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DEA Proceeds With Marijuana Grow Licensing Applications

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The Drug Enforcement Administration (DEA) is proposing to amend its regulations to comply with the requirements of the Controlled Substances Act, including consistency with treaty obligations, in order to facilitate the cultivation of "marihuana" for research and other licit purposes, according to the Federal Register.

"Specifically, this proposed rule would amend the provisions of the regulations governing applications by persons seeking to become registered with DEA to grow 'marihuana' as bulk manufacturers and add provisions related to the purchase and sale of this 'marihuana' by DEA."

DEA is starting the 303 investigation --the term the DEA uses for the formal investigations-- process to vet all 35 applicants.

MMJ Bio Pharma Cultivation, a medical cannabis research company, is one of the applicants to grow marijuana as bulk manufactures for cannabis research.

The company is developing an oral drug product from natural whole plant extract derivatives from the marijuana plant containing THC and CBD. MMJ will be utilizing its new product for an FDA-approved treatment for multiple sclerosis (MS) and Huntington's disease (HD).

Earlier this year, the DEA announced its plans to revise former President Obama's federal cannabis regulations, and in doing so would process applications for access to cannabis research. In order to obtain a federal license, applicants must adhere to very strict guidelines, including demonstrating a case for the public interest. One way to do this is to submit a filing to the FDA for the development of a pharmaceutical, and of the 35 applicants so far, only a few have filed for clinical trials with the FDA.

Universities and research institutes are the most likely candidates to obtain a federal growing license, yet MMJ Biopharma Cultivation claims it has met the strict guidelines set forth by the DEA for the product development and distribution to DEA-registered researchers.

According to Mr. Duane Boise, President of MMJ Biopharma Cultivation who has a pending bulk research application, "We meet the public interest requirement evidenced by our filings with the FDA, in our development of a cannabis-based drug to treat Multiple Sclerosis and Huntington's Disease. We have applied and awaiting approval for the DEA bulk manufacturing license to continue our development of an FDA-approved pharmaceutical.”

Aside from meeting the public interest requirement, Boise has another strategy: he plans to cultivate the crop on federally-protected Native American sovereign lands. The arrangement is mutually beneficial, as MMJ Biopharma Cultivation will end up employing several members of the tribe. The only approach so far that would be a viable opportunity to cultivate federally-approved cannabis would be the association with a university, but Boise CEO has apparently managed to circumvent it with his nascent approach.

The DEA amendments to the 2016 Obama policy statement supersede the current policy in place and govern applicants seeking to become registered. One of the key revisions of the policy includes moving away from a single grower system and registering additional growers.

The Department of Justice has also been involved in the process to "ensure that the marijuana growers’ program is consistent with applicable laws and treaties." The DEA first announced its intent to license private entities to grow Cannabis for FDA approved clinical trials in 2016. However, there was lingering progression by the DEA to approve access for medical grade cannabis delaying many researchers and private entities wanting to further their research for pharmaceutical grade medicines. The hold up is subsiding after a long waiting period from the DEA, and allows for MMJ Bio Pharma Cultivation to move forward with its goal to produce pure medical marijuana for patients facing pain and chronic illnesses.

Medical marijuana researcher Dr. Sue Sisley infamously sued the DEA in order for additional researchers to be allowed access to medical marijuana for research purposes.

Dr. Sue Sisley, heads the Scottsdale Research Institute in Arizona. She is seemingly frustrated by the University of Mississippi, inexplicably having the monopoly on federally-approved medical cannabis for research purposes. She believes the cannabis “Ole Miss” disseminates to other researchers is low-quality, which could detrimentally impact their research.