calibration shallbe maintained for inspection by the Department.

Cross References

This section cited in 28 Pa. Code § 25.214 (relating to recordkeeping).

§ 25.210. Receipt, disclosure agreement and money back guarantee topurchaser—purchaser protection.

(a) Receipt. Upon the sale of a hearing aid, the registrant shall provide thepurchaser a signed receipt. The receipt may be made out on more than one sheetof paper and shall contain the following:

(1) The date of sale.(2) The make, model and serial number or, if no serial number is appli-

cable, an identification number of the hearing aid.(3) The address of the principal place of business of the registrant.(4) If the hearing aid is used or reconditioned, a statement which provides

that information and which meets the requirements of § 25.215(23) (relating todenial, revocation or suspension of registrant’s certificate).

(5) The registrant’s registration certificate number.(6) The terms of any guarantee or express warranty made to the purchaser

with respect to the hearing aid.(7) A copy of the written forms as required by § 25.211 (relating to medi-

cal recommendations; waiver forms).(8) A statement on or attached to the receipt, in no smaller than 10 point

type, as follows:‘‘The purchaser has been advised at the outset of his relationship with the hear-ing aid dealer that any examination or representation made by a registeredhearing aid dealer and fitter in connection with the practice of fitting and sell-ing of this hearing aid, is not an examination, diagnosis or prescription by aperson licensed to practice medicine in this Commonwealth and therefore mustnot be regarded as medical opinion.’’

(9) A statement on the face of the receipt, in no smaller than 10 point boldtype, as follows: ‘‘If your rights are violated, you may contact the State Bureauof Consumer Protection, the Pennsylvania Department of Health in Harrisburg,or your local district attorney.’’(b) Disclosure agreement and money back written guarantee. Before the pro-

vision of any service incidental to or connected with the potential sale of a hear-ing aid, the registrant shall provide a disclosure agreement and money back writ-ten guarantee to the prospective hearing aid user or authorized representative, andshall explain it in detail in accordance with subsection (c). This shall be in 10

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point type or larger, and may be made out on more than one sheet of paper, butshall employ the following format or be on a form approved by the Department:

HEARING AID DISCLOSURE AGREEMENT/MONEY BACKGUARANTEE

(Business Name) (Business Address)

Telephone No. ( )

PART A.

Description of services included infitting procedure or process, andsale and delivery of hearing aid.

FEE (Statewhether fee iswaived if hearingaid purchased)

REFUNDABLE(Upon return ofhearing aids)

NOTREFUNDABLE

THIS DISCLOSURE AGREEMENT WAS PROVIDED, PARTS A AND BWERE EXPLAINED, AND PART A (FEES FOR SERVICES NOT PART OFTHE PRICE OF THE HEARING AID) WAS COMPLETED AT

(time) ON (date), BEFOREANY SERVICES WERE PROVIDED. PART B (CANCELLATION FEES THATWILL BE INCURRED IF A HEARING AID IS RETURNED UNDER THE30-DAY MONEY BACK GUARANTEE BELOW), WAS COMPLETED ANDEXPLAINED AFTER SERVICES WERE PROVIDED AND BEFORE ANYPAYMENT WAS MADE. IF PART B IS NOT COMPLETED, IT IS BECAUSEA HEARING AID WAS NOT RECOMMENDED OR NOT DESIRED.

NOTHING IN THIS DISCLOSURE AGREEMENT SHALL RELIEVE AREGISTRANT OF THE OBLIGATION TO REFUND ALL OR PART OF THEABOVE FEES, INCLUDING THOSE LISTED AS NOT REFUNDABLE, IF ACOURT DETERMINES THAT THE REGISTRANT HAS VIOLATED A PENN-SYLVANIA CONSUMER PROTECTION LAW IN THE SALE OR FITTINGOF THE HEARING AID (OR SIMILAR DEVICE) AND IF THE COURTORDERS SUCH REFUND.

Customer’s Signature Registrant’s Signature

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PART B.

HEARING AIDS &ACCESSORIES

DESCRIPTION ofGOODS—includemake, model, serialnumber(s) PRICE

REFUNDABLE(upon return ofhearing aid)

NOTREFUNDABLE(CancellationFee)

HearingAid(s)

Right

Left

Accessories (Describe, ifapplicable)

TOTAL

Total maximum Cancellation Fee is lesser of 10% or $150 per hearing aid includingaccessories.

30 Day Money Back Guarantee: If a hearing aid is returned within 30 daysof date of delivery in the same condition, ordinary wear and tear excluded, youare entitled to a refund of the portion of the purchase price of the hearing aid andaccessories as itemized on the receipt and above, less the cancellation fee statedabove. If a cancellation fee is imposed the nonrefundable amount for each aid andaccessories cannot exceed 10% of the purchase price of the hearing aid andaccessories or $150.00 per aid and accessories, whichever is less. You will, how-ever, be responsible for all nonrefundable service fees listed in Part A. If youcancel your order prior to delivery, you are entitled to full refund of the purchaseprice of the aid and accessories, and a full refund for services not yet rendered.

