uab - occupational health & safety - controlled substances

UAB - Occupational Health & Safety - Controlled Substances

http://www.uab.edu/ohs/controlled-substances[6/30/2014 10:34:41 AM]

Programs

Controlled SubstancesControlled substances (CS) are drugs or chemicals whose manufacture, possession and use are regulated by the state and federal governments. This may include illegal drugs, prescription medications or chemicals used to manufacture drugs.

UAB currently maintains federal Drug Enforcement Administration (DEA) registrations governing the use of controlled substances for teaching purposes, veterinary care, and all non-human research. Research using controlled substances in human trials are not administered through this program.

Follow the links below for more information on the use of controlled substances for teaching purposes, veterinary care and non-human research.

Determine if a chemical is a CSControlled Substances Use Authorization (CSUA)CSUA Web ApplicationResponsibilitiesTrainingOrdering CSManaging Your InventoryStorage RequirementsDisposal of CSPolicies and RegulationsFormsFrequently Asked Questions

Controlled Substances

Determining if a Chemical is a CS

Authorization

CSUA Web Application

Responsibilities

Training

Ordering CS

Managing Your Inventory

Storage Requirements

Disposal

Policies and Regulations

Forms

FAQ

Contact OH&S205-934-2487

Resources Training Services Programs Committees Contact Us About OH&S

UAB - Occupational Health & Safety - Determining if a Chemical is a CS

http://www.uab.edu/ohs/controlled-substances/determining-if-a-chemical-is-a-cs[6/30/2014 10:35:04 AM]

Programs

Determining if a Chemical is a CS If a chemical you require for research is classified as a Controlled Substance, you must apply for a Controlled Substance Use Authorization (CSUA) number before work can begin.

The following lists are considered Controlled Substances by either federal or state law. Click on the link to view the different lists.

1. CSUA is required for any chemical listed in the Controlled Substances Schedule . Note the Controlled Substance Schedule Number ("CSA Sch") and DEA Number for the chemical you require.

2. List I Chemicals - CSUA is required for List I chemicals only. List II chemicals have controls that are subject to high threshold amounts, which generally do not apply to normal campus users.

3. Precursor Chemicals - CSUA is required for all precursor chemicals identified by the Alabama Board of Pharmacy in the Alabama Administrative Code (Section 20-2-181).

Definitions

Controlled Substances: Psychotropic drugs and precursors regulated under the Federal Controlled Substances Act and the Alabama Uniform Controlled Substances Act. Not all drugs are considered controlled substances. Examples of drugs that are not controlled substances are Donepezil, Xylazine, and Atropine.

Listed chemicals: Chemicals that may be used to manufacture controlled substances. Listed chemicals are regulated in order to prevent the illicit manufacture of controlled substances.

Precursor chemicals: Compounds that are required in the synthetic or extraction processes of drug production, and become incorporated into the drug molecule. Not used in the production of cocaine or heroin. The Alabama Administrative Code considers these substances able to produce controlled substances.

For more information, contact the CS Program manager at 934-2487.



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UAB - Occupational Health & Safety - Authorization

http://www.uab.edu/ohs/controlled-substances/cs-authorization[6/30/2014 10:35:14 AM]

Programs

Authorization Principal investigators (PIs) must obtain a CSUA to possess and use CS for any of these purposes:

Research

Teaching

Veterinary care

Note: Clinical trials performed on campus through the pharmacy do not require a CSUA.

To find out if you need a CSUA, see Determining if a Chemical is a Controlled Substance.Additional authorizations and registrations from the CS program manager may be required for certain project specific substances, locations, or purposes not covered by the university's standard DEA registration.

How to get a CSUAThe Controlled Substance Use Authorization (CSUA) Web application is used by PIs to apply for an authorization number and to designate authorized personnel to work under his/her number. The web interface is also used to document training and CS possession and use in compliance with strict federal regulations and the UAB Controlled Substances Program. The controlled substances training program, CS245 "Use of Controlled Substances for Research, Teaching and Veterinary Care" must be completed and passed by investigators and all authorized personnel before approval can be given to purchase controlled substances.

