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PTCB chpt 2

Pharmacy Laws

QuestionAnswer
Pure Food and Drug Act 1906 Prohibit transport or sale of adulterated and misbranded food or drugs.
Food, Drug and Cosmetic Act of 1938 (FDCA1938) (FDA) Was created under this act and required all new Drug applications be filed with FDA/FDCA-Defined Adulteration and Misbranding of drug and food products.
Durham-Humphrey Act of 1951 Require all products to have adequate directions for use unless they contain the federal legend: "Caution: Federal Law Prohibits dispensing w/out a prescription"
Kefauver-Harris Amendment of 1963 Requires all medication in the USA to be pure safe and effective.
Comprehensive Drug Abuse Prevention and Control Act of 1970 (DEA) Was created and placed under supervision of the Dept. of Justice. Controlled Substances be placed in one of five schedules, by potential for abuse and accepted medical use in the US.
Poison Prevention Packaging Act of 1970 Reduce the accidental poisoning in children. Requires most OTC and Legend drugs be packed in "Child Resistant Containers" (cant be opened by kids under 5/ Can be opened by 90% of adults)
Occupational Health and Safety Act of 1970 (OSHA) (OSHA)- ensures a safe and healthful work place for employees, job safety, health standerds, reporting job-related injuries and illness, Reduce Hazards and Conduct Audits to ensure Compliance w/ the ACT. Requires usage of "Material Safety Data Sheets"
Drug Listing Act of 1972 11 Digit ID # to identify med. NDC (National Drug Code #) 1st (5)-manufacturer/Next (4)-drug product/Last (2)-package size&packaging
Orphan Drug Act of 1983 Orphan Drugs (non generic) are med for which there are less than 200,000 cases in the world. Law provides tax incentives&exclusive licensing for products of manufactures to (develop&market orphan medication.
Drug Price Competition&Patent-Restoration Act of 1984 Encourages the creation of both generic & new meds by streaming the process from generic drug approval and by extending patent licenses.
Prescription Drug Marketing Act of 1987 Prohibits the reimportation of a drug into the USA by anyone except the manufacturer.
Omnibus Budget Reconciliation Act of 1987(OBRA87) Established extensive revisions regarding Nedicar and medicaid Condions of Participation regarding long term care failites and pharmacy.
Anabolic Steroids Controled Act of 1990 Harsher penalties for abuse of anabolic steriods and thier misuse by althletes.
OMNIBUS Budget Reconciliation Act of 1990(OBRA90) Reqires manufacturters provide the lovest prices to any custojer or medicaid pt gy rebating each state medicaid agency the difference between their avg price and lowest price, ( Requires "Lowest price and offer to counsel"
FDA Safe Medical Devices Act of 1990 Requires all med devices be tracked and records maintained for durable med equipment(ex: infusion pumps)
Americans With Disabilities Act(ADA) 1990 ADA prevents discrimination of potential employees w/ potencial disabilitys.(Reasonable Accomodations"
Resource Conservation and Recovery Act The environmental Protection Agency (EPA) produced federal guidelines regarding the disposal of hazardous waste and controlled subtences (no flushing!)
FDA Modernization Act ("Federal Law prohibits the dispensing of this med w/ out a prescripion") is new represented by the abb. "RX" on container(more modern than Duphumphy law)
Dietary Supplement health and Education Act of 1994 (DSHEA) (DSHEA) REQUIRES herbal products must be labled as dietary (NOT DRUGS)Must identify ingredients,plant quantity.Set to prevent adulturation and follow good manufacturing practices!
Health Incurence Portability and Accountability Act of 1996 (HIPPA) Requires that Health care providers insure that patient confidentiality be maintained. (PHI)-HIPPA set these boundaries.
Accutane 2002 RX must bear a yellow qyalification sticker to be filled/2 neg preg test 1 month before, during and after/ 2 birth control/sign pt info on side affects/ COUNSELING/FILLED IN 7 DAYS/NO PHONE IN OR REFILLS REQUEST.
Any Willing Provider Law Allows any pharmacy to participate in a RX benefit plan. Phamacy must agree to the terms and conditions of the plan.
Freedom of Choice Law Allows member of a RX Drug plan to select any pharm for their benefict as long as pharm agrees to terms and concitions.
Freedom of Choice with Regard to Long Term Care Long term care residents may choose an outside pharm for RX if the pharmaceutical service is not provided under their contract. (protect pts and may require outside pharm to agree to polices)
Prescription Drug Equity Law Prohibits a Rx drug plan from requiring mail order prescription drugs coverage w/out also providing non-mail order coverage.
Medicare Drug, Improvement and Modernization Act of 2005 (MPDIMA) Provides for a voluntary prescription drug benefit to Medicare beneficiaries/Asss preventive medical benefits to senior citizens.
Created by: Heather Quirk on 2010-08-17



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