Pharmacy Law Review EXAM QUESTIONS AND ANSWERS 100% SOLVED (Newest 2025) 1906 Pure Food and Drug Act - Correct Answers ✅Prohibits the sale and transport of adulterated or mislabeled food, drinks and drugs.Prohibits the mislabeling and misbranding of products.1938 Food, Drug and Cosmetic Act (FDCA) - Correct Answers ✅This act requires that manufacture prove a new drug is safe for human consumption.Toxicological studies - done on animals.Clinical trials - done on humans.Gave rise to the Food and Drug Administration.Manufacturer must submit New Drug Application (NDA) to FDA.1951 Durham-Humphrey Amendment - Correct Answers ✅This act distinguishes legend drugs (prescription) from the over the counter drugs (OTC). This act requires companies to label legend drugs: "Caution: Federal law prohibits dispensing without a prescription". Refills may only be authorized by the subscriber.1962 Kefauver-Harris Amendment - Correct Answers ✅Required drugs be effective for the purpose they were marketed for. Written in response to Thalidomide incident in Europe. 1 / 2
Pharmacy Law Review EXAM QUESTIONS AND ANSWERS 100% SOLVED (Newest 2025) 1970 Comprehensive Drug Abuse Prevention and Control Act (Controlled Substance Act - CSA) - Correct Answers ✅Purpose is to regulate manufacture and sale of Narcotics.Drug Enforcement Agency (DEA) was formed. Introduced a stair step schedule for narcotics based on their abuse potential. Schedule I drugs have the highest abuse potential and Schedule V drugs have the lowest abuse potential.DEA Form 222 - to buy DEA Form 224 - to sell 1970 Poison Prevention Packaging Act - Correct Answers ✅This act required childproof packaging on most drugs dispensed in a pharmacy. Drugs that are exempt from this act are drugs used in emergency situations, such as nitroglycerin (Nitrostat SL), birth control pills, inhalers, ointments and creams.1972 Drug Listing Act - Correct Answers ✅Authorized the FDA to compile a list of all legal drugs for sale in the US.Assigned a unique identifier to all drugs called the National Drug Code (NDC) 12 digit code. Leading zero on the ones with only 4 digits in first sequence.1983 Orphan Drug Act - Correct Answers ✅Created to promote the research and development of drugs needed for the treatment of rare diseases. (less than 200,000)
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