Controlled Substances: Managing Inventory

Principal investigators (PIs) must have an approved CSUA before ordering CS. Purchase requisitions are placed through the CSU Web application. A "gift" of CS from a company or an agency must go through the same purchasing process with zero dollars for the cost. Transfer of CS is prohibited.

Note: CS are restricted from department orders.

Order online

Submit CS orders with the CSU Web application:

1. Go to My Research Safety.
2. Click the Authorizations tab and select Controlled Substance Use Authorization to open the CSU Web application.
3. In the CSU application, select the My Orders tab to create or complete a CS order, or monitor the status of pending orders. Use the Help tab for detailed instructions.

Plan ahead

Plan for your order. CS is obtained from a vendor and there is no on-site stock.

Allow time for delivery:

• Schedule II: 3 weeks
• Schedule III - V: 10 days
• Listed Chemicals and California Precursors (if their hazard class requires shipment by ground transportation): 20 days

CS orders are available for pickup after the primary lab contact receives an arrival confirmation e-mail. The e-mail states where to pick up the order. The person who picks up the order must have a UCSD ID and be listed as an authorized recipient on the CSUA.

After receiving your order, return directly to the approved secure storage location and secure the shipment until it's needed.

CS inventory is managed through the CSU Web application. PIs must also maintain a current CS log book in the lab, available for periodic audits. The log book contains important documents pertaining to your CSUA, and log sheets accounting for the dispensation of each CS product in the lab.

Online inventory management

Track CS inventory with the Controlled Substance Use application:

1. Go to My Research Safety.
2. Click the Authorizations tab and select Controlled Substance Use Authorization to open the CSU Web application.
3. In the CSU application, select the My Inventory tab to enter inventory changes.

On-site log book

• Keep separate log books for Schedule I-II substances and Schedule III-V substances.
• File copies of these documents in the log book:
  • Your Controlled Substance Use Authorization (CSUA) summary
  • Copied of Biennial inventory statements
  • Supplemental information forms
  • All CS usage log sheets (see below)
  • All disposal and return documents
• Secure the CS log book under lock and key.

  • Read Storage Requirements.

Log sheets

EH&S provides a log sheet for each CS container when the item is initially picked up. Each container is labeled with a unique identification number for ease of inventory documentation. Do not transfer a CS from the original container for storage purposes. Keep it in the original container.

Note: Obtain replacement log sheets by e-mailing the CS Program manager. Include the container identification number in your request.

Recording routine use on the log sheet:

• Enter each dispensation of CS on the log sheet at the time of use. The amount of CS in the lab must equal the amount recorded on the current log sheet at all times.
  • View a sample (PDF) completed log sheet.
  • Print additional log sheets (PDF).
• If using CS on large animals, include the animal identification number in the "reason for use" section.

• Track Buprenorphine as a box with 5 or 10 single-use ampoules on 1 log sheet.

Recording an empty or broken vial on the log sheet:

• If a CS container breaks, enter it on the log sheet, initialed by the individual responsible for the accident and co-signed by the PI.
• Upload or send a copy of all finished log sheets for empty or broken containers to the CS Program manager.
  • Upload instructions for the Web-based CSU application:
    • Go to My Research Safety.
    • Click the Authorizations tab and select Controlled Substance Use Authorization to open the CSU Web application.
    • In the CSU application, select the My Inventory tab.
    • Search for the item you want to clear from your inventory.
    • Select the View/edit button, change the Remaining Amount value to 0, and upload the log sheet.
  • Send by mail or fax:
    • Mail Code: 0089
    • Fax: (858) 822-0561
• Retain log sheets for a minimum of 3 years after complete use of container contents or disposal by EH&S.

Important: Report log discrepancies, suspected misuse, or theft to the CS Program manager, (858) 534-1362, immediately.

Requirement

The federal Drug Enforcement Administration (DEA) and UCSD PPM 516-7 requires an inventory be conducted and documented every 2 years. PIs must declare their inventory status even if there is zero CS in stock when biennial inventory is taken.

Notification

EH&S will notify the PI and lab contact(s) by e-mail with a specific date and instructions in advance when the Biennial Inventory is due.

When you receive notification:

• Go to My Research Safety.
• Click the Authorizations tab and select Controlled Substance Use Authorization to open the CSU Web application.
• In the CSU application, use the My Inventory tab to update and submit your Biennial inventory.
  • Do not include Listed Chemicals and California Precursors.
  • Keep a copy of the Biennial Inventory form in your CS log book.

Note: If you no longer need CS, Listed Chemicals, or California Precursors, use the online CSU application Inventory tab to submit a request to delete an approved CSUA. There can be no remaining items in inventory when a CSUA is deleted.

Perform periodic self-assessments to ensure your facility meets CS Program and storage requirements during audits and to ensure uninterrupted use of CS.

• Use the Self-Assessment Audit Sheet (PDF) to check compliance in your facility. Recommended frequency is based on usage:
  • Labs using 0–5 vials of CS per year, perform self-assessment once per quarter.
  • Labs using more than 5 vials of CS per year, perform self-assessment monthly.

Note: Expect an audit of your lab twice per year to evaluate compliance with UCSD's DEA registration. Unannounced spot-audits may be performed.

Use the CSU Web application to request disposal of CS:

1. Go to My Research Safety.
2. Click the Authorizations tab and select Controlled Substance Use Authorization to open the CSU Web application.
3. In the CSU application, select the My Inventory tab. Select the product from your inventory list and click the Submit Disposal Request button.

Request CS disposal when:

• A project closes or is terminated and a CS is still in supply
• A CSUA expires and a renewal has not been submitted
• The PI determines a CS is no longer required
• The PI terminates employment
• The CS expires

Note: To dispose of pharmaceuticals that aren't controlled substances, contact hazwaste@ucsd.edu.

Relocation of CS during lab moves or closures is strictly regulated and must be approved by EH&S.

Notify EH&S of your intended lab closure or move:

• Submit an online Lab Relocation or Closure Notification form 3 weeks before your intended move or lab closure.
  • See How to Close or Relocate a UCSD Laboratory.

If you're moving within UCSD:

New storage facilities must be approved by the CS Program manager before relocating inventory. Your CS inventory can be temporarily stored at a secure EH&S facility during your move. Important: Moving Services must not transport CS.

Use the CSU Web application to amend the storage location on in your CSUA:

1. Go to My Research Safety.
2. Click the Authorizations tab and select Controlled Substance Use Authorization to open the CSU Web application.
3. In the CSU application, use the My CSUA tab to amend the location associated with your CSUA.

If you're moving off campus or closing the lab:

Transfer of CS to another institution or PI is prohibited. When your lab closes or moves off campus, use the CSU Web application to deactivate your CSUA:

1. Go to My Research Safety.
2. Click the Authorizations tab and select Controlled Substance Use Authorization to open the CSU Web application.
3. In the CSU application, select the My CSUA tab. Select your CSUA and click the Deactivate CSUA button.

Federal DEA regulations prohibit shipping CS to other institutions or facilities in most cases.

• For shipping exceptions, like chemically inactivated CS, contact the CS Program manager, (858) 534-1362.