FEDERAL REGULATIONS OF MEDICATIONS

Food, Drug and Cosmetic ActProtect 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

1 A statement of the drug’s identity in terms of its established name and quantity and portion of each active ingredient.

2 A declaration of net quantity.3 A statement of the usual dosage.4 The federal caution legend.5 The route of administration if it is not for oral use.6 If it is a habit forming drug, the federal warning, “Warning: May be

habit forming.”7 If other than oral use, the names of all inactive ingredients- exceptions

are made for flavorings, perfumes, and color additives.8 An identifying lot or control number.9 A statement to the pharmacist specifying the type of container to be

used in dispensing.10 The name and place of business of the manufacturer, packer, or

distributor.11 The expiration date unless exempted.

Rx DRUG LABELING

1 Description2 Clinical pharmacology3 Indications and usage4 Contraindications5 Warnings6 Precautions7 Adverse reactions8 Drug abuse and dependence9 Overdosage10 Dosage and administration11 How 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