Controlled Substances

Drugs and other substances under the Controlled Substances Act (21 U.S.C.§801 et seq.) (CSA) are classified into five schedules depending on the drug’s acceptable medical use and the drug’s abuse or dependency potential. If a chemical you require for research is classified as a controlled substance, an approved Controlled Substance Use Authorization (CSUA) is required before work can begin. Check the lists below to see if the drug or chemical is controlled:

• List of Controlled Substances
• List I Chemicals
• California Department of Justice Precursor Chemicals List

A Controlled Substance Use Authorization (CSUA) is the authorization granted by EHS to researchers to work with Schedules II-V controlled substances and precursor chemicals. A CSUA is required to use controlled substances in research at UC Irvine.

CSUA Submission Requirements:

All items below must be completed and submitted to the CS Coordinator before final approval. Review and approval can take up to 3-4 weeks. Do not wait until you are planning to start your experiment to request your CSUA.

1. CSUA application: Primary PI listed on protocols must submit a Controlled Substances Use Authorization application to the CS Coordinator.
2. PSDS 1A form: PI must submit a PI Screening Data Sheet (Form 1A) to the CS Coordinator.
3. PSDS 2A forms: Each authorized user that will have access to CS and the storage location must submit a Personnel Screening Data Sheets (Form 2A) to the CS Coordinator.
4. Training: All authorized users, including the PI, must complete CS training requirement.
5. Storage: CS storage must meet storage requirements and will need CS Coordinator approval.

IACUC approval letter: If you work with animals, submit your IACUC approval letter to the CS Coordinator.

EHS does not manage DEA registrations for Schedule I CS. Researcher must individually obtain a Schedule I DEA registration under their name. The CS Coordinator can provide guidance and support through this process.

The Principal Investigator (PI) is responsible for maintaining a current CSUA, an accurate inventory and on-site CS Logbook, supervising their storage of CS inventory and Authorized Personnel (AP) in compliance with UC Irvine’s Controlled Substance Program (CSP), and informing the CS Coordinator of any updates to their CSUA.

Authorized Personnel (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 Coordinator following the verification of the DEA required information that applicants provide on the Personal Screening Data Sheet (PSDS). AP are responsible for using CS exclusively for the purpose stated in the CSUA, always maintaining CSP-approved storage location for CS only, returning CS to CSP-approved storage location when not in use, recording dispensation of any CS on the CS Usage Log, and properly disposing CS.

AP must not share CS with non-authorized personnel, not share CS with other research labs, and not dispense or log out CS for use by others. AP need to report CS inventory discrepancies, suspected misuse, or theft to CS Coordinator immediately. Access to CS is a privilege and can be revoked by the PI or EHS.

All personnel working with CS, including the PI, are required to complete the Controlled Substances training eCourse in UC Learning Center, with renewal required every 3 years. CS training can be found by logging into the UC Learning Center website and Typing “Controlled Substances” in the search box to register.

Storage of CS must provide effective prevention of theft. Principle investigators are responsible for providing and maintaining secure storage of CS inventory in the CSP-approved storage area and ensuring restricted access.

Storage units cannot be shared between CSUAs. The CSP-approved storage is designed solely for the associated CS and CS Usage Log(s); no other items (e.g., chemicals or supplies) are permitted. Schedules II and III-V materials must be segregated and clearly labeled with their respective schedules if stored in the same unit. Corridor storage of CS is prohibited.

CS storage must be approved by the CS Coordinator. To get your storage location approved or to develop a storage plan, contact the CS Coordinator. Below are the storage requirements, but the most important factor for locks on drawers is the mounting screws or bolts must be inaccessible, and the lock must be installed on the top drawer.

• Padlocks and hasps:
  • Mounting screws or bolts of the hasp-lock must be inaccessible when the drawer is closed, and the lock is fastened
• Safes and steel cabinet:
  • Must be affixed, cemented or bolted to the floor, wall, benchtop or another immovable laboratory fixture, or weigh more than 750 pounds to deter theft of entire safe/steel cabinet
• 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
  • Cabinetry encasing the drawer must be securely adhered to a wall or floor or independently weigh more than 750 pounds to deter theft of cabinetry itself
  • Must be secure enough to show forced entry
• Other storage units:
  • Must be secure enough to show forced entry and affixed to the floor or wall
  • Secondary containment (security locked box) is primarily required for Schedule II material to provide a double-lock system and separate materials from other items<

Refer to additonal Acceptable Storage Equipment Examples.

Before a lab can order CS, the principal investigator must have an approved Controlled Substances Use Authorization (CSUA). All acquisitions provided by a private drug company or any other institution of CS (Schedules II-V) for research are reviewed and approved by Environmental Health and Safety (EHS) Controlled Substance Program (CSP) and requisitioned through the UCI Procurement Services. CS requisitions for research are submitted as UCIBuy+ purchase requisitions.

Only CS approved in the CSUA may be requisitioned. It is critical that CSUA, inspection reports, and CS training are up to date, as non-compliance may impact your ability to acquire the necessary materials for your research. Below are Purchasing Controlled Substances/Precursor Chemicals instructions:

1. Vendor quote: Contact the vendor for a quote or obtain a screenshot of the catalog number and current price (also include vendor logo in the quote/screenshot). Do not place the order. UCI Procurement Services will place the order after EHS approves it.
   • Patterson Veterinary and MWI are vendors used for CS.
   • If using Patterson Veterinary, contact the CS Coordinator for the assigned account number for your department. This applies to CS orders only.
2. Submit a UCIBuy+ Requisition: Use Commodity Code 51211900 and include the name of the PI and the assigned Controlled Substance Use Authorization (CSUA) number and the approved IACUC protocol number. Attach the quote or screenshot and PI approval (legible PI signature on interdepartmental order form or email approval) to the purchase requisition. PI approval is required as they are ultimately responsible for orders under their CSUA.
3. Separate PO requisitions: CS orders must be submitted separately from non-controlled items. Additionally, DEA Schedule II substances must be separated from other CS as per DEA regulations.

