Durham humphrey amendment - Study guides, Class notes & Summaries

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 ...

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...

What is the 1938 Federal Food, Drug and Cosmetic Act? (Ans- Misbranding and mislabeling What is the 1951 Durham-Humphrey Amendment? (Ans- Distinction between legend drugs and otc drugs What is the 1970 Poison Prevention Packaging Act? (Ans- Made sure all manufacturers and pharmacies to place medications with childproof caps and packaging What is the 1983 Orphan Drug Act? (Ans- Encourages companies to develop drugs for rare diseases by providing research assistance, grants and co...

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-...

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...

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, ...

PTCB EXAM TEST BANK QUESTIONS AND ANSWERS LATEST WITH RATIONALE Multiple choice What is the route of administration for a prescription with the following directions: "i supp pr q 6 hr prn"? A. Orally B. Rectally C. Urethrally D. Vaginall {{Correct Ans- B. Rectally Rationale: "pr" means per rectum. What is the meaning of PDA? A. Personal digital aid B. Personal digital assistant C. Physician digital assistant D. Pharmaceutical data assistant {{Correct Ans- B. Personal dig...

Which pharmacy must provide one-time notice to patients informing them that Central Processing is being used to fill their prescriptions? SATA -Class A -Class C -Class D -Class E - correct answer Ans: -Class A -Class E Which provider pharmacy may establish a satellite pharmacy in a location that is not the same as the pharmacy? SATA -Class A -Class C -Class E -Class D - correct answer Ans: -Class A -Class C Durham-Humphrey Amendment of 1951 - correct answer -Established presc...

Nebraska MPJE Questions And Answers 100% Verified 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? - ANS-Food and Drug Administration (FDA) Modernization Act 1997 What legistation encouraged manufacturers to conduct research for new uses of drugs and to submit SNDAs for these uses? - ANS-FDA modernization act 1997 What act reduced the cose of orphan drugs? - ANS-...

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 after Durham-Humphrey Amendment -Not required to have directions for ...