Customer’s Signature Date and time of Sale DATE of DELIVERY

Registrant’s Signature Registration No. Customer’s Signature orInitials

(c) Additional responsibilities of registrant with respect to the disclosureagreement/money back guarantee.

(1) Before providing any services incidental to the possible sale of a hear-ing aid to the prospective hearing aid user, the registrant shall explain Part A ofthe disclosure agreement/money back guarantee to the prospective hearing aiduser or authorized representative and shall complete Part A. The registrant shallalso give a preliminary explanation of Part B, including any cancellation feesthat may be retained if a purchaser decides to return a hearing aid. The regis-trant shall include in Part A a complete description of what the fitting proce-dure or process includes, and shall itemize and disclose fees associated with thefitting procedure or process and the sale and delivery of the hearing aid. Foreach service provided, the registrant shall identify by dollar amount the portion

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of the fee that is refundable and the portion that is not refundable. If a fee willbe waived if a hearing aid is purchased, that shall be stated. If the registrantcharges no fees for services, the registrant shall note that in Part A.

(2) After Parts A and B have been explained and Part A has been com-pleted, the registrant shall have the prospective hearing aid user or authorizedrepresentative complete the time and date lines provided under Part A. Theprospective hearing aid user or authorized representative and registrant shallalso sign under Part A when appropriate.

(3) After completing the necessary testing, if it is determined that a hear-ing aid will be recommended, the registrant shall explain and complete Part B,itemizing any cancellation fee associated with the sale and delivery of a hear-ing aid and its accessories by designating that amount as ‘‘not refundable.’’ PartB shall be fully explained and completed before any payment is made. If PartB becomes inapplicable due to a decision by the registrant, prospective hearingaid user or authorized representative not to proceed further after testing, thedisclosure agreement/money back guarantee need not be fully completed. Theregistrant shall provide a copy of the partially completed disclosure agreement/money back guarantee to the prospective hearing aid user or authorized repre-sentative.

(4) If the registrant and the prospective hearing aid user or authorized rep-resentative decide to proceed, the registrant shall explain the 30-day moneyback guarantee. If the prospective user or authorized representative decides topurchase a hearing aid, the registrant shall have the purchaser sign the secondsignature line on the disclosure agreement/money back guarantee and completethe line for date and time of sale, and shall also sign when appropriate.

(5) The registrant may revise the relevant portion of the disclosureagreement/money back guarantee form to disclose the registrant’s policy ofoffering a money back guarantee return period longer than 30 days. The moneyback guarantee shall be for at least 30 days from the date of delivery.

(6) After the disclosure agreement/money back guarantee is fully com-pleted except for the date of delivery block and the hearing aid serial numbers,the registrant shall provide a copy of it to the hearing aid user or authorizedrepresentative.

(7) At the time the hearing aid is delivered to the hearing aid user orauthorized representative, the registrant shall ensure that the signature or ini-tials of the user or authorized representative is obtained and the date of deliv-ery and serial number are inserted in the block or section provided for that pur-pose on the disclosure agreement/money back guarantee. After the block iscompleted with the initials or signature and date and the serial number isinserted, the registrant shall provide a copy of the completed disclosureagreement/money back guarantee to the purchaser.

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(Editor’s Note: An Alternate Disclosure Agreement form was published at 42 Pa.B. 7061 (Novem-ber 10, 2012).)

Cross References

This section cited in 28 Pa. Code § 25.214 (relating to recordkeeping).

§ 25.211. Medical recommendations; waiver forms.(a) Except when selling a replacement of a worn out or damaged hearing aid,

when selling a hearing aid for the use of a prospective hearing aid user who is 19years of age or older, a registrant shall either obtain for the prospective user amedical recommendation that complies with § 25.212 (relating to medical rec-ommendations by examining physicians), or ensure that the prospective user orauthorized representative signs a waiver form as provided under section 403 ofthe act (35 P. S. § 6700-403). The waiver form shall be prepared and used as fol-lows:

(1) The waiver form shall be in 10 point type or larger.(2) The waiver shall be read to the prospective hearing aid user or autho-

rized representative and explained in a manners that the individual is notencouraged to waive a medical examination and so that the individual will bethoroughly aware that signing the waiver will not be in the prospective hearingaid user’s best interest.

(3) The waiver form shall read as follows:I have been advised that my best interests would be served if I had a medical

examination by an otologist or otolaryngologist or any licensed physician beforemy purchase of a hearing aid.

(Registrant’s Name) has fully and clearly informed me of thevalue of such medical examination. After such explanation, I voluntarily sign thiswaiver. I choose not to seek a medical examination before the purchase of thehearing aid.

