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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