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Pharmacy Laws
Pharmacy Laws from 1906-2013
| Term | Definition |
|---|---|
| 1906 Pure Food & Drug Act | *Required accurate labeling of drugs *Limited harmful substances in food and drugs *Start of the formation of the Food & Drug Administration (FDA) |
| 1914 Harrison Narcotic Act | *Enacted to curb the recreational use of Opium *Importations restricted *Distribution required a prescription |
| 1938 Food, Drug, & Cosmetic Act | *Officially formed the FDA & USDA *Required drug developers to be responsible for the safety of their drugs *Required package inserts + directions for consumers *All addictive substances had to be labeled "Warning: May be habit forming" |
| 1951 Durham-Humphrey Amendment | *Defined Rx drugs as those requiring a Rx from a physician *Separated OTC from legend drugs *Defined OTC & legend drugs *Labeling required on Rx drugs: "Caution: federal law prohibits dispensing w/out a prescription |
| 1962 Kefauver-Harris Amendment | *Required drug mfgs to show both safety and effectiveness of their drug *Began the drug approval process *Enacted "good mfg practices (GMP) *Reporting of adverse drug reactions to FDA *Banned the sale of Thalidomide in the U.S. |
| 1970 Comprehensive Drug Abuse Prevention + Control Act "The Controlled Substances Act" | *est. the Drug Enforcement Agency (DEA) *Regulated controlled substances *Created categories for controlled substances (schedule 1-4) *Requires prescribers to have a DEA # to write Rxs for controlled substances *Pharmacies & mfgs must be licensed |
| 1970 Poison Prevention Packaging Act | *All medications must be kept in child proof packaging *Exceptions: Physician/patient request, emergency meds (nitroglycerine inhalers), hospital meds, few legend drugs |
| 1972 Drug Listing Act | *Requires a 10 digit number, National Drug Code (NDC), be places on all meds (OTC & legend) *3 segments (MProP: Mfgs, Product code, Package Code) |
| 1983 Orphan Drug Act | *Facilitated the development of drugs for rare diseases |
| 1987 Prescription Drug Marketing Act | *Prevents counterfeit drugs from entering the supply chain *Limits diversion of pharmaceutical samples of Rx Drugs |
| 1990 Omnibus Budget Reconciliation Act (OBRA-90) | *Requires pharmacies to council patients receiving new Rxs *Intended for Medicare/Medicaid but most states have stricter guidelines and all patients must be offered *Pharmacists reviewed info with DUE/DUR |
| 1996 Health Insurance And Portability Act (HIPPA) | *Health Insurance remains available even when changing employers (COBRA) *defined "Protected Health Information" *Patient must sign a consent form to grant others access to their PHI |
| 2000 Drug Addiction Treatment Act (DATA 2000) | *Physicians can prescribe controlled substances for purposes of detoxification *DEA will begin with the letter X] *DATA waiver is required to do this |
| 2003 Medicare Modernization Act | *Provided a voluntary prescription drug plan for Medicare patients "Medicare Part D" |
| 2005 Combat Methamphetamine Act | *Restricted the sale/distribution & mfg of pseudoephinephrine products that can contain it *Limits sale to 3.6g/day, 9g/30 days, 7.5g /30 days (mail order) |
| 2010 Affordable Care Act (Obama Care Act) | *Required facilities to create 1) EHR, electronic health record; 2) MTM, med.Therapy management *Continuity of Care - ePrescriptions are electric transmissions of electric transmission of Rx for sourpusses of providing better care |
| 2013 Drug Quality & Security Act | *FDA Tracking of bulk compounds *Track & Trace System |
Created by:
Vickyb055
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