(Signature of Registrant)

(Address of Registrant)

(Signature of Purchaser)

(Date of Signature)(b) When selling a replacement of a worn out or damaged hearing aid for the

use of a prospective hearing aid user who is 18 years of age or older, a registrantshall either obtain for the prospective user a medical recommendation that com-plies with the requirements of § 25.212, or ensure that the prospective user orauthorized representative signs a legally proper waiver of the medical examina-tion. For purposes of this subsection, a legally proper waiver includes a medicalwaiver form as provided under section 403 of the act and described in subsection(a), or a Federal medical waiver form as approved by the Food and Drug Admin-istration of the United States Department of Health and Human Services.

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(c) Except when a registrant is selling a hearing aid to replace an identicalhearing aid, the registrant may sell a hearing aid for the use of a prospective user18 years of age or younger only if the registrant obtains a medical recommenda-tion that complies with the requirements of § 25.212 and is signed by a physi-cian specializing in otolaryngology or otology. When selling an identical replace-ment hearing aid for the use of an individual under 18 years of age, the registrantshall obtain a medical recommendation that complies with the requirements of§ 25.212.

(d) Before the sale of a hearing aid a registrant shall inform the prospectivehearing aid user or authorized representative, in writing, that it would be in thebest interest of the prospective hearing aid user to consult a physician specializ-ing in or qualified to deal with diseases of the ear if the prospective hearing aiduser has any of the following conditions:

(1) Visible congenital or traumatic deformity of the ear.(2) Active drainage from the ear within the previous 90 days or a history

of this symptom.(3) Sudden or rapidly progressive hearing loss within the previous 90 days

or a history of this symptom.(4) Acute or chronic dizziness.(5) Unilateral hearing loss of sudden or recent onset within the previous 90

days.(6) Visible evidence of cerumen accumulation or a foreign body in the ear

canal.(7) Significant air-borne gap of 15dB or greater at 500 Hz, 1000 Hz and

2000 Hz.(8) Pain in the ear within the previous 90 days.

Cross References

This section cited in 28 Pa. Code § 25.205 (relating to additional application requirements); 28Pa. Code § 25.210 (relating to receipt to purchaser—purchaser protection); 28 Pa. Code § 25.213(relating to consumer review); and 28 Pa. Code § 25.214 (relating to recordkeeping).

§ 25.212. Medical recommendations by examining physicians.

(a) Whenever a medical examination is performed under the act or Federalrequirements, before fitting and selling a hearing aid the registrant shall ensurethat a medical recommendation has been signed by the examining physician,within 180 days before the sale, on a form which includes the following statementor its equivalent:

I have medically evaluated the hearing ability of

(Patient’s Name)and a hearing aid may be beneficial to this person.

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(Signature of Physician)

(Date of Evaluation)(b) If the prospective hearing aid user is 18 years of age or younger, the reg-

istrant shall ensure that the prospective user’s date of birth has been included onthe medical recommendation form.

Cross References

This section cited in 28 Pa. Code § 25.211 (relating to medical recommendations; waiver forms);and 28 Pa. Code § 25.214 (relating to recordkeeping).

§ 25.213. Consumer review.(a) Before signing a waiver form under § 25.211 (relating to medical recom-

mendations; waiver forms) and before the sale of a hearing aid to or for the useof a prospective hearing aid user, the registrant shall:

(1) Provide the prospective hearing aid user or authorized representativewith a copy of the User Instructional Brochure for the hearing aid that has beenor may be selected for the prospective user.

(2) Review the content of the User Instructional Brochure with the pro-spective hearing aid user or authorized representative orally or in the predomi-nant method of communication used during the sale.

(3) Give the prospective hearing aid user or authorized representative anopportunity to read the User Instructional Brochure.(b) If goods or services having a sale price of $25 or more are sold or con-

tracted to be sold to a purchaser as a result of or in connection with a contact withor call on the purchaser at the purchaser’s residence, the purchaser may avoid thecontract or sale by notifying the registrant of that decision, in writing, within 3full business days following the day on which the contract or sale was made andby returning or holding available for return to the registrant, in its original con-dition, any merchandise received under the contract or sale. The notice of rescis-sion is effective when deposited in the United States mail or when service ismade in another manner which gives the registrant notice of rescission. These andadditional provisions relating to the sale of goods in the purchaser’s home,including specific items which shall be included on the purchase receipt, aremade a part of this section by incorporation of section 7 of the Unfair TradePractices and Consumer Protection Law (73 P. S. § 201-7).

§ 25.214. Recordkeeping.A registrant shall, upon the consummation of a sale of a hearing aid, keep and

maintain records in the registrant’s office or place of business at all times. Theserecords shall be kept for 7 years and shall include the following:

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(1) Results of all testing conducted under § 25.209 (relating to facilities,procedures and instrumentation). The minimum acceptable test records shall berecords of:

(i) Pure tone tests including air and bone conduction with maskingwhere appropriate, and the ambient noise level of the test area.

