PTU Rite Aid Final Exam Questions and Answers 100% Verified!
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 DAW 0 - ANSWER-no preference, OK to substitute DAW 1 - ANSWER-substitution not allowed by prescriber DAW 2 - ANSWER-substitution allowed, patient requested specific product
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