Durham humphrey amendment Study guides, Class notes & Summaries

Nebraska MPJE Questions And Answers 100% Verified 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? - ANS-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? - ANS-FDA modernization act 1997 What act reduced the cose of orphan drugs? - ANS-...

What is the Pure Food and Drugs Act of 1906? - Drugs marketed as interstate must comply with standards with strength, purity, and quality Who is the father of the U.S. food and drug law? - Harvey Wiley What is the Federal Food, Drug, and Cosmetic (FDC) Act? - -107 sulfanilamide elixir deaths in 15 states -Diethylene glycol (antifreeze) caused kidney damage -Congress created FDA NDA -Applications needed to be filed with safety and quality, not necessarily efficacy What is the Durham-Hump...

Federal MPJE (2024/2025) Exam Questions and Answers 100% Solved What did the FDCA of 1938 accomplish? Food, Drug, and Cosmetic Act Drugs must be safe prior to marketing 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 presc...

Who pass law (legislative body) that govern pharmacy practice in VA? - correct answer U.S congress and VA general assembly Who regulate (regulative body) pharmacy practice in VA? - correct answer FDA, DEA, and VA Board of Pharmacy What is the Pure Food and Drug Act of 1906? - correct answer Prohibits the shipment of adulterated or misbranded drugs in interstate commerce -have to meet quality and purity standards What is the Food, Drug, and Cosmetic Act of 1938? - correct answer Law tha...

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 ...

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

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...

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...

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...

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...