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State board updates controlled‑substance schedules to match recent DEA, seeks exception for FDA‑approved psilocybin drug

2107498 · January 8, 2025
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Summary

The State Board of Pharmacy asked the Senate Judiciary Committee to update North Dakota's controlled‑substance schedules to reflect recent DEA actions, add several fentanyl analogues and synthetic compounds, and include a limited exception so an FDA‑approved psilocybin drug could be prescribed.

The North Dakota State Board of Pharmacy asked the Senate Judiciary Committee to update the state's controlled‑substance schedules to reflect recent federal scheduling actions and to add several newly identified fentanyl analogues, synthetic cannabinoids, substituted cathinones and other novel compounds.

Mark Hardy, executive director of the State Board of Pharmacy, told the committee Senate Bill 2064 would bring state law into alignment with federal DEA scheduling actions from the last two years and add a set of synthetic compounds that prosecutors and law‑enforcement labs have encountered. "Our intention in drafting these compounds...is to be as proactive as possible to ensure that we have chemical modifications that could be made to the core chemical structure of a compound," Hardy said, explaining that small chemical changes can let illicit producers evade controlled‑substance prohibitions.

Hardy walked the committee through schedule‑by‑schedule changes: additional opioid and fentanyl derivatives for Schedule 1; replacement and addition of synthetic cannabinoids; added substituted cathinones (stimulants); Schedule 3 additions related to anabolic steroids; and a Schedule 4 depressant (zuranolone) recently marketed for postpartum depression. Hardy also proposed a narrowly drafted exception so that a pharmaceutical composition known in federal trials as COMP‑360 (a psilocybin formulation being studied for treatment‑resistant depression) could be made available as an FDA‑approved medicine even though psilocybin remains listed in Schedule 1 more broadly.

"The reason for that language offered in this amendment is due to psilocybin as it currently stands would be a schedule 1 compound without this specific addition," Hardy said. He noted the board has used similar statutory language before for FDA‑approved cannabis derivatives (for example, Epidiolex).

The board asked that the bill be considered an emergency measure so scheduling changes would take effect quickly if enacted. Committee members asked clarifying questions about the psilocybin exception and placement in Schedule 4 if the FDA approves a specific pharmaceutical composition; Hardy confirmed the broader substance (psilocybin) would remain Schedule 1 while an FDA‑approved product could be scheduled differently.

No opposition testimony was recorded. After closing remarks, the committee approved the bill and designated Senator Castaneda to carry it.

The board said the bill is largely technical and reactive to DEA actions; it adds named chemical compounds and broader class‑definitions used by the DEA to prevent small chemical modifications from creating unscheduled analogues.