(ii) Speech reception threshold expressed in decibels of hearing level.(iii) Most comfortable level expressed in decibels.(iv) Uncomfortable (tolerance) level expressed in decibels.(v) Word discrimination test results expressed in percentage indicating

the test words used, presentation level, masking level (if applicable), andsignal to noise ratio (if applicable).(2) A copy of the written receipt, disclosure agreement and money back

guarantee required by § 25.210 (relating to receipt, disclosure agreement andmoney back guarantee to purchaser—purchaser protection).

(3) The written physician’s recommendation required by § 25.212 (relat-ing to medical recommendations by examining physicians) or the waiver formrequired by § 25.211 (relating to medical recommendations; waiver forms).

§ 25.215. Denial, revocation or suspension of registrant’s certificate.The Secretary may deny, suspend or revoke a registration certificate provided

under the act or the Secretary may impose conditions of probation upon a regis-trant for any of the following causes:

(1) Gross incompetency which includes the improper or unnecessary fittingof a hearing aid.

(2) Conviction of a felony or misdemeanor involving moral turpitude.(3) Obtaining a registration certificate by fraud or deceit.(4) Using the term ‘‘doctor’’ or ‘‘physician’’ or ‘‘clinic’’ or ‘‘audiologist’’

or any derivation thereof as part of the firm name under which the registrantfits and sells hearing aids, unless authorized by law.

(5) Fraud or misrepresentation in the repair, fitting or selling of a hearingaid.

(6) Employing a person to perform a function within the scope of practiceof a hearing aid fitter who is not authorized by law to perform the function.

(7) Habitual intemperance.(8) Gross immorality.(9) Permitting another person to use the registration certificate for any pur-

pose, except permitting an audiologist or physician employed by the registrantto sell hearing aids for the registrant.

(10) Violating or, with notice or knowledge permitting an employee to vio-late, the act or this subchapter.

(11) A cause which would be a ground for denial of an application for aregistration certificate.

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(12) Having been enjoined from violating a provision of the Unfair TradePractices and Consumer Protection Law (73 P. S. §§ 201-1—209-6) or beingsubject to a final order of the Federal Trade Commission, the Department, orthe Food and Drug Administration of the United States Department of Healthand Human Services, concerning the sale or offering for sale of an unsafe,unhealthful or worthless hearing device or for engaging in conduct which hasthe tendency to mislead or deceive.

(13) Using, causing or promoting the use of any advertising matter, promo-tional literature, testimonial, guarantee, warranty, label, brand, insignia or anyother representation, however disseminated or published, that is misleading,deceiving, improbable or untruthful, such as a misrepresentation relating to:

(i) The grade, quality, quantity, origin, novelty, price, dealer cost, termsof sale, use, construction, size, composition, dimensions, type, design, devel-opment, visibility, durability, performance, fit, appearance, efficacy, benefits,cost of operation, resistance to climatic conditions, or physiological benefitsof a hearing aid or the psychological well-being induced by a hearing aid.

(ii) A service or adjustment offered, promised, or supplied to a pur-chaser of a hearing aid, or the fee associated with the service or adjustment.(14) Making a representation that a hearing aid is ‘‘guaranteed,’’ without

clear and conspicuous disclosure of:(i) The nature and extent of the guarantee.(ii) A material condition or limitation of the guarantee which is imposed

by the guarantor.(iii) The manner in which the guarantor will perform thereunder.(iv) The identity of the guarantor, with disclosure, if applicable, that any

guarantee made by the registrant which is not backed up by the manufactureris offered by the registrant only.

(v) The meaning of ‘‘life’’ or ‘‘lifetime’’ to clarify whether it refers tothe life of the purchaser, the product, or otherwise, whenever representationsare made that a hearing aid is ‘‘guaranteed for life’’ or has a ‘‘lifetime guar-antee.’’(15) Making a guarantee, warranty, or promise which, under normal condi-

tions, is impractical of fulfillment or which is for a period of time or of a naturethat may cause a purchaser to believe that the hearing aid has a greater degreeof service ability, durability or performance capability in actual use than is true.

(16) Making a misrepresentation as to the character of the business con-ducted by the registrant. Unless it is true, a registrant may not represent directlyor indirectly through the use of any word or term, in the corporate or tradename, in advertising, or otherwise, that the registrant owns or maintains a labo-ratory devoted to hearing aid research, testing, experimentation or develop-ment. A registrant may not misrepresent in any other material respect the char-acter, extent or type of business conducted by the registrant.

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(17) Causing deception that services or advice of a physician were used inthe design or manufacture of hearing aids. Unless it is true, a registrant maynot represent, directly or by implication, that the services or advice of a physi-cian have been used in the designing or manufacturing of hearing aids. Theprohibitions of this paragraph are applicable to the use of the terms ‘‘doctor,’’‘‘physician,’’ ‘‘otologist’’ or ‘‘otolaryngologist,’’ to the use of any abbrevia-tions, variations or derivatives of those terms; and to the use of any symbol,depiction, or representation having a medical connotation.

