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Federal Law

Federal Laws That Affect Pharmacy

QuestionAnswer
What do the Pure Food and Drug Act "PFDA" (1906) requre? Require all foods and drugs to meet a standard of strength and purity.
What do the Harrison Narcotic Act (1914) regulate? Regulated drugs that produced or sustain physical or physchological dependence. The importation, sale, manufacture, and use of:~Opium~Marijuana~synthetic agents~Derivatives
What do the Federal Food, Drug, and Cosmetic Act "FFDDCA" (1938) require? Required that manufacturers of drugs and cosmetics must prove that their products are safe and medical devices must be proved effective.
What do the Durham-Humphrey Amendments (1952) to the FFDCA require? Required a physician's consent in order to dispense refills, giving rise to the legend.
What do the Kewfauver-Harris Amendments (1962) to the FFDCA require? Required drug manufactures to prove the safety and efficacy of their products before approval was given by the FDA for marketing.
What do the Poison Prevention Packaging Act (1970? Requires child-proof packaging.
What do the Controlled Substances Act "CSA" (1970) classify? Classified drugs based on their potential for abuse Schedule I, II, III, IV, & V.
What is th mission of the Joint commission on accreditation of Health Care Organization (JCAHO). The mission of the JCAHO is to improve the quality of care provided to the general public.
What do the Omnibus Budget Reconciliation Act "OBRA-90" (1990) require? Required Pharmacista to offer counseling to Medicaid patients regarding medications.
What is the purpose of the Anabolic Steroids Control Act of 1990? Places "any drug or hormonal substance chemically and pharmacologically related to testosterone under regulatory provisions of the Controlled Substance Act.
What is the purpse of the FDA Modernization Act (1997)? Changed the legend requirements to "Rx Only" to be phased in by February 2003.
Created by: b_stokes2010
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