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.”


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.