Type of Posting: General Chapter Prospectus
Posting Date: 27-May-2022; updated 30-Jun-2022
Expert Committee: Botanical Dietary Supplements and Herbal Medicines (BDSHM)
Input Deadline: 31-Jul-2022
Proposed New Title: <1568> Quality Considerations for Cannabis and Cannabis-Derived Products for Clinical Research
Suggested audience: Organizations, manufacturers, suppliers, regulators, contract research organizations, clinical investigators involved in providing materials for clinical research using cannabis and cannabis-derived products.
Estimated Proposal PF: To be determined
Background and objectives: Due to active and growing interest in cannabis for medical purposes, definition of quality attributes can help support sound and reproducible basic and clinical research. In light of the permitted use of cannabis products for clinical research and the known and demonstrated quality issues related to these products, health care professionals, the research community and, perhaps most importantly, the public will benefit from increased quality control of cannabis and cannabis-derived products. Information on the quality attributes for evaluation of these materials in terms of identity, composition, and purity, and the scientific resources to test for these, can help improve the quality of clinical research results based on an understanding of the composition of the product(s) tested.
Description of scope and application: In this informational general chapter, standards that set forth specifications for quality attributes which are fundamental to characterization of the materials for clinical research will be introduced.
The scope of this informational general chapter covers necessary information regarding appropriate specifications, validated analytical procedures, acceptance criteria, and reference standards to assess the quality of cannabis and cannabis-derived products including:
- Nomenclature of cannabis and cannabis-derived compounds
- Laboratory verification of identity as cannabis and the specific cannabis chemotypes
- Quantitative composition of cannabinoids and terpenes
- Including calculation of the percent delta-9 THC
Tests to help ensure that the risk of exposure to contaminants such as pathogenic microorganisms, toxic elemental contaminants, mycotoxins, and pesticide residues is being appropriately controlled
Anticipated activities: USP is requesting early input from stakeholders on this proposed General Chapter <1568> Quality Considerations for Cannabis and Cannabis-Derived Products for Clinical Research which is planned to be published for comment in Pharmacopeial Forum.
Contact: Nam-Cheol Kim, Senior Scientist II (301-230-7428, firstname.lastname@example.org)
This Notice was updated on June 30, 2022 to extend the input deadline.