And cosmetic act of 1938 Study guides, Class notes & Summaries

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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...

Food, Drug, and Cosmetic Act of 1938 correct answers Due to sulfanilamide elixir deaths New drugs must be SAFE before marketing Established the FDA Durham-Humphrey Amendment of 1951 correct answers Created OTC vs. Legend drugs Verbal prescriptions Prescription refills Kefauver-Harris Amendment of 1962 correct answers "Drug Efficacy Amendment" New drugs must be SAFE and EFFICACIOUS Established GMPs FDA oversees prescription drug advertising Prescription Drug Market...

What is the Food, Drug, and Cosmetic Act of 1938? Correct Answer Passed by Congress Requires new drugs to prove their safety prior to marketing (the primary federal law dealing with food, drug, cosmetic, and medical device safety). Established the FDA. What is the Durham - Humphrey Amendment of 1951? Correct Answer Establishes 2 classes of drugs (Prescription and OTC). Allows for verbal prescriptions and prescription refills. What is the Kefauver-Harris Amendment of 1962? Correct Answer...

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

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...

Test Bank for Essentials of Pharmacology for Health Professions 8th Edition by Bruce Colbert & Ruth Woodrow ISBN 9781337395892 | Complete Guide A+. CHAPTER 1: CONSUMER SAFETY AND DRUG REGULATIONS TRUE/FALSE 1. The pharmaceutical manufacturer has the authority to add additional active ingredients to a previously approved pharmaceutical product. ANS: F According to the 1938 Federal Food, Drug, and Cosmetic Act and Amendments of 1951 and 1962, all labels must be accurate and include a listing of al...

CSA correct answers Controlled Substances Act (enforced by the DEA) Poison Prevention Packaging Act correct answers Sets child-resistant drug packaging requirements, under US Consumer Product Safety Commission HIPAA correct answers set by the department of health and human services CMEA correct answers Control Methamphetamine Epidemic Act (CMEA)- pseudoephedrine containing product requirements Hatch-Waxman Act correct answers included the ANDA approval process for generic drugs in...

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...

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 adulteration and misbranding of foods and drugs in interstate commerce; D...