• Check the DEA Controlled Substance Schedules list to determine if the chemicals you require are regulated by the DEA.
  • Note the CS schedule number for the controlled substance(s) you require. You'll need this information to:
  • Determine if pre-authorization from the Research Advisory Panel of California is required
  • Complete the CSUA application form
  • Determine if additional DEA registration is required
• Check the DEA Listed Chemical list or the CA Precursor list (PDF) to determine if the chemicals you require are regulated by the DEA.
  • Note: The same controlled substances procedures are used for List I and CA Precursor chemicals. List II chemical control is subject to high threshold amounts that generally do not apply to the normal campus user. A CSUA is therefore not required for List II chemicals.

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UCSD currently holds DEA registrations for each of the following locations: La Jolla and SIO campuses, Hillcrest campus, and Elliot Field. The CSUA provides information needed to support the DEA registration.

Refer to PPM 516-7 Controlled Substances for Research, Teaching, and Veterinary Care for policy governing controlled substances at UCSD.

• Apply for a CSUA if you require a controlled substance for any of the purposes below:
  • Research
  • Teaching
  • Animal care
  • Clinical trial only if your facility is located off campus (Clinical trials performed on campus through the Pharmacy do not require a CSUA)
• Read about other authorizations you may need to obtain in addition to a CSUA: Depending on the purpose and CS schedule number your work involves, state and federal regulations may require that other, additional authorizations be obtained and submitted simultaneously with your CSUA application at UCSD. Other possible additional authorizations include:
  • Research Advisory Panel of California pre-review and authorization
  • UCSD Animal Use Protocol
  • Additional, project-specific DEA registration

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• Any Schedule I controlled substance
• Human research using any Schedule I or Schedule II controlled substance
• Research for the treatment of drug abuse using any drug, scheduled or not

This review and authorization is conducted through the Research Advisory Panel of California in the Attorney General's Office.

Follow the steps below if your research project requires Research Advisory Panel authorization:

• See the Research Advisory Panel of California Web site for application forms and submittal procedures. Apply directly to the Research Advisory Panel.
• Send a copy of the authorization you receive to the Controlled Substances Program manager:
  • Mail Code: 0089
    Fax: (858) 822-0561

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• Read the Institutional Animal Care and Use Program Committee's (IACUC) What You Need to Know page for application procedures.
• IACUC shares Section 17 animal protocol data with Environment, Health & Safety (EH&S). Ensure compliance by doing the following:
  • List all CS administered to animals in the IACUC protocol Section 17. It is insufficient to list the CS solely outside of Section 17.
  • Amend your IACUC protocol to add controlled substances to Section 17, if necessary.
• Contact the IACUC, (858) 534-6069, if you have questions.

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Note: Renewals of Controlled Substance Authorizations issued by the Purchasing Department must be achieved by applying for a CSUA as a new applicant.

• Step 1: Apply for a CSUA. First-time applicants, follow the steps below to submit the 3 forms required for application:
  1. Form 1: Print and complete a Controlled Substance Use Authorization application form. Note: This is a 6-page form. (PDF) (Word)
  • Review this sample Section IIA for listing controlled substances: (PDF) (Word)
  2. Form 2: Print and complete a Controlled Substance Inventory form. (PDF) (Word)
  • Complete the information at the top of the Inventory form.
  • Write "zero inventory" in the "Number of Controlled Substances in PI Inventory" blank, if you do not possess any controlled substance.
  • If you currently have controlled substance(s) in the lab, enter the name and amount in possession on the inventory form.
  3. Form 3: Print and complete a Personnel Screening Data Sheet (PDF) (Word) for each individual requiring access to or handling of controlled substances.
  4. Send the completed, signed forms to:
     EH&S Controlled Substances Office
     Mail Code: 0089
     Fax: (858) 822-0561
  A CSUA number will be assigned to the prospective applicant when the CSUA paperwork is complete and filed with Environment, Health & Safety (EH&S).
• Step 2: Schedule a storage review meeting with the Controlled Substances Program manager, (858) 534-1362, to complete the application process.
  • A CSUA approval letter and a copy of the approved CSUA and authorization number will be sent to the PI and primary lab contact when all application forms and the storage review meeting are completed.
• Step 3: Review the Controlled Substances Program Procedures (PDF) (Word).

