Maryland MPJE questions with correct answers

Pure Food and Drug Act of 1906 (Wiley Act) - Answer Prevents adulteration and misbranding Drugs met standard of strength/quality/purity according to USP/NF Food, Drug, and Cosmetic Act of 1938 - Answer Required manufacturer to prove drug safety prior to marketing it Also defined/regulated: adulteration, misbranding, interstate commerce Durham Humphrey Amendment of 1951 - Answer Divided medications into OTC and prescription (legend) drugs Kefauver-Harris Amendment of 1962 - Answer Manufacturer's must prove that a drug is both safe and effective Poison Prevention and Packaging Act of 1970 - Answer Required child-resistant (C-R) packaging for drugs and dangerous household substances Exempt for C-R packaging: SL nitroglycerin Must record request for non C-R packaging on prescription or patient's profile Prescription Drug Marketing Act of 1987 - Answer Laws prohibiting reimportation of drugs