The UCLA Controlled Substance Program does not manage DEA Schedule 1 registrations.
- What are Schedule 1 substances?
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?
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?
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 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
Group 3: Non-human research with animal models OR in-vitro studies of Schedule I medications
Group 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
DEA Schedule I Registration Requirements and Guidance
Templates you can use and modify for you needs:
Institutional Authorization Letter
Personnel Screening Data Sheets
Power of Attorney for 222 Form
RAPC Cover Letter Template
RAPC Annual Report Template
Biennial Inventory Record
- RAPC Annual Progress Report Requirement
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