If you would like to join the Controlled Substance Program instead of maintaining an individual registration complete the following application. Application can take a minimum of 8 -10 week for DEA approval once all requirements have been met.
Controlled Substance Use Authorization (CSUA)
There are two addresses requested on a DEA Registration:
# 1 Storage Location Address
this is the address where your material will be stored and where it will be delivered. This should be your courier address not street address. What do I mean? Couriers deliver to loading docks.
For example you are located in Semel, Room A1-123A.
Your delivery address would be:
650 Charles E Young Drive, South
Semel, A1-123A
Los Angeles, CA 90095
# 2 Mail to Address
this is your UCLA mail to address. All postal mail is delivered toMDDS they then distribute the mail to all of campus using a UCLA Box# or mail code.
The box number is 95 plus the first four digits of the campus mail code. So if the campus mail code is 123456, the box number is 951234.
For more information: about UCLA mail service visit MDDS at:
https://mdds.ucla.edu/mail-services/address-standards-for-ucla-mail
A DEA Diversion Investigator will reach out to you and request the following items listed below. In order to streamline the process we have created templates that capture the information you will need to submit. You will need update these 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 emailaleiva@ehs.ucla.edu
Individual Registration Template Folder
| Document | Purpose |
| 1. Summary | Overview of lab information |
| 2. Storage Location Summary |
Information associated with you storage location, should include physical as will as administrative provisions. |
| 3. General Security Provisions | These are the broad security provisions for campus and building |
| 4. Power of Attorney for 222 Forms | This is a required document if you have other individuals ordering Schedule 2 material signing a 222 form |
| 5. Biennial Inventory | This is an inventory log for the inventory on hand that must be completed initially and every two years we recommend you complete this annually to be in compliance. |
| 6. Usage Logs | These are the log you will use to record the use of the material |
| 7. Personnel Screening Data Sheets | Complete for all individuals who have access to the material |
| 8. Protocols for example IACUC of BUA worked | 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) |
| 9. Protocol for In-Vitro Work if you do not have IACUC or BUA | Template (In-Vitro Work Authorization) has been created to outline your experiment |
| 10. PI CV or Biosketch | PI’s most current curriculum vitae (short version) or biosketch |
| 11. List of vendors | have a list of your suppliers and waste vendors with their DEA#. |
| 12. Institutional Authorization Letter | Departmental Approval of Use of Controlled Substance |
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
For vendor information visit:
Vendors
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. |
21 CFR 1304- RECORDS AND REPORTS OF REGISTRANTS
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
Services and Fee Page
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 withUC 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.
Diversion, Excessive Loss, Spills or Theft
If you are with DGSOM and need to order pharmaceuticals or dangerous drugs or devices.
Submit Request
For none DGSOM lab: A wholesaler may furnish a dangerous drug or device to a laboratory without a physician’s prescription, as long as purchase records maintained.
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
| 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.” |
