DEA Maintains Temporary Schedule I Placement for MGM-15 and MGM-16, Clarifies Status Apart from Mitragynine Pseudoindoxyl
Last updated 2026-10-14 · Source: DEA
Primary source: DEA: DEA Maintains Temporary Schedule I Placement for MGM-15 and MGM-16, Clarifies Status Apart from Mitragynine Pseudoindoxyl
The Drug Enforcement Administration (DEA) has issued a notice of intent to publish a new temporary order that will maintain the Schedule I status of two 7-hydroxymitragynine-related substances, MGM-15 and MGM-16. This action reaffirms their classification under the Controlled Substances Act, continuing the regulatory controls that have been in effect since August 26, 2026. The notice specifically distinguishes these substances from mitragynine pseudoindoxyl, addressing procedural clarity following a letter from the Department of Health and Human Services.
What this means for your practice
For healthcare businesses, including telehealth providers, medspas, dental practices, and chiropractic offices, this DEA action reinforces the critical importance of strict adherence to controlled substance regulations. While MGM-15 and MGM-16 may not be commonly prescribed or handled in many traditional clinical settings, any engagement with or research into novel compounds, particularly those related to psychoactive substances, demands extreme caution. The placement of a substance in Schedule I signifies that it has a high potential for abuse and no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. This classification means that handling, manufacturing, distributing, or prescribing these substances (or substances containing them) without proper DEA registration and compliance is subject to severe administrative, civil, and criminal sanctions. Practices must ensure their internal policies and practitioner training include robust screening for all substances to prevent any inadvertent involvement with scheduled compounds, especially as new substances are continually being identified and controlled. Remaining informed about the DEA's dynamic scheduling processes is crucial for maintaining compliance and mitigating regulatory risk.
WASHINGTON, D.C. — The Drug Enforcement Administration (DEA) has issued a notice of intent to publish a new temporary order concerning two 7-hydroxymitragynine-related substances, MGM-15 and MGM-16. This action is primarily procedural, serving to maintain the existing Schedule I status of these compounds and clarify their regulatory standing apart from a related substance, mitragynine pseudoindoxyl.
Background of the Temporary Scheduling Action
On August 26, 2026, the DEA had already published a temporary order placing mitragynine pseudoindoxyl, MGM-15, and MGM-16 in Schedule I of the Controlled Substances Act (CSA). The current notice, published October 14, 2026, specifically addresses MGM-15 and MGM-16. Its purpose is to publish a *new* temporary order that will continue their Schedule I placement without change. This ensures the ongoing application of stringent regulatory controls and associated sanctions for anyone handling these substances.
According to the DEA, this notice of intent for MGM-15 and MGM-16 is being issued for a
Key Facts
| Detail | Value |
|---|---|
| Agency | Drug Enforcement Administration (DEA) |
| Regulation Type | Proposed amendment; notice of intent (for temporary order) |
| Substances Concerned | MGM-15 (dihydro-7-hydroxymitragynine) and MGM-16 (9-fluoro-dihydro-7-hydroxymitragynine), including their isomers, esters, ethers, salts, etc. |
| Current Status | Temporarily placed in Schedule I of the CSA since August 26, 2026. New notice of intent aims to maintain this placement. |
| Effective Date of Notice | October 14, 2026 |
| New Temporary Order Publication | On or after November 13, 2026 |
Frequently Asked Questions
What are MGM-15 and MGM-16, and what is their current regulatory status?
MGM-15 (dihydro-7-hydroxymitragynine) and MGM-16 (9-fluoro-dihydro-7-hydroxymitragynine) are 7-hydroxymitragynine-related substances. They have been temporarily placed in Schedule I of the Controlled Substances Act (CSA) since August 26, 2026.
Why is the DEA issuing this new notice of intent if these substances are already scheduled?
The DEA is issuing this new notice of intent to publish a *new* temporary order for MGM-15 and MGM-16 to maintain their temporary Schedule I placement without change. This is for the technical and procedural purpose of distinguishing them from mitragynine pseudoindoxyl, following a letter from HHS that related only to mitragynine pseudoindoxyl.
What does being in Schedule I mean for these substances?
Placement in Schedule I means that these substances are subject to the most stringent regulatory controls and administrative, civil, and criminal sanctions under the CSA. These controls apply to persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess) or propose to handle them.
Will the temporary scheduling order for MGM-15 and MGM-16 ever expire?
The CSA provides the Attorney General with authority to temporarily place a substance in Schedule I for two years. If proceedings to permanently control a substance are initiated while it is temporarily controlled, the temporary scheduling can be extended for up to one year.
Did the Department of Health and Human Services (HHS) recommend controlling MGM-15 or MGM-16?
No, a letter from HHS dated October 6, 2026, related only to mitragynine pseudoindoxyl and did not recommend controlling MGM-15 or MGM-16. Therefore, the HHS letter has no impact on the DEA's control of these specific substances.
Source: DEA — Proposed Rule: Schedules of Controlled Substances: Temporary Placement of MGM-15 and MGM-16 in Schedule I · 2026-10-14