Term
FDA
Food and Drug Administration |
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Definition
- Approve new drugs to be sold in the US
- Process New Drug Applications (NDA)
- Regulate package inserts
- Regulate advertising of drugs
- Issue recalls
- Federal agency |
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Term
DEA
Drug Enforcement Agency |
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Definition
- Federal Agency (U.S. Dept. of Justice)
- Enforce the CSA (controlled substances act)
- Track controlled substances manufactured and sold
- Investigates all violations involving controlled substances
- Set the DEA Sch. Definitions
- Issue DEA Numbers |
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Term
BOP
Board of Pharmacy (each state) |
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Definition
- Regulate licensing of Pharmacists
- Regulate licensing of Pharmacy Technicians
- Set state laws / requirements
- Outline the operating guidelines in the pharmacy
- Investigate violations of the operating guidelines
- Determine state regulated controlled substances*
- State agency
* States may control drugs not controlled by DEA. |
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Term
The Joint Commission
Formerly JCAHO
Joint Commission on Accreditation of Healthcare Organizations |
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Definition
- Watches over Healthcare Organizations
- Third Party Auditors / Regulators for insurance Providers
**They changed their name in 2009 |
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Term
| How to remember who does what? |
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Definition
| When trying to determine which agency regulates what, first ask if the question involves a controlled substance. If it does then DEA will likely be the answer. If the question involved a drug that is not controlled, FDA will likely be the answer. If the question sounds state specific or involves licensing, then the BOP is likely the answer. |
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