PTU Final Exam QUESTION AND 100% CORRECT ANSWERS (REVISED)

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