The UCLA Controlled Substance Program does not manage DEA Schedule 1 registrations. The applying researcher should be the only individual completing and certifying by E-signature that the information provided is accurate for purposes of this DEA application.
Schedule I drugs, substances, or chemicals are defined as drugs with no currently accepted medical use and a high potential for abuse.
Some examples of Schedule I drugs are: heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), 3,4-methylenedioxymethamphetamine (ecstasy), methaqualone, and peyote. 21 CFR PART §1308.11 Schedule I
§1308.35 Exemption of certain cannabis plant material, and products made therefrom, that contain tetrahydrocannabinols.
You will need to process applications with the Drug Enforcement Administration (DEA) and the Research Advisory Panel of California (RAPC).
Check out our- Schedule I Registration Requirements and Guidance
DEA Application Form 225 RAPC Application
A DEA Diversion Investigator will reach out to you and request the items listed below. To streamline the process we have created templates that capture the information you will need to submit. These are templates you can modify. You will need update your records as needed and resubmit them to the DEA Diversion Investigator that conducted your initial inspection.
If you have questions, need help, or would like us to review your documents prior to your inspection please email: mwalston@ehs.ucla.edu
DEA Document Submission size limit is restricted
Individual Registration Template Folder
| Document | Purpose |
| Checklist of items needed for DEA application submission | |
| Summary | Overview of lab information |
| Storage Location Summary | Information associated with you storage location, |
| General Security Provisions | These are the broad security provisions for campus and building |
| Power of Attorney for 222 Form | This is a required document if you have other individuals order material and signing a 222 form |
| Institutional Authorization Letter | Departmental Approval of Use of Controlled Substance |
| Initial and Biennial Inventory | An Initial inventory must be taken once you have your registration this can be zero. Biennial inventory (visual inventory of what is in storage) must be completed every two years we recommend you complete this annually to be in compliance.6. |
| Usage Log | These are the log you will use to record the use of the material |
| Personnel Screening Data Sheets | Complete for all individuals who have access to the material |
| Protocols: example IACUC, BUA , IRB |
The necessary information may be contained in one of your existing protocols, including a current existing IACUC protocol, project summary/protocol in grant submission, IRB protocol, or IND submission. If this is a clinical investigation, see 21 CFR 1301.18b. You must separately identify each of the studies/projects, by Project Name, that are covered by this application. If your research involves one or multiple studies/projects you will need to provide information specific for each of these studies/projects. Print the following sections of you RATS protocol: (basic information, funding sources, scientific aims, and experiment section that show the use of the material, IACUC approval letter). |
| PI CV or Biosketch | PI’s most current curriculum vitae (short version) or biosketch |
| List of vendors | have a list of your suppliers and waste vendors with their DEA#. |
| RAPC Cover Letter Template | Cover letter required for application submission |
| RAPC Annual Report Template | The applicant’s submission of an annual progress report to the Panel is a mandatory requirement to maintain ongoing RAPC approval of the research project. For full requirements see: https://oag.ca.gov/research/progress |
Storage of controlled substances must provide effective prevention of theft. Proper storage of both material and usage logs is the responsibility of the Principal Investigator.
Registrants are responsible for understanding and being in compliance with associated regulations.
Visit our documents and resources section "DEA Regulations" page https://ehs.ucla.edu/documents/controlled-substances-program
Ordering Controlled Substances (All schedules)
Individual registrants are responsible for setting up accounts and procuring their material. Vendors will request compliance documents to setup accounts.
You are only allowed to procurer the schedules and annual amount you were approved for that is as listed on your registration.
You will need to maintain the following order records or be able to retrieve them upon request:
- Purchase Order
- Receipt document with date material was received
- Any returns or cancellations
Schedule 1 and 2 have additional requirements, see below:
Ordering Controlled Substances Schedule 1 & 2:
To place an order for schedule 1 and 2 registrants must submit Form 222 to vendors. Only registrants and their personnel who have power of attorney can sign these forms.
When placing an order a copy is retained with the registrant and the original is sent to the supplier. Once the item is received the quantity and date is listed on the copy. Supplier will reject Form 222 if the form looks modified or edited this includes corrections. If an error is made VOID the Form 222 and complete a new one.
Forms must be requested directly from the DEA.
