Federal MPJE (2022/2023) Graded A+

What did the FDCA of 1938 accomplish? Food, Drug, and Cosmetic Act 1) Drugs must be safe prior to marketing 2) Established the FDA - Food, Drug, Cosmetic, Medical device safety Durham-Humphrey Amendment of 1951 • Created a distinction between "OTC" and "Legend Drugs/Prescription". • Authorized verbal prescriptions/refills • Required Legend Drugs to carry the statement: "Caution: Federal law prohibits dispensing without a prescription.". Kefauver-Harris Amendment of 1962 1) Requires all medications in US to be pure safe and effective. 2) Established the Good Manufacturing Practices (currentGMPs) Prescription Drug Marketing Act of 1987 (PDMA) 1) Prevents re-importation of a drug into US. 2) Prohibited hospital and healthcare entities from reselling their pharamaceuticals. 3) Prohibits sale, trade, or purchase of Rx samples 4) "Samples Act" Drug Compounding Quality and Security Act 2013 (DQSA)