Misbranding - Study guides, Class notes & Summaries

Indiana MPJE Review Part 1, Indiana MPJE Review Part 2, Indiana MPJE Review Part 3, Indiana MPJE Review Part 4 Which federal act discusses adulteration and misbranding of drugs? Food Drug and Cosmetic Act T/F Adulteration/Misbranding can occur with both a drug and a device. True T/F A drug must be contaminated to be considered adulterated. F - if held under unsanitary conditions where it MAYA have been contaminated A container that contains a drug is made of poisonous or harmful mater...

Indiana MPJE Complete Answers Adulteration ️Something wrong with the preparation, strength, or purity of a product - making the product less pure Expired products - adulteration or misbranding? ️Adulteration Contaminated drug packaging - adulteration or misbranding? ️Adulteration Not meeting current good manufacturing practices (cGMP) - adulteration or misbranding? ️Adulteration Using an unsafe coloring agent - adulteration or misbranding? ️Adulteration Not meeting USP ...

Pure Food and Drug Act of 1906 (Wiley Act) - correct answer Prevents adulteration and misbranding Drugs met standard of strength/quality/purity according to USP/NF Food, Drug, and Cosmetic Act of 1938 - correct answer Required manufacturer to prove drug safety prior to marketing it Also defined/regulated: adulteration, misbranding, interstate commerce Durham Humphrey Amendment of 1951 - correct answer Divided medications into OTC and prescription (legend) drugs Kefauver-Harris Amend...

Maryland MPJE Questions and Answers Already Passed Pure Food and Drug Act of 1906 (Wiley Act) Prevents adulteration and misbranding Drugs met standard of strength/quality/purity according to USP/NF Food, Drug, and Cosmetic Act of 1938 Required manufacturer to prove drug safety prior to marketing it Also defined/regulated: adulteration, misbranding, interstate commerce Durham Humphrey Amendment of 1951 Divided medications into OTC and prescription (legend) drugs Kefauver-Harris Amendment of 1...

What is the 1938 Federal Food, Drug and Cosmetic Act? (Ans- Misbranding and mislabeling What is the 1951 Durham-Humphrey Amendment? (Ans- Distinction between legend drugs and otc drugs What is the 1970 Poison Prevention Packaging Act? (Ans- Made sure all manufacturers and pharmacies to place medications with childproof caps and packaging What is the 1983 Orphan Drug Act? (Ans- Encourages companies to develop drugs for rare diseases by providing research assistance, grants and co...

NJ MPJE QUESTIONS AND ANSWERS ALREADY PASSED Neither _____ nor _____ are required by an *ANDA*. -pre-clinical animal studies -clinical studies *bioequivalence only Prescription drug advertising is regulated by the _____, while OTC drug advertising is regulated by the _____. -FDA -FTC (Federal Trade Commission) Any false or misleading statements in a drug advertisement could be considered _____. - misbranding Pure Food and Drug Act (1906) description -mandated accurate p...

PA MPJE 2024 QUESTIONS AND ANSWERS GRADED A+ Generic drug companies can submit what two abbreviated drug applications? ANDA or 505(b)(2) application What is the key difference between an ANDA and 505(b)(2) application? Drugs submitted under ANDA must be bioequivalent and have same route of administration, strength, and formulation Drugs submitted under 505(b)(2) can have different strength or formulation What Act approved in March of 2020 includes OTC monograph reform? The CARES Ac...

Pure Food and Drug Act (1906) aka Wiley Law - correct answer Prohibits adulteration and misbranding Food, Drug and Cosmetic Act (1938) - correct answer -New drug could not be marketed unless safe -Required manufacturer label to have directions for use and warnings about habit forming drugs Durham-Humphrey Amendment (1951) - correct answer -Established prescription and OTC drug categories -Allowed for oral prescriptions -Allowed for refills Manufacturer label on Rx drugs after Durham-...

Pure Food and Drug Act of 1906 (Wiley Act) Prevents adulteration and misbranding Drugs met standard of strength/quality/purity according to USP/NF Food, Drug, and Cosmetic Act of 1938 Required manufacturer to prove drug safety prior to marketing it Also defined/regulated: adulteration, misbranding, interstate commerce Durham Humphrey Amendment of 1951 Divided medications into OTC and prescription (legend) drugs Kefauver-Harris Amendment of 1962 Manufacturer's must prove that a drug is bo...

What is a statute? - Answer A law What is administrative law? - Answer Rules and regulations created by administrative agencies such as the FDA and Indiana Board of Pharmacy What was accomplished by the pure food and drug act of 1906? - Answer Prohibited adulteration and misbranding of foods and drugs in interstate commerce (does NOT include that misbranding includes false or misleading efficacy claims) What was accomplished by the food, drug, and cosmetic act of 1938? - Answer...