Controlled Substances Program

At UC San Diego, controlled substances (CS) include all DEA-scheduled substances, DEA List 1 chemicals, and California Precursor Chemicals.

If a chemical you require for research is classified as a CS, you must have an approved Controlled Substance Use Authorization (CSUA) before work can begin.

• See Determine if a Chemical is a Controlled Substance

Research authorization

Principal investigators (PIs) must obtain a CSUA to possess and use CS for any of these purposes:

• Research
• Teaching
• Veterinary care

Clinical trials performed on campus through the pharmacy or the Investigational Drug Service do not require a CSUA.

Additional authorizations and registrations from the CS Program Manager may be required for certain project-specific substances, locations, or purposes not covered by the university's standard DEA registration structure.

CSUA online application

The CSUA online application provides a central and secure resource for the essential business processes and internal controls of UC San Diego's CSP, from application and authorization to inventory and personnel management.

• Read CSUA Application to learn how to:
  • Apply for a new CSUA
  • Designate CSUA Lab Contacts
  • Manage Authorized Personnel
  • Upload Personnel Screening Data Sheets (PSDS) forms
  • Monitor training status
  • Order CS online
  • Manage inventory online
  • Request CS disposal
  • Amend, renew, or deactivate a CSUA

Learn more about the CS Program:

• Controlled Substances Training
• CS Frequently Asked Questions
• How to Manage Your Online CSUA (PDF)

Principal investigators (PI)

• CSUA: PIs are responsible at all times for maintaining a current CSUA, accurate online inventory and on-site CS Log Book, and supervising their CS facility and Authorized Personnel (AP) in compliance with UC San Diego's CSP.

• Secure storage and inventory: The PI will establish and maintain secure storage of CS Inventory in the CSP-approved storage area and ensure restricted access. CS Usage Logs and CS Log Books must be kept in the CSP-approved CS storage area.

• Training: All personnel working with CS, including PIs, are required to complete the Controlled Substances Training eCourse on UC Learning Center, with refresher training required every 4 years.

• Personnel Screening Data Sheet: All personnel working with CS, including PIs, are required to complete a Personnel Screening Data Sheet (PSDS)- PI.  

• Sabbatical: A CSUA may remain active during sabbatical leave when an acting PI is named in writing and approved by the Department Chair and CS Program Manager. Alternatively, the Department Chair may serve as the acting PI.

Authorized Personnel (AP)

AP are individuals designated by the PI to access and work with CS under a specific CSUA.

Final approval of AP rests with the CS Program Manager, following verification of DEA-required information applicants provide on the Personnel Screening Data Sheet (PSDS). Having access to CS is a privilege and can be revoked by the PI or CSP.

• AP responsibilities:
  • Use CS exclusively for the purpose stated in CSUA
  • Maintain CSP-approved secure storage location for CS at all times
  • Return CS to the CSP-approved secure storage location when not in use
  • Record dispensation of any CS on the CS Usage Log
  • Do not share CS with non-authorized personnel (refer to CSUA for authorized personnel list)
  • Do not share CS with other research labs- CS are exclusively acquired for the use in accordance with a PI's CSUA
  • Do not dispense or log out CS for use by others
  • Properly dispose of CS
  • Report CS inventory discrepancies, suspected misuse, or theft to the CS Program Manager, (858) 534-1362, immediately

• Training: AP working with CS are required to complete the Controlled Substances Training eCourse on UC Learning Center, with refresher training required every 4 years.

• Personnel Screening Data Sheet: All personnel working with CS are required to complete a Personnel Screening Data Sheet (PSDS)- Authorized Personnel.  

Department Chairs

• Department Chairs must notify the CS Program Manager when:
  • A new PI is expected to arrive on campus in possession of CS
  • A PI with CS authorization dies or intends to terminate employment

• CSUA applications: Department Chairs review, and approve or reject, CSUA applications for their department. Department Chairs cannot authorize their own CSUA.

• Inventory and CS Usage Logs: Department Chairs are responsible for ensuring that a current inventory of all CS under their purview is maintained by the PI on corresponding CS Usage Logs in an on-site CS Log Book available for periodic audit by EH&S and/or the DEA.

Final approval of all CSUA applicants and AP rests with the CS Program Manager, following verification of DEA-required information applicants provide on the PSDS.

• PSDS Forms for PIs and Applicants are available on the EH&S Forms page in the Controlled Substances section.

All applicants must answer questions concerning:

• Felony convictions in connection with CS
• Surrendering previous registrations or having registration revoked, suspended, or denied
• Any use of narcotics, amphetamines, or barbiturates other than those prescribed to the applicant by a physician

PIs, CSUA Lab Contacts, and AP who require access to CS must complete Controlled Substances Training eCourse on UC Learning Center, with refresher training required every 4 years. (UC BUS-50 Controlled Substances)

How to get the training:

• See Controlled Substances Training

• See Storage Requirements

• See CS: How to Order for requisition procedures

• See Managing Inventory

• See CS: Disposal for instructions

Note: To dispose of pharmaceuticals that are not CS, see Pharmaceuticals Disposal.

Audits

Controlled Substances (CS) inventory must be made available for audits by EH&S, Institutional Animal Care and Use Committee (IACUC) and the DEA.

• Researchers must conduct self-audits regularly, in between EH&S visits. Use the UC San Diego Lab Self-Audit Form to document this whole-lab safety review, and the CS Self-Assessment form for the CS portion.  Maintain these records in the lab.  Retain the completed CS Self-Assessment forms CSUA section of your CS Logbook. 
• The EH&S Research Assistance Program (RAP) audits labs on a regular basis. These audits will include a documented review of the CS inventory and the CSUA. The full audit criteria used to evaluate compliance is denoted on the CS Self-Assessment sheet. If you have questions about the RAP or CS audits please contact your RAP representative.
• IACUC will also inspect your CS during laboratory visits to ensure that you do not have any expired CS for use in animals and that you have drugs required for animal pain management in your inventory. Any expired CS should be labeled as “Expired Not for Use in Animals” and request a CS Disposal appointment. Any questions regarding IACUC policy and inspections should be directed to the IACUC office.
• The DEA performs unannounced visits to campus to audit laboratories that have CS. It is crucial that CS inventories and authorizations be kept up to date in preparation for unannounced DEA inspections.

• EH&S Forms - Controlled substances

UC San Diego

• PPM 516-7 Controlled Substances for Research, Teaching, and Veterinary Care (PDF)
• UC San Diego Controlled Substances Program Procedures (PDF) – Describes the campus CS Program in detail.

University of California

• UC BUS-50 UC Controlled Substances Policy (PDF)
• UC Guidance Memo 18-01 on Marijuana Research (PDF)
• UC Guidance on Research with Industrial Hemp (PDF)
• UC Guidance Memo 19-02 on Considering Funding from the Marijuana Industry (PDF)

Federal

• Controlled Substances Act (21 U.S.C. §801 et seq.) (CSA)
• Title 21 Code of Federal Regulations (CFR) Part 1300 to end (21 CFR §1308)

State

• California Uniform Controlled Substances Act

It is your responsibility to immediately report any CS problems to the PI and the CSP. This includes discrepancies on CS Usage Logs and disposal records, and any suspected theft, loss or disappearance of CS. The CSP will investigate any reported issues and contact UCPD and the DEA if required. 

You may report illicit activities, anonymously if you wish, by calling Wendy Scott at 858-534-1362 or Monica Esswein at 858-534-9016. Call immediately after determining the material was lost, stolen or improperly disposed. You may also contact the CSP with any additional questions by calling the numbers above or emailing ehscs@ucsd.edu.