USP Announces Chapter Elaboration on Quality Considerations for Cannabis

The USP Expert Committee on Botanical Dietary Supplements and Herbal Medicines (BDSHM) announced the elaboration of a new general chapter <1568> Quality Considerations for Cannabis and Cannabis-derived Products for Clinical Research. The input deadline for comments is 30 June 2022.

Background of Chapter <1568> Elaboration

Due to the ongoing growing interest in medical cannabis harmonized quality attributes are needed. Information on the quality attributes in terms of identity, content, and purity can help improve the quality of medical cannabis in clinical research. Harmonized quality parameters are also needed for stability studies. Previously, the FDA already published a draft guideline on "Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research".  In addition, the USP Cannabis Expert Panel recently issued an article on the quality requirements for medical cannabis. The article describes the appropriate use of USP General Chapters related to chromatographic methods and controls for contaminants.

According to the USP the scope of the new general chapter <1568> will cover "necessary information regarding appropriate specifications, validated analytical procedures, acceptance criteria, and reference standards to assess the quality of cannabis and cannabis-derived products", including:

  • A glossary of terms for Cannabis and Cannabis-derived compounds
  • Verification of identity as Cannabis and the specific Cannabis chemotypes (i.e., THC-dominant, intermediate (with both THC and CBD), and CBD-dominant)
  • Quantitative composition of cannabinoids and terpenes (including calculation of delta-9 THC percentage)
  • Tests to help ensure that the risk of exposure to contaminants such as pathogenic microorganisms, toxic elements, mycotoxins, and pesticide residues is being appropriately controlled

The USP is requesting early input from stakeholders (e.g. manufacturers, suppliers, regulators, contract research organizations (CROs), clinical investigators) on the proposed USP General Chapter <1568> Quality Considerations for Cannabis and Cannabis-Derived Products for Clinical Research which is then expected to be published for comment in Pharmacopeial Forum.

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