DEA Temporarily Places O-Desmethyltramadol (O-DSMT) in Schedule I of the Controlled Substances Act

What this means for your practice

This temporary scheduling action by the DEA carries critical implications for all healthcare businesses, including telehealth providers, medspas, dental practices, and chiropractic offices. As O-DSMT is now a Schedule I controlled substance, it is deemed to have no currently accepted medical use in treatment in the United States and a high potential for abuse. This means that manufacturing, distributing, dispensing, prescribing, or possessing O-DSMT, even for purported medical purposes, is strictly prohibited and subject to severe administrative, civil, and criminal penalties under federal law.

Providers must ensure that no medications or substances they handle or prescribe, directly or indirectly, contain O-DSMT. This includes vigilance against illicit substances that may be misrepresented. While O-DSMT is not an FDA-approved drug, its status as a mu-opioid agonist and its potential for abuse mean that healthcare entities, particularly those operating in pain management or prescribing any controlled substances, must be acutely aware of this classification. Any involvement with this substance could lead to significant legal repercussions, including loss of licensure, hefty fines, and imprisonment. Compliance programs should be updated to reflect this new scheduling, and staff should be educated on the prohibition of O-DSMT to mitigate risk.

Washington, D.C. — The Drug Enforcement Administration (DEA) has announced a temporary order to place O-desmethyltramadol (O-DSMT), a substance known for its mu-opioid agonist properties and abuse potential, into Schedule I of the Controlled Substances Act (CSA). This decisive action underscores the DEA's commitment to public safety by addressing substances that pose an imminent hazard.

The Temporary Scheduling Order

Effective August 12, 2026, the DEA's temporary order will classify O-DSMT, including its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, as a Schedule I controlled substance. This temporary scheduling is set to remain in effect until August 12, 2028. The DEA has indicated that should this order be extended or made permanent, a subsequent document will be published in the Federal Register.

The agency's rationale for this action is rooted in its finding that the immediate control of O-DSMT is necessary to avert an imminent hazard to public safety. As a direct consequence of this classification, individuals and entities that engage in any activities involving O-DSMT—including manufacturing, distributing, reverse distributing, importing, exporting, research, instructional activities, chemical analysis, or possession—will be subject to the full spectrum of regulatory controls and administrative, civil, and criminal sanctions applicable to all Schedule I controlled substances.

Legal Authority and Process

The authority for this temporary scheduling is granted to the Attorney General, and subsequently delegated to the Administrator of the DEA, by the CSA under 21 U.S.C. 811(h). This provision allows for the temporary placement of a substance in Schedule I for a period of two years if such action is deemed necessary to avoid an imminent hazard to public safety, without immediate regard for the full evaluation requirements typically mandated by 21 U.S.C. 811(b).

Furthermore, if formal proceedings to control a substance under 21 U.S.C. 811(a)(1) are initiated while it is under temporary control, the Attorney General has the discretion to extend the temporary scheduling for an additional year. A substance can be temporarily scheduled if it is not already listed in any other schedule under 21 U.S.C. 812, and if there are no existing exemptions or approvals for the substance under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355).

Consultation with Health and Human Services (HHS)

In accordance with legal requirements, the DEA Administrator is mandated to notify the Secretary of Health and Human Services (HHS) of an intent to temporarily schedule a substance. On May 27, 2025, the DEA transmitted the necessary notice regarding O-DSMT to the then-Acting Assistant Secretary for HHS.

HHS, following a review conducted by the Food and Drug Administration (FDA), responded on June 11, 2025. The review confirmed that there were no active Investigational New Drug Applications (INDs) or approved New Drug Applications (NDAs) for O-DSMT. Importantly, HHS communicated no objection to the DEA's temporary placement of O-DSMT in Schedule I of the CSA. The DEA duly considered these comments as required by 21 U.S.C. 811(h)(4) prior to issuing its order.

Basis for Imminent Hazard Finding

To determine that temporary placement in Schedule I is necessary to avoid an imminent hazard to public safety, the DEA Administrator must consider specific factors outlined in 21 U.S.C. 811(c). These include:

• The substance's history and current pattern of abuse: This involves examining how the substance has been misused and its prevalence.
• The scope, duration, and significance of abuse: Assessing the extent and impact of the substance's abuse on the population.
• The risk to public health: Evaluating any potential harms or dangers posed by the substance to the general public.

Consideration of these factors incorporates any available information indicative of actual abuse, diversion from legitimate channels, and clandestine importation, manufacture, or distribution of O-DSMT.

Characteristics of Schedule I Substances

Substances classified under Schedule I of the CSA are legally defined by three key characteristics:

1. High potential for abuse: The substance carries a significant risk of misuse and addiction. 2. No currently accepted medical use in treatment in the United States: There is no recognized legitimate medical application for the substance in clinical practice within the U.S. 3. Lack of accepted safety for use of the drug under medical supervision: The substance's safety profile is not established or deemed acceptable for use even under strict medical oversight.

O-DSMT fits these criteria, having been identified as a mu-opioid agonist that is actively being abused for its psychoactive effects. It is also noted as a metabolite of the parent compound tramadol.

Public Notification

In compliance with 21 U.S.C. 811(h)(1)(A), the DEA published a notice of intent (NOI) to temporarily schedule O-DSMT in the Federal Register on June 24, 2026. This NOI detailed the findings from DEA's Three-factor analysis, which was completed in May 2026 and made accessible to the public on www.regulations.gov.

Key Facts

| Detail | Value | |---|---| | Agency | Drug Enforcement Administration (DEA), Department of Justice | | Action | Temporary amendment; temporary scheduling order | | Substance | O-desmethyltramadol (O-DSMT), including its isomers, esters, ethers, salts | | Scheduling Status | Temporarily placed in Schedule I of the Controlled Substances Act | | Effective Date | August 12, 2026 | | Expiration Date | August 12, 2028 (unless extended or made permanent) | | Basis for Action | Finding that placement in Schedule I is necessary to avoid an imminent hazard to public safety |

Frequently Asked Questions

What substance is affected by this DEA order?

This DEA order affects O-desmethyltramadol, also known as O-DSMT, desmetramadol, or 3-[(1R,2R)-2-[(dimethylamino)methyl]-1-hydroxycyclohexyl]phenol, including its isomers, esters, ethers, and salts.

What does it mean for O-DSMT to be placed in Schedule I?

Placing O-DSMT in Schedule I means it is considered to have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision.

When is this temporary scheduling order effective?

This temporary scheduling order is effective from August 12, 2026, until August 12, 2028.

Can healthcare providers legally handle O-DSMT during this temporary scheduling?

No, during this temporary scheduling, persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess) O-DSMT will be subject to the regulatory controls and administrative, civil, and criminal sanctions applicable to Schedule I controlled substances.

Why did the DEA temporarily schedule O-DSMT?

The DEA temporarily scheduled O-DSMT based on a finding that placing it in Schedule I is necessary to avoid an imminent hazard to public safety, considering factors such as its history and pattern of abuse, the scope and significance of abuse, and the risk to public health.

Source: DEA — Rule: Schedules of Controlled Substances: Temporary Placement of O-Desmethyltramadol in Schedule I · 2026-08-12