AZ MPJE exam 2023 with 100% correct answers

Durham-Humphrey Amendment of 1951 - correct answer • Created a distinction between "OTC" and "Legend Drugs". • Required Legend Drugs to carry the statement: "Caution: Federal law prohibits dispensing without a prescription.". • All drugs require "Adequate directions for use" Kefauver-Harris Amendment of 1962 - correct answer • Also known as the "Drug Efficacy Amendment". • Required drug manufacturers to provide proof of the effectiveness and safety of their drugs before approval . • Required drug advertising to be more closely regulated and disclose accurate information about side effects • Established Current Good Manufacturing Practices (CGMP) • Requires ADRs and ADEs be reported (MedWatch, FAERS, ISMP C-MERP) •DESI drugs Medical Device Amendment of 1976 - correct answer This calls for classification, safety and efficacy of medical devices. Class I Medical Device - correct answer Lowest Risk Needles, scissors, exam gloves, stethoscope, toothbrush Class