KS MPJE 128 Review Questions with 100% Correct Answers | Updated 2024 | Guaranteed A+

Pure Food and Drug Act of 1906 - ️️Focused on Purity and Quality Prohibited the interstate transfer of adulterated or misbranded drugs Recognized USP/NF Standards Food, Drug, and Cosmetic Act of 1938 - ️️Focused on Safety New drug cannot be marketed until proven safe (drugs prior to 1938 were exempt) Power given to Congress via authority over interstate commerce Durham-Humphrey Amendment of 1951 - ️️Established 2 classes of drugs: Rx and OTC Established provisions for dispensing prescription drugs Established labeling requirements for OTC and prescription drugs Established use of NDC numbers Labeling requirements for OTC Drugs - ️️"Adequate directions for use" Labeling requirements for Rx Drugs - ️️"Adequate information for use" Kefauver-Harris Amendments of 1962 - ️️Focused on safety AND efficacy Impacts all drugs after 1962 and new drugs with an NDA approved since 1938 Established effectiveness as a standard Established Good Manufacturing Practices (GMP) Transfered jurisdiction of Rx advertising from FTC to FDA