BRIEFING

 〈1568〉 Cannabis Inflorescence Quality Attributes for Clinical Investigations. A previous proposal for a new informational general chapter, titled "Quality Considerations for Cannabis and Cannabis-Derived Products for Clinical Research 〈1568〉", was published in PF 49(3) [May–Jun 2023]. That proposal has been cancelled and is being replaced with this new proposal on the basis of comments received. The following changes were made:

1. Change the chapter title to reflect our intent of defining quality attributes of cannabis as an investigational article.

2. 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.

3. Include additional references to support newly added information.

4. Revise the Loss on Drying test for consistency with the Agriculture Improvement Act of 2018 (commonly referred to as the "2018 Farm Bill").

 USP invites stakeholders to submit supporting data for all sections of this proposal, including the sections on loss of drying, ash content, and water activity, as well as input on the proposed specifications.

 (BDSHM: N. Kim)

 Case ID—SUB-614