Kefauver harris amendment Study guides, Class notes & Summaries

The medication that has an expiration date 12/14 would expire on - correct answer the last day of December 2014 at midnight in the NDC , what is represented by the second set of numbers - correct answer NDC number is 10 digits long and comprised of three sets of numbers - the 1st set: 4-5 digits and represents the manufacturer - The 2nd set: 3-4 = the product name, strength and dosage form. - The 3rd set: 2 digits = package size A pharmacy technician's scope of practice includes ......

1906 - Federal Food and Drug Act - correct answer This act prohibits the sale of adulterated or mislabeled food, drinksand drugs 1914 - Harrison Narcotic Act - correct answer This act limits the transport of opium. In order to purchase opium, a prescription is required. 1938 - Food Drug and Cosmetic Act - correct answer This act made the food and Drug Act more comprehensive to include cosmetics. The act also defines misbranding or adulteration of drugs to be illegal, This act require...

Alabama MPJE Latest Update (2024/2025) Already Graded A 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 afte...

TEST BANK FOR CLAYTONS 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 ...

Federal MPJE 2023/2024 Questions and Answers Already Passed 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 pr...

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 A dministration (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 adulteration or misbrandi...

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, ...

Florida MPJE: June 2023 Questions and Answers 100% correct Food, Drug, and Cosmetic Act of 1938 Due to sulfanilamide elixir deaths New drugs must be SAFE before marketing Established the FDA Durham-Humphrey Amendment of 1951 Created OTC vs. Legend drugs Verbal prescriptions Prescription refills Kefauver-Harris Amendment of 1962 "Drug Efficacy Amendment" New drugs must be SAFE and EFFICACIOUS Established GMPs FDA oversees prescription drug advertising ...

Food, Drug, and Cosmetic Act - correct answer - Established FDA - New drugs must be SAFE prior to marketing Durham-Humphrey Amendment - correct answer - Established OTC + prescription drug classes - Authorized verbal Rxs and refill Rxs Kefauver-Harris Amendment - correct answer - New drugs must be safe AND effective - Established GMPs - Gave FDA jurisdiction over prescription drug advertising Prescription Drug Marketing Act - correct answer - Bands re-importation of prescrip...

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-...