On August 12, 2016, the DEA published a policy in the federal register (81 Fed. Reg. 53846) designed to increase the number of entities registered under the CSA to grow marijuana to supply legitimate researchers in the United States. The DEA has concluded that the best way to satisfy the current researcher demand for a variety of strains of marijuana and cannabinoid extracts is to increase the number of federally authorized marijuana growers. While the new policy does not entirely make clear what entities may apply to become federally authorized marijuana growers, it seems that “commercial enterprises” may apply. Specifically, the policy states that “under the historical system, there was no clear legal pathway for commercial enterprises to produce marijuana for product development. In contrast, under the new approach… persons may become registered with DEA to grow marijuana not only to supply federally funded or other academic researchers, but also for strictly commercial endeavors funded by the private sector and aimed at drug product development.”

The DEA will evaluate each application to determine: (1) whether adding such applicant to the list of registered growers is necessary to provide an adequate and uninterrupted supply of marijuana to researchers in the United States; and (2) whether the proposed registration would be consistent with the public interest. Among the factors to be considered are whether the applicant has previous experience handling controlled substances in a lawful manner and whether the applicant has engaged in illegal activity involving controlled substances.

What does this mean?

Importantly, the DEA has concluded that in lieu of requiring the growers to operate under a contract with NIDA, a registered grower will be permitted to operate independently, provided the grower agrees (through a written memorandum of agreement with DEA) that it will only distribute marijuana with prior, written approval from DEA. This is still unproven and there is no certainty that the private sector will be able to take advantage of this.