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# FDA Releases Cannabis Clinical Research Guidance
- URL: https://www.fdaweb.com/fda-releases-cannabis-clinical-research-guidance/
- Published: 2023-01-23T12:00:00.000Z
- Updated: 2026-09-14T18:12:45.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5153595

FDA has issued its long-awaited final guidance entitled [*“Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Guidance for Industry.”*](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDAsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMzAxMjMuNzAyNTAxNTEiLCJ1cmwiOiJodHRwczovL3d3dy5mZGEuZ292L3JlZ3VsYXRvcnktaW5mb3JtYXRpb24vc2VhcmNoLWZkYS1ndWlkYW5jZS1kb2N1bWVudHMvY2FubmFiaXMtYW5kLWNhbm5hYmlzLWRlcml2ZWQtY29tcG91bmRzLXF1YWxpdHktY29uc2lkZXJhdGlvbnMtY2xpbmljYWwtcmVzZWFyY2gtZ3VpZGFuY2UtaW5kdXN0cnk%5FdXRtX21lZGl1bT1lbWFpbCZ1dG1fc291cmNlPWdvdmRlbGl2ZXJ5In0.5sKqk7NFbxX1uCH2iWkIjr3c5Kq9Vnz9qns%5FRrCbHwk/s/1255931999/br/153255865973-l?ref=fdaweb.com) Changes the agency made since a draft was released 7/2020 include “clarifying sources of cannabis for clinical research (including Schedule I sources), adding resources explaining expectations for investigational new drug (IND) applications in various stages of drug development, and providing guidance on quality considerations for INDs,” according to the guidance The final guidance also:

- Lists United States Pharmacopeia resources on quality testing, including the assessment of leachables from packaging and delivery systems.
- Identifies relevant International Council for Harmonization guidelines, FDA guidances, and considerations for devices used in combination with a drug.
- Addresses the calculation of delta-9 THC content, which is relevant to determine control status for cannabis and cannabis-derived compounds.

The guidance broadens the sources available for providing cannabis for clinical research. Previously, the National Institute on Drug Abuse (NIDA) Drug Supply Program (DSP) was the only domestic, federally legal source of cannabis for clinical research, and now sponsors have new sourcing options that do not involve DSP. “Additionally, 7 CFR 990 and the changes made by the 2018 Farm Bill allow hemp, as defined in the bill24 (i.e., cannabis at or below 0.3 percent delta-9 THC on a dry weight basis), to serve as a source of cannabis and cannabis-derived compounds for drug development,” the guidance says.

“It is critical FDA continues to support robust scientific research needed to develop new drugs from cannabis,” the agency says, adding that it continues to conduct research on various cannabis quality considerations, including recent research on [quality standards in state programs permitting cannabis for medical uses](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDIsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMzAxMjMuNzAyNTAxNTEiLCJ1cmwiOiJodHRwczovL3d3dy5saWViZXJ0cHViLmNvbS9kb2kvMTAuMTA4OS9jYW4uMjAyMS4wMTY0P3V0bV9tZWRpdW09ZW1haWwmdXRtX3NvdXJjZT1nb3ZkZWxpdmVyeSJ9.B-WqY11Uc4xK03UUkiNCNjWeql9WjoM3B1Mo-2fndus/s/1255931999/br/153255865973-l?ref=fdaweb.com) and [investigation of microorganisms in cannabis after heating in a commercial vaporizer](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDMsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMzAxMjMuNzAyNTAxNTEiLCJ1cmwiOiJodHRwczovL3d3dy5mcm9udGllcnNpbi5vcmcvYXJ0aWNsZXMvMTAuMzM4OS9mY2ltYi4yMDIyLjEwNTEyNzIvZnVsbD91dG1fbWVkaXVtPWVtYWlsJnV0bV9zb3VyY2U9Z292ZGVsaXZlcnkifQ.Y8nOlEjkOg1EHlvLtTcF9w-BJBqew1ko-S72-Dv5xSE/s/1255931999/br/153255865973-l?ref=fdaweb.com).