Frequently Asked Questions
Revised December 6, 2010
*This document does not apply to clinical patient care or clinical human subjects research*
1. Why do we need a controlled substance policy?
The Drug Enforcement Agency (DEA) and the Missouri Bureau of Narcotics & Dangerous Drugs (BNDD) regulations are designed to assure that the owners of registrations to use controlled substances have policies and procedures in place to prevent the inappropriate diversion of or inadvertent access to controlled substances. Our enhanced policy clarifies the roles and responsibilities of the individuals with access to controlled substances in their research projects.
2. Why is WUSTL enhancing its Controlled Substances Program?
The Office of the Vice Chancellor for Research is working with the Drug Enforcement Agency (DEA) and the Missouri Bureau of Narcotics & Dangerous Drugs (BNDD) to identify opportunities to strengthen our existing oversight of controlled substances. Washington University is committed to complying with federal and state laws and regulations. In addition, this program is important for the safety and health of our employees and members of the community.
3. What has changed?
Previously, all WUSTL PIs could obtain controlled substances for research from the Division of Comparative Medicine (DCM) stockroom on the Medical School Campus. The Missouri Bureau of Narcotics & Dangerous Drugs (BNDD) and Drug Enforcement Agency (DEA) recently clarified the regulations. Our new policy clarifies that a WUSTL registration is applicable only to its specific "location" (i.e. campus). WUSTL now has separate BNDD/DEA registrations for DCM on the School of Medicine Campus and the Danforth Animal Facility (DAF) on the Danforth Campus. Principal Investigators (PI) may now obtain controlled substances from the stockroom only when using the substances in Institutional Animal Care and Use Committee (IACUC) approved animal research protocol and the use of the substances is on-campus. Medical School campus PIs may obtain substances from the DCM stockroom and Danforth Campus PIs should use the DAF. If controlled substances are used off-campus or in non-IACUC approved research (e.g. in vitro), the PI must obtain an individual registration and order controlled substances directly from a commercial vendor or receive them from a governmental agency.
The enhanced Washington University Controlled Substance Policy has:
- Clarified the need for individual research registrations, as required by the BNDD, if using controlled substances in a non-IACUC approved research project.
- Clarified the identification and approval process for individuals to access, use and dispose of controlled substances.
- Enhanced the Environmental Health and Safety (EH&S) and IACUC laboratory inspection programs for these materials.
- Clarified the difference between on-campus and off-campus locations.
4. May I use my clinical practice DEA license to obtain controlled substances for my research program?
No, Washington University, in accordance with the laws of the State of Missouri and the regulations of the Missouri Bureau of Narcotics & Dangerous Drugs (BNDD), require that an individual maintain separate registrations for their research and clinical programs. You may obtain information on how to apply for both the Drug Enforcement Agency (DEA) and BNDD research registrations by reviewing the Controlled Substance policy or reviewing the following links:
BNDD website, BNDD Application for a Missouri Controlled Substances Registration
DEA Office of Diversion Control website, DEA Registration
5. If I have a clinical registration and underwent a background check for that registration, do I need to obtain a new background check?
No. If you have already been through a background check for your clinical registration, you will not have to undergo a second check. However, please submit the Human Resources (HR) background check form and indicate that you have a Drug Enforcement Agency (DEA) clinical registration so that we have a record that you will be obtaining an individual research registration or obtaining controlled substances from the Division of Comparative Medicine (DCM) or Danforth Animal Facility (DAF) stockrooms. HR will notify the DEA that you have a clinical DEA registration. Once the DEA acknowledges this notification, you will be able to obtain controlled substances.
6. I have always used the animal stockroom to obtain the controlled substances that I use in my animal research programs. Do I have to obtain a separate registration?
If you have an approved Institutional Animal Care and Use Committee (IACUC) animal research protocol and you are located on the Medical School Campus, you may obtain your controlled substances from the Division of Comparative Medicine (DCM) storeroom. There are new requirements that must be completed. Please review the Instructions for Medical School.
Danforth Campus faculty may no longer obtain controlled substances from the DCM storeroom. If you have an IACUC-approved animal research protocol and you are located on the Danforth Campus, you may obtain your controlled substances from the Danforth Animal Facility (DAF). There are new requirements that must be completed. Please review the Instructions for Danforth Campus.
If you are using controlled substances in your in vitro research or you are located off-campus, such as the CORTEX or Tyson Research facilities, you must obtain an individual researcher registration.
