Pure food and drugs act Study guides, Class notes & Summaries

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...

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-...

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...

According to the Quality System Regulation, when an investigation of a complaint is conducted all of the following are requirements for inclusion in the record of the investigation EXCEPT: A. The dates and results of the investigation B. The nature and details of the complaint C. Changes in procedures correcting quality problems D. Any reply to the complainant - Answer-C. A regulatory affairs professional wants to schedule a pre-NDA meeting with FDA. He or she should: A. Write a letter to...

Pure Food and Drug Act of 1906Answer - prohibited the adulteration and misbranding of foods and drugs in interstate commerce Food, Drug, and Cosmetic Act of 1938Answer - Core of today's drug laws. No new drug can be marketed/sold until proven safe and approved by FDA. Labels must contain adequate directions for use and warnings about their habit-forming properties Durham-Humphrey Amendment of 1951Answer - Established two classes of medications: Rx and OTC. Authorized oral prescriptions...

Respiratory Therapy - Lindsey Jones/Clinical Simulations 459 Questions with Verified Answers Information Gathering - Emphysema: (Abnormal condition of the alveoli resulting destruction and loss of elasticity) - CORRECT ANSWER LEVEL I : Cyanosis, Barrel chest, increased A-P diameter, Accessory muscle use, Digital clubbing of the nail beds, Significant history of smoking and/or occupational exposure to smoke or other pulmonary irritant LEVEL II : Dyspnea, Wheezing breath sounds LEVEL III ...

Administrative Procedure Act - correct answer federal law enacted in 1946, "notice and comment rulemaking" 1906: The Pure Food and Drug Act (PFDA) - correct answer interstate commerce labeling 1912 Pure Food and Drug Act - correct answer revised in 1912, stated that a drug was misbranded if its label contained a "false and fraudulent" statement regarding "curative or therapeutic effect." 1938 FD&C Act - correct answer • extended control to cosmetics and therapeutic de...

Test Bank for Essentials of Pharmacology for Health Professions 8th Edition by Bruce Colbert & Ruth Woodrow ISBN 9781337395892 | Complete Guide A+. CHAPTER 1: CONSUMER SAFETY AND DRUG REGULATIONS TRUE/FALSE 1. The pharmaceutical manufacturer has the authority to add additional active ingredients to a previously approved pharmaceutical product. ANS: F According to the 1938 Federal Food, Drug, and Cosmetic Act and Amendments of 1951 and 1962, all labels must be accurate and include a listing of al...

Pure Food and Drug Act of 1906 (Wiley Act) - correct answer Prevents adulteration and misbranding Drugs met standard of strength/quality/purity according to USP/NF Food, Drug, and Cosmetic Act of 1938 - correct answer Required manufacturer to prove drug safety prior to marketing it Also defined/regulated: adulteration, misbranding, interstate commerce Durham Humphrey Amendment of 1951 - correct answer Divided medications into OTC and prescription (legend) drugs Kefauver-Harris Amend...

Test Bank for Psychology Themes and Variations, 6th Canadian Edition By Doug McCann Name: Class: Date: Chapter 1 - The Evolution of Psychology Copyright Cengage Learning. Powered by Cognero. Page 1 Multiple Choice 1. The term “psychology” comes from the Greek words psyche and logos. What does logos mean? a. the study of a subject b. the soul c. logic d. discipline ANSWER: a 2. Psychological research is sometimes distorted or grossly simplified in media coverage, leading to misinformation or ...