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The licensee/registrant must maintain applicable, accurate records in a secure storage location for two (2) years from the date of last transaction. All records must be readily available for audit purposes to U-M, the State of Michigan, or DEA Diversion Investigators.
The tables below list each record by its type (e.g., security) with a description of its use.
Blank templates and forms are available from the links in the Record Template columns. Click the link to download or open.
Certify each person (e.g., PI, lab personnel) who will handle controlled substances as part of a research protocol. May be done in addition to a formal background check.All authorized agents must meet State of Michigan requirements per R 338.3145 Employees; disqualification.
|Authorized Personnel Log
List each person (e.g., PI, lab personnel) allowed to handle controlled substances for research use as an authorized agent or authorized personnel.
Include a date range for the authorization.
Record controlled substances at a new storage location (including transfers and changes of address) immediately upon receipt of a DEA registration.
|Initial & Closing Inventory Example
List all of the controlled substances currently stored at the State of Michigan (SOM) licensed location.
Perform yearly (April 1 - June 30) and file with your other controlled substances records.
|Annual Inventory Example
|DEA Biennial Inventory
List all of the controlled substances currently stored at the DEA registered location.
Perform every two (2) years after initial inventory. Keep the completed biennial inventory with the controlled substance records.Tip: If the timing coincides, the DEA biennial inventory can be performed at the same time as the SOM annual inventory.
|General Inventory Log
Summarize the usage of a controlled substance from the time of acquisition to the end of use (e.g., administration and/or disposal), including recording expired or damaged controlled substances.
Also called a “perpetual inventory,” this log is likely used in conjunction with other usage records that fully detail the use of the controlled substance (e.g., multiple dose log, dilution log).
|General Inventory Example
|Reverse Distributor Inventory List
Submit inventory of all expired, unwanted, or damaged controlled substances to be picked up by U-M Environment, Health & Safety (EHS) Hazardous Materials Management program as part of the reverse distribution process.
Note: See the Disposal procedure for more information.
List the controlled substances stored at a registered location upon the closing of that location.
May use the General Inventory Log, but clearly label it "Closing Inventory."
|Initial & Closing Inventory Example
|Multiple Dose Log
Document the details for each use of any controlled substance amount removed from its original container, including the:
|Multiple Dose Log Example
|Diluted Solution Log
Document the usage details for a controlled substance that has been withdrawn from its original container and mixed with a solution to dilute the concentration, including the:
|Diluted Solution Log Example
Purchasing, Waste, & Theft/Loss Records
Record the receipt/pickup of the controlled substances from the supplier, including the signed and dated:
Note: See the Ordering & Receiving procedure for more information
Record controlled substances that are wasted on site (i.e., in the laboratory) by the DEA registrant or authorized personnel in the course of normal controlled substance administration or container breakage/spillage. Complete online, print, and file with controlled substance paperwork for a minimum two (2) years.
Do not waste expired, unwanted, or significant quantities of damaged controlled substances on site. Contact EHS-Hazardous Waste for pick up through the reverse distribution process.
Note: See the Disposal procedure for more information, including a link to detailed instructions.
|DEA Form 106 Theft/Loss (online submission)
Submit an online report within one (1) day of significant loss/theft:
Note: See the Report Theft/Loss procedure for more information, including the fax number for the Detroit DEA Office.