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Regulatory Agencies
Unit 2
| Term | Definition |
|---|---|
| Food and Drug Administration (FDA) | created under the department of Health and Human Services (1938 Food, Drug & Cosmetic Act). enforce guidelines for manufacturers to ensure the safety and effectiveness of medications. - misbranding & adulteration, National Drug Code, monographs. |
| 1972 Drug Listing Act; National Drug Code | First set of numbers identifies manufacturer (FDA assigns). Second set of numbers identifies strength, dosage form and formulation. Third set of numbers identifies the package size and type. |
| Monographs/Package Inserts | Limited room on container for all information required by FDA. desc, indic and usage, dosage, and how supplied, warnings, precautions, adverse reactions (Black Box Warnings if required by FDA), drug abuse and dep -Facts and Comparisons in pharmacy |
| FDA Program | allows consumers and healthcare professionals to report any discrepancies in medication or adverse reactions to medications. |
| FDA Recall | FDA “request” recall in writing. Classes 1: Products could cause serious or even fatal harm. 2: Products cause a temporary health problem or a slight threat. 3: Products that may have a minor defect or other condition that would not harm the patient |
| Drug Enforcement Agency (DEA) | - created under the Department of Justice (1970 Drug Abuse Prevention & Control Act) - Works w/ FDA when rating new drugs as con. sub. -Prevent the illegal distrib. and misuse of narcotics -Issues licenses to pract, pharm, and manu of con. sub. |
| Occupational Safety and Health Administration (OSHA) | Division of the U.S. Dept. of Labor. Purpose of OSHA is to make the workplace safe for employees. - Hazard Comm, Standards, Hazardous Drug Prep., Storage, Handling & Ad. (MSDS), Disposal of Hazardous Drugs, Latex Allergy, Ergonomics, Workplace Violence |
| The Joint Commission (TJC) | Addresses quality of patient care and patient safety. - Hospitals (including inpatient pharmacies), urgent care, surgery, imaging centers, home health & hospice care, nursing homes, clinical labs - Required for Medicare and Medicaid reimbursement |
| State Board of Pharmacy (SBOP) | Regulates and registers: - Pharmacy facilities - Pharmacists - Pharmacy technicians Can reprimand and revoke licenses of facilities or pharmacy professionals. Texas State Board of Pharmacy (TSBP) |
| State Laws | Each state has its own set of laws that must be followed by all employees in the pharmacy. States have laws that differ from federal law. The strictest law is the one that must be followed. |
Created by:
huynhleslie0914
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