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Law and Ethics
Law and Ethics terms and definitions
| Term | Definition |
|---|---|
| 1906 Federal Food & Drug Act | No labels required Truthful info if label |
| 1914 Harrison Narcotic Act | No opium w/o a Rx |
| 1938 Federal Food, Drug, & Cosmetic Act | Cosmetics FDA created NDA must be filed Products must be safe |
| 1951 Durham-Humphrey Amendment | "Caution: Federal Law prohibits dispensing w/o a Rx" Verbal Rx's accepted Difference between OTC & legend drugs |
| 1962 Kefauver-Harris Amenments | Safe & effective drugs INDA before human trials |
| 1970 Comprehensive Drug-Abuse Prevention & Control Act | Drug classes DEA was created |
| 1970 Poison Prevention Act | Childproof caps |
| 1972 Drug Listing Act | NDC created |
| 1983 Orphan Drug Act | Drugs used by few people Tax incentives |
| 1984 Drug Price Competition & Patent-Term Restoration Act | Patents created |
| 1984 Hatch Waxman Act | 5 year extension for patents |
| 1987 Prescription Drug Marketing Act | Vets need to write a Rx for animals |
| 1990 The Omnibus Budget Reconciliation Act | DUR for Medicaid pts. |
| 1990 Anabolic Steroid Control Act | Stricter regulations due to abuse by athletes |
| 1996 HIPAA | Privacy |
| 1997 Food & Drug Administration Modernization Act | "Rx Only" label change |
| 2005 Combat Meth Act | Sudafed purchase limitations 9 grams MAX w/in 30-day period I.D. required & must sign |