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Law and Ethics

Law and Ethics terms and definitions

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
Created by: Jazsymin



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