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PHAR442 - Federal
Federal Law - Amendment and Act
| Pure Food and Drug Act 1906 | Prohibited adulterating and misbranding of drugs |
| Food, Drug and Cosmetic Act of 1938 | Regulates drug quality, requires new drugs be proven safe before marketing, labels need "adequate directions for use", warnings of habit forming properties |
| Durham-Humphrey Amendment of 1951 | Prescription meds don't need "adequate directions for use", two classes of drugs: OTC and prescription, Oral prescriptions, refills, Rx label needs "Caution: Federal law prohibits dispensing w/o prescription." |
| Kefauver-Harris Amendment of 1962 | Required drugs to be safe and EFFECTIVE, Good Manufacturing Standards (GMP), New drug approval, Advertising: Rx (FDA), OTC (Federal Trade Commission = FTC) |
| Poison Prevention Packing Act of 1970 | Protect children from poisoning by "household substances", all OTC/Rx requires special packing, child-resistant container (No more than 20% of children under 5yo. can open) |
| Medical Devices Act of 1976 | Safety and efficacy requirements of med. devices, Classes of devices, Class I - low risk, Class II - risk evaluated, CIII - Premarket required! (life-support, etc) |
| Orphan Drug Act of 1983 | Tax & licensing incentives - manufacturers to produce drugs for diseases affecting few people |
| Prescription Drug Marketing Act of 1987 | Sales restriction and recordkeeping for Rx drug samples, prohibits hospital/healthcare from reselling, requires state licensing of drug wholsalers |
| OBRA 90 | Purpose: SAVE MONEY, Drug Utilization Review Programs: Prospective DUR - 3 components: 1) Screening Rxs prior to dispensing, 2) Patient counseling by pharmacist, 3) Pharmacist documentation of relevant information |
| Dietary Supplement Health and Education Act of 1994 | Regulates dietary supplements |
| Food and Drug Administration Modernization Act of 1997 | Expedited availability of safe & effective drugs and devices, Fast track drug approval to treat serious/life threatening diseases, establish database on clinical trials, expand FDA control over OTC |
| HIPAA | Ensure security/privacy of patients' medical records (electronic), "Privacy Rule" to protect health info called "Protected health information"(PHI) |
Created by:
Angelmiko
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