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.
RAPC has identified 4 groups that it reviews. RAPC Guidelines for affected groups- 2026 Guidelines
Group 1: Academic human research of Schedule I or Schedule II
Group 2: Human controlled substance use disorder treatment research utilizing ANY scheduled or non-scheduled medications by an academic institution or a multicenter or single-center clinical drug trial research study sponsored by NIDA or a pharmaceutical company, or supported by a contract research organization (CRO)
Group 3: Non-human research of Schedule I controlled substances with animal models or in-vitro studies.
Group 4: Any single-center or multicenter clinical drug trial research by a pharmaceutical company/contract research organization (CRO) evaluating or comparing any Schedule I and Schedule II controlled substances.
Group 5: Human tissue research utilizing a Schedule I or Schedule II controlled substance. Human tissues include but are not limited to blood, hair, saliva, skin, stem cells, progenitor cells, or cadaver tissues (e.g. muscle, bone, tumor cells, etc). Where informed consent is required, the application process mirrors human research. Where informed consent is not required, the application process mirrors non-human research.
Each group has specific application forms are requirements.
For application submission deadlines see:Meeting Dates and Submission Deadlines (external link)
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: RAPC@doj.ca.gov
Report should include:
- the PR# (Panel Review number) plus the name of the study
- 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 (requests to approve the procurement of additional controlled substances should be sent separately as an amendment request)
- A photocopy of the controlled substances inventory log maintained at the site for record keeping (if applicable)
The Drug Enforcement Administration (DEA) may require RAPC approval for research work that fall under one of the four groups listed by RAPC.
This may impact CSUA additions to existing or new department DEA registrations.
