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- 2. Regulatory Requirements
- 2j. Working with Drug Enforcement Administration (DEA) materials
2j. Working with Drug Enforcement Administration (DEA) materials
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- 2a. Disclosing financial interests related to research
- 2b. Working with animals
- 2c. Working with human subjects in research
- 2d. Complying with export control regulations
- 2e. Working with biological materials / organisms
- 2f. Working with chemicals
- 2g. Working with radioactive materials / radiation producing machines
- 2h. Disposing of chemical, radioactive and biohazardous waste
- 2i. Serving on committees
- 2j. Working with Drug Enforcement Administration (DEA) materials
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- Whom do I contact for questions related to the use of controlled substances?
- How do I know if I need to register and/or obtain approval to work with controlled substance?
- How do I get started if my research requires registration? What are the recommended steps?
- What are the training obligations? Are educational resources available?
- What should I expect after I submit?
- What are my responsibilities related to compliance?
- What are my responsibilities related to managing controlled substances?
- Will I be monitored after my approval?
- How do I close a research study that uses controlled substances?
1. Whom do I contact for questions related to the use of controlled substances?
The Environmental Health and Safety Office (EHS) provides general guidance on controlled substances (see contact information below). Faculty and research staff must contact the Department of Inspections, Appeals, and Licensing (DIAL) or the Drug Enforcement Administration (DEA) field offices for questions related to controlled substance applications and registration.
Contact Information
EHS
319-335-8501
EHS website
Department of Inspections, Appeals, and Licensing (DIAL; previously Iowa Board of Pharmacy)
515-281-5944
DIAL website
DEA field offices
Des Moines: 515-284-4709
Cedar Rapids: 319-393-6085
DEA Diversion Control Division website
2. What approvals do I need to work with controlled substances?
Researchers who intend to use controlled substances in their activities must obtain a researcher registration from both the DEA and DIAL before purchasing or possessing controlled substances.
3. How do I get started if my research requires registration? What are the recommended steps?
- Submit an application to DIAL.
- After DIAL approval, submit a registration application to the DEA.
Guidance on this process is available in the Controlled Substances Guide.
4. What are the training obligations? Are educational resources available?
Anyone working with controlled substances must understand requirements for secure storage, handling, dispensing, recordkeeping, and disposal to prevent diversion. Review the Controlled Substances Guide for detailed guidance.
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?
As the registrant, you are responsible for the safe handling, use, control, security, disposal, and recordkeeping of all controlled substances under your registration.
You may not distribute controlled substances to individuals not covered by your DIAL or DEA registration, including colleagues on or off campus. The DEA must preapprove any transfer or distribution to another registered individual.
7. What are my responsibilities related to managing controlled substances?
Controlled substances must be used only in research locations and conditions as described in the researcher’s DEA and DIAL registrations.
The researcher is solely responsible for managing controlled substances by:
- Maintaining current registration
- Purchasing only the quantities necessary for research objectives
- Ensuring proper storage and security
- Managing proper dispensing and disposal
- Maintaining complete and current dispensing and disposal records
- Maintaining an accurate inventory with expiration dates and conducting self-audits to ensure no expired substances remain
- Retaining all required documentation
8. Will I be monitored after my approval?
Yes. Both the DEA and DIAL may inspect facilities before and after registration approval.
The Office of Animal Resources (OAR) also reviews and monitors the use of controlled substances during OAR audits. Controlled substances should be included in each laboratory’s chemical inventory, along with expiration dates to support proper management and disposal.
9. How do I close a research study that uses controlled substances?
After completing a research study involving controlled substances, the registrant must surrender unused controlled substances for proper disposal. EHS may assist with water-soluble controlled substances. Otherwise, the registrant must arrange for disposal through a reverse distributor.
The researcher must maintain all records for at least two years after the final disposal of each controlled substance acquired under that license/registration for inspection by the DEA or DIAL.
Refer to the Controlled Substances Guide for disposal of unused substances guidance.