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PHAR 441

Pharmacy Law

QuestionAnswer
Pure Food and Drug Act of 1906 Prohibited adulterating and misbranding of drugs
Food, Drug and Cosmetic Act of 1938 Safety of drugs prior to being marketed, labels must contain "adequate directions for use", warnings about habit forming properties
Durham-Humphrey Amendment of 1951 Need not contain "adequate directions for use", OTC and Rx class, authorizes oral Rxs, authorizes refills, authorizes FDA to switch Rx to OTC, label must say "Caution: Federal law prohibits dispensing without a prescription"
Kefauver-Harris Amendment of 1962 Drugs to be proven safe AND effective, established GMP, NDA process
Poison Prevention Packaging of 1970 Protecting children from "household substance" poison, OTC and Rx drugs subject to special packaging requirements
Medical Devices Act of 1976 Strengthened safety and efficacy of medical devices, Class I - low risk, no pre-market testing, Class II - safety and efficacy tbd, Class III - life-supporting devices, pre-market approval is required
Orphan Drug Act of 1983 Tax and licensing incentives for manufactures to develop drugs for diseases that affect few
Drug Price Competition & Patent-Term Restoration Act of 1984 Streamlines generic approval process
Prescription Drug Marketing Act of 1987 Record keeping requirements, prohibits hospitals from reselling, requires state licensing of drug wholesalers
OBRA 90 Primary goal is to save money, DUR Programs - 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, serious drug fast track approval process, clinical trial database, manufacturer right to disseminate unlabeled use information, expands FDA's authority over OTC drugs
HIPAA Security and privacy of PHI
Evaluation of therapeutic duplication, drug-disease contraindications, drug-drug interactions, incorrect dose, duration, drug-allergy interactions, and evidence of clinical abuse/misuse Prospective DUR
Created by: sdeck86