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United States Pharmacopeia Prepares to Add the Cannabis Plant to Its List of Herbal Medicines

By Leo Bear-McGuinness

Published: Sep 28, 2022   

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The United States Pharmacopeia (USP) is in the process of adding Cannabis sativa to its list of herbal medicines and their properties.

A draft of the plant’s botanical characteristics and suggested methods of testing it was published by the USP on September 21 and is open to public comments until December 20.

Cannabis in the pharmacopeia

The USP’s Herbal Medicines Compendium is an extensive list of herbal ingredients, their qualities, and how they can be analyzed. The compendium is internationally recognized as a quality reference list of testing standards.

And now cannabis is getting added to its list.

The proposed cannabis monograph lists scientifically validated methods for testing the plant substance, information on physical reference standards, 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,” Dr. Jaap Venema, USP’s chief science officer, said in a statement.

“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.”

Anyone with relevant expertise has now been invited to review the monograph on the USP’s website. Cannabis producers, researchers, and regulators have been encouraged to offer their views.

Earlier this year, the USP was in the process of adding a more specific cannabis constituent, CBD, to its National Formulary, an extensive list of drugs and their methods of detection that is officially recognized by the US federal government.

Speaking to Analytical Cannabis at the time, Nam-Cheol Kim, scientific liaison at the USP, remarked on how long the review process for CBD’s inclusion would take.

“USP will follow its standard process for reviewing comments received on the proposed monograph with the Botanical Dietary Supplements and Herbal Medicines Expert Committee. Only after this review can the Expert Committee determine the appropriate next steps, which could potentially include republication in the Pharmacopeial Forum for additional stakeholder feedback on any proposed changes to the monograph. As such, at this time we are unable to provide an anticipated timeline.”

 

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