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Stimuli Article: The Advisability and Feasibility of Developing USP Standards for Medical Cannabis Posted for Comment

Type of Posting: General Announcement

Posting Date: 26–Feb–2016

Archive Date: 24–Jun–2016

Expert Committee: Botanical Dietary Supplements and Herbal Medicines

The members of the United States Pharmacopeia staff, have posted a Stimuli article to present their current thinking on Advisability and Feasibility of Developing USP Standards for Medical Cannabis in Pharmacopeial Forum 42(1) [Jan.–Feb. 2016].

This Stimuli article “The Advisability and Feasibility of Developing USP Standards for Medical Cannabis“ analyzes the need for public quality standards for medical cannabis (defined herein as marijuana used for medical purposes under state laws) and the potential role of the U.S. Pharmacopeial Convention (USP) in addressing that need. Following legalization of the medical use of cannabis in several U.S. states and internationally, USP has received requests to investigate the advisability and feasibility of developing quality standards for medical cannabis. Development of quality standards for medical cannabis requires consideration of a wide range of scientific, legal, and policy issues that reach far beyond its classification as a botanical drug or herbal medicine. This article discusses the current regulatory and scientific landscape regarding medical cannabis, identifies issues related to the lack of quality standards for medical cannabis, and explores potential options for developing quality standards. USP seeks input from stakeholders on whether USP should proceed with development of quality standards for medical cannabis and if so, what approaches should be utilized to establish such standards.

Your comments and suggestions are desired. Comments will be accepted until March 31, 2016, the end of the comment period for Pharmacopeial Forum 42(1).

Should you have any questions or comments, please contact Gabriel I. Giancaspro, Vice President, Dietary Supplements and Herbal Medicines (gig@usp.org, medicalcannabis@usp.org or 301 816-8343).