Schedules of Controlled Substances: Temporary Placement of O-Desmethyltramadol in Schedule I

What it does

• •Temporarily places O-desmethyltramadol (O-DSMT), a mu-opioid agonist and metabolite of tramadol, in Schedule I of the Controlled Substances Act effective August 12, 2026.
• •Applies all Schedule I regulatory controls and criminal, civil, and administrative sanctions to persons who manufacture, distribute, import, export, research, or possess O-DSMT and its isomers, esters, ethers, and salts.
• •Imposes the temporary scheduling order for two years, until August 12, 2028, unless extended or made permanent through future Federal Register notice.

Why it matters

• •The DEA determined temporary scheduling was necessary to avoid an imminent hazard to public safety based on O-DSMT's high abuse potential, documented overdoses and deaths, clandestine production, emergence in the designer drug market, and lack of approved medical use in the United States.
• •O-DSMT has significantly higher affinity for opioid receptors and greater potency than its parent compound tramadol, creating a substantial public health concern despite limited safety and toxicological data.

Who is affected

• •Persons and entities that manufacture, distribute, import, export, possess, or conduct research or instructional activities with O-DSMT and related chemical forms.
• •The drug enforcement and pharmaceutical regulatory systems, as HHS (FDA) confirmed no investigational or approved new drug applications exist for O-DSMT.

What happens next

The temporary scheduling order is effective immediately and remains in place for two years; DEA may extend or make the scheduling permanent, which would be published in the Federal Register.