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Pharmacy Laws

Pharmacy Laws. 1906 Pure Food and Drug Act. Enacted to stop sale of inaccurately labeled drugs All manufacturers required to put truthful info on labels Required all food and drug meet standard of purity and strength Gov’t pre-approval required. 1914 Harrison Narcotic Act.

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Pharmacy Laws

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  1. Pharmacy Laws

  2. 1906 Pure Food and Drug Act • Enacted to stop sale of inaccurately labeled drugs • All manufacturers required to put truthful info on labels • Required all food and drug meet standard of purity and strength • Gov’t pre-approval required

  3. 1914 Harrison Narcotic Act • Restricted to opium usage • Eventually extended to non-narcotics: i,.e. cocaine • Limited opium transport • Available only with Rx, harder to get

  4. 1938 Food, Drug, and Cosmetic Act • Provided legal status for Food and Drug Administration (FDA) • Enacted because 1906 act didn’t include cosmetics, not worded strong enough • Required package inserts • All controlled substances labeled with warning • Required new drugs be safe before marketing

  5. 1951 Durham-Humphrey Amendment • Require label “Caution: Federal Law prohibits dispensing without a prescription” an all controlled substances • Doctor order and supervision required; Dr. must authorize refills • Established difference btwn legend and OTC medications

  6. 1962 Kefauver-Harris Amendments • Set label requirements for mftr and dispenser to pts • Required drug mftr to provide proof of safety and efficacy before marketing • FDA placed in charge of advertising • Stopped US selling of Thalidomide (until recent years)

  7. 1962 Kefauver-Harris Amendments

  8. Thalidomide Tragedy

  9. 1970 Comprehensive Drug Abuse Prevention Control Act or Controlled Substance Act • Drug Enforcement Agency (DEA) created to enforce laws about controlled substances • Drug Schedule introduced • Based on potential for abuse

  10. 1970 Poison Prevention Packaging Act • Required child-proof packaging on ALL controlled substances and on most Rx drugs

  11. Occupational and Safety Act of 1970 • Ensures safe and healthful workplace environment by reducing hazards • Gave rise to OSHA-Occupational Safety and Health Administration • All pharmacies should: • Post phone number to poison control • Have Material Safety DataSheets(MSDS) for “hazardous materials in the pharmacy” • Should have reference guide for toxicities

  12. 1983 Orphan Drug Act • Allowed drug companies to provide meds to persons /c rare diseases /s going through the long requirement of testing

  13. 1987 Prescription Drug Marketing Act • Controlled use of drugs in animals by requiring veterinarians to write Rx

  14. 1990 Anabolic Steroid Control Act • Increased regs dealing with abuse problems and misuse by athletes

  15. 1990 Omnibus Budget Reconciliation Act (OBRA 90) • Required pharmacists to counsel Medicaid and Medicare patients getting new Rx • Board of Pharmacy can fine pharmacies AND pharmacists

  16. Health Insurance Portability and Accountability Act of 1996 (HIPAA) • Provided broad and stringent regulation to protect patient safety

  17. 1997 FDA Modernization Act • Simplified the labeling requirements: “Rx only” symbol statement replaced the “Caution: Federal Law…” statement • Changed to legend requirement to “Rx only” phased in by Feb. 2003

  18. FDA • Main fxn: enforce guidelines for manufacturers to ensure safety and effectiveness • MedWatch program allows consumers and HCP to report discrepancies and adverse rxn with meds

  19. DEA • Created under Dept of Justice • To prevent illegal distribution and misuse of drugs • Issues licenses to pharmacies, practitioners, and manufacturers of controlled substances

  20. The Joint Commission (TJC) • Mission to improve quality of care provided to general public

  21. OSHA • Mission: to prevent work-related injuries, illnesses, and death by issuing and enforcing standards for workplace safety and health

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