Pharmacy LawsPoison prevention act of 1970to 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 dispenserequested by patient in writingOTC must have different size for elderly with warning on packagedrugs for institutionalized patients if dispensed by employeeinhalation aerosols, contraceptives taken cyclically, prednisoneunder 105mg/package, sublingual nitroglycerin
Pharmacy LawsOccupational Safety and Health act of 1970OSHA
ensure job safety and health standards for employees.reporting for job-related injury and illnessreduce workplace hazardsaudits to ensure compliancecovers air contaminants, flammable, and combustible liquids, eye/skin protection.requires MSDS (material safety data sheet) provided by seller
Pharmacy Laws
Drug listing act of 1972each drug gets 11 digit number for identification.NDC number (national drug code)1-5= manufacturernext 4= drug productfinal 2= package size and packaging
Pharmacy Laws
Orphan drug act of 1983
orphan drugs=medication for rare cases.under 200,000 worldwide cases.tax incentives and exclusive licensing for manufactures
Pharmacy Laws
Drug price competition and patient termrestoration act of 1984
encourage new and generic creation by streamliningthe process for generic drug approval and extending patent licenses.
Pharmacy Laws
Prescription drug marketing act of 1987
prohibits reimportation of a drug into US except bymanufacturer.drug samples distributed only by prescriber request.requires label on veterinary drugs.
Pharmacy LawsOminbus budget reconciliation act of 1987OBRA-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 tosee if drug can be discontinued.long term care facilities must have consultantpharmacist.no significant medication errors.medications stored and locked according to laws.
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