3j. Working with Drug Enforcement Administration (DEA) materials

  1. Whom do I contact for questions related to the use of controlled substances?
  2. How do I know if I need to register and/or obtain approval to work with controlled substance?
  3. How do I get started if my research requires registration?  What are the recommended steps?
  4. What are the training obligations?  Are educational resources available?
  5. What should I expect after I submit?
  6. What are my responsibilities related to compliance?
  7. Will I be monitored after my approval?
  8. How do I close a research study that uses controlled substances?
  9. Relevant policies, procedures, ethical statements, etc.

1.  Whom do I contact for questions related to the use of controlled substances?

The Environmental Health & Safety Office (EHS) has a lot of information regarding controlled substances (see contact information below). Faculty and research staff can also contact the IBPE or DEA field offices in Des Moines. 

EHS
Phone: 319-335-8501 Main office
http://ehs.research.uiowa.edu

Iowa Board of Pharmacy Examiners (IBPE) 
Phone: 515-281-5944
http://www.state.ia.us/ibpe/controlled_substance/index.html

The DEA Field Office in Des Moines 
Phone: 515-284-4709
http://www.deadiversion.usdoj.gov/

2.  What approvals do I need to work with controlled substances? 

Faculty researchers who intend to use controlled substances in their research activities must obtain a registration from both the DEA and IBPE prior to the purchase and/or possession of controlled substances.

3.  How do I get started if my research requires registration?  What are the recommended steps?

  1. Submit an application form to the IBPE.
  2. After approval by the IBPE, submit a registration application to the DEA

Guidance on this process is available in the Laboratory Guidelines for Managing Controlled Substances in Research Laboratories (CSG).

4.  What are the training obligations?  Are educational resources available?

Anyone working on a project that involves controlled substances must understand the safe and secure storage, handling, dispensation, recordkeeping, and proper disposal of controlled substances to eliminate the potential for diversion of controlled substances. To become informed about the requirements, read and review the Laboratory Guidelines for Managing Controlled Substances in Research Laboratories (CSG).

5.  What should I expect after I submit?

After the application is approved by the IBPE, a faculty researcher must install a locker or cabinet where the controlled substances can be securely stored. Expect site visits by IBPE/DEA personnel to evaluate the secured locker and storage area. Additionally, the faculty researcher will be required to undergo a DEA background check and provide additional information, as requested. 

6.  What are my responsibilities related to compliance?

You, as the faculty researcher (registrant), are ultimately responsible for the safe handling, use, control, security, disposal, and recordkeeping of the controlled substances procured under your registration. This includes the prohibition of distributing drugs to anyone who does not have an IBPE/DEA registration, including colleagues on or off campus.  The DEA must pre-approve any transfer/distribution of a controlled substance to a registered individual.

7.  Will I be monitored after my approval?

Yes, both the DEA and IBPE have the authority to oversee and inspect facilities before and after the registration is approved.  The Office of Animal Resources (OAR) monitor will also review the use of controlled substances during OAR audits. Controlled substances should be listed in each laboratory’s chemical inventory; include the expiration dates to help manage and properly dispose of drugs prior to their expiration. 

8.  How do I close a research study that uses controlled substances?

After the completion of research study involving controlled substances, the faculty researcher must surrender unused controlled substances through a DEA approved reverse distributor.  DEA has surrender forms that are to be used for this purpose. All records must be maintained by the faculty researcher at least for two years after the final disposal of each controlled substance acquired under that license/registration for inspection by the DEA or IBPE. The CSG provides information regarding the disposal of unused substances.

9.  Relevant policies, procedures, ethical statements, etc.

  • Controlled substances must be used only in research locations and conditions as described in the faculty researcher’s DEA and IBPE registration(s).
  • The faculty researcher is solely responsible for managing controlled substances in his/her possession by: 
(a) keeping the registration current, 
(b) purchasing controlled substances that are required for the completion of a research objective,
(c) proper storage and security,
(d) proper dispensing and disposal,
(e) maintaining complete and current dispensation and disposal records, 
(f) maintaining a current inventory with expiration dates and conducting self-audits that ensure no expired controlled substances remain in the licensed researcher’s inventory,
(g) retaining all required documentation.