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Maintain Controlled Substance Records

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.

Security Records

Record Template  Use to...

Authorized Personnel Screening Statement

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.

Inventory Records

Record Template Use to... Example

Initial Inventory

Record controlled substances at a new storage location (including transfers and changes of address) immediately upon receipt of a DEA registration.

  • May use the General Inventory Log, but clearly label it “Initial Inventory”.
  • If you have yet to store controlled substances at that location indicate, “Zero inventory – no controlled substances at present location.” 
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.

 
Closing Inventory

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

Usage Records

Record Template Use to... Example
Multiple Dose Log                   

Document the details for each use of any controlled substance amount removed from its original container, including the:

  • Amount withdrawn
  • Waste amount (if applicable), and
  • Remaining balance through final disposal
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:

  • Amount withdrawn
  • Waste amount (if applicable), and
  • Remaining balance through final disposal
Diluted Solution Log Example

Purchasing, Waste, & Theft/Loss Records

Record Template Use to... Example
Purchasing Records

Record the receipt/pickup of the controlled substances from the supplier, including the signed and dated:

  • UMHS B2 Pharmacy request forms
  • Invoices and packing slips
  • Executed DEA Form 222s (blue copy - receiving) with the Number of Items Received column completed

Note:  See the Ordering & Receiving procedure for more information

DEA Form 222 Example

DEA 41 Form - Drugs Destroyed                                     

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:

  • Complete after faxing notification to the Detroit DEA field office
  • Must be completed by the DEA registrant

Note:  See the Report Theft/Loss procedure for more information, including the fax number for the Detroit DEA Office.

 

 

Questions?

Have questions regarding the controlled substance templates and forms?  Contact the UMOR Controlled Substance Monitors at: CS-monitors@med.umich.edu