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Pharmacy Laws

This text provides a detailed summary of various pharmacy laws and regulations, including the Poison Prevention Act of 1970, Occupational Safety and Health Act of 1970, Drug Listing Act of 1972, Orphan Drug Act of 1983, Drug Price Competition and Patient Term Restoration Act of 1984, Prescription Drug Marketing Act of 1987, Omnibus Budget Reconciliation Act of 1987, and the Medicare Modernization Act of 2003.

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Pharmacy Laws

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  1. Pharmacy Laws Poison prevention act of 1970 to reduce accidental poisoning requires most OTC and prescriptions be packaged in child resistant containers. this means 80% of kids under 5 cannot open and 90% of adults can open. exceptions--- single time dispense requested by patient in writing OTC must have different size for elderly with warning on package drugs for institutionalized patients if dispensed by employee inhalation aerosols, contraceptives taken cyclically, prednisone under 105mg/package, sublingual nitroglycerin

  2. Pharmacy Laws Occupational Safety and Health act of 1970 OSHA ensure job safety and health standards for employees. reporting for job-related injury and illness reduce workplace hazards audits to ensure compliance covers air contaminants, flammable, and combustible liquids, eye/skin protection. requires MSDS (material safety data sheet) provided by seller

  3. Pharmacy Laws Drug listing act of 1972 each drug gets 11 digit number for identification. NDC number (national drug code) 1-5= manufacturer next 4= drug product final 2= package size and packaging

  4. Pharmacy Laws Orphan drug act of 1983 orphan drugs=medication for rare cases. under 200,000 US cases. tax incentives and exclusive licensing for manufactures

  5. Pharmacy Laws Drug price competition and patient term restoration act of 1984=Hatch-Waxman Act encourage new and generic creation by streamlining the process for generic drug approval and extending patent licenses. As a result, about 85 percent of all prescriptions filled are for generic versions.

  6. Pharmacy Laws Prescription drug marketing act of 1987 prohibits reimportation of a drug into US except by manufacturer. drug samples distributed only by prescriber request. requires label on veterinary drugs.

  7. Pharmacy Laws Ominbus budget reconciliation act of 1987 OBRA-87 Medicare and Medicaid revisions for long term care facilities and pharmacy. residents must be free of unnecessary medications. no antipsychotics unless patient has specific condition. need diagnosis for antipsychotic indication. must use drug holidays and behavioral modification to see if drug can be discontinued. long term care facilities must have consultant pharmacist. no significant medication errors. medications stored and locked according to laws.

  8. Medicare rx drug, improvement, modernization act of 2003=MMA • Birth of medicare part D=drugs for medicare • Low cost monthly, voluntary program, no ‘cosmetic’ drugs paid • annual premium of $420 ($35 per month) and an annual deductible of $250. Medicare beneficiaries pay 25 percent of all prescription drug costs until total drug expenditures reach $2,250. • Then at $5,100 the beneficiary is responsible for 5 percent of the drug expenditures and the Medicare program will cover the remaining 95 percent.

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