Tag Archives: Pharmacopeia

USP Door For Cannabis?

uspThere are a number of ways that Cannabis could be recognized as a medical substance or at least treated differently than it is now.  One is the DEA, well we already know how helpful they are.  Another would be the FDA, they already supply the misinformation used by the DEA so are they an option?  Maybe.  The other is to get something back into the Formulary through the USP.

The USP has legal authority given to it by the FDA back in 1966:

The U.S. Federal Food, Drug, and Cosmetics Act designates the USP–NF as official compendia for drugs marketed in the United States. A drug product in the U.S. market must conform to the standards in USP–NF to avoid possible charges of adulteration and misbranding.

Could the USP be a door for Medical Cannabis?  The USP (United States Pharmacopeia) is one of several formularies used by Health Care Practitioners and the FDA to determine medical value of substances and plants.

What most people don’t know is that while the USP creates monographs for chemicals they do the same for Food Ingredients and Dietary Supplements.  Again with legal authority given to them by the FDA

Currently, over 200 FDA regulations cited in the U.S. Code of Federal Regulations incorporate the food ingredient standards that USP publishes in the Food Chemicals Codex (FCC) compendium. The first edition of the FCC, which was published in 1966 by the Institutes of Medicine, was given quasi-legal recognition in July 1966 by means of a letter of endorsement from FDA Commissioner James L. Goddard, which was reprinted in the book. The letter stated that “the FDA will regard the specifications in the Food Chemicals Codex as defining an ‘appropriate food grade’ within the meaning of Sec. 121.101(b)(3) and Sec. 121.1000(a)(2) of the food additive regulations, subject to the following qualification: this endorsement is not construed to exempt any food chemical appearing in the Food Chemicals Codex from compliance with requirements of Acts of Congress or with regulations and rulings issued by the Food and Drug Administration under authority of such Acts.”

and

USP’s standards for dietary supplements may be found in USP–NF and Food Chemicals Codex (FCC) compendia. Legal recognition varies depending from which compendia the standards are published.

To do this the USP works with manufacturers to develop monographs for items:

USP develops public standards to provide quality oversight for dietary supplements and their ingredients. Public input and interaction are vital to the development of these standards, which originate from the draft monographs and data provided by dietary supplement manufacturers, users, and suppliers. USP’s scientific staff and the volunteer Dietary Supplements Expert Committee review data, conduct necessary laboratory tests, and ensure that the information is subject to a process of public review and comment.

They do this through several public forums which they operate:

Proposals for new or revised dietary standards from USP–NF and FCC that appear in the DSC are first published for public review and comment in either the Pharmacopeial Forum or the FCC Forum. Through these free online forums, interested parties have the ability to provide feedback on the proposed standards and revisions and participate in the USP standards-setting process.

They encourage people to submit their substances for inclusion:

USP encourages you to submit draft monographs for the dietary supplements you manufacture or supply. Your draft monograph will become the starting point for the public standard. USP staff will involve you in the public process of review and comment to refine and finalize the monograph for publication in the next USP-NF edition or supplement.

The USP sounds like it is an avenue that is open to Medical Cannabis in the form of a Food Ingredient or as a Dietary Supplement and they tell you how to do it.

USP wants Medical Cannabis Experts

uspLooking deeper into the USP and what they might be doing with Medical Cannabis we run across that they are looking for Experts to sit on a panel.

Posted Aug 30th on their website they are seeking qualified candidates to sit on a panel to “develop quality standards for cannabis used for medical purposes.”

That expert panel will then make recommendations to the Botanical Dietary Supplements and Herbal Medicines Expert Committee.

They expect to have this panel in place by the end of Sept 2016

“Expert panels are formed to provide additional expertise on a particular compendial topic, thereby supplementing Expert Committee expertise. Each Expert Panel has a specific charge (including scope of work, deliverables, and timeline for completion) and will be dissolved at the conclusion of its work. Expert Panels are advisory to one or more Expert Committees; they are not decision-making bodies.”

A person can apply to be on the expert panel at the following link –  USP

For additional information, contact Nandakumara Sarma, Director, Herbal Medicines (dns@usp.org or 301-816-8354).

US Pharmacopeia looking at Medical Cannabis

uspFollowing up on why would the USP want to be registered with the DEA we found, The US Pharmacopeia is looking at medical Cannabis and how to set a Monograph.  This is extremely important for anyone seeking to get FDA approval and DEA to re-schedule.

Based on what we have found in the USP website it’s clear that they are aware that Cannabis has a long history of medical use. “In 1850, USP admitted cannabis as a recognized drug in the United States Pharmacopeia (USP) and published an Extractum Cannabis (or Extract of Hemp) monograph”

usp-mjIt’s also pretty clear that they can develop standards for Cannabis products.  “USP has a long history of developing quality standards for herbal medicines, either as pharmaceuticals or as dietary supplements. USP has state-of-the-art laboratories throughout the world, and global scientific expertise in the form of USP staff and expert volunteers. This cumulative experience and expertise at USP could be used as a foundation for standard development for cannabis products.”  adding  “USP is considering organizing an open forum for discussion of these proposals to gather input for a suitable path forward toward the potential development of quality standards for medical cannabis.”

However they fear the results without working closely with the FDA and DEA.  “Another important consideration would be where to publish the standards that USP may develop for medical cannabis. USP’s flagship compendia, the USP–NF, are recognized as “official compendia” under United States law and contain standards for identity, strength, quality, and purity of medicines that are enforceable by the FDA. Generally, USP–NF only contains monographs for drugs that were included in USP before the 1938 amendment to the Food, Drug and Cosmetic Act, or drugs that are legally marketed in the U.S., which presents an important challenge given that marijuana is currently illegal under federal law. Given medical cannabis’ current legal status, the regulatory implications of publishing cannabis standards in USP–NF would need to be carefully reviewed and analyzed with input from regulators and other stakeholders. In particular, input from the FDA and U.S. Drug Enforcement Administration will be critical.”

USP is clearly looking at Medical Cannabis and how they might control or help it’s regulation and use.  “As the use of medical cannabis is growing, the need for a USP public scientific standard to help ensure identity, purity, quality, and strength has been identified. Public quality standards for medical cannabis are important for many reasons, including the avoidance of adulteration, accurate identification, control of contaminants, and considerations regarding constituent composition and strength.”

Concluding “USP is committed to working with stakeholders to determine the advisability and feasibility of developing public quality standards for medical cannabis. USP welcomes comments on the issues and ideas presented in this Stimuli article and on all aspects of developing such standards, including scientific and public health considerations, legal and regulatory issues, and mechanisms for obtaining appropriate scientific expertise and ongoing stakeholder input.”

USP recognizing medical cannabis would help change DEA scheduling of Cannabis.  For more information and link to the Article they published follow here – LINK

The USP recently filed an application with the DEA to deal with Cannabis a schedule I substance.