Cannabis and botanical extraction research: rules, funders, standards

Cannabis and botanical extraction research is governed first by licensing and by quality rules, and only then by method. In Canada, the Cannabis Regulations (SOR/2018-144) set separate Part 2 licence classes for cultivation, processing, analytical testing, sale for medical purposes and research, with Part 5 covering Good Production Practices. In the United States, human drug research on a cannabis-derived product generally needs an Investigational New Drug application, and work with Schedule I material needs DEA registration. NIDA supplies research-grade cannabis grown under a contract with the University of Mississippi. FDA's December 2016 Botanical Drug Development guidance and its January 2023 quality considerations guidance for cannabis clinical research set the chemistry and manufacturing expectations.

The 2018 Farm Bill defines hemp as Cannabis sativa L. with a delta-9 THC concentration of not more than 0.3 percent on a dry weight basis, which separates hemp work from drug-type cannabis. Extraction practice spans supercritical CO2, which needs more than 31 degrees C and 74 bar, volatile-solvent methods using ethanol, butane, propane or hexane that carry fire and explosion hazards, and solventless products such as rosin. Non-cannabis botanicals are covered by the European Medicines Agency's HMPC monographs and by industry resources such as the AHPA Atlas.

Funding comes mainly from NIDA and NCCIH, and the main learned society is the International Cannabinoid Research Society. Cannabis and Cannabinoid Research is a flagship journal. Cultivation, extraction, testing, hemp, drug development, product quality and botanical extracts each have their own specialist hub.