See Controlled Substance Use Authorization Web Application to learn how to:

Access the CSUA Web Application

Apply for a CSUA

Amend, renew, or activate a CSUA

Manage authorized personnel

Identify secure storage facilities

Manage inventory

Request disposal of CS



Authorization


Responsibilities

Training

Ordering CS



Disposal


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FAQ



UAB - Occupational Health & Safety - Authorization

http://www.uab.edu/ohs/controlled-substances/cs-authorization[6/30/2014 10:35:14 AM]

Learn more about the CS ProgramCS FAQ

Accessibility | Contact Us | © Copyright | Disclaimer | UAB Web Pages Policy

UAB - Occupational Health & Safety - CSUA Web Application

http://www.uab.edu/ohs/controlled-substances/csua-web-appliation[6/30/2014 10:35:26 AM]

Programs

CSUA Web Application The Controlled Substance Use Authorization (CSUA) Web Application provides a central and secure resource for the essential business processes and internal controls of UAB Controlled Substance Program, from application and authorization to inventory and personnel management.Use the CSUA Web Application to:

Apply for a new Controlled Substance Use Authorization (CSUA)

Amend, renew, or deactivate a CSUA

Manage authorized personnel

Identify secure storage facilities

Manage inventory

Request disposal of CS

Note: Principal investigators and their CSUA lab contacts have access to this application. Other individuals listed as authorized personnel on a CSUA do not.

Follow this link to apply for and manage a CSUA >>




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UAB - Occupational Health & Safety - Responsibilities

http://www.uab.edu/ohs/controlled-substances/cs-responsibilities[6/30/2014 10:35:34 AM]

Programs

ResponsibilitiesPrincipal investigators

PIs are responsible at all times for maintaining a current CSUA, an accurate inventory and on-site log book, and supervising their CS facility and authorized personnel in compliance with UAB's Controlled Substances Program.

Sabbatical: A CSUA remains active during a PI's sabbatical leave when an acting PI is named in writing and approved by the department chair and Controlled Substances Program manager. Alternatively, the department chair may serve as the acting PI.

Authorized personnel

Authorized personnel are individuals designated by the PI to have access and/or work with controlled substances under a particular CSUA number. Authorized personnel must complete and pass the controlled substances training program CS245, "Using Controlled Substances for Research, Teaching and Veterinary Care at UAB." Final approval of authorized personnel rests with the CS Program manager, following verification of DEA-required information applicants provide on the Personnel Screening Data Sheet.

Authorized personnel applicants must answer questions concerning:Felony convictions in connection with controlled substances

Surrendering previous registrations or having a registration revoked, suspended, or denied

Any use of narcotics, amphetamines, or barbiturates other than those prescribed to the applicant by a physician

Authorized personnel must:Use CS exclusively for the purpose stated in CSUA.

Maintain a secure storage location for CS at all times.

Return CS to the secure storage location when not in use.

Record dispensation of any CS in the usage log .



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UAB - Occupational Health & Safety - Responsibilities

http://www.uab.edu/ohs/controlled-substances/cs-responsibilities[6/30/2014 10:35:34 AM]

Properly dispose of CS.

Department chairsDepartment chairs must notify OH&S when:

A new PI is expected to arrive on campus in possession of CS

A PI with CS authorization dies or intends to terminate employment

Department chairs review and approve or reject CSUA applications for their department. Department chairs cannot authorize their own CSUA application.


UAB - Occupational Health & Safety - Training

http://www.uab.edu/ohs/controlled-substances/cs-training[6/30/2014 10:35:44 AM]

Programs

Training The UAB Controlled Substances Program provides training for all authorized personnel working with controlled substances at UAB. This includes information about the DEA website, identifying controlled substances, storage requirements, purchasing requirements and recordkeeping.

All individuals listed on the CSUA are required to take and pass CS245: Using Controlled Substances in Research, Teaching and Veterinary Care. In addition to the on line training, the Controlled Substances website provides training in several areas by way of specific “Job Aids”, such as how to order through Oracle, etc.

Training links:

Controlled Substances Program GlossaryCS245: Using Controlled Substances in Research, Teaching, and Veterinary CareHow to Order CS through the Oracle Purchasing SystemHow to Manage Your Online CSUA Inventory




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UAB - Occupational Health & Safety - Ordering CS

http://www.uab.edu/ohs/controlled-substances/ordering-cs[6/30/2014 10:35:51 AM]

Programs

Ordering CS Before a lab can purchase CS, the principal investigator (PI) must have an approved Controlled Substance Use Authorization (CSUA). Only those substances which have been authorized and approved on the PI's CSUA may be requisitioned by that PI.

