Durham law Study guides, Revision notes & Summaries

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

Administrative Procedure Act - correct answer federal law enacted in 1946, "notice and comment rulemaking" 1906: The Pure Food and Drug Act (PFDA) - correct answer interstate commerce labeling 1912 Pure Food and Drug Act - correct answer revised in 1912, stated that a drug was misbranded if its label contained a "false and fraudulent" statement regarding "curative or therapeutic effect." 1938 FD&C Act - correct answer • extended control to cosmetics and therapeutic de...

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 Manufacturer label on Rx drugs after Durham-Humphrey Amendment -Not required to have directions for ...

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...

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...

Pure Food and Drug Act: Year correct answer: 1906 Pure Food and Drug Act came from what? correct answer: "The Jungle" by Upton Sinclair that discussed filthy conditions of meat processing Quinine Regulation: Year correct answer: 1848 Quinine Regulation: Activities? correct answer: Mexican-American war resulted in malaria, farmers sold bark by weight, started added debris to gain profit, regulation enacted by Dept. of Agri. Food Drug and Cosmetic Act: year and formation activiti...

Virginia MPJE Exam Questions and Answers 100% CorrectVirginia MPJE Exam Questions and Answers 100% CorrectVirginia MPJE Exam Questions and Answers 100% CorrectVirginia MPJE Exam Questions and Answers 100% Correct Who pass law (legislative body) that govern pharmacy practice in VA? - ANSWER-U.S congress and VA general assembly Who regulate (regulative body) pharmacy practice in VA? - ANSWER-FDA, DEA, and VA Board of Pharmacy What is the Pure Food and Drug Act of 1906? - ANSWER-Prohibits th...

NHA Question and answers already passed 2024 How should prescription records be filed? - correct answer By the prescriptions serial number What organization issues a pharmacy's National Provider Identifier (NPI)? - correct answer Centers for Medicare and Medicaid Services (CMS) Which of the following types of medications requires a patient package insert (PPI) to be included with the prescription? -Contraceptives -Benzodiazepines -opiates -insulin - correct answer Contraceptiv...

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...