(18) Making a deceptive representation as to the visibility or the construc-tion of a hearing aid. A registrant may not do any of the following:

(i) Represent, directly or by implication, through the use of such wordsor expressions as ‘‘invisible,’’ ‘‘hidden,’’ ‘‘hidden hearing,’’ ‘‘completely outof sight,’’ ‘‘conceal your deafness,’’ ‘‘hear in secret,’’ ‘‘unnoticed even byyour closest friends,’’ ‘‘no one will know you are hard of hearing,’’ ‘‘yourhearing loss is your secret,’’ ‘‘no one need know you are wearing a hearing-aid,’’ ‘‘hidden out of sight when inserted in the ear canal’’ or by any otherwords or expressions of similar import, that any hearing aid, device, or partis hidden or cannot be seen unless it is hidden or cannot be seen.

(ii) Represent directly or by implication that a hearing aid utilizing boneconduction has a specified feature such as the absence of anything in the earor leading to the ear, or the like, without disclosing clearly and conspicuouslythat the instrument operates on the bone-conduction principle and that, inmany cases of hearing loss, this type of instrument may not be suitable.

(19) Making an advertisement or other representation which may have thetendency or effect of misleading or deceiving a purchaser or prospective pur-chaser to believe that a hearing aid or device or part or accessory thereof is anew invention or involves a new mechanical or scientific principle, when thatis not true. Representations of the following or similar types, when not fullyjustified by the facts, are among those prohibited by this paragraph: ‘‘amazingnew discovery,’’ ‘‘revolutionary new invention,’’ ‘‘radically new and different,’’‘‘sensational new laboratory development,’’ ‘‘remarkable new electronicdevice,’’ ‘‘brand new invention,’’ ‘‘marvelous new hearing invention,’’ ‘‘newscientific aid’’ and ‘‘miracle.’’

(20) Misrepresenting the commercial nature of the registrant’s business. Aregistrant may not represent, directly or by implication, that a commercialhearing aid establishment is a governmental or public one or is a nonprofitmedical, educational or research institution, through the use of a term having amedical, professional or scientific connotation, such as ‘‘Hearing Center,’’‘‘Hearing Institute,’’ ‘‘Hearing Bureau,’’ ‘‘Hearing Clinic,’’ ‘‘State’s HearingClinic,’’ or ‘‘State’s Speech and Hearing Center.’’ Nothing in this paragraphprecludes a registrant from representing, if true, that the registrant owns, oper-ates or controls a ‘‘Hearing Aid Center’’ or from using other words or expres-

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sions which clearly and nondeceptively identify the registrant’s establishmentas a commercial hearing aid enterprise.

(21) Making a deceptive advertisement of a hearing aid part, accessory orcomponent. A registrant may not use or cause to be used any type of advertis-ing or promotional literature depicting or describing only a single part, acces-sory or component of a hearing aid or device, such as a battery on the fingeror a transistor held in the hand, in a manner that may have the tendency tomislead or deceive a purchaser or prospective purchaser to believe that the part,accessory or component is all that must be worn or carried.

(22) Making a deceptive testimonial or other endorsement. A registrant maynot advertise or otherwise represent that:

(i) A particular individual, organization or institution endorses, uses orrecommends the registrant’s hearing aids or devices when that is not true.

(ii) A particular individual wears the registrant’s hearing aids or deviceswhen that is not true.(23) Making a representation either directly or indirectly that a hearing aid

or part thereof is new, unused or rebuilt when that is not true.(i) In the marketing of a used hearing aid or a hearing aid which con-

tains used parts, a registrant shall make full and nondeceptive disclosure ofthe fact in advertising and promotional literature relating to the product onthe container, box or package in which the product is packed or enclosed.The required disclosure may be made by use of words such as ‘‘used,’’‘‘second-hand,’’ ‘‘repaired’’ or ‘‘rebuilt,’’ whichever applies to the productinvolved, and it shall appear on a tag physically attached to a hearing aid.

(ii) A registrant may not misrepresent the identity of the rebuilder of ahearing aid. If the rebuilding of a hearing aid was done by other than theoriginal manufacturer, a registrant shall disclose the fact wherever the origi-nal manufacturer is identified.(24) Doing any of the following:

(i) Representing or using a seal, emblem, shield or other insignia whichrepresents, directly or by implication that a hearing aid or device has beentested, accepted or approved by an individual, concern, organization, groupor association unless it is true and unless the hearing aid or device has beenused in a manner as will reasonably ensure the quality and performance ofthe instrument in relation to its intended use and the fulfillment of a materialclaim made, implied or intended to be supported by the representation orinsignia.

(ii) Representing that a hearing aid or device tested, accepted orapproved by an individual, concern, organization, group or association hasbeen subjected to a test based on a more severe standard of performance,workmanship and quality than is true.