Purchase Order Requisitions will need to be generated by the PI through the Oracle Purchase Order system. All orders entered for CS at UAB for research, teaching or veterinary care will be routed through workflow to Occupational Health and Safety (OH&S) and placed with the vendor by OH&S.

It is important to manage your inventory carefully and plan ahead. Follow the instructions below to avoid delays in your purchase and ensure your order follows the proper approval path.

How to requisition CS online:1. In Oracle, in the requisition header screen Order Method, select

PHONE (NOT fax or mail). OH&S will phone in all orders for controlled substances to the vendor. If fax or mail is selected there is possibility of duplication with the vendor.

For all Controlled Substances, Schedules II–V, OH&S will require a copy of the completed requisition to file required DEA paperwork and to place in the CSUA applicant’s file. The PI must also keep a copy of the requisition in the Usage Log binder.

Schedule II Controlled Substances must be ordered on a separate requisition than Schedules III-V.

No other items may be ordered on the CS requisitions from the vendor.

2. Under the Lines tab, enter the CON number of the CS from this list into the item column.Example: CON.30000 - The CS description, which is also on the



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CON number list , will populate except for the catalog number. If you require a different concentration or size as it appears in the description, contact the This email address is being protected from spambots. You need JavaScript enabled to view it. (934-2487) before ordering.

3. In the description field, add the Catalog # in front of the CS name and description which populated from the CON number entry. These are the usual descriptions and sizes used in research at UAB. If you require a different concentration or size, please contact the This email address is being protected from spambots. You need JavaScript enabled to view it. .

click on image to enlarge

4. Under the "[ ]" column, click on the empty box to open the Requisition Lines box where you must provide the Associated Protocol # (or other applicable term; e.g. veterinarian, or teaching), CSUA#, and Amount on Hand.

click on image to enlarge

5. Complete the rest of the requisition with quantity, price, supplier, etc., as you would with any Oracle requesition.

Contact the This email address is being protected from spambots. You need JavaScript enabled to view it. (934-2487) if you have any questions.

Once you approve the requisition, it will be forwarded through workflow to OH&S. After OH&S reviews and approves your purchase order requisition for CS, OH&S will place your order with the vendor and submit any necessary DEA paperwork.



Note: Transfer of controlled substances is prohibited.

Plan aheadThere is no on-site stock. Controlled substances are obtained from suppliers, so plan to order quantities sufficient for a 3-6 month period to minimize expired waste and risk of theft.

Allow time for delivery:Schedule II: 3 weeks

Schedule III - V: 10 days

Listed chemicals and precursors (if their hazard class requires shipment by ground transportation): 20 days

PickupCS orders will be available for pickup once the primary lab contact receives an arrival confirmation e-mail from OH&S. The e-mail states where to pick up the order and the times available without an appointment. The person who picks up the order must have a UAB ID, a valid driver's license, and be listed as an authorized recipient on the CSUA.

After receiving your order, return directly to the approved secure storage location and secure the shipment until it is needed. The receipt and the Usage Log Sheet(s) sent with the order should also be placed into the Usage Log binder and the current inventory verified. Your electronic inventory will automatically update and show the drugs transferred to the approved storage location.


UAB - Occupational Health & Safety - Managing Your Inventory

http://www.uab.edu/ohs/controlled-substances/cs-managing-inventory[6/30/2014 10:36:00 AM]

Programs

Managing Inventory Learn how to manage controlled substances (CS) inventory, log sheets, and maintain an on-site Usage Log Book.

CS inventory is managed through the CSUA Web application. PIs must also maintain a current CS Usage Log Book made available for periodic audits by the DEA or UAB CS Staff. The Log Books are required to be stored in the approved storage cabinet with the controlled substances when not being used. Each PI that is issued a CSUA will receive Usage Log book/binders appropriate for the CS Schedules being used. Each log book or binder is divided into labeled sections for maintaining the required legal documents for using controlled substances at UAB. The log book contains important documents pertaining to your CSUA including a CSUA summary, the Usage Log sheets accounting for the dispensation of each CS dosage unit in your inventory, signed receipts of any new CS ordered through the CS Program, and any disposal records, such as the usage logs of any CS returned to the CS Program for disposal.

