University of Minnesota  Procedure

Using and Disposing of Controlled Substances

Employees who work with controlled substances for research review the following websites and complete the online educational module: Controlled Substances. After completing the module, the record will become part of the employee's training record.

Using and Recording the Disposition of Controlled Substances – Individuals Conducting Research and/or Teaching Activities with Controlled Substances

Document all actions taken with the controlled substances. This includes receiving, using, diluting/combining, transferring and disposing of expired, excess, or unwanted controlled substances. Record the use of controlled substances on disposition records. Disposition records are to be page numbered and filed for two years.

Recommended disposition use records:

Taking Inventory

DEA Registrants or a departmental designee complete audits of their authorized users annually to compare the actual count of controlled substances in the safe to the amount in the written disposition records. More frequent audits are recommended for new laboratories, laboratories using Schedule I or Schedule II drugs, high volumes, multiple controlled substances, or having many Authorized Users.

The authorized user lab must complete a DEA Biennial inventory. The recommended inventory form contains all the required information to meet the DEA regulations. A copy of this inventory has to be forwarded to the DEA registrant.

Maintaining Registrations

  • DEA registrations must remain current.
  • UHS and DEA must be notified when a registration address changes or becomes inactive.

Disposal of Controlled Substances

Controlled substances that are expired, excess, and unwanted must be disposed of according to DEA regulations and UHS guidelines:

Researchers who have excess controlled substances in syringes after a research procedure are required to collect the excess in a slurry bottle and document the contents of the slurry bottle on a Controlled Substances Disposal Form, which can be obtained from the UHS Department of Environmental Health and Safety web page. UHS provides slurry bottles in several sizes upon request to [email protected]. Please discuss usage of slurry bottles and record keeping with UHS. 

Schedule I and II controlled substances should be placed in a separate slurry bottle from those in Schedules III-V. In addition, each Schedule I and II controlled substance should have its own slurry bottle.

Controlled substances in their original container or any mixtures the researchers made which need to be disposed of should remain in the container with the volume recorded on the Controlled Substance Disposal Form.

Reporting Theft or Loss

Reporting a Theft

  1. If a theft is suspected, immediately notify the DEA Registrant who will notify U of MN Police, the DEA, and UHS.
  2. The DEA Registrant must then complete DEA Form 106, Report of Theft or Loss of Controlled Substances and submit it electronically to the DEA with a copy to UHS.

Reporting a Loss

  1. If a container of a controlled substance is broken, the DEA Registrant will document the loss in the disposition record, to include the date of the incident and the signature of a witness, if available.
  2. The DEA Registrant completes DEA Form 41 for the amount of the substance lost and write "unintentional destruction" on the form.
  3. The DEA Registrant obtains the signatures of the person who broke the bottle and the witness (if possible) and sign the Form 41 as required.
  4. The original form 41 is retained in the disposition binder in the laboratory.

DEA Contact Information

DEA
100 Washington Avenue South, Suite 800
Minneapolis, MN 55401
Phone: 612-344-4128

Retaining Records

Controlled substances records are to be maintained for at least two years. Other contracts or regulations may require longer retention periods.

Oversight

UHS reviews controlled substances records and security measures periodically as well as security measures and compliance procedures for controlled substance storage facilities as needed.

UHS audits DEA Registrants to ensure they are full-filling their audit responsibilities. 

In addition, UHS performs the audit of the DEA registrants labs.