Regulatory Agencies

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  1. Bureau of Alcohol, Tobacco and Firearms (ATF)
    Sets regulations regarding the purchase of tax-free alcohol. Tax-free alcohol may be used in hospitals and clinics.
  2. Centers for Medicare and Medicaid Services (CMS)
    Oversees Medicare and Medicaid; establishes conditions for a facility to be reimbursed for services rendered.
  3. Drug Enforcement Agency (DEA)
    Enforces compliances with the Controlled Substances Act. This includes placing medications into the appropriate schedule, monitoring records and reports of controlled substances, registering pharmacies, issuing DEA Forms 222 and 41, and monitoring the destruction of controlled substances. The DEA is overseen by the Department of Justice.
  4. Environmental Protection Agency (EPA)
    Sets guidelines for the disposal of hazardous waste (includes disposal of controlled substances).
  5. Food and Drug Administration (FDA)
    Ensures that all pharmaceutical products are pure, safe, and effective. Reviews information supplied on MedWatch Forms. Can issue drug recalls if product is adulterated or misbranded (will perform postrecall audits to verify that manufacturers, wholesalers, pharmacists, and customers have been notified and appropriate action has occurred). Regulates the distribution of patient package inserts and the repackaging of medications. Reviews new drug applications and investigational new drug applications
  6. Institutional Review Board
    A board, committee, or other group designated by a institution to approve biomedical research in accordance with the FDA.
  7. The Joint Commission (TJC)
    TJC addresses quality of patient care and patient safety. Establishes standards and accredits the following health care providers: hospitals, home healthcare agencies, home infusion providers, long-term pharmacies, ambulatory infusion pharmacies, home medical equipment and home oxygen providers, ambulatory surgical centers, community health centers etc..
  8. National Association of the Boards of Pharmacy (NABP)
    Composed of all State Boards of Pharmacy. Has no regulatory authority but meets to discuss current trends and issues in pharmacy that affect the practice of pharmacy.
  9. State Boards of Pharmacy (BOP)
    Regulatory state agency that oversees the practice of pharmacy in a given state. Clearly degines regulations affecting pharmacy and the roles, duties, and expectations of pharmacists, and possibly pharmacy technicians for improper behavior.
  10. United States Pharmacopeia (USP)
    TheUSP is an official public standards-setting authority for all prescription and OTC medicines and other health care products manufactured or sold in the United States. USP also sets widely recognizedrecognized standards for food ingredients and dierary supplements. USP sets standards for the quality, purity, strength, and consistency of these products -- critical to public health. USP's standards are recognized and used in more than 130 countries around the globe.
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Regulatory Agencies
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