Federal Legislation & Agencies Flashcards
Pure Food & Drug Act of 1906
Prohibited the adulteration & misbranding of foods & drugs in interstate commerce
What were the loopholes to the Pure Food & Drug Act of 1906
- Labels not required to list ingredients
- Misbranding provisions did not prevent false or misleading efficacy claims, it only prevented false statements as to the drug’s identity (i.e., strength, quality and purity)
- Did not provide authority to ban unsafe drugs
- Did not regulate cosmetics or medical devices
The 1906 Pure Food and Drugs Act only authorized two methods of enforcement to remove violative products from the market:
Seizure & Criminal prosecution
Food, Drugs & Cosmetics Act of 1938
Requires that new drugs cannot be marketed until proven safe for use under the conditions described on the label and approved by the FDA
Expanded misbranding and adulteration definitions
Labels must contain adequate directions for use and warnings about habit-forming properties (if applicable)
Expanded coverage to cosmetics and devices
Unites States Pharmacopeia (USP)
Official compendia established in 1820 which contains monographs of active ingredients which include the approved titles, definitions, descriptions, and standards for identity, quality, strength, purity, packaging, stability, and labeling for a drug
NF (National Formulary)
Monographs of inactive ingredients
Homeopathic Pharmacopeia of the United States (HPUS)
An official compendium for homeopathic products
Durham-Humphrey Amendment (1951)
Authorized oral prescriptions and refills, and established two classes of drugs:
- Prescription drugs (a.k.a. “legend drugs”)
- OTC or non-prescription drugs
Under the Durham-Humphrey Amendment (1951), prescription drugs must contain
- “adequate information for use”: (indications, effects, dosages, routes, methods, frequency, warnings, hazards, contraindications, side-effects, etc.)
- “Caution: Federal law prohibits dispensing without a prescription”
Under the Durham-Humphrey Amendment (1951), OTC drugs must contain
“adequate directions for use” for the layperson: purposes for use, dose, frequency of administration, duration of use, route, etc.
Kefauver-Harris Amendment of 1962
- Required drugs be proven safe and also effective
- Established good manufacturing practices
- Established new drug approval process
- Established advertising oversight: FDA over legend drugs, FTC over OTC drugs
Medicare Part A
Hospital (inpatient)
Medicare Part B
Medical (Outpatient)
Medicare Part C
Advantage (Gap coverage)
Medicare Part D
Prescription Drug