Manage your CS inventory with the CSUA Web application1. Log into the Controlled Substances Use Authorization (CSUA)

Web Application Enter your Blazer ID and strong password. Once you see the CSUA Dashboard you can check and manage your inventory from here.

2. The Inventory summary is the last tab on the right. It tracks the amount of each controlled substance on hand and the number of containers based on dilutions made, administrations recorded, waste returned etc. The Inventory tab is used for verifying that the amount of controlled substance on hand matches the amount on the written dispensing logs. This data is also used to submit required quarterly inventories and the DEA biennial inventory.

3. The Stock Materials tab lists both the controlled substance ordered and any dilutions made from the CS along with the container ID. The container ID must be on every bottle and must match the one on the dispensing log. After entering a new dilution into the system select this tab to get the new container ID. The new dilution and ID will be in bold letters.



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4. The Dispensing/Use tab is used to generate new container IDs for dilution bottles, for recording administrations, for documenting and witnessing waste and for requesting a CS Waste pickup.

On-site Usage Log BookKeep separate Usage Log books for Schedule I-II substances and Schedule III-V substances.

File copies of these documents in the log book:Your Controlled Substance Use Authorization (CSUA) summaryThe summary should list current authorized personnel having access to CS in your lab

It should also contain a list of the drugs you have been approved to work with by your Department Chairman under your protocols or projects.

A copy of all requisitions signed by the PI for the purchase of CS

Signed receipts for CS picked up at OH&S and placed into inventory

All CS usage log sheets (see below)

Any other documents related to CS disposal, witnessed losses, etc.(which have to reported to CS Manager).

Secure the CS Usage Log book under lock and key with controlled substances.Read the Storage Requirements.

Usage Log Sheets

CS Program provides a Usage Log Sheet for each CS container when the item is initially picked up. The sheet is pre- printed with the PI Name, PI’s CSUA #, Drug Name, unique Container ID number, Concentration, starting amount and date. Each container is also labeled with the Pis last name, the unique container Identification number, and barcode for ease of inventory documentation. Do not transfer a CS from the original container for storage purposes. Keep it in the original container.

Do not loan any Controlled Substances to another PI. Investigators should keep a 3 to 6 months supply in inventory. If for some reason a PI is in emergency need of a controlled substance for an animal then contact one of the Animal Resources veterinarians for assistance. They cannot transfer any CS to the PI however they may be able to relieve the emergency situation.

The Controlled Substances Use Authorization Web Application uses the



container ID and will automatically send the PI and secondary contact a notice 30 days in advance that a CS is about to expire. The default expiration date for dilutions is 30 days and must be written on the dilution bottle along with the concentration when the bottle is made.

Dilutions: If you are planning on making a dilution from a stock bottle (with barcode label on it) then you will need to generate a new container ID and use a new log sheet to track doses. Before going to the animal area, select the Dispensing/Use Tab and select the +Add New Use link located at the top of the table on the right. When the CS Dispensing/Use Log Entry Form appears, select the stock CS you wish to use from the Container ID drop down menu. Then select Dilution from Use Type menu and click Submit. The container ID of the stock bottle will appear on the new page along with other needed information. Do not use the Hub Loss or # Needle changes here but enter the amount of CS used in the displayed units. Then enter the final volume of the dilution and click Submit. Select the Stock Materials tab to view the new container ID, concentration and expiration date in Bold on the new page. This information must be recorded on the new log sheet and on a new label for the dilution bottle. Be sure to indicate on the log sheet for the stock bottle the dose withdrawn was used to make a dilution and reference the new ID used on the new bottle and log sheet. Keep the new log sheet in the binder along with the stock CS. Both bottles will appear in your Inventory tab

Record routine use on the log sheet:Enter each dispensation of CS on the log sheet at the time of use. The amount of CS in the lab must equal the amount recorded on the current log sheet at all times.View a sample completed log sheet for a stock bottle and a dilution .

Print additional log sheets .

If using CS on large animals, include the animal identification number in the "reason for use" section.

