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Pharm. Amendments
study flashcards for HOSA Pharmacology Knowledge Test
Term | Definition |
---|---|
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 |