Following 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”
It’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.