USP HMC publishes revised Cannabis Draft Monograph

Recommendation

5/6 June 2024

GMP for Cannabis – what you need to know - Live Online Conference
All relevant GMP/GDP/GACP aspects for Medical Cannabis

The USP Herbal Medicines Compendium (HMC) published a revised version of the previously proposed Cannabis Species Inflorescence monograph. The comment end date is 1 November 2023.

Proposed Changes

Based on the comments received, the previously published Cannabis Species Inflorescence monograph has been revised as follows:

• The Identification section has been revised to clarify that the requirements are met by complying with the Identification A for macroscopic and microscopic characteristics, plus one of the following: Identification B (HPTLC), C (HPLC), or D (GC). In addition, a Visual Representation of Chromatographic Identification Procedures is provided for information. 
• Loss on Drying <731> (max. 10.0%): A method has been included which is performed under vacuum at 40° for 24 h to avoid potential loss and other degradation not related to loss of water (e.g., from decarboxylation of acidic cannabinoids and loss of terpenes). 
• The proposal does not require "on the dried basis" for expression of cannabinoid content because the term "dried basis" is subject to interpretation differently by different groups (e.g, leading to possible inflation of the labeled cannabinoid content). Thus, the revised monograph proposes that the quantitative analysis is performed on the "as is basis“ at specified water activity level (water activity during storage should be maintained at 0.60 ± 0.05).
• The Microbial Contaminants specifications have been revised as follows: 
  - Option 1: Specific acceptance criteria for total aerobic microbial count (TAMC), total combined yeasts/moulds count (TYMC), and  specified microorganisms (tests according to USP general chapters <61> and <62>).
  - Option 2 (particularly for inhalation products): More stringent requirements for TAMC, TYMC, and specified microorganisms based on USP general chapter <1111>. The label should then identify the product as having a reduced microbial load. In addition, the label indicates whether the article has been treated to reduce the microbial load and the method used.
• The Content of Terpenes section has been removed from Specific Tests because "there is insufficient information to support the use of terpenes for medical purposes". Terpenes are now mentioned only as constituents of interest (i.e., b-Caryophyllene, D-limonene, b-myrcene, a-pinene, terpinolene).

Stakeholder are invited to send their comments on the above revisions and other sections of the revised proposal to the USP HMC until 1 November 2023.

For more information please see the USP HMC Monograph Cannabis Species Inflorescence Proposed For Comment Version 0.1.

Already save the date: the next GMP for Cannabis Conference will be held Live Online on 5/6 June 2024.