Kefauver harris amendment - Study guides, Class notes & Summaries

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-...

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 ...

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...

(Updated) EXCPT Pharmacy Technician Exam Study Guide with complete solutions |Latest 2024/2025 1. Pure Food and Drug Act (1906) Prohibits interstate commerce of misbranded and adulterated drugs and foods. 2. Misbranded a drug product is misbranded if its labeling is inaccurate, incomplete, or misleading 3. Adulterated a drug product that fails to meet quality, strength, or purity standards 4. Federal Food, Drug, and CosRequires drug manufacturers to provide the FDA with evidence of saf...

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...

Utah MPJE-Federal Law Questions and Answers Graded A+ What does CFR relate to? federal regulations What does USC relate to? united states code (laws) What does UAC relate to? Utah administrative code What does UCA relate to? Utah code annotated (law) What are the 4 parts of negligence? duty (obligation by the individual to conform to a specific standard of conduct) breach- violation of that legal obligation by defendant causation- the breach is the actual and proximate cause...

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...

What is the Pure Food and Drugs Act of 1906? - Drugs marketed as interstate must comply with standards with strength, purity, and quality Who is the father of the U.S. food and drug law? - Harvey Wiley What is the Federal Food, Drug, and Cosmetic (FDC) Act? - -107 sulfanilamide elixir deaths in 15 states -Diethylene glycol (antifreeze) caused kidney damage -Congress created FDA NDA -Applications needed to be filed with safety and quality, not necessarily efficacy What is the Durham-Hump...

State the three (3) most important characteristics of any drug. effectiveness, safety, selectivity Is it possible to have a selective drug? No, all medications have side effects Define the four phases of pharmacokenetics. Absorption, distribution, metabolism and excretion Define pharmacodynamics. The nature and intensity of the response the drug has on the body Name the three most important goals of pre-administration assessment. Evaluate effects, identify high risk patients, and assess f...