PTU FINAL EXAM

PTU FINAL EXAM Food, Drug, and Cosmetic Act of 1938 purity, strength, and safety Pure Food and Drug Act of 1906 forbade the manufacture or transport or sale of mislabeled or adulterated food or drugs and poisonous patent medicines. Durham-Humphrey Amendment of 1951 • Created a distinction between "OTC" and "Legend Drugs". Patient Package Insert (PPI) Manufacturer's patient product information included with the product package. Hatch-Waxman Act of 1984 promoted the manufacturing of generic drugs and new medications MedGuides FDA-approved documents created to educate patients about how to minimize harm from potentially dangerous drugs Class I recall Serious adverse effects on health or death Class II recall temporary or reversible adverse effects Class III recall Unlikely to cause adverse health consequences Market Withdrawal permanent removal from the market, drug is harmful of unapproved pharmacological alternative