Proposed Rule 25 Jul 2025 compliance, regulatory, administrative practice and procedure, reporting and recordkeeping requirements, business impact, controlled substances, drug traffic control, drug enforcement, benzodiazepines

⚖️Proposed Rule for Scheduling Designer Benzodiazepines as Controlled Substances

The Drug Enforcement Administration proposes placing clonazolam, diclazepam, etizolam, flualprazolam, and flubromazolam and their salts, isomers, and salts of isomers, whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation, as identified in this proposed rule, in schedule I of the Controlled Substances Act. These five substances were temporarily scheduled in an order dated July 26, 2023, and subsequently extended until July 26, 2026, pursuant to an extension published elsewhere in this issue of the Federal Register. This action will also enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. If finalized, this action would make permanent the existing regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle these five specific controlled substances.

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Rule 25 Jul 2025 compliance, regulations, pharmaceuticals, controlled substances, drug enforcement administration, law, benzodiazepines

⚖️Extension of Temporary Scheduling for Designer Benzodiazepines

The Acting Administrator of the Drug Enforcement Administration (DEA) is issuing this temporary scheduling order to extend the temporary schedule I status of five designer benzodiazepines--clonazolam, diclazepam, etizolam, flualprazolam, and flubromazolam. In an order dated July 26, 2023, DEA temporarily placed these five substances in schedule I of the Controlled Substances Act. This temporary order will extend the temporary scheduling of five designer benzodiazepines for one year, or until the permanent scheduling action for these substances is completed, whichever occurs first. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances will continue to be imposed on 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 these five specified controlled substances.

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