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• Contact the Controlled Substances Program manager, (858) 534-1362, for details if any of the following circumstances apply:
  • If the CS is listed in Schedule I
  • Any CS required for teaching purposes
  • If research requires the manufacturing of CS

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• Add new authorized personnel to your CSUA by doing the following:
  • Print and complete a Personnel Screening Data Sheet (PDF) (Word) for each new authorized individual.
  • Check the "Authorized Recipient" box on the Personnel Screening Data Sheet if the person is authorized to pickup incoming shipments.
  • Mail or fax the completed and signed form to the Controlled Substances Program manager:
    Mail Code: 0089
    Fax: (858) 822-0561
• Remove authorized personnel from your CSUA by following these steps:
  • Print an Authorized CS Personnel List (PDF) (Word) and check the "Remove from CSUA box."
  • Mail or fax the signed form to the Controlled Substances Program manager:
    Mail Code: 0089
    Fax: (858) 822-0561

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• Maintain a secure storage location at all times. Read about secure storage requirements below.
• Record use of any controlled substance on the log sheet.
• Use the controlled substance(s) exclusively for the purpose stated in CSUA.
  • Report unauthorized use of CS immediately to the Controlled Substances Program manager, (858) 534-1362.
• Do not share CS with other labs or unauthorized personnel.
• Return controlled substance(s) to the secure storage location when not in use.
• Properly dispose of CS through Chain of Custody via EH&S. Read the return or disposal of controlled substances section below.

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• Register for the Controlled Substances Training Program via Enrollment Central.
• Review the Controlled Substances Program Procedures (PDF) (Word).
• Print a flowchart (use landscape orientation) illustrating UCSD's Controlled Substances Program (PDF) (Word).
• Read:
  • Controlled Substances: FAQ
  • Authorized personnel responsibilities

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View an illustrated overview of the CS procurement process (PDF) so you’ll know what to expect. Then follow the steps below to buy CS.

• Plan your controlled substance purchase in advance. Each CS acquisition is obtained directly from the vendor. There is no on-site stock of CS available for researchers at UCSD. Plan for the following delivery times:
  • Allow 3 weeks for Schedule II orders.
  • Allow 10 days for Schedule III through V orders.
  • Allow 20 days for Listed Chemicals and California Precursors to arrive if their hazard class requires shipment by ground transportation.
• Identify the item and quantity needed. See a price list of commonly purchased items and their standard packaging size and strength: (PDF) (Word)
  • Note: If used in animals, this item must appear in the IACUC protocol Section 17.
• Prepare your CS order using the 2 forms below:
  • Form 1: Use a paper requisition form (Marketplace Preview part number 2200).
  • Use one requisition form per vendor or supplier.
  • Requisition Schedule II items separately from Schedule III-V items.
  • See sample requisitions below:
  • Ketamine, Animal (PDF) (Word)
  • Nembutal, Animal (PDF) (Word)
  • Testosterone, In Vitro (PDF) (Word)
  • L1 Chemical, In Vitro (PDF) (Word)
  • Have the PI sign and approve each requisition order.
  • Form 2: Attach an appropriate supplemental information form (SIF) to all orders:
    • Animal
    • Animal SIF (PDF) (Word)
    • Sample: Ketamine, Animal SIF (PDF) (Word)
    • In Vitro
    • In Vitro Research SIF (PDF) (Word)
    • Sample: Piperidine, In Vitro SIF (PDF) (Word)
    • Sample: Testosterone, In Vitro SIF (PDF) (Word)
• Send the PI-approved requisition form and supplemental information form to:
  Wendy Scott
  EH&S Controlled Substances Office
  Scan and e-mail the forms: ehscs@ucsd.edu (preferred method)
  Mail Code: 0089
  Fax: (858) 822-0561
• Upon EH&S approval, your CS requisition will be sent to Purchasing for order placement. What to expect:
  • The primary lab contact will be copied on the approval e-mail to Purchasing. No action is needed from the lab at this point.
  • The approval e-mail can be used as confirmation that the order was received and approved by EH&S.
  • The primary lab contact will receive an additional e-mail when Purchasing has generated a PO number for the requisition.
  • This e-mail has a shipment receipt attached that lists the Authorized Recipients.
  • Note that the shipment has not arrived until an e-mail is received stating that the shipment has arrived.
  • Contact Purchasing for estimated order arrival date: (858) 534-4438. Have your requisition number and PI name ready.
• The primary lab contact indicated on the CSUA will be e-mailed when the order has arrived and informed where to pick it up.
  • Important: Individuals picking up a controlled substance order must have a UCSD ID and be listed as an Authorized Recipient on the PI’s Controlled Substance Use Authorization.
  • After receiving the package, return directly to the EH&S-approved storage location and secure the shipment until it is ready to be used.