7. What is defined as off-campus?
On the Danforth Campus, off-campus is defined as anything that is not contiguous with the main Danforth Campus and the South-40; for example, the North, South and West Campuses, the Tyson Research Center, the Lewis Center and 560 Music Center are considered as off-campus.
On the Medical School Campus, off-campus is defined as anything that is not contiguous with the main complex connected by the overhead walkways; for example, the CORTEX buildings, 22 N. Euclid and off-site School of Medicine clinics, such as West County, are considered off-campus.
8. Can I charge the registration for individuals to my grants?
Yes, the registration fees for Principal Investigators (PI) utilizing controlled substances for research can be charged as a direct cost to a sponsored fund.
9. How do I get the controlled substances that I need for my research?
Materials for use in approved Institutional Animal Care and Use Committee (IACUC) research protocols can be obtained from the Division of Comparative Medicine (DCM) for the Medical School or from the Danforth Animal Facility (DAF) on the Danforth campus.
Materials for use in non-IACUC approved research (e.g. in vitro) must be obtained under an individual’s researcher registration. A medical practitioner’s registration cannot be used to order controlled substances for use in research.
Details on obtaining individual registrations are available at the Drug Enforcement Agency (DEA) and Missouri Bureau of Narcotics & Dangerous Drugs (BNDD) websites.
10. May I use my individual researcher registration to obtain controlled substances from a vendor or governmental agency without using the Division of Comparative Medicine (DCM) or Danforth Animal Facility (DAF) stockroom for use in my Institutional Animal Care and Use Committee (IACUC) approved animal research?
Yes, although we recommend you use the DCM/DAF stockrooms for obtaining controlled substances for use in your IACUC approved animal research. If you use your individual researcher registration to obtain controlled substances, you must have an IACUC-approved protocol. You must also meet all of the responsibilities for initial and annual inventories, documenting use and disposal, storage and security and assuring background checks are approved for all individuals with access to the controlled substances in your laboratory.
Anyone who is responsible for obtaining, assuring secure storage, managing the initial or annual inventory, completing the aliquot logs, record keeping, distributing controlled substances or a dilution thereof to other approved laboratory personnel, dispensing to an animal or disposing.
12. What are acceptable storage and security practices?
Regardless of the source of the controlled substance:
Inventory Requirements include:
- Materials must be securely locked:
- See the Storage and Security Guidelines document.
- A two key security system must be in place. Existing casework may be sufficient to limit inappropriate access if a cabinet or drawer is locked in a non-glass cabinet or drawer integral to the casework.
- See the list of Recommended Narcotic Storage Cabinets
- Controlled substances obtained under an individual’s registration must be stored separately from substances obtained from the Division of Comparative Medicine (DCM)/Danforth Animal Facility (DAF) stockrooms for use in approved Institutional Animal Care and Use Committee (IACUC) research.
- Access to controlled substances should be available only to individuals with a completed DEA Narcotics and Dangerous Drugs Information System (NADDIS) and National Crime Information Center (NCIC) approved background check:
- Human Resources on the Danforth and Medical School Campuses are coordinating the background checks. The instructions and necessary forms are located on the Background Checks Procedures page of this site.
- Controlled substances are accessible only to those who passed the background check and are used only for legitimate research purposes.
- Order and store only the minimum amount of controlled substances necessary for the planned experiments.
- Any inventory discrepancies or other signs of diversion must be immediately reported to WUPD (Danforth Campus 314.935.5555) or WUSM Protective Services (314.362.4367):
- Annual physical inventory must be performed
- Hands-on inventory, not a database check
- Must be completed in a single business day
- DCM/DAF and Environmental Health and Safety (EH&S) will coordinate annual inventories for materials obtained from DCM or DAF
- Individual registrants are responsible for their own annual inventory
- Use the WUSTL Controlled Substances Initial Inventory Form and Annual Inventory Form.
13. Can I charge the purchase of a new safe to my grant?
The costs of securing the controlled substance in a secured cabinet or lockbox could vary substantially between labs. Sponsored Projects Accounting (SPA) would like to address this issue on a case-by-case basis. Contact Krystina Gross, 314.935.5793, in SPA for more information.
14. I am the Principal Investigator (PI) on the research study but don’t use the controlled substances. Do I still need to obtain an approved Human Resources (HR) background check?
Yes, as the individual with primary responsibility for the research project and supervisory responsibility for overseeing the safety and security of all research materials, the PI needs to obtain an approved Drug Enforcement Agency (DEA) background check.
