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 2019 and 2020, the Panel reviewed forty-nine research study submissions. Forty-six were approved by the Panel. Among the approved studies, thirty-five studies were Academic research studies, ten studies were Multi-Center Clinical Drug Trial research studies, and one was a Substance Abuse Treatment research study.
The Panel is currently monitoring one hundred and seventy 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 DEA: Diversion Control Division website for further information on controlled substance schedules.