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Pure Food and Drug Act of 1906 (Wiley Act) ✔✔Prevents adulteration and misbranding Drugs met standard of strength/quality/purity according to USP/NF Food, Drug, and Cosmetic Act of 1938 ✔✔... Required manufacturer to prove drug safety prior to marketing it Also defined/regulated: adulteration, misbranding, interstate commerce Durham Humphrey Amendment of 1951 ✔✔Divided medications into OTC and prescription (legend) drugs Kefauver-Harris Amendment of 1962 ✔✔Manufacturer's must prove that a drug is both safe and effective Poison Prevention and Packaging Act of 1970 ✔✔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 ✔✔Laws prohibiting reimportation of drugs Patients can not buy drugs in other countries and bring to US unless: 1. It is for a 90 day supply or less and for that specific patient (not resold) 2. Effective treatment not available in the US, the condition is serious, and drug has no unreasonable risk Omnibus Budget Reconciliation Act of 1990 ✔✔Required counseling and patient profiles for all Medicaid patients Dietary Supplement Health And Education Act of 1994 ✔✔Defined dietary supplements as food products MD Board of Pharmacy Members ✔✔Total of 12 members: [Show More]

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