A very interesting report from Cannabis Business Executive who have published the following piece on organizations like U.S. Pharmacopeial Convention (USP), a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide, has begun evaluating the advisability and feasibility of developing USP standards for medical marijuana.
They write….(links at original article)
According to Wikipedia, USP establishes written (documentary) and physical (reference) standards for medicines, food ingredients, dietary supplement products, and ingredients. These standards are used by regulatory agencies and manufacturers to help to ensure that these products are of the appropriate identity, as well as strength, quality, purity, and consistency.
Prescription and over-the-counter medicines available in the United States must, by federal law, meet USP-NF public standards, where such standards exist. Many other countries use the USP-NF instead of issuing their own pharmacopeia, or to supplement their government pharmacopeia.
CBE recently discovered that USP, the Food and Drug Administration and key industry stakeholders had recently met to do just that, CBE contacted USP and was pointed in the direction of a link to an abstract on their site, www.usp.org, by Christine Feaster, Vice President, Head of Strategic Marketing and Program Operations — Dietary Supplements & Herbal Medicines at USP to the following document which provides a scientific abstract discussing the current regulatory and scientific landscape regarding medical cannabis.
You will have to sign-up for an account to access the document (it is a little tricky to navigate their site to find the document which encourages all stakeholders, CBE’s stakeholder readers, licensees, ancillary businesses and regulatory readers, to review the document we are citing and communicate your input and feedback directly to USP.
Correspondence should be addressed to: Gabriel I. Giancaspro, Vice President, Science-DS & Herbal Medicines, US Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, MD 20852-1790; tel. +1.301.816.8343; e-mail: firstname.lastname@example.org.
In short, the document lays the historical background of cannabis in the U.S. and abroad. It also cites:
- The current slate of 202 open clinical trials in the U.S. through August of 2015, many of which are researching new medical treatments for a variety of conditions and the recognition that there is a need for quality specifications for the cannabis used in these studies.
- The need to establish quality pharmacopoeial standards criteria for medical cannabis to address the issues of purity, strength, adulteration (contamination) due to the concern for public safety and efficacy.
- Establishing pharmacopeial identification tests for medical scannabis (USP Compendia like USP-NF, the Herbal Medicines Compendium and others already exist).
The document also outlines a variety of approaches for developing Compendial Standards for Cannabis. USP believes that its experience in developing quality standards criteria for herbal medicines, either as dietary supplements or pharmaceuticals could be used as a foundation of standard development for cannabis products.
- USP is considering the establishment of an Expert Panel under USP’s Botanical Dietary Supplements and Herbal Medicine Expert Committee.
- Publish standards that USP may develop for medical cannabis using its flagship and accepted US Regulatory compendia, the USP-NF which is enforceable by the FDA which must play a key stakeholder role to ensure success.
- Utilize the USP Herbal Medicines Compendium that was launched in 2013.
The Cannabis Industry, USP and federal regulatory groups like the FDA, U.S. Department of Agriculture, National Institutes of Health, etc., have the experience in making cannabis safety part of the best oversight structure in the world and it is incumbent on all of us to seek this mutually beneficial partnership to advance the legalization of medical and adult use cannabis in order to set up a totally transparent, federally regulated industry and to end prohibition sooner than later.
Please review the cited document and let’s all reach out to USP today to move to ball forward.