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DEA revises temporary scheduling intent for 7-hydroxymitragynine and pseudoindoxyl

DEA’s October14 notice proposes revised threshold-based ScheduleI controls for 7-hydroxymitragynine and mitragynine pseudoindoxyl. A later temporary order, announced for on or after November13, is required. The existing pseudoindoxyl order continues; below-threshold status is not a safety finding.

What happened

DEA published an October 14 notice of intent, signed October 8, to temporarily place 7-hydroxymitragynine and mitragynine pseudoindoxyl above revised thresholds in Schedule I. It follows an October 8 HHS recommendation and replaces the earlier 7-hydroxymitragynine scheduling intent through a separate withdrawal notice. DEA states that a temporary order will be published on or after November 13. This notice is the advance step, not the later order that would impose the revised controls, and November 13 is not an automatic effective date.

The proposed threshold is met when either substance alone, or their combined amount if both are present, exceeds 1 milligram per gram in solid forms or 1 milligram per milliliter in liquids, or when the mass of mitragynine divided by the mass of the relevant substance or their combined amount is less than 100. The strict greater-than and less-than conditions matter. The August 26 temporary order placing mitragynine pseudoindoxyl in Schedule I without a threshold remains effective until it expires or a replacement order is published and the prior order withdrawn, whichever occurs first. DEA expressly cautions that the threshold is not a finding that below-threshold products are safe. The notice describes eventual Schedule I controls for covered handling, research and possession when the new order takes effect.

Scope and timing

Authority status
Proposed
Applicability
Potentially applicable
Audience
Health systems, Provider networks, Health-tech
Jurisdiction
Federal
Responsible owner
Compliance

Why it matters

Pharmacy, research and substance-use teams may encounter products with different concentration and composition claims. A proposed threshold cannot be used to treat an already controlled substance as unregulated or to equate a below-threshold product with an approved or safe treatment.

Implementation playbook

  1. Recommended internal target: inventory potentially affected materials and identify actual substance and concentration evidence. Clinical Operations · Due 2026-10-30
  2. Recommended internal target: review existing controls and assign monitoring for the later temporary order, without assuming automatic November13 effectiveness. Legal · Due 2026-11-06

Sources

Complete edition and supplemental material

This finding in the complete approved report →

Regulatory horizons, CIA trends and implementation trackers remain in the full report.

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