The US Food and Drug Administration (FDA) have released a draft guidance on the conduct of clinical research involving cannabis-derived compounds.
Cannabis and derived products containing less than 0.3% of delta-9 tetrahydrocannabinol (THC), the main psychoactive ingredient in cannabis, are now defined as “hemp”. Any products containing more than 0.3% are still classed as Schedule I controlled substances, enforced by the Drug Enforcement Administration (DEA). This guidance provides extensive instructions on how to calculate THC content in solution-based and solid oral dosage forms.
Those developing cannabis-containing drugs should follow the same quality considerations as for other botanical drug products. Developers are also reminded to consider details such as container closure systems and the potential for the product to be considered a combination product if a delivery system such as an inhaler is to be used.
The guidance also gives detailed information about sampling and testing methods to evaluate THC levels. Applicants are expected to provide quantitative data about THC content in botanical raw material, along with a detailed description of the testing methods used to arrive at the conclusion of the THC content. Furthermore, quantitative data regarding phytochemicals such as cannabinoids, terpenes and flavonoids, which are present in the proposed product, should be provided.
The recommendations are applicable for human drug development only. For more information, click here.