Track Buprenorphine or other CS that come as a box with 5 or 10 single-use ampoules on 1 log sheet.

Record empty or broken vials on the log sheet:If a CS container breaks, enter it on the log sheet, initialed by the individual responsible for the accident and co-signed by another authorized person or the PI.

Send an electronic copy of all finished log sheets for empty or broken containers to the CS Program manager.Send by email after scanning to This email address is being protected from spambots. You need JavaScript enabled to view it. or



Fax to 205-934-7487

Retain log sheets in your Usage Log Book for a minimum of 2 years after complete use of container contents or disposal by CS Program.

Important: Report log discrepancies, suspected misuse, or theft to the This email address is being protected from spambots. You need JavaScript enabled to view it. , 205-934-2487, immediately.


UAB - Occupational Health & Safety - Storage Requirements

http://www.uab.edu/ohs/controlled-substances/cs-storage-requirements[6/30/2014 10:36:11 AM]

Programs

Storage Requirement and RestrictionsNotify OH&S, 205-934-2487 immediately of missing controlled substances.

Principal investigators (PI) are responsible for providing and maintaining secure storage for their controlled substances inventory that meets these criteria:

Storage

Store controlled substances according to schedule number:Schedule I-II: Store in a safe or steel cabinet equivalent

Schedule III-V: Store in a locked drawer or cabinet that is inaccessible from above or below.

Store controlled substances in their own unique storage unit, together with the Usage Log binders.

Steel cabinets and drawers must be able to accommodate up to two Usage Log Binders if using both Schedule II and Schedule III-V drugs. This requires a steel cabinet with minimum size of 11" wide x 15" high x 6" deep.

Separate by shelf or divider drugs in Schedule II from drugs in schedules III–V.

Equipment

Install the following equipment according to these standards:Padlocks and hingesMust have the mounting screws or bolts of the hasp inaccessible when the door is closed and the lock is fastened.

Safes and steel cabinet equivalentsMust be cemented or bolted to the floor or wall, or weigh more than 750 pounds.

Storage unitsMust be secure enough to show forced entry.

Drawers



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UAB - Occupational Health & Safety - Storage Requirements

http://www.uab.edu/ohs/controlled-substances/cs-storage-requirements[6/30/2014 10:36:11 AM]

Must be inaccessible from the upper or lower drawers in the stack. Assign the top drawer of the stack to use as the storage facility, if possible.

Storage RestrictionsDo not share controlled substances storage facilities.

Do not transfer controlled substances from its original container for storage purposes.

Do not store other chemicals or supplies in a controlled substances storage unit.

Do not store controlled substances in a corridor.

Security

Access ControlRestrict access only to authorized personnel on your Controlled Substances Use Authorization (CSUA) and follow these precautions:

Keep storage key(s) in the physical custody of authorized personnel at all times.You can make multiple key copies and assign them to authorized personnel.

Do not store keys in a drawer or on the wall.

Personnel changesWhen authorized personnel leave their position in the lab:

Change combinations or retrieve the individual's keys.

Document authorized personnel security changes in your Usage Log Binder.

Remove the authorized personnel by amending your CSUA through the website.


UAB - Occupational Health & Safety - Disposal

http://www.uab.edu/ohs/controlled-substances/cs-disposal[6/30/2014 10:36:19 AM]

Programs

Disposal of Controlled Substances (CS)Note: Disposal of CS is strictly regulated by federal law!

Return all unwanted CS to Occupational, Health & Safety (OH&S) for disposal.If more CS will be ordered soon, CS for disposal may be returned to OH&S at the same time new CS are picked up (please bring the corresponding usage log sheet).

How to request disposal of CS

You may request disposal of CS in two ways: from the CSUA Web Application or by phone.From the Web Application do the following:

1. Login to the CSUA Web Application

2. Enter your Blazer ID and Strong Password

3. From the CSUA Web Application main dashboard, select Dispensing/Use. Select the +Add New at the top right side of the table.

4. Select the bottle you wish to dispose of in the pull down list for Select Container ID.

5. In the Select Use Description pull down list, select Disposal Request.

For the Amount of Substance used put 0 and select either mg or ml.6. Then select submit and an email will notify the CS Manager that

the PI has a CS to dispose of. We will contact you for a time to pick up the CS.

