Who regulates Pharmacy in the US ?


Pharmacy is regulated by several agencies. As a Pharmacy Technician It's mandatory to generally know which does what to prepare for the PTCB or ExCPT exams.

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 (each state)


- 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.



The Joint Commission
Formerly
JCAHO
Joint Commission on Accreditation of Healthcare Organizations


- Watches over Healthcare Organizations
- Third Party Auditors / Regulators for insurance Providers

**They changed their name in 2009



How to remember who does what?

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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