TX MPJE EXAM 2024 WITH 100% CORRECT ANSWERS

Food Drug and Cosmetic Act of 1938 - correct answer Followed deaths by sulfanalimide elixier; required new drugs to be SAFE; established FDA as primary federal law dealing with food, drug, costmetic, and medical device safety Durham-Humphrey Act of 1951 - correct answer Established Rx and OTC drug class; authorized verbal prescriptions and prescription refills Kefauver-Harris Amendment of 1962 - correct answer Required new drugs to be SAFE and EFFECTIVE; increased safety requirements for drugs and established GMPs; gave FDA jurisdiction over Rx drug advertising Prescription Drug Marketing Act of 1987 (4 things) - correct answer PDMA; bans reimportation of Rx drugs and insulin produced in US (except by manufacturer); bans sale, trade, or purchase of Rx drug samples in the pharmacy; exception is pharmacies owned by charitable organizations or by city/state/county govt providing care to indigent population; may only be provided at no charge to patient; mandates storage, handling, and recordkeeping requirements for prescription drug samples; prohibits, with some exceptions, resale of prescription drugs purchased by hospitals Drug Quality and Security Act of 2013 (2 topics) - correct answer Drug Compouding Quality Act; Drug Supply Chain Security Act Drug Compounding Quality Act - correct answer Maintains traditional compounding regulations but establishes new section to FDCA that allows facilities that are compounding sterile pharmaceuticals to register with FDA as outsourcing facility; These facilities are exempt from new drug provisions, adequate directions for use, and drug track/trace provisions Drug Supply Chain Security Act - correct answer Provides uniform national framework for electronic track/trace system for Rx drugs through supply chain (exempt are blood products, radioactive drugs, imag