Controlled Substance Program

Controlled Substance Custodian

  1. Only PI's are authorized to be controlled substance custodians.
  2. PI's receive authorization from EHS to become a custodian after undergoing a background check, completing a request for authorization, and completing controlled substance training.
  3. If you are new to using controlled substances in research, contact EHS to begin the authorization process.
  4. A PI must be granted authorization from EHS before controlled substance orders will be approved.

Training

Controlled Substance training applies to all PI's who are designated as custodians and for employees the PI has granted authorization in writing to work with controlled substances. Employees must complete training before working with controlled substances. 

Contact EHS (X3420) for more information or to be enrolled in the Controlled Substance Training Program.

Ordering

  1. PI completes the RFUMS Controlled Substance Request for Purchase  form.
  2. Include the following documents with your request
  3. After completing, forward to EHS for approval and keep copies of everything for your files
  4. EHS will review information and once approved, will notify purchasing (via Datatel approval)
  5. EHS will send PI a signed copy of the form for their files​

Receiving

  1. ​​Receiving department will notify PI that package has arrived
  2. Packing slip will be used as the receiving record
  3. ​​​PI will go to receiving to retrieve the package and perform the following tasks
  4. Receiving will make 2 copies of packing slip and return original to PI for their files
  5. Receiving will keep a copy of the packing slip and also send EHS a copy
  6. PI is now responsible for the controlled substance

Authorized User Signature Log

  1. PI to complete RFUMS Authorized Users Signature Log and keep current
  2. This form identifies who has authorized access
  3. Keep form with usage logs

Controlled Substance Usage Log

  1. PI will create a Controlled Substance Usage Log for the newly received controlled substance
  2. Each entry on usage log must account for 100% of controlled substance at all times
  3. Usage Log balance must match physical balance at all times
  4. Discrepancies must be documented with explanations and EHS notified
  5. Any breakage of containers must be initialed by individual responsible and co-signed by the PI

Disposal

  1. ​Original containers of expired or unwanted controlled substances to be transferred to EHS for disposal
  2. Amount for disposal from testing to be transferred to EHS for disposal
  3. Empty controlled substance bottle defaced and placed in garbage (if any residue remains, transfer bottle to EHS)
  4. Document all transfers to EHS on Controlled Substance Usage Log

Theft and Significant Loss

  1. ​Any theft or significant loss must be reported to EHS immediately (verbal)
  2. PI will follow up with Controlled Substance Loss/Incident of Diversion Report

Storage/Security

  1. ​Lab should be locked at all times (if possible) and PI controls issuing keys
  2. Controlled substances need to be stored in a double locked, secured area
  3. PI is only one who has access to keys (exception is 1 backup for DEA inspection purposes)
  4. Do not label the secure area​

Use in the Lab

  1. There needs to be sufficient drawers with keys to secure controlled substances in area where employees are working
  2. Only employees with written authorized access by the PI can work with controlled substances
  3. All authorized employees must be on file with EHS and undergo a background check
  4. Controlled substance should not be left out on benches unless diluted in liquid rendering it useless for theft and diversion​

Records

  1. ​Maintain records 2 years for DEA inspections
  2. Maintain records 5 years for civil actions.
  3. Keep separate files for 2 year and 5 year records​

DEA Unannounced Audits and Inspections

  1. DEA can do random unannounced inspections
  2. PI will be notified immediately if DEA is on site, prepare your paperwork​
  3. Refer to the DEA Audit and Inspection Procedure

Bi-Annual Inventories

  1. ​One inventory completed by PI in December
  2. One inventory completed by EHS in June
  3. Use RFUMS Controlled Substance Inventory
  4. Physical inventory needs to match usage logs

Resources

Controlled Substance Manual
Controlled Substances Policy

Life in Discovery
3333 Green Bay Road, North Chicago, Il 60064-3095 • 847-578-3000