1938 food - Study guides, Class notes & Summaries

TEST BANK FOR CLAYTON’S BASIC PHARMACOLOGY FOR NURSES 18TH Edition by Willihnganz Chapter 1: Drug Definitions, Standards, and Information Sources Test Bank MULTIPLE CHOICE 1. What is the name under which a drug is listed by the U.S. Food and Drug Administration (FDA)? a. Brand b. Nonproprietary c. Official d. Trademark ANS: C The official name is the name under which a drug is listed by the FDA. The brand name, or trademark, is the name given to a drug by its manufacturer. The nonproprietary, ...

1938 Federal Food, Drug, and Cosmetic Ac

Pure Food and Drug Act (1906) aka Wiley Law - correct answer Prohibits adulteration and misbranding Food, Drug and Cosmetic Act (1938) - correct answer -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) - correct answer -Established prescription and OTC drug categories -Allowed for oral prescriptions -Allowed for refills Manufacturer label on Rx drugs after Durham-...

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...

Drug Standards - ANSWER rules set to assure that consumers get what they pay for, that all preparations by the same drug name must be of uniform strength, quality, and purity 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 - ANSWER created to enforce rules such as labeling, drug approval before release, and warning labels (such...

What are drug standards? - ANSWER rules that drug manufactures must follow when they produce drugs 1906 Pure Food and Drug Act - ANSWER est. drug standards for strength, purity, and quality. also mandated that drugs with with dangerous ingredients be labeled as such 1938 Federal Food, Drug, and Cosmetic Act - ANSWER established the Food and Drug Administration (FDA), which is meant to enforce rules such as labeling, drug approval before release, and warning labels

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...

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