Synopsis of DEA Rescheduling Dronabinol

In late September, DEA proposed a new rule that would effectively place dronabinol (the active chemical in MARINOL) in Schedule III.

Wait a second, isn’t MARINOL already in Schedule III?

It is. When MARINOL was first marketed, it was placed in Schedule II. Once DEA was shown that it had a low potential for abuse, they agreed to place it in Schedule III. But the narrow language only places in Schedule III MARINOL’s specific formulation (synthetically derived dronabinol, suspended in sesame oil). All other formulations remain in Schedule I.

Now that the MARINOL patent is almost up, Professor ElSohly (yes, the same man who runs the only federally-approved marijuana growing facility) has a contract to supply would-be generic manufacturers of MARINOL. They petitioned DEA to re-schedule ALL formulations of dronabinol, whether or not the chemical is suspended in sesame oil, and whether or not the chemical is sourced from whole-plant marijuana. That’s right, folks! DEA may soon allow an FDA-approved medication to be derived from the marijuana plant.

In order to applaud this change in thinking, and to insist that the NIDA monopoly be lifted, MAPS submitted a public comment to the Federal Register about the proposed new rule. The focus of the comment is the issue of fairness; namely, it is absolutely ridiculous that DEA would re-schedule the active ingredient in MARINOL at the behest of a private producer for private profit, all the while refusing to approve Professor Craker’s bid to grow marijuana for non-profit, research purposes.

See a PDF of MAPS Public Comment on Docket No. DEA-308P; 72 Fed.Reg. 54226 (Technical Amendment to Listing in Schedule III of Approved Drug Products Containing Tetrahydrocannabinols).