DEA’s New Draft Rules For Cannabis Medical Research
The DEA (Drug Enforcement Agency) released a new draft rule to create controls that will enhance the cultivation of cannabis for various research purposes in the U.S., which will amend its current regulations to comply with the long standing Controlled Substances Act (CSA) and bring about research that may result in the burgeoning development of cannabis-based medicines that could be approved by the Food and Drug Administration (FDA). If these position sinew adopted, this draft rule will replace the DEA’s old 2016 rule regarding applications to register under the CSA to manufacture cannabis for researchers in the U.S.
Under CSA rulings, cultivators of controlled substances have to register with the DEA to plant, cultivate, grow, or harvest cannabis as a means to supply lab researchers. In the draft rule, there are three types of manufacturers who may seek registration:
- Growers who manufacture cannabis for internal researcher.
- Growers who for DEA registrants like the National Institutes of Health (NIH)
- Growers who supply cannabis to support the NDA (National Institute on Drug Abuse) program.
The new rule would require all registrants to notify the DEA with details like their harvest date and total crop yield. This new rule also gives the DEA the right to wholesale trade, import, export, and maintain stock of their crop.
This new rule is key as it creates an endless supply of cannabis for medical research, as well as a variety of strains. In addition to the expansion of cultivators, the production of cannabis will increase to 3,200 kilograms. To date, the only medical cannabis product approved by the FDA is a compound referred to as Epidiolex. A neutered form of CBD prescribed to treat seizures associated with the diseases Lennox-Gastaut syndrome and Dravet syndrome.
Institutions in California and Mississippi are advancing the science and research of medical cannabis by studying the benefits of various tinctures, the treatment of various autistic children, varying levels of neuropathic pain, multiple sclerosis patients, and other pain-related conditions.
Remarks on this draft rule are due by May 22, 2020. Growers, cultivators, and other interested parties must review the draft rule and submit comments to the DEA before the aforementioned date.
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