Proposed USP Quality Attributes for Cannabis in Clinical Investigations

The USP republished the proposed new USP chapter <1568> Cannabis Inflorescence Quality Attributes for Clinical Investigations. The revised draft is open for comment until 31 July 2025.

Background

A previous proposal for a new informational USP general chapter<1568>, entitled Quality Considerations for Cannabis and Cannabis-Derived Products for Clinical Research, was published in Pharmacopeial Forum (PF) 49(3) [May–June 2023]. However, on the basis of comments received, the proposal has been cancelled and is being replaced with a new proposal published in PF 51(3). In comparison with the previous draft chapter, the following changes were made:

• Change in the chapter title to reflect USP's intent of defining quality attributes of cannabis as an investigational article,
• Add a new section, Scope and Intent, to describe the chapter scope and target audience and to align with the FDA Guidance for Industry: Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research,
• Include additional references to support newly added information,
• Revise the Loss on Drying (LOD) section for consistency with the US Agriculture Improvement Act of 2018 (the "2018 Farm Bill"): For determining whether a cannabis material is a controlled substance, the USDA-required expression of delta-9-THC content on a dry weight basis is expected. Therefore, for this purpose, the USDA testing and sampling guidelines should be followed when testing cannabis samples.

The USP encourages stakeholders to submit supporting data for all sections of this proposal, including the sections on LOD, Ash Content, and Water Activity, as well as input on the proposed specifications.

More information is available in the Pharmacopeial Forum.