15. Do my trainees or graduate students need a background check?
Yes, any individual engaged in the research being conducted in the Principal Investigator's (PI) laboratory and who has access to the controlled substance (See Question # 11) must obtain an approved Drug Enforcement Agency (DEA) background check.
16. Is it true that I need to keep separate Controlled Substance Aliquot Logs after a drug cocktail is created?
Yes, once a controlled substance is used to make a drug cocktail, it is important to track the use, disposition and disposal of the new cocktail which contains controlled substances. Please follow the procedures described in the Drug Storage and Records of Use section of both the Division of Comparative Medicine (DCM) and Danforth Animal Facility (DAF) procedures. These procedures state that:
An appropriate entry should be recorded on the original stock bottle's Controlled Substance Aliquot Log and a new, separate Controlled Substance Aliquot Log should be generated and maintained by the investigator to record activity associated with the compounded product.
17. When should I dispose of a drug cocktail?
For animal research, cocktails should be disposed of according to the earliest expiration date of the associated drugs. Different standards apply for clinical research.
18. How should I dispose of a drug cocktail?
If you obtained your controlled substances used to make your cocktail from either the Division of Comparative Medicine (DCM) or Danforth Animal Facility (DAF), please return the unused portion for proper disposal.
19. How can I dispose of unwanted, contaminated or expired controlled substances?
If you obtained the controlled substances from Division of Comparative Medicine (DCM) or Danforth Animal Facility (DAF), return the controlled substances to them for proper disposal.
If you obtained the controlled substances under an individual registration, please contact Environmental Health and Safety (EH&S) for assistance in determining proper disposal procedures, which will include working with an authorized reverse distributor. DO NOT submit a “Hazardous Waste Disposal” request for pick-up as you would for hazardous chemical waste as EH&S is not authorized to remove controlled substances. DO NOT return to the DCM or DAF stockroom. Please note that there are additional costs for working with a reverse distributor that will be the responsibility of the Principal Investigator (PI). These costs are allowable on the sponsored fund under which the controlled substance work is being conducted.
20. Can I charge the disposal of the controlled substances to my grants?
Yes, the disposal costs (via an external vendor) can be charged as a direct cost to a sponsored fund.
21. I usually send my research technicians to pick up my drugs from the Division of Comparative Medicine (DCM) storeroom. Is that still ok?
If they have completed an approved Drug Enforcement Agency (DEA) Narcotics and Dangerous Drugs Information System (NADDIS) and National Crime Information Center (NCIC) background check, as verified by Human Resources (HR), and they are approved under your approved Institutional Animal Care and Use Committee (IACUC) protocol, and/or your individual Missouri Bureau of Narcotics & Dangerous Drugs (BNDD) and DEA researchers license, have required training on-file and they follow all University guidelines for proper management of controlled substances, then they are approved to pick up your drugs.
22. I already have an approved Institutional Animal Care and Use Committee (IACUC) protocol and have hired someone new to work in my lab. Do I have to file an amendment?
Yes, the NIH has mandated that when new personnel are added to a protocol, an amendment must be submitted to assure that the appropriate training has been completed relative to the duties described in the protocol.
23. Is there a fee for the background checks?
Yes, Human Resources will conduct the background check on behalf of the investigator but the fees will be charged to the individual Principal Investigator (PI). These fees are allowable on a sponsored fund if the background check is conducted on an individual who needs access to the controlled substance and is being paid for working on the grant.
24. Does WUSTL have discounts for the purchase of controlled substances?
Yes, WUSTL is working with vendors to establish appropriate pricing. Please contact Ronald Moses in Resource Management at 314.935.9462 with any questions regarding the purchase of controlled substances.
25. Who can I call with questions?
For policy questions, contact the Office of the Vice Chancellor for Research:
Associate Vice Chancellor for Research Administration
For Institutional Animal Care and Use Committee (IACUC) approved protocols and acquisition, use and/or disposal of your controlled substances either through Division of Comparative Medicine (DCM) on the Medical School Campus, or the Danforth Animal Facility (DAF) on the Danforth Campus.
Medical School: Ken Boschert
Danforth Campus: Tammie Keadle
For disposal of controlled substances purchased under an individual researcher’s BNDD/DEA license, or orphaned material (found material not associated with any licensed researcher or associated with any past or present animal research), contact Environmental Health and Safety at 314.362.6816, firstname.lastname@example.org.