Kefauver harris amendment - Study guides, Class notes & Summaries

TEST BANK For Clayton’s Basic Pharmacology for Nurses 19th Edition Michelle Willihnganz ||All Chapters (1 - 48)||Newest Version 2024 A+ Test Bank For Clayton’s Basic Pharmacology for Nurses 19th Edition By Michelle J. Willihnganz, Samuel L. Gurevitz, Bruce Clayton Complete MULTIPLE CHOICE 1. Which name identifies a drug listed by the US 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 i...

Chapter 01: Drug Definitions, Standards, and Information Sources Willihnganz: Clayton’s Basic Pharmacology for Nurses, 19th Edition DIF: Cognitive Level: Knowledge REF: p. 9 OBJ: 1NAT: NCLEX Client Needs Category: Safe, Effective Care Environment TOP: Nursing Process Step: Assessment CON: Patient Education 2. Which source contains information specific to nutritional supplements? a. USP Dictionary of USAN & International Drug Names b. Natural Medicines...

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...

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 .....

2. Which source contains information specific to nutritional supplements? a. USP Dictionary of USAN & International Drug Names b. Natural Medicines Comprehensive Database c. United States Pharmacopoeia/National Formulary (USP NF) d. Drug Interaction Facts ANS: C United States Pharmacopoeia/National Formulary contains information specific to nutritional supplements. USP Dictionary of USAN & International Drug Names is a compilation of drug names, pronunciation guide, and possible future FDA...

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...

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 ...

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...

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...

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...