food, drug, and cosmetics act 2013
TRANSCRIPT
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CHAPTER VIProhibited Acts and Penalties
Sec. 11. The following actsand the causing thereof arehereby prohibited:
a. The manufacture, sale,
offering for sale or transfer ofany food, drug, of any food,drugs, of cosmetic that isadulterated ormisbranded.
b. The adulteration or
misbranding of any food,drug, device or cosmetic.
c. The refusal to permitentry or inspection asauthorized by Sectiontwenty-seven hereof or to
follow samples to becollected.
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Prohibited Actse. Forging,
counterfeiting,simulating, or falselyrepresenting or withoutproper authority using anymark, stamp, tag label, orother identification deviceauthorized or required by
regulations
f. The using by any personto his own advantage, orreveling, other than to theSecretary or officers or
employees of theDepartment or to thecourts when relevant in anyjudicial proceeding underthis Act, any informationacquired under authority ofSection nine, or concerningany method or process
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Prohibited Actsg. The alteration, mutilation,destruction, obliteration, orremoval of the whole or anypart of the labeling of, or thedoing of any other act withrespect to, a food, drug,device, or cosmetic, if such actis done while such article is heldfor sale (whether or not the firstsale) and results in such articlebeing adulterated or misbranded.
h. The use, on the labeling ofany drug or in any advertisingrelating to such drug, of anyrepresentation or suggestionthat an application with
respect to such drug is effectiveunder Section twenty-one hereof,or that such drug complies withthe provisions of such section.
i. The use, in labeling,advertising or other sales
promotion of any reference toany report or analysis furnished
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PenaltiesSec. 12. (a) upon conviction, be subject to
imprisonment ofnot less than six monthsand one day, but not more than fiveyears, or a fine of not less than onethousand pesos, or both suchimprisonment and fine
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AdulteratedMisbranded
Unsanitarypreparation,
Has a hazardouscomponentadded, oressential
componentremoved,
Poisonous,
Illegalcom onent
Labeling is false ormisleading
Label does not containname and place ofbusiness of the
manufacturer, Inaccurate statement of
the quantity of thecontents in terms ofweight, measure, ornumerical count
Its container is so made,formed, or filled as to bemisleading;
Any word, statement, orother informationrequired to appear on the
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Definitions andStandards forFood
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HONG KONG Cypriot
inspectors found arsenicin the frozen calamari. TheItalians discovered
maggots in the pasta.There were glass chipsin the pumpkin seedsbound for Denmark, andSpanish regulators blocked ashipment of frozen duck meat
because of forgedpapers. It has been arough year for Chinese food
exports to Europe.
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Misbranded food
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Controla. The Secretary after investigation in domestic
commerce of any class of food may be injurious to
health, and cannot be adequately determined aftersuch articles have entered domestic commerce, canpromulgate regulations of the manufacture,processing, or packaging of these products andstop the sale and manufacture of these productsuntil the manufacturer can meet the standardsof the Secretary
b. The Secretary can suspend immediately anypermit if any conditions have been violated
c. Any officer or employee designated by the Secretary
shall have access to any factory or establishment, toascertain whether or not conditions of thepermit are being complied with; if deniedaccess, permit will be suspended until access isgiven by the operator
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Tolerances for Poisonous Ingredients
in FoodCoal-Tar Color for food
(a) Any poisonous or deleterious substance addedto any food, shall be deemed to be unsafeexcept when such substance is required orcannot be avoided in its production ormanufacture. The Secretary will regulatewhat quantities are safe and unsafe
And shall promulgate regulations providing forthe listing of coal-tar colors which are harmlessand suitable for use in food.
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Adulterated drug-Alysena 28
CHAPTER VIIDrugs and Devices
i
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Devices
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Exemption in Case of Drugs and
DevicesSec. 20. (a) The Secretary can promulgate regulations
exempting from any labeling or packaging requirementof this act drugs and devices which are not adulteratedor misbranded
Must bear statement Caution: Food, Drug andCosmetics Law prohibits dispensing withoutprescription
Drugs that are habit formingHave toxicity or potentially harming effect or
method of use is not safe except under supervisionof a practitioner licensed to administer the drug
Are new drugs whose application are limited to
investigational use and dispensed only uponprescription
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New Drugs
Sec. 21. (a) No person shall manufacture, sell,offer for sale or transfer any new drug, unless anapplication filed is effective with respect to suchdrug.(b) To apply, one must submit to the Secretary:
(1) full reports of investigations which have beenmade to show whether or not such drug is safe foruse(2) a full list of the articles used as components ofsuch drug; (3) a full statement of the compositionof such drug;(4) a full description of the methods used in andthe facilities and controls used for themanufacture, processing, and packing of suchdrug;(5) such samples of such drug and of the articleused as components thereof as the Secretary may
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New Drugs(c) Secretary has 180 days to:
Approve application
Give the applicant notice of an opportunity for ahearing of approval
After fair evaluation, Secretary can deny
application if application does not have all therequirements or if the drug is not safe based onclinical trials
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CHAPTER IXCertification of Drugs containing Penicillin,Streptomycin, Chlortetracycline,
Chloramphenicol or BacitracinSec. 22. (a) The Secretary shall certify
batches of drugs composed of any kind ofpenicillin, streptomycin, chlortetracycline,
chloramphenicol, bacitracin, or any otherantibiotic drug, or any derivative thereof,based on identity, strength, qualityand purity, as the Secretary prescribes to
insure safety and efficacy of use
Anti-biotic drug: any drug produced bymicro-organism and has the capacity to
inhibit or destroy micro-organims in dilute
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Questions?