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PHAR 441
Pharmacy Law
| Question | Answer |
|---|---|
| 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
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