(iii) Making any other false, misleading or deceptive representationrespecting the testing, acceptance or approval of a hearing aid device by an

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individual, concern, organization, group or association. It is not necessary foran individual hearing aid or device to be tested if the method employed is asample testing and full and nondeceptive disclosure of this fact is given inadvertising and otherwise.

(iv) Making a false, misleading or deceptive representation regarding thepractice of another registrant or the quality of a hearing aid product made bya hearing aid manufacturer, which enhances or is likely to enhance the reg-istrant’s business as a repairer, fitter or seller of hearing aids.(25) Doing any of the following:

(i) Imitating or simulating the trademark, trade name, brand or label ofa competitor which may have the tendency or effect of misleading or deceiv-ing a purchaser or prospective purchaser.

(ii) Using in advertising the name, model name or trademark of a par-ticular manufacturer of hearing aids in a manner that implies a relationshipwith the manufacturer that does not exist or which otherwise may mislead ordeceive a purchaser or prospective purchaser.

(iii) Using a trade name, corporate name, trademark or other designationwhich may have the tendency or effect of misleading or deceiving a pur-chaser or prospective purchaser as to the name, nature or origin of a hearingaid or of a material used therein or which is false, deceptive or misleading inanother material respect.(26) Advertising a particular model, type or kind of hearing aid for sale

when a purchaser or prospective purchaser responding to the advertisementcannot purchase or is dissuaded from purchasing the advertised model, type orkind, if it is established that the purpose of the advertisement is to obtain pros-pects for the sale of a different model, type or kind than that advertised.

(i) In determining whether there has been a violation of this paragraph,consideration will be given to acts or practices indicating that the offer wasnot made in good faith for the purpose of selling the advertised product butwas made for the purpose of contacting prospective purchasers and sellingthem a product or products other than that offered. Among acts or practiceswhich will be considered in making that determination are the following:

(A) The creation, through the initial offer or advertisement, of a falseimpression of the product offered in a material respect.

(B) The refusal to show, demonstrate or sell the product offered inaccordance with the terms of the offer.

(C) The disparagement, by acts or words, of the product offered or thedisparagement of the guarantee; credit terms; or availability of service,repairs or parts or the disparagement in another respect, in connection withit.

(D) The showing, demonstrating and in the event of sale, delivery of aproduct which is unusable or impractical for the purpose represented orimplied in the offer.

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(E) The refusal, in the event of sale of the product offered, to deliverthe product to the purchaser within a reasonable time thereafter.

(F) The failure to have available a quantity of the advertised productat the advertised price sufficient to meet reasonably anticipated demands.(ii) It is not necessary that each act or practice set forth in subparagraph

(i) be present to establish that a particular offer violates this paragraph; anyone will be sufficient.(27) Failing to furnish evidence of the required continuing education or

truthful information regarding the continuing education secured when applyingfor renewal of a registration certificate as a hearing aid fitter.

Cross References

This section cited in 28 Pa. Code § 25.210 (relating to receipt to purchaser—purchaser protection).

§ 25.216. Continuing education requirements.(a) General requirements. Except as provided in subsection (d), the continu-

ing education requirement for renewal of a hearing aid fitter’s registration certifi-cate is 20 hours of continuing education credit in the 2 years immediately pre-ceding the expiration of the current registration certificate. If the applicant forrenewal has had a registration certificate for less than 2 years, the required num-ber of continuing education hours shall be calculated by prorating the number ofcredit hours required over a 2-year period by the number of months in which theapplicant for renewal had the registration certificate which is about to expire.Only months in which the applicant had the registration certificate for at least 15days shall be considered in the calculations.

(b) Requirements for renewal of an expired registration certificate. Except asprovided in subsection (d), the continuing education requirement for renewal ofa hearing aid fitter’s registration certificate that has expired is 20 hours of con-tinuing education credit in the 2 years immediately preceding the filing of theapplication for renewal, provided that the application for renewal is filed within5 years after expiration of the previous registration certificate. If more than 5years have passed since the registration certificate expired, the registration certifi-cate may not be renewed. Instead, the individual shall repeat the hearing aid fit-ter’s certification examination and satisfy other requirements then in effect for anoriginal hearing aid fitter’s registration certificate.

(c) Requirements for renewal of a suspended registration certificate. Thecontinuing education requirement for renewal of a hearing aid fitter’s registrationcertificate which has been suspended is the same as in subsections (a) and (d). Ifthe individual does not satisfy the continuing education requirement during theperiod in which the hearing aid fitter’s registration certificate is suspended, thesuspended registration certificate shall be considered to have expired, and thecontinuing education requirements in subsection (b) shall apply for renewal of theexpired registration certificate.

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(d) Phase-in requirements. The first 2-year period for which continuing edu-cation requirements shall be required began on April 15, 2003.