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Provide and maintain secure storage that meets this criteria:

• Do not share controlled substance storage facilities. Each PI must maintain his or her own secure storage.
• Store controlled substances according to their classification as follows:
  • Schedule I controlled substances: Store in a safe or steel cabinet equivalent.
  • Schedule II-V controlled substances: Store in a substantial locked drawer or cabinet that is inaccessible from above or below.
    Important: Store only the controlled substance(s) and the log book here.
• Ensure the storage unit is:
  • Secure enough to show forced entry
  • Bolted or cemented in place or weighs more than 750 pounds
• Install the following equipment, if used, according to these standards:
  • Padlocks must be installed so that the mounting screws or bolts of the hasp are inaccessible when the door is closed and the lock is fastened.
  • Safes and steel cabinet equivalents must be cemented or bolted to the floor or wall.
  • Drawers must be inaccessible from the upper or lower drawers in the stack. Assign the top drawer of the stack to use as the storage facility, if possible.
• Do not transfer a controlled substance from the original container for storage purposes.
• Prohibited storage areas:
  • Corridor storage of controlled substances is prohibited.
  • Do not store controlled substances with other general use items, even if the cabinet locks.

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• Restrict access to controlled substances to authorized personnel by following these precautions:
  • Keep the key(s) to the storage location at all times in the physical custody of the individual(s) authorized on the CSUA by the PI.
  • Do not store keys in a drawer or on the wall.
  • Multiple copies of the key may be made and assigned to authorized personnel listed on the CSUA.
• When an authorized individual leaves their position in the lab, do the following:
  • Change numbered padlocks.
  • Retrieve the individual's keys to secured storage facilities.
  • Note the personnel changes and resulting changes in security measures in the CS log book.
  • Remove the authorized person from the CSUA. See Add or remove authorized personnel above for instructions.

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Use the required log sheets provided below to record controlled substance usage.

• Print and use the Controlled Substance Usage Log Sheet (PDF) (Word) to track usage for each vial of controlled substance. View a sample (PDF) completed CS Usage Log.
• Use the CS Usage Log sheet as follows:
  • Immediately after receiving a controlled substance:
  • Label each vial of CS with a unique number for ease of inventory documentation.
  • Create a log sheet specific to each container. Note: Buprenorphine may be tracked as a box with 5 single-use ampules on one log sheet.
  • Record each CS dispensation on the log sheet at the time of dispensation.
  • Include the animal identification number in the “reason for use” section on the log sheet if using CS on large animals.
• Keep a copy of each of these documents in the CS log book:
  • The current CSUA
  • All CS Inventory forms
  • All CS Requisitions and Supplemental Information forms
  • All CS Usage Log Sheets
• Keep the log book with the controlled substances under lock and key.
• Keep your CS log book current and available for audit by EH&S and the U.S. Drug Enforcement Administration.
• Retain CS Usage Log Sheets for a minimum of 3 years after complete use of vial contents or disposal date by EH&S.

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• Adding a substance
• Changing storage locations

Use the applicable sections in the CSUA form described below to file for an amendment.

• Print a Controlled Substance Use Authorization application form. (PDF) (Word)
  • Add a substance: Use sections I and II to add a substance to the CSUA. If the substance will be used for work involving research animals, an IACUC protocol must be approved prior to amendment approval.
  • Note: The item must be listed in Section 17 of the IACUC protocol.
  • Change a storage location: Use sections I and IV to submit a storage location change.
  • Contact the Controlled Substances Program manager, (858) 534-1362, for storage recommendations in the new location prior to laboratory moves.
  • For convenience and security, Controlled Substances may be stored at EH&S during a laboratory move.
• Send the completed, signed forms to:
  EH&S Controlled Substances Office
  Mail Code: 0089
  Fax: (858) 822-0561
  An amendment approval letter will be issued and returned by campus mail to the PI and primary lab contact.
• Keep the amendment approval letter in the CS log book.

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Perform periodic self-assessments as recommended below to ensure your facility meets CS Program requirements during audits and to ensure continued use of CS without interruption.

• Use the Self-Assessment Audit Sheet (PDF) (Word) to check compliance in your facility. Recommended frequency is based on usage:
  • Labs using 0 to 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

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Declaration of inventory is mandatory even if no controlled substances remain in stock.

