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Controlled Substance Use in Research and Teaching
Policy Summary
University of Minnesota policy 2.1.4, "Using Controlled Substances for Research and Teaching" which has been in effect since July 1, 1997, was revised April 2000. The policy and associated procedures may be downloaded from the following website: http://www.fpd.finop.umn.edu/groups/ppd/documents/policy/controlled_substance.cfm
Who is covered?
All investigators using controlled substances as part of their research or teaching activities.
What is the purpose of the policy?
The purpose of the policy is to ensure that the University of Minnesota complies with federal and state regulations on the use of controlled substances.
Who administers the policy?
The Department of Environmental Health and Safety (DEHS) and the Office for Regulatory Affairs (ORA) are responsible for oversight of the policy. The Fairview Investigational Drug Service also has oversight authority for clinical studies performed at Fairview-University.
Key components of the policy:
For more information, contact DEHS)
Registration
- All registrations must be coordinated through the DEHS. Controlled Substance Application Form
- Registrations for research and teaching activities must be maintained separately from clinical registrations.
- Each Unit must designate a Unit Registrant to hold the DEA registration as well as Minnesota Board of Pharmacy (MNBP) registrations. A DEA registration is required to purchase controlled substances. Under the revised policy, only a Unit Registrant or an "exempted" Location Registrant is allowed to hold a DEA registration for research or teaching purposes.
- Each Location (non-contiguous) must designate a Location Registrant to hold the Minnesota Board of Pharmacy (MNBP) registration. Location Registrants are responsible for all controlled substances used and records maintained at their Location.
- Each Location Registrant must designate Authorized User(s) who are eligible to receive and/or use controlled substances under the Location Registrant's MNBP registration. Authorized Users must be listed on the Location Registrant's University Registration record, which is maintained by DEHS.
- All controlled substance use must be described in an approved Animal Usage Form, Human Subjects Application Form, grant or other research protocol, as appropriate for the situation.
Purchase
- Controlled substances must be purchased through a Unit Registrant. The Unit registrant may purchase from commercial suppliers, Boynton Health Service Pharmacy or the College of Veterinary Medicine Pharmacy.
- Unit Registrants are responsible for determining that the person requesting the purchase has a current MNBP registration and a valid use for the substance. They are also responsible for the acquisition and disposition records of the drug purchases they authorize.
- Schedule I and II drugs must be purchased using a DEA Form 222. Vendors who sell Schedule III-V drugs usually require that a copy of the Unit registrant's DEA registration be provided annually.
- If personnel other than a registrant are to receive controlled substances, they must be listed on the University registration record as Authorized Users.
Inventory and record keeping
- Records must be maintained on-site. Financial and shipping records may be maintained centrally if there is prior notification to the DEA of this intent.
- Separate records must be maintained for each Schedule I and II controlled substance used. Schedule III-V controlled substances records may be maintained together as long as the use of each individual drug can be identified.
- Records (continuous inventory) must include information on the purchase/acquisition; quantity used; annual inventory and reconciliation; and disposition/disposal for all controlled substances. The date of each activity and the initials of the Authorized User documenting the information must also be recorded. See the inventory form "Research Controlled Substance Disposition Record"
- Location Registrants should keep a log of Authorized Users with their names, signatures and initials.
- Records must be maintained for a minimum of 3 years. (The FDA or study sponsor may require records to be maintained for a longer period.)
- A record of individual administration must be maintained for all Schedule I and II controlled substances. The information that must be documented includes: name and dose of controlled substance; date of administration; and signature/initials of the Authorized User administering the drug. The initials/number of each subject receiving the drug must be documented for research involving human and animal subjects.
Security
- Controlled substances must be stored in a securely locked cabinet or safe, as specified in the regulations, and separately from other materials.
- Access to controlled substances should be limited to the minimum number of people necessary.
- Ancillary security measures such as alarms or a locked room are also needed.
- Information on approved safes and "how to order" may be obtained from Greg Casura (626-5338).
- DEHS will review your security measures at no charge. Call Greg Casura (626-5338) for more information.
Reporting
- Discrepancies in drug inventories must be reported to DEHS and University Police immediately.
- An annual self-audit report must be provided to DEHS.