Pharm Law Lecture 7

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Food and Drug Administration (FDA)

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component of the Department of Health and Human Services (DHHS) that is divided into 5 centers that share authority:
-Center for Biologics Evaluation and Research
-Center for Food Safety and Applied Nutrition
-Center for Drug Evaluation and Research
-Center for Veterinary Medicine
-Center for Devices and Radiological Health

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drug product

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a drug subject to regulation under section 505, 512, or 802 of this Act or under section 351 of the Public Health Service Act.

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drug

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A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 403(r)(1)(B) and 403(r)(3) or sections 403(r)(1)(B) and 403(r)(5)(D), is made in accordance with the requirements of section 403(r) is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 403(r)(6) is not a drug under clause (C) solely because the label or the labeling contains such a statement.

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prescription drug

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a drug that is:
-unsafe for use except under the supervision of a practitioner because of the toxicity, the method of use, or the collateral measures necessary to use the drug
-Subject to the new drug application (NDA) approval process

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counterfeit drug

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a drug which, or the container or labeling of which, without authorization, bears the trademark, tradename, or other identifying mark, imprint, or device, or any likeness thereof, of a drug manufacturer, processor, packer, or distributor otherthat the person or persons who in fact manufactured, processed, packed, ir distributed such drug which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other drug manufacturer, processor, packer, or distributor

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labeling

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all labels and other written, printed, or graphic matters (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.
-includes package insert, etc.

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label

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a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of this Act that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper.

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device

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-an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is--

(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,

(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

(3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

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cosmetic

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1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.

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food

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(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article

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Federal Trade Commission (FTC)

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can affect the pharmacy profession by administering the Federal Trade Commission Act, enforcing unfair business practices and antitrust violations

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legend drug

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a prescription drug
-established by the Durham-Humphrey Amendment of 1951, requiring that Rx drugs contain the legend; "Caution, Federal Law prohibits dispensing without a precription

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non-legend drug

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a non-prescription drug; OTC

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biologic

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a drug that is made up of proteins/peptides rather than certain chemical entitities; a biological drug is subject to slightly different regulatory procedures than a non-biologic drug