DEA to Allow More Manufacturers of Cannabis

On Friday Aug 12, 2016 the DEA will announce that it is going to increase the number of legal manufacturers of Cannabis.  - Federal Register - or here 2016-17955

In response to increased need for Medical Grade Cannabis the DEA is set to allow others to manufacture medical grade cannabis.  In a release to the Federal Register set for Friday the DEA will announce the following:

“To facilitate research involving marijuana and its chemical constituents, DEA is adopting a new policy that is designed to increase the number of entities registered under the Controlled Substances Act (CSA) to grow (manufacture) marijuana to supply legitimate researchers in the United States.”

While giving positive reasons for allowing more manufacture of cannabis “There is growing public interest in exploring the possibility that marijuana or its chemical constituents may be used as potential treatments for certain medical conditions.” it continues with the following “no drug product made from marijuana has yet been shown to be safe and effective in such clinical trials”.  Makes one wonder why some forms of Cannabinoids are in Schedule III and also unscheduled according to Sigma-Aldrich (a company that makes and distributes all of the various cannabinoid analogs so far known).

Giving more we are happy to help comments like “one of the ways DEA can help to facilitate research involving marijuana is to take steps, within the framework of the CSA and U.S. treaty obligations, to increase the lawful supply of marijuana available to researchers.”

DEA States that it had relied on a single supplier to supply only Federal Funded studies on Cannabis.  However “under the new approach explained in this policy statement, 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. Likewise, under the new approach, should the state of scientific knowledge advance in the future such that a marijuana-derived drug is shown to be safe and effective for medical use, pharmaceutical firms will have a legal means of producing such drugs in the United States—independent of the NIDA contract process.”

So how will they do this?  Well they explain it out like this:

“DEA is obligated to register only the number of bulk manufacturers of a given schedule I or II controlled substance that is necessary to “produce an adequate and uninterrupted supply of these substances under adequately competitive conditions for legitimate medical, scientific, research, and industrial purposes.”  So how many bulk manufacturers are needed? it doesn’t specify leaving open the door that the single producer can make as much as is necessary.

“DEA will evaluate each application it receives to determine whether adding such applicant to the list of registered growers is necessary to provide an adequate and uninterrupted supply of marijuana (including extracts and other derivatives thereof) to researchers in the United States.”

Unfortunately the next section just about eliminates all those that have a great deal of experience with the plant DEA states  “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. In this context, illegal activity includes any activity in violation of the CSA (regardless of whether such activity is permissible under State law) as well as activity in violation of State or local law.”

Applicants will be subject to abnormally high scrutinty “applicants will be asked to provide a written explanation of how they believe they would be able to augment the nation’s supply of research-grade marijuana within the meaning of subsection 823(a)(1). Applicants may be asked to provide additional written support for their application and other information that DEA deems relevant in evaluating the application under section 823(a).”

In order to comply with International Treaty DEA is changing it’s model from NIDA owned Cannabis to Cannabis not owned by NIDA “DEA believes it would be consistent with the purposes of articles 23 and 28 of the Single Convention for DEA to register marijuana growers outside of the NIDA-contract system to supply researchers, provided the growers agree that they may only distribute marijuana with prior, written approval from DEA.  In other words, 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.”

How does one apply?  “Persons interested in applying for a registration to become a bulk manufacturer of marijuana to supply legitimate researchers can find instructions and the application form by going to the DEA Office of Diversion Control website registration page at www.deadiversion.usdoj.gov/drugreg/index.html#regapps. Applicants will need to submit Form 225.”

Finally a note of This MIGHT BE the way we do things at the DEA they add “While this document reflects how DEA intends to implement the relevant statutory and regulatory provisions, it does not establish a rule that is binding on any member of the public.”