Conducting Marijuana Research
Definition of Marijuana
The federal Controlled Substances Act defines marijuana (or “marihuana”) as: “all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin. Such term does not include the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination.”
Marijuana, including derivatives of the marijuana plant, is listed by the DEA as a Schedule I controlled substance. In addition, the DEA separately lists both THC and “Marijuana Extract” (defined by DEA as “an extract containing one or more cannabinoids that has been derived from any plant of the genus Cannabis…") as a Schedule I controlled substance.
The plant material known as industrial hemp is a variety of the same Cannabis sativa L. plant as marijuana, but with a concentration of THC no more than 0.3 percent on a dry weight basis. Hemp was historically included in the Controlled Substances Act definition of “marihuana.” However, in December 2018, the 2018 Farm Bill was signed into law, which among other things, amended the Controlled Substances Act to exclude hemp (the plant Cannabis sativa L. with a THC concentration of not more than 0.3% on a dry weight basis) and hemp derivatives (extracts and cannabinoids) from the definition of “marihuana.” Thus, hemp and hemp derivatives are no longer regulated as Schedule I Controlled Substances.
Conducting Marijuana Research
Research that involves the direct use or possession of marijuana, marijuana derivatives or extracts, such as CBD derived from marijuana or THC, may be conducted if the researcher:
- Has received approval from the Research Advisory Panel of California (RAPC) in the California Attorney General’s Office for any planned research project to be conducted in California requiring the use of a Schedule I or Schedule II Controlled Substance as its main study drug;
- Has an approved Schedule I Researcher registration to conduct the research and follows all applicable DEA regulations and guidelines, including those pertaining to storage and disposal;
- Submitted an investigational new drug (IND) application to the FDA (if there are human research participants involved); and
- Obtains research-grade marijuana from a DEA-approved source.
- In addition, any research involving humans or animals must go through the Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC) respectively.
Please contact Monique Skahan at EH&S (firstname.lastname@example.org) for assistance with the DEA Schedule I Researcher registration and RAPC application process for controlled substances.
Research about marijuana that does not involve the direct use, possession, distribution, or cultivation of marijuana in a research procedure does not require a DEA registration or approval by the RPAC. However, all the usual requisite approvals for research must be obtained including IRB and/or IACUC review, where applicable, for studies involving human subjects or animals. Such research includes for example:
- Human observational studies in which research subjects use marijuana, but the researchers do not procure the marijuana and the marijuana is not used on campus.
- Environmental impact studies in which researchers observe the impact of marijuana cultivation, for example on wildlife, water resources, or other aspects of the natural habitat.
- Policy or legal studies looking at economic, social, political or other issues involving marijuana and marijuana legislation.
The intent of DEA registration numbers is to identify and validate individuals and institutions that have been authorized by the DEA to purchase, possess, distribute or prescribe controlled substances. Controlled substances and precursor chemicals intended for research and instructional purposes and acquired though drug companies or any other outside institutions must be obtained under an applicable university DEA registration. If an operation remote from the campus requires controlled substances, a separate registration is necessary for each type of activity involved.
Individual Research Registration (Schedule I)
Environmental Health & Safety (EH&S) does not maintain an institutional research registration. Those individuals who wish to use a Schedule I controlled substance in their research must register independently with the DEA. The individual registration can be processed by submitting Form 225 to the DEA. For more information, please visit the DEA website.
In addition Principal Investigators (PI’s) who wish to use a Schedule I controlled substance must have their project reviewed by the state Attorney General’s office. Review may take several weeks to months.
Institutional Research Registration (Schedules II-V)
EH&S maintains the required institutional departmental research registrations issued by the DEA covering use of Scheduled II-V controlled substances and precursor chemicals for research, instructional and chemical analysis purposes.
Researchers who wish to use a Schedule II controlled substance in a human subject’s protocol must have their project reviewed by the State Attorney General’s office. This review may take several weeks to months. A current letter of approval from the state Attorney General’s office must be provided to EH&S prior to obtaining the drugs.
Please visit the EH&S website for more information on controlled substances.
Obtaining Marijuana for Research
Researchers wishing to conduct marijuana research must obtain the marijuana through NIDA, or another source approved by the DEA. At present, the University of Mississippi, operating under a contract with NIDA, is the only facility authorized to produce marijuana plant-based products for use by researchers in the U.S. See: https://pharmacy.olemiss.edu/marijuana/ for more details.
As the date of this guidance, Epidolex, Marinol, Syndros and Cesamet are the only FDA approved cannabis-related products. The FDA-approved drugs Syndros and Marinol contain a synthetic form of THC and are regulated as Schedule II and III controlled substances, respectively, by the DEA. The FDA has also approved Epidiolex oral solution for the treatment of certain seizures associated with child epilepsy. This is the first FDA-approved drug that contains CBD, and has been classified as Schedule V. Any clinical testing of Epidiolex for conditions other than its single FDA-approved indication would require submission and approval of an Investigational New Drug request with the FDA. In addition, despite the recent rescheduling of Epidiolex, CBD preparations other than Epidiolex remain classified as Schedule I controlled substances. The agency has not approved a marketing application for cannabis for the treatment of any disease or condition at this time.
Research-grade cannabinoids for in vitro and animal studies are available from a variety of research vendors, but are still considered Schedule I preparations and require an appropriate DEA research registration in order to purchase and use in the laboratory setting.