Orders are reviewed for unusual amounts and frequency. Plan ahead and allow for processing and delivery time. Note that Schedule II requires additional time due to order request form (DEA Form 222) submitted by EHS CS Coordinator and California Precursors must be purchased from a California supplier and require a 21-day hold prior to shipping.

• Schedule II: 3 weeks
• Schedule III-V: 10 days
• Listed chemicals (if hazard class requires shipment by ground transportation): 20 days
• California precursors (has 21-day CS Dept. of Justice review period): 40 days

All CS orders are delivered to EHS, and the CS Coordinator verifies and processes them before releasing them to authorized personnel. They will be emailed to schedule a time to be picked up at EHS. The authorized user who picks up the order must bring a UCI ID or government issued ID and be listed as primary or pick up only authorized personnel to sign for the release of the CS and issued CS Usage Logs.

After receiving your order, return directly to the CSP-approved storage location and secure the shipment until needed. File the CS Usage Log in the lab’s CS Logbook.

For non-controlled veterinary supplies, please refer to ULAR Veterinarian Services.

The CS Coordinator assigns a container ID and generates a corresponding CS Usage Log for each item received. Orders and their associated CS Usage Logs can be picked up by Authorized Personnel (AP) from EHS by appointment. Additional CS Usage Logs can be requested, and EHS will provide them as needed.

PIs are required to keep CS Usage Logs in their CSP-approved storage location. AP must document the CS use on the provided CS Usage Log to record each CS dispensation from the original container at the time it is dispensed. Usage Logs must have all fields completed correctly and readily available for periodic audit by EHS and/or the Drug Enforcement Administration (DEA). Follow these routine practices:

• The physical amount of CS in the original container must equal the remaining amount recorded on the CS Usage Log at all times. Enter each dispensation of CS on the CS Usage Log at the time of use
• Only approved CS AP are permitted to use CS in accordance with the protocols listed on the CSUA. Do not share CS with non-AP
• The individual listed under “Authorized Personnel Name” on the CS Usage Log must be the one administrating the CS in the experiment/animal
• Do not dispense or log out CS for use by others
• Record the amount dispensed and the amount remaining in the same units as documented on the first line of the CS Usage Log
• If using CS on USDA-covered species, include the protocol number in the "In Vitro/ IACUC Protocol #" column
• Do not use CS after their expiration date in animal research
• The CS Usage Log records the usage of the container’s contents as originally supplied. Do not alter contents of the original CS container. Do not add anything to or make solutions in the original container
• Do not dispense more CS from the original container than what is needed for the same day’s experiments
• Controlled substances shall not be transferred from the original containers for storage and/or inventory purposes

Solutions/Dilutions:

If making a solution or dilution, log the amount dispensed from the original container to make the solution on the CS Usage Log at the time the mixture is made. Dilutions and mixtures of CS are handled the same as the stock material. These materials should never be left unattended on the countertops and/or lab benches.

Proper labeling is required. Label containers with name of the drug, ID number, expiration date, final concentration of each component, and the date when the drugs are diluted or opened. CS must never be used after their expiration date in animal research. Do not record the usage of a solution/dilution on the CS Usage Log meant for the original container. See below for a copy of Aqueous and Equithesin Usage Log:

• Aqueous Usage Logs (Appendix H-1A)
• Equithesin Usage Logs (Appendix H-1B)

Disposal of CS is strictly regulated by federal law. All waste generated by our authorized users are managed by EHS. This includes expired or unused material no longer needed and all associated Usage Logs. Properly dispose of CS following the steps below.

When to request CS disposal:

Unused, unneeded, or expired CS and CS dilutions must be returned to the CS Coordinator if there is any movable solid or liquid remaining in the container.

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

How to request CS disposal:

Contact the CS Coordinator or use our online request form to request disposal of unused, unneeded, or expired CS and/or CS dilutions.

1. Contact CS Coordinator: Contact CS Coordinator or submit a Disposal of Controlled Substances and Empty Bottles  online request form.
2. Book appointment: The CS Coordinator will contact your lab to schedule the CS disposal.
3. Post-appointment: After item has been relinquished to the CS Coordinator, retain CS Usage Log and Disposal Log in the CS Logbook for an additional 3 years.

• Aqueous Usage Logs (Appendix H-1A)
• Controlled Substances Use Authorization
• Disposal of Controlled Substances and Empty Bottles
• Equithesin Usage Logs (Appendix H-1B)
• Personnel Screening Data Sheets (Form 2A)
• PI Screening Data Sheet (Form 1A)

• California Uniform Controlled Substances Act
• Controlled Substances Act (21 U.S.C.§801 et seq.) (CSA)
• Controlled Substances and Precursor Chemicals Program for Research
• University of California, Business Policy 50

• Chemical Hygiene Plan
• Drug and Chemical Information
• EHS Commodity Codes
• FAQs for Criminal History Checks
• Industrial Hemp Guidance
• Office of Diversion Control
• Research Advisory Panel - California Attorney General’s Office
• University of California Policy on Marijuana Research

It is your responsibility to immediately report any CS problems to the PI and EHS Controlled Substance Coordinator. This includes discrepancies on CS Usage Logs and disposal records, and any suspected theft, loss or disappearance of CS. The EHS CS Coordinator will investigate any reported issues and contact the University of California Police Department (UCPD) and the Drug Enforcement Administration (DEA) if required.