So who qualifies?
ST. PETERSBURG, FL / ACCESSWIRE / September 24, 2019 / To obtain a federal license, applicants must meet additional stringent guidelines, including demonstrating a case for the public interest, such as FDA fillings for the development of a pharmaceutical. Among the 33 current applicants, only two companies have filed for clinical trials with the FDA. Other than Universities and Research institutes, Duane Boise, CEO of MMJ Biopharma Cultivation, based in Florida, believes he has a fairly decent shot at obtaining a federal license to cultivate medical marijuana.
“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 for the DEA bulk manufacturing license to continue our development of an FDA-approved pharmaceutical,” says Boise.
The feather in Boise’s cap is that he plans to cultivate on federally-protected Native American sovereign lands. A mutually beneficial arrangement, it serves the interest of the tribe, many of whom will be employed by MMJ Biopharma’s endeavor.
The partnership with a Native American tribe is a carefully strategic maneuver on Boise’s part. His nascent approach is a far cry from needing to be associated with a university – which is the only viable opportunity for cultivating federally-approved cannabis thus far.
The application process:
According to the application issued by the DEA and obtained exclusively by Sara Brittany Somerset, for Forbes Online, the 21 pages long, 92 questionnaire process is not for the faint of heart or easily discouraged. One can almost hear the clicking of keyboards and grinding of gears as legions of attorneys begin to unpack this daunting, bureaucratic document. Many of the more mundane questions relate to logistics, such as the applicant’s proposed air filtrations systems, experience with certain chemicals, and security protocols.
Luckily for Boise, the Native American tribe has its police force.
Within the next 30 days, the DEA is expected to release their amendments to the 2016 Obama policy statement. The new guidelines will supersede the current Obama policy in place and govern applicants seeking to become registered.
The 2016 policy statement provided information on how it intended to expand the number of registrations and described in general terms the way it would oversee those additional growers. Therein, DEA recognized the need to move past the single grower system and register additional growers.
Moreover, since the publication of the 2016 policy statement, “the Department of Justice, in consultation with other federal agencies, has been engaged in a policy review process to ensure that the marijuana growers program is consistent with applicable laws and treaties.”
One such treaty, the 1961 Single Convention on Narcotic Drugs, while wholly ignored by Uruguay and Canada in their cannabis legalization process, does not apply to the Native American tribe.
According to the DEA’s document, that review process remains ongoing; however, it has progressed to the point where the DEA can issue a notice of applications. Throughout the policy review process, the Department of Justice (DOJ) has also determined that adjustments to the DEA’s policies and practices related to the marijuana growers’ program may be necessary.
Currently, out of the 33 registered applicants, several are already disqualified. Time will tell which, if any, applicants are approved.
SOURCE: MMJ BioPharma Cultivation
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