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.
California law, pursuant to Health & Safety Code Sections §11480 & §11481, requires proposed research studies using certain opioid, stimulant, and hallucinogenic drugs classified as Schedule I and Schedule II Controlled Substances as their main study drug(s), to be reviewed and authorized by the Research Advisory Panel of California in the Attorney General's Office. https://oag.ca.gov/research
RAPC has identified 4 groups that it reviews. RAPC Guidelines for affected groups- Link
Group 1: Academic human research of Schedule I or Schedule II medications
Group 2: Research into the treatment of controlled substance use disorder utilizing ANY scheduled or non-scheduled medications.
Group 3: Non-human research with animal models OR in-vitro studies of Schedule I medications only
Group 4: Multi or single center clinical drug trial research sponsored by a pharmaceutical company/CRO evaluating or comparing any Schedule I and II controlled substances
For application submission see: https://oag.ca.gov/research/meeting
The Panel Office is required to monitor all current ongoing Schedule I and Schedule II controlled substance research activity in California. 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 more information see: https://oag.ca.gov/research/progress
Below are templates you can use and modify for you needs:
DEA Document Submission size limit is restricted
|DEA Schedule I Registration Requirements and Guidance
|Checklist of items needed for DEA application submission
|Overview of information
|Institutional Authorization Letter
|Departmental Approval of Use of Controlled Substance
|Personnel Screening Data Sheets
|Complete for all individuals who have access to the material
|General Security Provisions
|These are the broad security provisions for campus and building
|Storage Location Summary
|Information associated with you storage location, should include physical as will as administrative provisions
|Power of Attorney for 222 Form
|This is a required document if you have other individuals order material and signing a 222 form
|Initial and Biennial Inventory Form
|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.
|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
|These are the log you will use to record the use of the material
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’s most current curriculum vitae (short version) or biosketch
|List of vendors
|have a list of your suppliers and waste vendors with their DEA#.
Full Annual Progress Report Requirement
The Panel requires an Annual Progress Report (APR) sent by the end of February every year in PDF format.
Report should include:
- A brief summary of research performed and findings made during the year (this requirement may be
augmented by including reprints of papers or copies of reports published)
- Research plans for the upcoming calendar year (with indication of any additional controlled substances
planned for procurement in the upcoming year)
- Notation of any changes in the research project, (substantive changes should be explained in detail so
that the Panel can review them as protocol amendments)
- A photocopy of the controlled substances inventory log maintained at your site for record keeping
- RAPC Annual Report Template
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
Suppliers will only ship material to the address listed on your registration via courier (i.e. FedEx, UPS), ensure that you track your package.
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.
Individual registrants are responsible for the disposal of their controlled substances for more information visit: https://ehs.ucla.edu/controlled-substance-waste
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.