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
Document information
- Uploaded on
- March 4, 2024
- Number of pages
- 11
- Written in
- 2023/2024
- Type
- Exam (elaborations)
- Contains
- Questions & answers
