RAC Test Prep

* first food and drug law * prohibits interstate commerce of misbranded and adultered foods, drinks, drugs * law regulates LABELING statements (not premarket assessment of safety/efficacy) (not false health claims)

Prohibits false and fraudulent label claims of therapeutic effectiveness

Stricter controls over all narcotics. MD's and Pharmacists had to keep records of what was dispensed

Food, Drug and Insecticide Administration 1927

Trigger = sulfanilamide *required that drugs be cleared for safety before being introduced into the market *prohibited interstate commerce of food, drug cosmetic or device that was adulterated or misbranded

Amendment to FD&C Act Added new standards to ensure the purity, quality, strength and identity of insulin-containing products

Extended coverage and control to cosmetics and therapeutic devices

Required that safe tolerances be established for unavoidable poisonous substances such as pesticides

Authorized food standards of identify, quality and container fill

Authorized factory inspections

Added injunctions to the previously existing penalties of seizure and prosectution

Required drugs intended for humans to bear labels warning against habit formation

Defined drug, device, cosmetic, label and labeling terminology

Introduced regulation of biological products and control of communicable diseases

Precursor to 1963 extended certification to other antibiotic drug or derivatives.