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Pharm. Amendments

study flashcards for HOSA Pharmacology Knowledge Test

TermDefinition
Food, Drug, and Cosmetic Act of 1938 A New drug could not be marketed until proven safe, tested for toxicity, and required adverse drug effects to be reported.
Kefauver-Harris Amendment (1962) Requires proof of safety and efficacy of a drug for approval before marketing
Drug Listing Act of 1972 Drugs must have a National Drug Code number.
Drug Regulation and Reform Act of 1978 Quicker development and distribution of new drugs
Anabolic Steroid Control Act of 1990 Placed all into category III drugs (CSA)
Prescription Drug Amendments of 1992 Allowed rapid approval of drugs for life-threatening diseases
Food and Drug Administration Modernization Act of 1997 Allowed rapid approval of drugs by the FDA
Pure Food and Drug Act (1906) Forbade the manufacture, sale, and transportation of adulterated or mislabeled foods and drugs.
Shirley Amendment of 1912 Prevented fraudulent therapeutic claims by drug manufacturers
Harrison Act of 1914 Established the word narcotic and required the use of a stamp on narcotic drug containers. Also regulated the importation, manufacture, sale, and use of opium, codeine, and their derivatives.
Durham-Humphrey Amendment (1951) Replaced Laws of 1938. Required designation of whether or not the drug was prescription or OTC
Controlled Substances Act (1970) Replaced all laws passed prior to it concerning drug control. 5 drug schedules put in place based on potential for abuse.
Poison Prevention Packaging Act (1970) Implemented child resistant packaging
Orphan Drug Act of 1983 Established funding for research of rare chronic illnesses for new and old drugs.
Drug Price Competition and Patent Term Restoration Act of 1984 Eased requirements for marketing generic drugs
Omnibus Budget Reconciliation Act (OBRA 1990) Mandated that OTC drugs be documented
Created by: AashrithaV07
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