Under the 1961 international Single Convention on Narcotic Drugs (PDF, 680KB) (amended in 1972), cannabis is designated a Schedule I substance, and participating countries are required to restrict production, manufacture, possession and distribution of marijuana except for medical and scientific purposes. The Drug Enforcement Administration (DEA) regulates the cultivation of marijuana for research purposes through registration requirements and establishing annual aggregate production quotas under the authority of the 1970 Controlled Substances Act (CSA), which implements the Single Convention. Since then, the DEA has only issued a single registration for the cultivation of marijuana for research, to the University of Mississippi, which is funded through a NIDA contract. In March 2020, the DEA posted a proposed rule in the Federal Register to facilitate registering additional growers. The proposed rule is open for public comment until May 22, 2020, and may be revised in response to public comment. Questions on the proposed rule or the process of registering marijuana growers for research should be addressed to the DEA.
NIDA contracts with the University of Mississippi to grow marijuana for use in research studies. The contract was renewed in 2015 under an open solicitation process. The University designates a secure plot of land where marijuana crops are grown every few years, based on current and expected demand. The marijuana is grown, harvested, stored, and made available as bulk marijuana or other purified elements of marijuana to use for research. For more information on the marijuana farm and current supply: See Information on marijuana farm contract.
Marijuana for use in research can be obtained through the NIDA drug supply program through a process that was updated by the Department of Health and Human Services in June 2015 (PDF, 381KB). Applicants are encouraged to contact the NIDA Drug Supply Program prior to submitting their application to obtain information on availability of the marijuana strain(s) to be requested. All applicants must fulfill the following requirements:
For NIH Funded Projects (for all studies from basic science to human trials):
- Demonstrate scientific validity and ethical soundness through NIH review, consisting of three steps: (1) the NIH peer review system, which assesses the scientific and technical merit of all grant applications; (2) the National Advisory Council of the funding institute, comprising eminent scientists as well as public members; and (3) the funding Institute’s Director, who makes the final decision on the merit of an application for funding, based on peer review, public health significance, and Institute priorities. To find studies approved through this NIH review process, go to https://reporter.nih.gov/ (you should use the search terms “marijuana,” “cannabis,” and “cannabinoid”).
- An active-status Investigational New Drug (IND) application on file with the FDA (for human research only), which has been evaluated by FDA and found safe to proceed.
- A DEA registration for marijuana, a Schedule I controlled substance.
For Non-NIH Funded Human Research Projects:
- Demonstrate scientific validity and ethical soundness through review by the Food and Drug Administration (FDA) IND process. Research protocols will undergo a scientific review which assures the safety and rights of subjects and the scientific quality of the clinical investigations, and assesses the likelihood that investigations will yield data capable of meeting the statutory standards for drug marketing approval; and
- A DEA registration for marijuana, a Schedule I controlled substance.
When the above steps have been completed, investigators contact the NIDA Drug Supply Program to place an order for marijuana with specific characteristics with regard to concentrations of delta-9-tetrahydro-cannabinol (THC), cannabidiol (CBD), and other cannabinoids. The program official verifies that the application is complete (with all the above-mentioned steps fulfilled), and forwards the order on to the contractor responsible for shipping the marijuana.
For Non-NIH Funded Non-Human/Basic Research Projects: See NIDA Drug Supply Program
Note: While not required in all cases it is recommended that researchers contact the NIDA Drug Supply Program early in the planning of a study to obtain information on specific strains of marijuana available so that this information can be included in the protocol and IND.
Mold and Yeast Standards
The National Institute on Drug Abuse (NIDA) has supplied marijuana to researchers through our drug supply program for over 40 years without any known health consequences from contaminants. All plant materials contain mold and yeast, which are naturally occurring in air and soil.
There is currently no universally accepted standard for levels of mold and yeast on marijuana and different health organizations set cutoffs for acceptable levels spanning an enormous range [from 500-200,000 colony forming units (CFU)/g]. In response, NIDA is conferring with the Food and Drug Administration (FDA) to determine what analyses and specifications are appropriate for NIDA-supplied marijuana.