Schedule 1 Registrations

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 
                           Application Form

          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 medications
                          - see Clinical Drug Trials

  • Schedule 1 Documents 
  • 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
  • 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