The Controlled Substances Program manager will notify CSUA holders in advance by e-mail when the biennial inventory is due. When you receive biennial inventory notification, do the following before the close of business on February 4, 2009:

• Print and complete a CS Biennial Inventory form. (PDF) (Word)
• Follow the instructions below for completing the form:
  • Print a sample form for reference. (PDF) (Word)
  • Record controlled substances possessed as of the close of business on February 8, 2007.
  • Do not include Listed Chemicals and California Precursors.
  • Investigators with project-specific DEA registrations must record items obtained under the university's DEA registration on a separate form from those obtained under individual registration.
  • Add additional rows to the inventory table if needed.
  • Write the total number of Line Items on the line below the table. Write "zero" in the line if you have no inventory to report.
  • Note: Read how to terminate a CSUA if you no longer need controlled substances, Listed Chemicals, or California Precursors. In order to terminate a CSUA, there can be no remaining items in inventory.
• Have the completed form signed by the PI even if there is zero inventory in stock at the time.
• Keep a copy of the Biennial Inventory form in your CS log book.
• Mail or fax the form to the Controlled Substances Program manager:
  Mail Code: 0089
  Fax: (858) 822-0561

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• Disposal of unused material:
  • Contact the Controlled Substances Program, (858) 534-9016, to schedule a collection appointment.
  • Arrange for disposal of unused material when:
    • A project has been closed or terminated and a CS is still in supply
    • A CSUA has expired and a renewal has not been submitted
    • The PI determines a CS is no longer required
    • The CS has expired
    • The PI terminates employment
• Disposal of empty CS containers:
  • Zero-out the log sheet entry for the empty container.
  • Deface the vial label with a black marker and dispose of it in the regular trash.
  • Mail or fax a copy of the log sheet to the Controlled Substances Program manager:
    Mail Code: 0089
    Fax: (858) 822-0561
  • Keep the log sheet for 3 years.
• Read how to terminate your CSUA if you no longer need authorization to possess, purchase, or store controlled substances for research purposes at UCSD.

  Note: For disposal of pharmaceuticals that are not controlled substances, send inquiries to hazwaste@ucsd.edu for detailed instructions.

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• Renew your authorization annually when you receive a notification request from the Controlled Substances Program manager. Follow the steps below to submit the 2 forms required for renewal:
  • Form 1: Print and complete the CSUA application for your renewal. Note: This is a 6-page form. (PDF) (Word)
  • Review this sample Section IIA for listing controlled substances: (PDF) (Word)
  • Form 2: Print and complete a Controlled Substance Inventory form. (PDF) (Word)
  • Complete the information at the top of the Inventory form.
  • If you currently have controlled substance(s) in the lab, enter the name and amount in possession on the inventory form.
  • Write "zero inventory" in the "Number of Controlled Substances in PI Inventory" blank, if you do not possess any controlled substance.
• Complete the CSUA application parts I, II, III, and V. Revise information on the CSUA as needed to ensure accuracy.
  • Refer to the CSUA summary sheet provided with the renewal request to see the current information on file with EH&S.
  • Complete a Personnel Screening Data Sheet with your renewal only if adding a new individual to the CSUA. (PDF) (Word)
• Review the Controlled Substances Program Procedures (PDF) (Word).
• Send the completed, signed forms to:
  EH&S Controlled Substances Office
  Mail Code: 0089
  Fax: (858) 822-0561

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• Notify EH&S with the online Lab Relocation or Closure Notification form 3 weeks before your intended move or lab closure.
  • Read How to Close or Relocate a UCSD Laboratory for more information.
• If moving within UCSD, contact the Controlled Substances Program manager, (858) 534-1362, to have your new storage locations approved prior to moving. Controlled substances may be temporarily stored at a secure EH&S facility during your move.
  • Note: Controlled substances must not be transported by Moving Services.
• If moving off campus or closing the lab, follow the steps below to terminate your CSUA.

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• Contact the Controlled Substances Program manager, (858) 534-1362, for more information.

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• Terminate a CSUA by following the steps below:
  • Print and complete a Termination of CSUA form (PDF) (Word).
  • If you are leaving UCSD, attach copies of all CS log sheets less than 3 years old.
  If you are not leaving UCSD, keep your log sheets for a minimum of 3 years after complete use of vial contents or disposal date by EH&S.
  • Mail or fax the Termination form and log sheet copies, if applicable (include log sheet copies only if you are leaving UCSD), to the Controlled Substances Program manager:
    Mail Code: 0089
    Fax: (858) 822-0561
• Return all CS remaining in inventory through EH&S by appointment.
  • Contact the Controlled Substances Program manager, (858) 534-1362, to schedule an appointment.
  Important: Controlled substances cannot be transferred to another PI, nor can they be taken to another university or institution.

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