Critical

Schedules of Controlled Substances: Temporary Placement of Mitragynine Pseudoindoxyl, MGM-15, and MGM-16 in Schedule I

Detected August 24, 2026 · in Pharmaceutical Manufacturing (FDA/DEA)

DEA temporarily places mitragynine pseudoindoxyl, MGM-15, and MGM-16 in Schedule I, making them illegal to handle without DEA registration.

Aforeworn detected this change in the Pharmaceutical Manufacturing (FDA/DEA) space on August 24, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated Critical. All pharmaceutical manufacturers, API suppliers, contract manufacturers, and compounding outsourcing facilities that handle or intend to handle mitragynine pseudoindoxyl, MGM-15, or MGM-16. should confirm how it applies to their specific situation before acting. There is a time constraint attached: Effective immediately upon publication in the Federal Register (temporary scheduling is effective for up to two years, with possible extension).. 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

These substances are now temporarily listed as Schedule I controlled substances, imposing the highest level of regulatory control and prohibiting any unregistered activity.

Who it affects

All pharmaceutical manufacturers, API suppliers, contract manufacturers, and compounding outsourcing facilities that handle or intend to handle mitragynine pseudoindoxyl, MGM-15, or MGM-16.

What you must do

Immediately cease all manufacturing, distribution, or research involving these substances unless you hold a DEA Schedule I registration specifically authorizing such activity. If you have existing stock, contact DEA for disposal guidance.

Deadline

Effective immediately upon publication in the Federal Register (temporary scheduling is effective for up to two years, with possible extension).

Source: https://www.federalregister.gov/public-inspection/2026-17429/schedules-of-controlled-substances-temporary-placement-of-mitragynine-pseudoindoxyl-mgm-15-and

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