Texas MPJE questions with correct answers

What is the Food, Drug, and Cosmetic Act of 1938? - Answer Passed by Congress Requires new drugs to prove their safety prior to marketing (the primary federal law dealing with food, drug, cosmetic, and medical device safety). Established the FDA. What is the Durham - Humphrey Amendment of 1951? - Answer Establishes 2 classes of drugs (Prescription and OTC). Allows for verbal prescriptions and prescription refills. What is the Kefauver-Harris Amendment of 1962? - Answer Requires drug companies to prove safety & efficacy for their claimed use Increases the safety requirements for drugs Establishes Good Manufacturing Practices (GMPs) Gave FDA jurisdiction over prescription drug advertising What is the Prescription Drug Marketing Act of 1987? - Answer Bans re-importation of prescription drugs and insulin products (except by the manufacturer). Bans sales/trade/purchase of prescription drug samples Mandates the storage/handling/recordkeeping requirements for prescription drug samples Prohibits resale of prescription drugs purchased by hospitals or healthcare facilities What is the Drug Quality and Security Act of 2013? - Answer Encompasses the Drug Compounding Quality Act (DCQA - large scale co