USP Cannabis Monograph

Following the previously published USP HMC draft Cannabis Monograph a revised USP Herbal Medicines Compendium (HMC) monograph has been posted in April 2024. The comment end date is July 2024. The previous proposal that appeared in August 2023 is being replaced with the new draft version. On the basis of comments received, the Cannabis Species Inflorescence monograph has been revised as follows:

• Considering the medical use of cannabis, the specifications for the labeled amount of tetrahydrocannabinol (THC) and cannabidiol (CBD), as well as other cannabinoids were changed from > 80% and <120% to >90% and < 110%.
  
  
• The Contaminants section has been edited to provide two options for Microbial Contaminants:
  - Option 1 specifies the limits for total aerobic bacterial count (max. 10⁵ CFU/g), total yeasts and molds count (max. 10⁴ CFU/g), and absence of specified microorganisms using USP general chapters <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests and <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms. The total bile-tolerant Gram-negative bacteria does not exceed 10³ CFU/g.
  - Option 2 specifies more stringent limits for total aerobic bacterial count (max. 10² CFU/g), total yeasts and molds count (max. 10¹ CFU/g), and absence of specified microorganisms using general chapters <1111> Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use and <62> for at-risk populations. Such populations include immunocompromized patients who inhale Cannabis flower, placing them at greater risk of microbial infection compared to healthy individuals.

Stakeholder comments and input are invited regarding these revisions as well as other sections of the revised proposal. More information is available in the draft monograph Cannabis Species Inflorescence published in the USP Herbal Medicines Compendium.