FEDERAL REGULATIONS OF MEDICATIONS Food, Drug and Cosmetic Act Protect consumers from adulterated and misbranded foods, drugs, cosmetics, or devices.
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FEDERAL REGULATIONS OF MEDICATIONS Food, Drug and Cosmetic Act Protect consumers from adulterated and misbranded foods, drugs, cosmetics, or devices
FOOD Articles used for food and drink Chewing gum Articles used for components of any such article
DRUG Listed in USP, Homoeopathic Pharmacopeia of US, NF or supplements Intended for use in Diagnosis Cure Mitigation Treatment Prevention
DRUG (cont) Intended to affect structure or function of body Intended for use as a component of the others Achieve intended purpose through chemical action
DEVICE Listed in USP, NF, or supplements Intended Diagnosis of disease or other conditions Cure Mitigation Treatment Prevention
DEVICE (cont) Intended to affect structure or function Does not achieve primary intended purposes through chemical action and is not dependent on being metabolized
LABEL Written, printed, or graphic matter upon the immediate container of any article
LABELING All labels Other written, printed, or graphic matters upon article or any of its containers or wrappers Material accompanying such article
ADULTERATION Consists of any filthy, putrid, or decomposed substance Prepared or held under unsanitary conditions Does not meet CGMP Varies from USP standards Contains unapproved color additive Container leaks or causes drug decomposition
MISBRANDING Labeling is false or misleading Drug is subject to deterioration, unless label states precautions Drug is subject to but not packaged according to Poison Packaging Act Dispensing of non FDA approved drug Dispense Rx drugs or refill without authorization or prescription
NEW DRUG APPROVAL “New drug” NDA approved by FDA Reports showing drug’ safety and efficacy Drug’s components and composition Methods, facilities, and controls used Samples of the drug and its components Proposed labeling of the drug
NEW DRUG TESTING (IND) Phase I (to detect adverse effects) Small number of people Examines Toxicity Metabolism Bioavailability Elimination Other pharmacologic activities
NEW DRUG TESTING (Cont) Phase II (determine efficacy and dosages) Patients with the disease Continue pharmacological testing to ensure safety
NEW DRUG TESTING (Cont) Phase III Given to large numbers of patients to further determine safety and efficacy If successful may submit NDA
OTC LABEL 1. The name of the product; 2. The name and address of the manufacturer, packer, or distributor; 3. The net contents of the package; 4. The established name of all active ingredients, and the quantity of certain other ingredients whether active or not; 5. The name of any habit ‑ forming drug contained in the preparation; 6. Cautions and warnings needed for the protection of the user; and 7. Adequate directions for safe and effective use.
Rx DRUG 1A statement of the drug’s identity in terms of its established name and quantity and portion of each active ingredient. 2A declaration of net quantity. 3A statement of the usual dosage. 4The federal caution legend. 5The route of administration if it is not for oral use. 6If it is a habit forming drug, the federal warning, “Warning: May be habit forming.” 7If other than oral use, the names of all inactive ingredients- exceptions are made for flavorings, perfumes, and color additives. 8An identifying lot or control number. 9A statement to the pharmacist specifying the type of container to be used in dispensing. 10The name and place of business of the manufacturer, packer, or distributor. 11The expiration date unless exempted.
Rx DRUG LABELING 1Description 2Clinical pharmacology 3Indications and usage 4Contraindications 5Warnings 6Precautions 7Adverse reactions 8Drug abuse and dependence 9Overdosage 10Dosage and administration 11How supplied
DURHAM-HUMPHREY AMENDMENT OF 1951 Only upon the written prescription of a physician licensed by law to administer such drugs; Upon the physician’s oral prescription, which is reduced promptly to writing and filled by the pharmacist; By refilling a written or oral prescription if the refill is authorized by the prescriber either on the original prescription or orally and then reduced to writing and filled by the pharmacist; or By administration (dispensing) directly by the physician.
KEFAUVER-HARRIS AMENDMENTS OF 1962 Before marketing any new drug, manufacturers were required to supply: a) proof of safety, and b) proof of effectiveness. Current Good Manufacturing Practices, the so-called CGMP, were established, and if a manufacturer produced a drug without adhering to such practices, that drug was considered adulterated. Prescription drug advertising was placed under the supervision of the FDA, while the Federal Trade Commission (FTC) continued to supervise the advertising of OTC items. The amendments established a procedure for new drug applications and for investigational drug procedures which required assurances of the informed consent of the research subjects and required reporting of adverse drug reactions. Qualifications of drug investigators were subject to review.
MEDICAL DEVICE AMENDMENT OF 1976 All medical devices in Classes I, II, or III, on the basis of the risk Class III devices are subject to pre- market approval.
ORPHAN DRUG ACT OF 1983 Provides tax incentives and a limited exclusive license (7 years) to manufacturers of drugs for rare diseases or conditions A rare disease or condition is one that affects less than 200,000 persons in the U. S One that affects more than 200,000 persons in the U. S. and for which there is no reasonable expectation of recovering the development costs
DRUG PRICE COMPETITION AND PATENT TERM RESTORATION ACT OF 1984 Extended the ANDA process to include generic versions of all post-1962 approved drugs, except antibiotics, which already had a generic approval process in place Act permits extension of patent life
PRESCRIPTION DRUG MARKETING ACT OF 1987 Reduce the potential public health risks that may result from diversion of prescription drugs from legitimate commercial channels States license wholesale distributors The reimportation of prescription drugs produced in the U. S. is banned It also bans sale, trade or purchase of drug samples and the trafficking in and counterfeiting of drug coupons