DEA just issued a final rule decontrolling Samidorphan--a former Schedule II substance that DEA and FDA agree has no currently accepted medical use in treatment in the U.S. As I explained in a previous post discussing the notice of proposed rulemaking that preceded this final rule, this is a bit of a surprising move given that DEA has, for years, insisted that "Congress established only one schedule—schedule I—for drugs of abuse with 'no currently accepted medical use in treatment in the United States.'" E.g., 84 FR 20023-02 (DEA May 8, 2019).

Technically, there arguably is no contradiction in DEA's previous statements and its action with respect to Samidorphan. The explanation might go like this: If Samidorphan were to be scheduled, it would have to go to Schedule I; because it lacks abuse potential, however, it doesn't belong in any schedule.


DEA Decontrols Former Schedule II Substance With No Currently Accepted Medical Use
Share this