Durham humphrey amendment Study guides, Class notes & Summaries

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...

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 ......

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...

PTU RITE AID Final Exam- Complete Questions & Answers (100% Verified) PTU RITE AID Final Exam- Complete Questions & Answers (100% Verified) Food, Drug, and Cosmetic Act of 1938 - ANSWER - purity, strength, and safety Pure Food and Drug Act of 1906 - ANSWER - forbade the manufacture or transport or sale of mislabeled or adulterated food or drugs and poisonous patent medicines. Durham-Humphrey Amendment of 1951 - ANSWER - • Created a distinction between "OTC" and "Legend Drugs". ...

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 ...

PTU Rite Aid Final Exam 2023-2024 Questions and Answers 100% VerifiedPTU Rite Aid Final Exam 2023-2024 Questions and Answers 100% VerifiedPTU Rite Aid Final Exam 2023-2024 Questions and Answers 100% VerifiedPTU Rite Aid Final Exam 2023-2024 Questions and Answers 100% Verified Food, Drug, and Cosmetic Act of 1938 - ANSWER-purity, strength, and safety Pure Food and Drug Act of 1906 - ANSWER-forbade the manufacture or transport or sale of mislabeled or adulterated food or drugs and poisonous ...

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...

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 ...