The FDA treats any research on cannabis as research into an investigational new drug, which requires a formal application to the agency. The university would also be required to obtain a letter of authorization from NIDA, which is the only source for legally obtaining a supply of cannabis for study. This authorization letter will include information about the researcher’s facilities, as well as any important characteristics of the cannabis product at issue. Finally, the university would also need to seek registration with the DEA and a license for the specific facilities where the research would be conducted. The DEA may also require a review of the documentation submitted to NIDA and the FDA, as well as physical site inspections and a security protocol review. Any deficiency detected by these agencies could freeze or end a cannabis research effort.
States—including those that have already legalized cannabis for medical and recreational use— have also taken an interest in regulating the research of cannabis. Many universities would need to seek approval from state cannabis regulators, medical boards, or advisory panels, which is often a prerequisite for submitting a compliant application to the FDA or DEA.
Failing to comply with the rules and regulations of cannabis research could be absolutely fatal to a university, and no school wants to be the example. Universities with the wherewithal and competent advisors will be able to find success navigating this vast bureaucratic landscape. Many schools are already doing so and have created research centers dedicated to cannabis and hemp. Starting with hemp research may also be a good launching point for a larger research program in the future, but with far less risk in the present. Following the passage of the 2014 Farm Bill, universities were permitted to grow and possess hemp and hemp-derived products—essentially, cannabis with 0.3% or less THC by dry weight—for research purposes. With the passage of the 2018 Farm Bill just a few years later, hemp was removed from Schedule I of the Controlled Substances Act and fully legalized on the federal level.
As cannabis continues to gain in popularity and acceptance, the hope is that similar legislation will legalize cannabis research, and ultimately cannabis itself, to allow university-level research to grow with far less risk and far fewer bureaucratic road blocks to the important work yet to be done.
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