Proposed Cannabis Monograph Open for Public Comment in USP Herbal Medicines Compendium

Rockville, Md. — The United States Pharmacopeia (USP) has opened a 90-day review period for their proposed Cannabis Species Inflorescence monograph in the Herbal Medicines Compendium (HMC), a laboratory quality standards testing reference used internationally.  The proposed cannabis monograph provides scientifically validated methods, information on physical reference standards, and acceptance criteria to establish the identity of cannabis chemotypes, content of cannabinoids and terpenes, and limits on contaminants.

“Cannabis is becoming more widely accepted around the world and is being widely researched by many international organizations for medicinal purposes. A key component of USP’s mission to improve global health is providing public standards and guidance to help ensure the quality of all medicines, including herbal medicines,” said Dr. Jaap Venema, USP’s Chief Science Officer.

During the HMC monograph review period, stakeholders, including manufacturers, researchers and regulators, are encouraged to evaluate the definition and constituents of interest, as well as methods and specifications for identification, composition and contaminants.  Publicly available standards can help improve the quality and consistency of cannabis-related research, and also help ensure the quality of current products by providing tools to identify and limit impurities, such as pesticides and heavy metals.

USP’s proposed definition of Cannabis inflorescence in the HMC begins as follows:

“The article consists of the dried pistillate (female) inflorescence of the Cannabis sativa L. (Fam. Cannabaceae) and its subspecies, varieties, and chemotypes. It is derived from homogeneous cultivars to contain NLT 80% and NMT 120% of the labeled amount (in mg/g) of the total tetrahydrocannabinol (THC) including Δ9-THC and THCA, and NLT 80% and NMT 120% of the labeled amount (in mg/g) of the total cannabidiol (CBD) including CBD and CBDA.”

The proposed monograph continues by describing the analytical methods and acceptance criteria to define THC-dominant, CBD-dominant and THC/CBD-intermediate chemotypes, and the limits on contaminants such as pathogenic microorganisms, toxic elemental contaminants, mycotoxins, and pesticide residues.

HMC is a freely available, online resource that provides standards for herbal ingredients used in herbal medicines. Herbal ingredients eligible for HMC standards include those that have been approved by a national authority for use in herbal medicines or are included in a national pharmacopoeia. The standards in HMC are expressed primarily in monographs, each of which contains general information, including the definition of the herbal ingredient relative to the monograph title, followed by a specification. The specification contains tests for critical quality attributes of the herbal ingredient and includes procedures and acceptance criteria. HMC employs validated analytical procedures for the tests of its monographs, using state-of-the-art techniques and associated reference materials.

If you are interested in providing comments on the proposed Cannabis inflorescence monograph for HMC, please visit hmc.usp.org.



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