(e) Subject matter requirements. Any subject matter that contributes directlyto the professional competence, skills and education of a hearing aid fitter isacceptable subject matter for a continuing education program. At least one-halfof all continuing education credit hours by which the hearing aid fitter seeks toqualify for renewal of the registration certificate shall be secured in some combi-nation of the following core subject matter: hearing evaluation, hearing instru-mentation technology, ear mold technology, hearing aid repair and maintenance,technical devices to assist the hearing-impaired, psychology of the hearing-impaired, and office procedures and compliance with the act.

Source

The provisions of this § 25.216 adopted May 28, 2004, effective May 29, 2004, 34 Pa.B. 2808.

Cross References

This section cited in 28 Pa. Code § 25.204 (relating to application for and renewal of registration);and 28 Pa. Code § 25.217 (relating to approval of continuing education programs).

§ 25.217. Approval of continuing education programs.(a) A person may apply to the Department for approval of a continuing edu-

cation program by submitting to the Department an application on a form sup-plied by the Department. The applicant shall supply the information requested inthe application, including specification of whether the program is fully or par-tially devoted to any of the core subjects specified in § 25.216(e) (relating tocontinuing education requirements). The Department will grant approval of acontinuing education program and designate whether the program is assigned fullor partial credit in one of the core subjects, if the applicant satisfies the Depart-ment that the program the applicant will offer will meet the following minimumstandards:

(1) The program shall contribute directly to the professional competence,skills and education of a hearing aid fitter.

(2) The program instructors shall possess the necessary practical and aca-demic skills to conduct the program effectively.

(3) Program materials shall be clear, informative, grammatical, carefullyprepared, readable and distributed to attendees at or before the time the pro-gram is offered whenever practical.

(4) The program shall be presented by a responsible instructor who isexperienced and knowledgable in the subject matter being taught, in a settingthat is conducive to learning the material being taught, including any necessaryequipment and facilities, and is devoted to the educational purpose of the pro-gram.

(5) The program shall be open to persons who have a current, suspendedor expired hearing aid fitter’s registration certificate.(b) Approval of a continuing education program shall be effective for 3 years.

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(c) If renewal of the Department’s approval of a continuing education pro-gram is desired, at least 90 days before expiration of the 3-year period the personwho offered the program shall apply to the Department to renew the Depart-ment’s approval of that program. The criteria and process applicable to theDepartment’s initial approval of a continuing education program shall apply torenewal of the approval of that program.

Source

The provisions of this § 25.217 adopted May 28, 2004, effective May 29, 2004, 34 Pa.B. 2808.

§ 25.218. Credit for continuing education.(a) Credit hour. A hearing aid fitter shall receive 1 hour of credit for each 50

minutes of instruction in a continuing education program presented in a class-room setting. Credit may not be given if attendance or other participation in theprogram is not adequate to meet the educational objectives of the program asdetermined by the person offering the program. For completing a continuing edu-cation program that is not presented in a classroom setting, the hearing aid fittershall receive the number of credit hours assigned to the program by the Depart-ment.

(b) Program completion. A hearing aid fitter shall receive no credit for a con-tinuing education program not completed, as evidenced by satisfaction of thecheck-in/check-out process for a continuing education program presented in aclassroom setting and the continuing education report verifying that the hearingaid fitter completed the program, both of which are submitted to the Departmentby the person who offered the program. The program shall also not be consideredcompleted if the hearing aid fitter does not satisfy other program completionrequirements imposed by this subchapter and the continuing education provider.

(c) Continuing education credit for instruction. A hearing aid fitter shallreceive credit equal to the number of hours served as an instructor in a continu-ing education program approved by the Department, or in a program that satis-fies requirements for initial certification as a hearing aid fitter, except that onlyhalf of the credit hours necessary for renewal of a hearing aid fitter’s registrationcertificate may be obtained through serving as an instructor. The remaining cred-its necessary to renew a certificate shall be obtained through attendance at con-tinuing education programs.

(d) Repeat completion or teaching of a continuing education program. TheDepartment will not accept more than one completion or teaching of a continuingeducation program for credit toward renewal of a fitter’s registration certificate,but will accept a subsequent completion or teaching of the same continuing edu-cation program for a subsequent renewal of a fitter’s registration certificate.

(e) Continuing education credit through endorsement. A hearing aid fitterwho attends or teaches a continuing education program offered outside this Com-monwealth may apply to the Department to receive credit for the program. Thehearing aid fitter shall have the burden of demonstrating to the Department that

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the course meets standards substantially equivalent to the standards imposed inthis subchapter. The Department will assign credit to the program, including thepossibility of no credit or partial credit, based upon considerations of whether theprogram bears entirely upon appropriate subject matter and whether the methodof presenting the program meets standards substantially equivalent to those pre-scribed in this subchapter.

