Kefauver harris amendment - Study guides, Class notes & Summaries

North Carolina MPJE Questions and Answers Rated A+ Pure Food and Drug Act of 1906 prohibited the adulteration and misbranding of foods and drugs in interstate commerce Food, Drug, and Cosmetic Act of 1938 Core of today's drug laws. No new drug can be marketed/sold until proven safe and approved by FDA. Labels must contain adequate directions for use and warnings about their habit-forming properties Durham-Humphrey Amendment of 1951 Established two classes of medications: Rx and ...

Federal MPJE (2022/2023) Graded A+ What did the FDCA of 1938 accomplish? Food, Drug, and Cosmetic Act 1) Drugs must be safe prior to marketing 2) Established the FDA - Food, Drug, Cosmetic, Medical device safety Durham-Humphrey Amendment of 1951 • Created a distinction between "OTC" and "Legend Drugs/Prescription". • Authorized verbal prescriptions/refills • Required Legend Drugs to carry the statement: "Caution: Federal law prohibits dispensing without a prescription.". Ke...

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...

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...

Alabama MPJE Questions and Answers Already Passed Pure Food and Drug Act (1906) aka Wiley Law Prohibits adulteration and misbranding Food, Drug and Cosmetic Act (1938) -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) -Established prescription and OTC drug categories -Allowed for oral prescriptions -Allowed for refills Manufacturer label on Rx drugs after Durham-Humphrey A...

Pure Food and Drug Act (1906) aka Wiley Law Prohibits adulteration and misbranding Food, Drug and Cosmetic Act (1938) -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) -Established prescription and OTC drug categories -Allowed for oral prescriptions -Allowed for refills Manufacturer label on Rx drugs after Durham-Humphrey Amendment -Not required to have directions for ...

What legistation was created for the provisions for the fast track review of some NDA submissions to expedite approval of new drugs used to treat life-threatening conditions? - ️️Food and Drug Administration (FDA) Modernization Act 1997 What legistation encouraged manufacturers to conduct research for new uses of drugs and to submit SNDAs for these uses? - ️️FDA modernization act 1997 What act reduced the cose of orphan drugs? - ️️Orphan drug act 1983 What act prohibited the...

Texas MPJE, Ultimate Texas MPJE 2024 Already Graded A Texas pharmacist can administer all vaccines True What age can pharmacist administer influenza 7 What is the min age for all other vaccines 14 How many hours for nuclear training 700 hours State board is made up of how many members 11 How many pharmacists are on the state board 7 How many techs are on the state board 1 How many public members are on the state board? 3 What are pharmacists requirements to be on th...

CPHT 2024 Exam Questions with Correct Answers Food and Drug Administration - Answer-Leading fed. enforcement agency for regulations concerning drug products Drug Enforcement Agency - Answer-controls the distribution of drugs that can be easily abused Food and Drug act of 1906 - Answer-Government pre approval of drugs 1938 Food, Drug, and Cosmetic Act - Answer-New drugs must be safe before marketing; in response to 107 poisonings 2 Requirements in 1951 Durham-Humphrey Amendment - An...

1906 Pure Food and Drug Act - Answer 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) - Answer 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...