The UCLA Controlled Substance Program does not manage DEA Schedule 1 registrations.
- What are Schedule 1 substances?
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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. - How to apply for a Schedule 1 registration?
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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 - What is RAPC?
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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- LinkGroup 1: Academic human research of Schedule I or Schedule II medications
Group 2: Research into the treatment of controlled substance addiction or abuse utilizing any
scheduled or non-scheduled medications by an academic institution or by a multi or single
center clinical drug trial research sponsored by NIDA and by a pharmaceutical
company/CRO: SAT Research - Note: SAT Clinical Drug Trials - Do not complete an
Application FormGroup 3: Non-human research with animal models OR in-vitro studies of Schedule I medications
onlyGroup 4: Multi or single center clinical drug trial research sponsored by a pharmaceutical
company/CRO evaluating or comparing any Schedule I and II medications
- see Clinical Drug Trials - Schedule 1 Documents
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DEA Schedule I Registration Requirements and Guidance
Templates you can use and modify for you needs:
CSUA Summary
Institutional Authorization Letter
Personnel Screening Data Sheets
Security Provisions
Power of Attorney for 222 Form
RAPC Cover Letter Template
RAPC Annual Report Template
Usage Log
Biennial Inventory Record - RAPC Annual Progress Report Requirement
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Full Annual Progress Report Requirement
The Panel requires an Annual Progress Report (APR) sent by the end of February every year in PDF format.
Contact: Tanveer.KhanFarooqi@doj.ca.gov
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