PTU RITE AID Final Exam- Complete Questions & Answers (100% Verified)

PTU RITE AID Final Exam- Complete Questions & Answers (100% Verified) Food, Drug, and Cosmetic Act of 1938 - CORRECT ANSWER - purity, strength, and safety Pure Food and Drug Act of 1906 - CORRECT ANSWER - forbade the manufacture or transport or sale of mislabeled or adulterated food or drugs and poisonous patent medicines. Durham-Humphrey Amendment of 1951 - CORRECT ANSWER - • Created a distinction between "OTC" and "Legend Drugs". Patient Package Insert (PPI) - CORRECT ANSWER - Manufacturer's patient product information included with the product package. Hatch-Waxman Act of 1984 - CORRECT ANSWER - promoted the manufacturing of generic drugs and new medications MedGuides - CORRECT ANSWER - FDA-approved documents created to educate patients about how to minimize harm from potentially dangerous drugs Class I recall - CORRECT ANSWER - Serious adverse effects on health or death Class II recall - CORRECT ANSWER - temporary or reversible adverse effects Class III recall - CORRECT ANSWER - Unlikely to cause adverse health consequences Market Withdrawal - CORRECT ANSWER - permanent removal from the market, drug is harmful of unapproved pharmacological alternative - CORRECT ANSWER - same active ingredient, different dosage form/strength therapeutic alternative - CORRECT ANSWER - different active ingredient, same drug class DAW 0 - CORRECT ANSWER - no preference, OK to substitute DAW 1 - CORRECT ANSWER - substitution not allowed by prescriber DAW 2 - CORRECT ANSWER - substitution allowed, patient requested specific product DAW 7 - CORRECT ANSWER - substitution not allowed; brand mandated by law DAW 8 - CORRECT ANSWER - Substitution allowed; generic drug not available in marketplace