Regulatory Agencies Flashcards
1
Q
FDA
Food and Drug Administration
A
- 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
2
Q
DEA
Drug Enforcement Agency
A
- 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
3
Q
BOP
Board of Pharmacy (each state)
A
* States may control drugs not controlled by DEA.
- 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
4
Q
The Joint Commission
Formerly JCAHO
Joint Commission on Accreditation of Healthcare Organizations
A
- Watches over Healthcare Organizations
- Third Party Auditors / Regulators for insurance Providers
**They changed their name in 2009
