Pharmacy Law exam 2 QUESTIONS AND ANSWERS 100% SOLVED (Newest 2025) Designed to protect the public health by requiring safe effective and properly labeled drugs and devices - Correct Answers ✅Federal food drug and cosmetic act What did the Durham-Humphrey amendment of 1951 do? - Correct Answers ✅establish Rx and OTC What does proper labeling under Durham-humphrey act require? - Correct Answers ✅pharmacy name/address, Rx #, Date, Dr name, Patient name, directions What did the Kefauver-Harris amendments of 1962 do? - Correct Answers ✅Established safety and efficacy requirements What did the Drug Abuse Control amendments of 1965 do? - Correct Answers ✅controlled use of depressants, stims, hallucinogens, What was the Drug Abuse Control amendment a precursor to? - Correct Answers ✅Federal controlled substance act What did the Drug Price Competition and Patent Term Restoration Act of 1984 do? - Correct Answers ✅ANDA process for generic drug approval 1 / 3
Pharmacy Law exam 2 QUESTIONS AND ANSWERS 100% SOLVED (Newest 2025) What does ANDA stand for? - Correct Answers ✅abbreviated new drug applications What did the Prescription Drug market act of 1987 do? - Correct Answers ✅Bans reimportation, sales, trade or purchase of Rx sample What did the FDA modernization act of 1997 do? - Correct Answers ✅Legend Rx only, clarify compounding v manufacturing Established REMS and requires side effects toll free number statement? - Correct Answers ✅Food and Drug Administration Amendments In 2009 created an abbreviated approval pathway for biological drugs that are biosimilar and interchangeable to FDA licensed biological product. - Correct Answers ✅Biologics Price Competition and innovation act What act in 2013 made the large scale compounding by pharmacies, and uniform track and trace system for drug supply chain? - Correct Answers ✅Drug quality and security act 2 / 3
Pharmacy Law exam 2 QUESTIONS AND ANSWERS 100% SOLVED (Newest 2025) What would make a product be considered both adulterated and misbranded - Correct Answers ✅wrong strength of drug on label what does FDA OTC review do? - Correct Answers ✅evaluate safety and effectiveness What do mineral oil, wintergreen oil, ipecac syrup, and salicylates have under law - Correct Answers ✅Special warnings What is the ipecac syrup sold in? - Correct Answers ✅sold in 30 ml containers what warning do salicylates have? - Correct Answers ✅Reye's syndrome what are the prohibited acts? - Correct Answers ✅adulteration, misbranding What are the prohibited acts applied to? - Correct Answers ✅pharmacists, pharmacies Who is in charge of prescription drug advertising? - Correct Answers ✅FDA
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