- Request you Form 222 from the DEA
- DEA Form 222 Q & A
Shipping:
Suppliers will only ship material to the address listed on your registration via courier (i.e. FedEx, UPS), ensure that you track your package.
Individual registrants are responsible for record maintenance and retention. Per UC Records Retention Schedule
"Retain records for 3 years after the end of the fiscal year in which the specific controlled substances are disposed." Records must be separates by Schedule 1-2 and Schedule 3 - 5.
Required Inventory Records:
| Initial and Biennial Inventory Form | For your initial inventory use this form to take and inventory of all material on hand on the date that you start, this can be zero. After the initial inventory is taken, the registrant shall take a new inventory of all stocks of controlled substances on hand at least every two years. The biennial inventory may be taken on any date which is within two years of the previous biennial inventory date. A usage log is not a substitute for a biennial inventory. |
| Usage Logs (Stock) Form | Usage logs are used to document what material was dispensed from you stock solution. This can be for direct administration to a subject, experiment, or for dilution. To avoid discrepancies document the amount that was visibly taken from the container not the calculated amount. |
| Dilution Logs | Dilution logs are only necessary if you are storing the solution for longer than a day. If the dilution is used the same day you do not need to create a log. |
The Controlled Substance Program has available courses we recommend you and your staff take. Additional lab specific training for your processes is requires and must be documented.
see: https://ehs.ucla.edu/personnel-and-training
Individual registrants are responsible for the disposal of their controlled substances for more information visit: https://ehs.ucla.edu/controlled-substance-waste
The Controlled Substance Program offers the following services for individual registrants who manage their own registration. This is to assist with some administrative burden and help ensure that you are meeting compliance.
Services and Fee Page
Record maintenance and retention falls under the responsibility of the Individual Registrant. It is important that you keep up to date your personnel and materials records. Certain updates will need to be submitted to the DEA for approval such as changes to registration schedules, addition of new material you will be using, increases in annual usage amounts, or storage location/address changes. To update the DEA email the Diversion Investigator that approved your registration.
Important records to take note of:
- DEA for 222 and Power of attorney (for schedule 1 and 2 material only)
- acquisition and final disposition records
- usage logs including dilution logs
- Biennial Inventory
- list of personnel approved to access material
- any reported diversion or excessive loss reports
If you have an individual registration it is your responsibility to have these documents ready for review in the event of a DEA inspection.
For more information on inspections visit our information page: Inspections, Investigations, and Audits
Records must be retained in accordance with federal regulation and with UC Record Retention Schedule Policy.
Retention Period: Official Record should be retain for 3 years after the end of the fiscal year in which the records are created or 2 years from final disposition of material. Never retain records longer than required.
Records may include but are not limited to:
• power of attorney records;
• transfer and chain-of-custody records;
• acquisition, use, and disposition records;
• usage logs and inventory records;
• auditing, monitoring and inspection records; and
• investigation records.
At time there can be material loss or spills for information on what is diversion, a significant loss and how to report it visit our information page:
Diversion, Excessive Loss, Spills or Theft
Labs are responsible for setting up accounts and procuring their material. Vendors will request compliance documents to setup accounts.
Records
It is recommended for labs to maintain the following records:
- purchase and acquisition records
- Justification- you should be able to reference an institutional protocol (e.g. BUA, ARC, RUA) or lab book for and experiment
Storage
Maintain Dangerous Drugs and Devices secured and inaccessible to the public as you would an hazardous chemical. Do not store these materials with your controlled substances.
Disposal
These items should be placed in a pharmaceutical waste containers. Liquids should be in closed containers to prevent spillage. These containers differ from biohazardous container.
Researchers are able to drop off their pharmaceutical waste containers at secured UCLA Medical Waste Accumulation sites.
To request access visit Self Drop-Off Areas for Medical Waste
Regulation:
| California law does not require a physician prescription or a physician license on file for a wholesaler to supply dangerous drugs to a research laboratory. |
| A wholesaler may furnish a dangerous drug to a laboratory without a physician’s prescription, as long as purchase records are maintained. (Cal. Bus. & Profs. Code 4059(b)). |
| A “laboratory” is defined under Cal. Bus. & Profs. Code 4031 as “a research, teaching, or testing laboratory not engaged in the dispensing or furnishing of drugs or devices but using dangerous drugs … for scientific or teaching purposes.” |
