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. See the Guidelines page for specific criteria.
The Research Advisory Panel of California primarily seeks to ensure the safety and protection of participating human research subjects and adequate security of the controlled substances used in the study. The Panel Members evaluate the scientific validity of each proposed project, and may reject proposals where the research is poorly conceived, would produce conclusions of little scientific value, or would not justify the exposure of California subjects to the risk of research.
During calendar year 2021, the Panel reviewed sixty-nine new and amended research submissions. Forty-seven new and eighteen amended studies were approved by the Panel. Among the approved studies, eighteen studies were Academic or Independent research studies, eighteen studies were Multi-Center Clinical Drug Trial research studies, and two studies were on the Treatment of Controlled Substance Use Disorder. The Panel also approved twenty-seven new Non-Human research projects.
At the end of 2021, the Research Advisory Panel was monitoring one hundred and twenty-seven research studies.
California does not have a separate controlled substance license requirement. When researchers need to apply for DEA license/registration, go to the DEA: Diversion Control Division website, select Form 225, and write N/A in section 4.
Applicants may utilize the Controlled Substance Schedules website for further information on controlled substance schedules.