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FDA + DEA·US·June 24, 2026HIGH

DEA issues notice of intent to temporarily place O-desmethyltramadol in Schedule I of the Controlled Substances Act

Risk profileHIGH — The forthcoming temporary order imposes Schedule I criminal and civil sanctions on all handlers of O-DSMT across the regulated population, requiring immediate registration, inventory, and supply-chain review by any firm or institution currently working with the substance or its derivatives.

The DEA published a notice of intent on June 24, 2026 to place O-desmethyltramadol (O-DSMT) in Schedule I on a temporary basis. The forthcoming order imposes full Schedule I controls and criminal, civil, and administrative sanctions on all persons who handle the substance.

Signals

Full Schedule I Control Regime Incoming.Once the temporary order issues, every handler of O-DSMT, including manufacturers, distributors, importers, exporters, researchers, and possessors, becomes subject to the complete Schedule I regulatory framework. No grandfather period is indicated in the notice of intent.
Broad Substance Definition Captures Derivatives.The scheduling action covers O-DSMT's isomers, esters, ethers, salts, and salts of isomers, esters, and ethers. Firms handling any chemically related form of the substance must assess whether their inventory falls within the defined scope before the order issues.
Research and Analytical Use Requires DEA Authorization.Instructional activities and chemical analysis with O-DSMT are explicitly listed as regulated conduct. Academic institutions, contract research organizations, and analytical laboratories currently working with the substance must obtain Schedule I researcher registration before the order takes effect.
Criminal Sanctions Attach Upon Order Issuance.The notice confirms that criminal sanctions applicable to Schedule I substances will apply to handlers upon issuance of the temporary order. Distributors and suppliers in the gray-market novel psychoactive substance space face immediate exposure at that point.

Bottom lineThe notice of intent initiates the formal process under which O-DSMT becomes a Schedule I controlled substance. Upon issuance of the temporary order, all manufacture, distribution, import, export, research, and possession of O-DSMT without DEA Schedule I authorization becomes subject to criminal, civil, and administrative sanctions. Firms and institutions currently handling O-DSMT in any form, including its salts and isomers, carry an immediate obligation to assess their registration status and supply-chain exposure before the order issues.

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HIGH

EMA CHMP recommends EU marketing authorisation revocation for Tavneos following GCP breach finding in pivotal trial

The EMA's Committee for Medicinal Products for Human Use recommended on June 27, 2026 that the EU marketing authorisation for Tavneos (avacopan) be revoked.

European Medicines Agency · EU/UK

HIGH

TGA activates mandatory Unique Device Identification requirements for specified medical devices effective 1 July 2026

Australia's Therapeutic Goods Administration published a notice on 30 June 2026 confirming that mandatory Unique Device Identification requirements for specified medical devices take effect 1 July 2026.

Therapeutic Goods Administration · APAC

HIGH

FDA issues CGMP warning letter to Genzyme Ireland Limited citing biologics manufacturing deviations

The FDA issued a warning letter dated June 22, 2026 to Genzyme Ireland Limited citing current good manufacturing practice violations and deviations under the firm's Biologics License Application.

FDA CBER · US

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