Pharmacy is regulated by several agencies. As pharmacy Technicians' it is mandatory to generally know which agency does what to prepare for the PTCB exam.
These agencies do more than what is listed below. We're just covering the areas that involve pharmacy.
FDA
Food and Drug Administration
- 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
DEA
Drug Enforcement Agency
- 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
BOP
Board of Pharmacy (Individual States)
- 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
The Joint Commission (Formerly JCAHO)
Joint Commission on Accreditation of Healthcare Organizations
- Watches over Healthcare Organizations
Third Party Auditors / Regulators for insurance Providers
When trying to determine which agency regulates what, first ask, if the question involves a controlled substance. If id does then the 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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