Using and Disposing of Controlled Substances

Employees who work with controlled substances for research are strongly recommended to review the following websites and complete the online tutorial: Using Controlled Substances for Research. After taking the tutorial, the record will become part of the employee's training record.

• Research Education and Oversight: Department of Environmental Health and Safety: Using Controlled Substances for Research
• Online Tutorial: Using Controlled Substances for Research

Mandatory DEA-based questionnaire

All individuals conducting research and/or teaching activities, with the exception of Drug Enforcement Administration (DEA) Registrants, must complete the DEA-based questionnaire for employee screening procedures.

1. The individual must complete the questionnaire found at http://www.research.umn.edu/riop/documents/DEArelatedquestionnaire120611.pdf
2. Once completed, submit the questionnaire to the DEA registrant in your unit.
3. The DEA registrant will maintain a file of the completed questionnaire.

Using and Recording the Disposition of Controlled Substances

All individuals conducting research and/or teaching activities with controlled substances must document all actions taken with the controlled substances. This includes receiving, using, diluting/combining, transferring and disposing of expired, excess, or unwanted controlled substances.

1. Unit registrant will have a log to record controlled substances.
2. Record the use of controlled substances on disposition records. Disposition records must be page numbered and filed in a binder for three years.

Recommended disposition use records:

• Research Controlled Substance Disposition Record
• Single Drug Disposition Record
• Combined Drug Disposition Record

Taking Inventory

At least once a year, DEA Registrants must complete an inventory to compare the actual count of controlled substances in the safe to the amount in the written disposition records. More frequent inventories are recommended for laboratories using Schedule I or Schedule II drugs, higher volumes, multiple controlled substances or with many Authorized Users. The recommended inventory form contains all the required information to meet the DEA regulations. Registrants must send a copy of the inventory annually to the Department of Environmental Health and Safety (DEHS) Controlled Substance office.

Maintaining Registrations

DEA registrations must remain current.

DEHS 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 and DEHS regulations:

"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 Substance Disposal Form which can be obtained from the Department of Environmental Health & Safety."

Controlled substances in their original container which need to be disposed of should remain in the original 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, U of MN Police, the DEA, MNBP, and DEHS.
2. The unit 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 the Minnesota Board of Pharmacy (MNBP).
3. The unit registrant will send a copy of the report to DEHS.

Reporting a Loss

1. If a container of a controlled substance is broken, the unit 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 unit registrant must complete DEA Form 41 for the amount of the substance lost and write "unintentional destruction" on the form.
3. The unit registrant must then obtain the signatures of the person who broke the bottle, the witness (if possible) and the DEA Registrant as required on Form 41.
4. The original form 41 is sent to the Minneapolis DEA and a copy if retained in the disposition binder in the unit.

Retaining Records

Controlled substances records must be maintained for at least three years. Other contracts or regulations may require longer retention periods.

Oversight

DEHS will review controlled substances records and security measures periodically as well as security measures and compliance procedures of controlled substance storage facilities as needed.