FEDERAL MPJE 2023 EXAM

FEDERAL MPJE 2023 EXAM • What did the FDCA of 1938 accomplish?: Food, Drug, and Cosmetic Act • Drugs must be safe prior to marketing • 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 bepure safe and effective. 2) Established the Good Manufacturing Practices (currentGMPs) • Prescription Drug Marketing Act of 1987 (PDMA): • 1) Prevents re-importationof a drug into US. • Prohibited hospital and healthcare entities from reselling their pharamaceuticals. • Prohibits sale, trade, or purchase of Rx samples • "Samples Act" • Drug Compounding Quality and Security Act 2013 (DQSA): 1) Outsourcing(503B) facilities can compound (w/o a prescription) - Regulated by FDA/cGMP • 503B are exempt from premarket approval, adequate directions for use, andtrack-and-trace provisions. • Benefits and restrictions of a 503A facility: 503A facilities can pre-emptively compound (anticipatory) but only pursuant to a prescription or medication order. Regulated by states/USP standards