Laws realted to pharmacy
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11 terms
Terms | Definitions |
|---|---|
 Pure Food and Drug Act 1906 | Forbade the manufacture, sale, or transport of adulterated food products or poisonous patent medicines |
| Food, Drug, and Cosmetic Act 1938 | promped by the Sulfanilamide disaster of 1937 Established the FDA Regulated who could prescribe legend drugs |
| Durham-Humphry Amendment 1951 | "Prescription Drug Amendment" Required Rx to bear the legend "Caution: Federal law prohibits dispensing without a prescription" Later: "Rx only" |
| Kefauver-Harris Amendment 1962 | "Drug Efficacy Amendment" prompted by the thalidomide disaster of 1962 manufacurers required to provide proof for the effectiveness of the drugs |
| Comprehensive Drug Abuse Prevention and Control Act 1970 | "Controlled Substances Act of 1970" Established DEA Established five "classes" or schedules for controlled substances (6 in MA) |
| Drug Listing Act 1972 | National Drug Code 5-4-2 manuf - product - size |
| Orphan Drug Act 1983 | intended to stimulate development of drugs for rare diseases affecting 200,000 or fewer |
| Drug Price Competition and Patent Term Restoration Act 1984 | "Hatch-Waxman Act" est modern system of generic drugs manuf of generic drugs can seek FDA approval for generic versions of drugs whose patent protection is set to expire |
| Omnibus Budget Reconciliation Act 1990 (OBRA '90) | Increased necessity of pharm techs Focused on federal funding for Medicare and Medicaid Mandated that pharmacists perform drug utilizaton reviews (DUR) and offer counseling to patients |
| Health Insurance Portability and Accountability Act 1996 (HIPAA) | Ensure patient confidentiality and privacy Give patients the right to review medical records Est requirement of patient consent for transfer of medical records Defines protected health info (PHI) - info that may identify a patient, info created or received by the pharmacy, info related to the patients health; mental or physical; past, present, or future |
| Combat Methamphetamine Epidemic Act 2005 (CMEA) | regulates over the counter sales of ephedrine, pseudophedrine, and phenylpropanolamine products (cough medicine) |
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