(f) Continuing education credit assigned to self-study courses. Credit may besought from the Department for a self-study continuing education program. Thehearing aid fitter shall submit an application to the Department to approve theself-study program for credit before commencing the program and shall supplythe Department with the materials the Department requests to conduct the evalu-ation, which may include any of the materials used in the course. The Departmentwill assign credit to the program based upon considerations of whether the pro-gram addresses appropriate subject matter and whether the method of completingthe program meets standards substantially equivalent to those prescribed in thissubchapter. The Department may require modifications to the proposed self-studyas a precondition to approving it for credit. If the materials are unavailable to thefitter prior to taking the course, the fitter may apply to the Department for creditafter completing it. However, the Department reserves the right to disapprove thecourse for credit after it has been completed if it does not meet the standards pre-scribed in this subchapter.

(g) Continuing education credit assigned to courses not presented in a class-room setting. A hearing aid fitter shall be awarded credit for completing a con-tinuing education program without the hearing aid fitter physically attending theprogram in a classroom setting, provided the program has been approved by theDepartment for credit when presented in that manner.

(h) Resolution of discrepancies. The Department will resolve all discrepan-cies between the number of continuing education credits reported and the numberof continuing education credits a hearing aid fitter alleges to have earned. To helpresolve disputes, the hearing aid fitter should retain the original certificate ofcompletion of a continuing education program if a certificate of completion hasbeen received by the hearing aid fitter.

Source

The provisions of this § 25.218 adopted May 28, 2004, effective May 29, 2004, 34 Pa.B. 2808.

§ 25.219. Responsibilities of persons offering continuing education pro-grams.

(a) Record of attendance. A person who offers a continuing education pro-gram shall maintain a record of attendance for a program presented in a class-room setting by maintaining a check-in/check-out process approved by theDepartment, and shall assign at least one person to ensure that all individualsattending the course check in when entering and check out when leaving. If anindividual enters a course after the starting time, or leaves a course before the

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finishing time, the assigned person shall ensure that the time of arrival or depar-ture is recorded for the individual.

(b) Reporting attendance. A person who offers a continuing education pro-gram shall report to the Department, in the manner and format prescribed by theDepartment, attendance at each continuing education program presented in aclassroom setting.

(c) Course evaluation. A person who offers a continuing education programshall develop and implement methods to evaluate the program to determine itseffectiveness. The methods of evaluation shall include providing a programevaluation form to each person who attends the continuing education program,and requesting each person to complete the form.

(d) Record retention. A person who offers a continuing education programshall retain the completed program evaluation forms and the check-in/check-outrecord for a program presented in a classroom setting. The person shall retain therecords for at least 4 years from the presentation of the program.

(e) Providing records. A person who offers a continuing education programshall promptly provide the Department with complete and accurate records relat-ing to the program as requested by the Department.

(f) Program not presented in a classroom setting. A person who offers a con-tinuing education program shall be exempt from the requirements of subsections(a) and (b) for a program which is not presented in a classroom setting, if theprogram is approved by the Department for credit when presented in that man-ner. When presenting the program to the Department for approval for credit, theperson shall present a procedure for monitoring, confirming and reporting hear-ing aid fitter participation in a manner that achieves the purposes of subsections(a) and (b).

(g) Monitoring responsibilities. A person who offers a continuing educationprogram shall ensure that the program was presented in a manner that met all ofthe educational objectives for the program, and shall determine whether eachhearing aid fitter who enrolled in the program met the requirements of this sub-chapter and of the continuing education program to receive credit for completingthe program.

(h) Program completion. A person who offers a continuing education pro-gram shall report to the Department, in a manner and format prescribed by theDepartment, completion of a continuing education program by a hearing aid fit-ter who completes the program, and shall identify to the Department a hearing aidfitter who seeks credit for a program but who did not meet the requirements ofthe program or this subchapter to receive continuing education credit. The personwho offers a continuing education program shall also provide a hearing aid fitterwho completes the program with a document certifying completion of the pro-gram.

Source

The provisions of this § 25.219 adopted May 28, 2004, effective May 29, 2004, 34 Pa.B. 2808.

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§ 25.220. Right to enter, inspect and obtain records.Upon request of a Department representative during regular and usual business

hours, or at other times when that representative possesses a reasonable beliefthat a violation of this subchapter may exist, and upon the representative present-ing documentation to identify himself as a representative of the Department, aregistrant or person who offers a continuing education program shall:

(1) Produce for inspection equipment and supplies maintained pursuant tothis subchapter.

(2) Produce for inspection, permit copying and provide within a reasonableperiod of time, records maintained under this subchapter.

Source

The provisions of this § 25.220 adopted May 28, 2004, effective May 29, 2004, 34 Pa.B. 2808.

§ 25.221. Exceptions.The Department may grant an exception to a requirement of this subchapter for

good cause shown, except for a statutory requirement that is repeated in this sub-chapter.

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28 § 25.220 PREVENTION OF DISEASES Pt. III

25-204(304218) No. 357 Aug. 04 Copyright � 2004 Commonwealth of Pennsylvania