7. Always verify that the amount remaining in the electronic inventory corresponds to the actual amount in the bottle. If not, you must determine where the error occurred.

If not using the web application, This email address is being protected from spambots. You need JavaScript enabled to view it. to set up an appointment to have the CS picked up. The electronic inventory will need to be reconciled with the written Usage Log when CS is picked up.



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UAB - Occupational Health & Safety - Disposal

http://www.uab.edu/ohs/controlled-substances/cs-disposal[6/30/2014 10:36:19 AM]

When to request CS disposalA project closes or is terminated and a CS is still in supply

A CSUA expires and a renewal has not been submitted

The PI determines a CS is no longer required

The PI terminates employment

The CS expires

If you have questions about CS disposal, contact the This email address is being protected from spambots. You need JavaScript enabled to view it. or by phone at 934-2487.


UAB - Occupational Health & Safety - Policies and Regulations

http://www.uab.edu/ohs/controlled-substances/cs-policies-procedures-regulations[6/30/2014 10:36:28 AM]

Programs

Policies, Procedures, and RegulationsTitle 21 United States Code (USC), sections 1300 to 1308

Title 21 USC, Controlled Substances Act, section 801 et seq.

Title 20 Chapter 2, Alabama Uniform Controlled Substances Act 1407, Alabama Legislature 1971

UAB Policy on Use of Controlled Substances for Research, Teaching and Veterinary Care




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UAB - Occupational Health & Safety - Forms

http://www.uab.edu/ohs/controlled-substances/cs-forms[6/30/2014 10:36:36 AM]

Programs

FormsControlled Substances Usage LogControlled Substances Self Assessment Audit Sheet




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UAB - Occupational Health & Safety - FAQ

http://www.uab.edu/ohs/controlled-substances/cs-faq[6/30/2014 10:36:44 AM]

Programs

Frequently Asked Questions1. What is a CSUA number and how is it different from a DEA

License?A CSUA number is an authorization number to use controlled substances regulated by the DEA and the State for a specific purpose at UAB. This would include things like research projects or for teaching. A CSUA number is associated with a specific DEA License that may cover several researchers.

2. Do I have to renew my CSUA number? If so how will I know when to renew?Yes, your CSUA number requires annual renewal on the anniversary date just like a research DEA License. You will be sent a reminder by email at least 30 days in advance to go the website and check if anything has changed with regard to staff or projects, etc.

3. I don’t use a lot of controlled substances during the year, what if it expires before I use it? Since we have to order our own won’t there be a delay in me getting new material.The CSUA Web Application will send you an email letting you know that our records indicate that a specific Controlled Substance identified by a unique number is about to expire within 30 days so you can take necessary steps to get new material and dispose of the old stock.

4. Why have storage requirements changed? We already had our storage location approved years ago.Diversion of controlled substances has become a nationwide problem so UAB has established new guidelines to meet current federal Drug Enforcement Administration Regulations. Storage of dispensing logs with the drugs and separation of records in certain schedules is important to an overall diversion control program.

5. What do I do with empty controlled substance (CS) bottles?First make sure you have accounted for the used CS in your inventory by checking the Usage Log for proper signatures for all doses, matching container ID numbers on the bottle and log sheet, and ensuring the remaining physical inventory matches the Usage Log binder. Follow the instructions at the bottom of the



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UAB - Occupational Health & Safety - FAQ

http://www.uab.edu/ohs/controlled-substances/cs-faq[6/30/2014 10:36:44 AM]

Usage Log sheet. Be sure to reconcile your electronic inventory in the CSUA Web application under the Dispensing/Use tab.

6. How do I store my listed chemicals and precursors?You may mix listed chemicals in with other lab chemicals of the same class, however the DEA gets reports when these chemicals are purchased and will ask where you are storing them. They should only be stored in a lab that can be locked and is under the control of the researcher. They should not be stored in the same cabinet with other Controlled Substances.

7. What program administers the use of controlled substances in human research?Research using controlled substances in humans must be obtained with the physician/practitioner's personal DEA registration and be delivered to the Research Pharmacist in the hospital so it can be dispensed as required by the FDA. Contact the Research Pharmacist at 934-3488.


uab - occupational health & safety - controlled substances

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