Marijuana is less dangerous than some substances in other schedules, but it will stay in Schedule I for now, DEA said Thursday. The agency also said that it supports marijuana research, is developing an online application system to apply for Schedule I research registrations, and will allow more manufacturers to grow marijuana for research.
The Continued Evolution of DEA’s Due Diligence Requirements
On May 11, 2016, the Drug Enforcement Administration filed its brief in Masters Pharmaceutical, Inc. v. Drug Enforcement Administration (Docket No: 15-1335), in the United States Court of Appeals for the District of Columbia. The vast majority of the Government’s brief addresses whether “substantial evidence” (the applicable standard of review) supports Acting Administrator Rosenberg’s decision to revoke Masters’ DEA registration. Curiously, the Government does not dedicate much effort to one of the seminal issues in the case: whether DEA imposed new obligations on registrants in violation of the Administrative Procedure Act.
Rather than attempt to defend the indefensible, the Government invoked a creative reading of the Masters Final Order that is starkly at odds with Administrator Rosenberg’s decision. In its brief, DEA states that Administrator Rosenberg’s decision “did not impose any new duties on distributors.” In defending this position, the Government’s brief goes on to say the following:
Most of the “new duties” that Masters and amici cite in their briefs were obligations that Masters had voluntarily imposed on itself through its own compliance program. [citation omitted] The Administrator cited Masters’ failure to perform many of these duties – such as obtaining utilization reports or asking customers for explanations of unusually large orders – because Masters sought to rely on its compliance program to justify its reporting failures. However, in highlighting Masters’ disregard for its own program’s requirements, the Administrator did not impose those same requirements on all registered distributors.
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DEA Administrator Overrules ALJ, Revokes Distributor Registration in Sweeping Decision
The Chronicles welcomes guest blogger Katea Ravega, a Q&B Health Law attorney.
In a 308-page decision dated September 8, 2015, the new Acting Administrator of the DEA, Chuck Rosenberg, issued an Order revoking the DEA registration of wholesale distributor Masters Pharmaceuticals, Inc. (“Masters”). In doing so, the Administrator rejected the recommendation from DEA’s…
DEA to Continue Take Back Programs
On September 23, 2014, DEA announced that its ninth Take Back Day would be the agency’s last. The announcement was made shortly after DEA published the Final Rule implementing the Secure and Responsible Drug Disposal Act of 2010. The regulations promulgated by DEA allow “authorized collectors” the opportunity to receive and securely dispose of prescription…