After seven long years, a Memorandum Of Agreement with the intent to issue a Schedule One cultivation registration (referred to by individual states as a vertical license) that is contingent upon further compliance was finally issued to a cannabis manufacturing company that sued the Drug Enforcement Agency (DEA) to obtain it.
MMJ Biopharma Cultivation (MMJBC), which plans to manufacture a cannabis-based pharmaceutical, was issued a Memorandum Of Agreement (MOA) by the DEA on Wednesday.
These licenses fall under strict DEA supervision and require stringent rules of operation.
For instance, regarding the reproduction of the bud (flower), the DEA rule stipulates that the licensee has to prove the chemical reproducibility of the bud to be able to either supply the National Institute on Drug Abuse (NIDA) for the National Institute of Health’s (NIH) drug supply program.
In the case of MMJBC, the company is manufacturing a 2B FDA-approved orphan drug to help alleviate the symptoms of Huntington’s Disease within very tight tolerances.
“I’m confident we’re the only company that can grow cannabis flower within the tight tolerances. The University of Mississippi grows outdoor cannabis. If you turn that cultivation from harvest to harvest, you will get a variance of between 10 and 30% of chemical substances in the bud itself. This cannot be replicated in large-scale indoor cultivation facilities, which are 3-400,000 ft². It is impossible even to try,” declared Boise.
When asked if, after several years, MMJBC ever gave up hope or considered restructuring, Boise buoyantly replied exclusively to Cannabis & Tech Today, “When treasure hunter Mel Fisher was looking for a lost shipwreck Atocha – which took him 14 years to find – he would wake up and say daily, ‘Today’s the day!’ After half the amount of years, today is the day. We finally have our MOA.”
The MOA outlines how the company intends to do business with the DEA once a couple of minor tweaks are made under the DEA’s guidelines when the final registration is issued.
MMJBC is performing clinical trials and using an in-house lab for analysis while growing strain-specific plant genetics under tightly controlled environmental conditions.
The cultivation facility includes infrared cameras to detect mold, air filters, and controlled fertigation to ward off any potential plant contaminants.
As Schedule One licenses are only awarded to cultivators that are affiliated with an academic institution for the intention of research and development, MMJBC partnered with the University of Connecticut to create a Center of Marijuana Excellence.
With the MOA issued and MMJBC on track to receive a vertically integrated Schedule One cannabis cultivation and manufacturing license, the company plans on dismissing its lawsuit against the DEA.
A representative from the DEA could not be reached for comment.