Durham humphrey amendment - Study guides, Class notes & Summaries

What legislation 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 legislation 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 adulteration or misb...

Harrison Narcotic Act - Established record keeping for receipt of opium or coca leaf products Durham-Humphrey Amendment to FD&C - 1. Defined prescription drugs from OTC drugs 2. Rx must come from doctor 3. Refills 4. Oral rxs Kefauver-Harris Amendment to FD&C - Brought on by thalidomide disaster 1. Evidence of effectiveness before marketing 2. Compliance with CGMP 3. Generic approval easier 4. Extended patent life - 20 years from first filing 5. Bans sale of drug samples

PTU RITE AID Final Exam Questions with Correct Answers 100% Verified Food, Drug, and Cosmetic Act of 1938 - Correct Answer purity, strength, and safety Pure Food and Drug Act of 1906 - Correct Answer forbade the manufacture or transport or sale of mislabeled or adulterated food or drugs and poisonous patent medicines. Durham-Humphrey Amendment of 1951 - Correct Answer • Created a distinction between "OTC" and "Legend Drugs". Patient Package Insert (PPI) - Correct Answer Manufactu...

Nebraska MPJE Questions and Answers Already Passed 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...

Pharmacy Law MPJE Exam: Federal Law Latest Update Already Passed What did the Federal Controlled Substances Act do? Why was it implemented? Legislators very concerned in the 1960s about legal and illegal drugs being abused They were given the opportunity to design an act/law Created the DEA to promulgate and enforce the law Created a closed system between: manufacturer, distributors, prescriber, dispenser, and patient. What did the Pure Food and Drug Act of 1906 do? Prohibited the adulterati...

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...

Pure Food and Drug Act of 1906Answer - prohibited the adulteration and misbranding of foods and drugs in interstate commerce Food, Drug, and Cosmetic Act of 1938Answer - 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 1951Answer - Established two classes of medications: Rx and OTC. Authorized oral prescriptions...

1. Pure Food and Drug Act of 1906 (Wiley Act) ANS Prevents adulteration and mis- branding Drugs met standard of strength/quality/purity according to USP/NF 2. Food, Drug, and Cosmetic Act of 1938 ANS Required manufacturer to prove drug safety prior to marketing it Also defined/regulated ANS adulteration, misbranding, interstate commerce 3. Durham Humphrey Amendment of 1951 ANS Divided medications into OTC and prescription (legend) drugs 4. Kefauver-Harris Amendment of 1962 ANS Manufact...

Which stage of new drug development involves giving the medication to large numbers of individuals with the disorder that the medication intends to treat? A. Developmental stage - phase 1 B. Developmental stage - phase 2 C. Developmental stage - phase 3 D. Postmarketing surveillance stage - C. Developmental stage - phase 3 Which legislation was enacted to stimulate development and availability of drugs to treat rare diseases? A. The Food and Drug Act of 1979 B. The Fast Tracking rules C...

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...