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Schedules of Controlled Substance: Temporary Placement of 7-Hydroxymitragynine Above a Specified Threshold in Schedule I

Detected July 16, 2026 · in Pharmaceutical Manufacturing (FDA/DEA)

DEA proposes temporary Schedule I placement for 7-hydroxymitragynine above a threshold, impacting manufacturers, distributors, and compounders handling this substance.

Aforeworn detected this change in the Pharmaceutical Manufacturing (FDA/DEA) space on July 16, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated High urgency. Branded drug makers, generic/ANDA manufacturers, API & contract manufacturers, compounding outsourcing (503B) that produce, distribute, or compound products containing 7-hydroxymitragynine above the specified threshold. should confirm how it applies to their specific situation before acting. There is a time constraint attached: Effective date upon publication in Federal Register (typically 30 days after publication); comments due within 60 days of publication.. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Pharmaceutical Manufacturing (FDA/DEA) continuously and turns every detected change into a plain-English briefing like this one, so you always know first. Forewarned is forearmed.

What changed

7-hydroxymitragynine above a specified threshold will be temporarily placed in Schedule I, making it illegal to manufacture, distribute, or possess without DEA registration.

Who it affects

Branded drug makers, generic/ANDA manufacturers, API & contract manufacturers, compounding outsourcing (503B) that produce, distribute, or compound products containing 7-hydroxymitragynine above the specified threshold.

What you must do

Identify any products or ingredients containing 7-hydroxymitragynine above the threshold; cease all activities unless registered with DEA for Schedule I; submit comments or objections before the effective date.

Deadline

Effective date upon publication in Federal Register (typically 30 days after publication); comments due within 60 days of publication.

Source: https://www.federalregister.gov/documents/2026/07/06/2026-13580/schedules-of-controlled-substance-temporary-placement-of-7-hydroxymitragynine-above-a-specified

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