Test Bank for Conscientious and Ra-tional Prescribing in the 21st Century

Test Bank for Conscientious and Rational Prescribing in the 21st Century Chapter 1. Multiple Choice Identify the choice that best completes the statement or answers the question. ____ 1. Which statement regarding herbals, vitamins, minerals, and food supplements is true? A. Herbals, vitamins, minerals, and food supplements are not regulated by the U.S. Food, Drug, and Cosmetic Act (FDCA). B. Manufacturers must prove the safety of their herbals, vitamins, minerals, and food supplements. C. Manufacturers must prove that their herbals, vitamins, minerals, and food supplements are free from adulteration. D. Manufacturers must prove the legitimacy of any claims they make about their herbals, vitamins, minerals, and food supplements. ____ 2. Which amendment to the FDCA established the two classes of drugs: legend or prescription only and over the counter? A. Durham-Humphrey Amendment (Prescription Drug Amendment) B. New Drug Application Amendment C. Health Education and Welfare Amendment D. Kefauer Harris Amendment ____ 3. The package insert (PI) attached to a prescription drug contains all of the following information except: A. U.S. Food and Drug Administration (FDA)-approved drug information. B. Highly detailed adverse effects and dosage information for the prescriber. C. Information in layman’s terms for the patient. D. Pharmacodynamic and pharmacokinetic drug information.