1. Using - Disposition Records
The Authorized User must document all actions taken with the controlled substance,
which include receiving, using, diluting/combining, transferring or disposing
of expired and waste controlled substances. Record the use of controlled substances
on disposition records. Disposition records must be page numbered and filed
in a binder.
Recommended disposition use records:
2. Taking Inventory
At least once a year, Location 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 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.
Location Registrants must send a copy of the inventory to the Unit Registrant.
Annually the Unit Registrant must send a copy of each inventory to the Office
of Regulatory Affairs.
3. Maintaining Registrations
The MNBP and DEA registrations must be renewed every year.
The Office of Regulatory Affairs, the DEA, and the MNBP must be notified
when a registration address changes or becomes inactive.
4. Disposing of Controlled Substances
Controlled substances that are outdated, surplus or contaminated must be
disposed of according to Federal regulations. Dispose of contaminated waste
controlled substances in a slurry bottle. To obtain a slurry bottles or to
arrange for disposal pickup, contact DEHS. The disposal of controlled substances
must be recorded on Controlled Substances Disposal Form. The form and detailed
disposal information is available on the disposal website.
5. Reporting Theft or Loss
If you suspect a theft, immediately notify the Unit Registrant, U of M Police,
and the Office of Regulatory Affairs. The DEA requires that theft or loss
of controlled substances be reported on DEA Form 106 Report of Theft or Loss
of Controlled Substances. Send a copy of Form 106 to the Office of Regulatory
Affairs.
If a container of a controlled substance is broken, document this in the
disposition record and have a witness sign and date it, if possible. Complete
a DEA Form 41 for the amount of the substance lost and write "unintentional
destruction" on the form. Signatures of the person who broke the bottle, the
witness and the Unit Registrant are required on Form 41. Mail the original
to the Minneapolis DEA and file a copy in the controlled substance records.
6. Retaining Records
Controlled substances records must be maintained at least for 3 years. Other
contracts or regulations may require longer retention periods.
7. Oversight
The Office of Regulatory Affairs will review Unit and Location Registrants
controlled substances records and security measures periodically. The Department
of Environmental Health and Safety may also review security measures as needed.
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