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Part 4
Taking Inventory, Loss or Theft, Record Maintenance, Oversight

Taking Inventory of Controlled Substances

The University of Minnesota policy requires that each Location using controlled substances for research must complete an annual inventory. An inventory is the comparison of the quantity of controlled substances in your safe with the quantity written in your disposition records. These amounts should be the same.

The recommended Research Controlled Substances Inventory Record contains the required elements from the DEA regulations.

Looking at the inventory form, the “Expected Amount” is what is recorded in your disposition record and the “Actual Inventory” is what you count in your safe at the time of the inventory.

If you find a discrepancy between the amount of controlled substances in your safe and the amount recorded in your records, this discrepancy must be reported. These reporting requirements are covered below.

This example inventory is for a laboratory with two of the most common controlled substances used for animal research at the University, sodium pentobarbital and ketamine.

Lines 1 and 2 record the inventory of sodium pentobarbital and ketamine.
The Expected Amount is found in your disposition record for each controlled substance.
The Actual Inventory is the amount you count in the safe. Be sure to use “mls” or “mg” for each entry. Unused lines are crossed out. Each entry is initialed and the inventory must be dated.

The following are important requirements for taking an inventory: 

• An inventory must be conducted at least once per year, according to the University policy.
• The Location Registrant is usually the one to perform the inventory.
• The Location Registrant must provide a copy of the inventory to the Unit Registrant and file the original inventory with the Location records.
• The Unit Registrant sends a copy of each inventory to Kathy Fox, Office of Regulatory Affairs in Research Integrity and Oversight Programs (ORA/RIOP).

Reporting Theft and Loss of Controlled Substances

The DEA and MNBP regulations require reporting the loss of controlled substances. The DEA Form 106 “Report of Theft or Loss of Controlled Substances must be used to file this report online.

Procedures to follow concerning a loss of controlled substances:

If there is an obvious or suspected break-in to your safe or other diversion of controlled substances, immediately contact the University Police at 612-624-COPS in the Twin Cities and the local police on other campuses.

If a discrepancy is identified during an inventory or other reconciliation:

• The Location Registrant must investigate the discrepancy.
• Immediately report the discrepancy to the Unit Registrant.
• The Unit and Location Registrants must decide if it is necessary to use Form 106 to report the loss to the DEA and MNBP.
• If there is consistent loss of controlled substance that can be explained, write a Memo to File for your controlled substance records the explains this consistent loss. An example would be loss in the hub of the needle that is consistent over a number of experiments.

If a discrepancy cannot be reconciled or if there has been a diversion, it must be reported to the MNBP and DEA using DEA Form 106.

The Unit Registrant and Location Registrant must file a copy of the completed Form 106 with the controlled substance records. A copy of the Form 106 should also be sent to Jessy Thomas, ORA/RIOP.

Reporting Accidental Loss

In case of accidental loss of controlled substances due to spilling or breaking a container, use DEA Form 41.

Online Version of Form

Maintaining and Retaining Records of Controlled Substances

DEA regulations and University policy have requirements for maintaining and retaining records about the use of controlled substances for research. 

Maintain and retain the following records on use of controlled substances for research:

• MNBP and DEA registrations
• Authorized Users Signature Log
• Copy of purchase records: purchase receipts for all schedules and Forms 222 for C-II
• Disposition records
• Inventory records
• Copy of disposal records

• The person performing the tasks (receiving, using, diluting, disposing) is responsible for documenting information on the disposition record.
• It is highly recommended that laboratory records be maintained in a 3-ring binder so that nothing is lost or misplaced.

• Keep disposition records and other associated records at the Location for a minimum of 3 years according to the University controlled substances policy.
• NIH regulations or other sponsors may require a longer retention period.

Oversight: Inspection and Compliance Reviews

Compliance reviews and inspections can happen at any time, and can be done by the University, DEA and MNBP.

DEA and MNBP Inspections can occur with or without notice. These inspections focus on storage, security and all controlled substances records.

Other University Inspections can be scheduled or unscheduled. These inspections will focus on security and all records of the Unit and Location Registrants. These inspections include University programs like the Office of Animal Welfare and the Office of Internal Audits.

• Taking inventory
• Reporting theft and loss
• Maintaining and retaining records
• Oversight

Part 4: Knowledge Check