Drug Enforcement Administration July 2023 – Federal Register Recent Federal Regulation Documents

The Administrator of the Drug Enforcement Administration is issuing this temporary order to schedule five synthetic benzodiazepine substances: etizolam, flualprazolam, clonazolam, flubromazolam, and diclazepam, in schedule I of the Controlled Substances Act. This action is based on a finding by the Administrator that the placement of these five substances in schedule I is necessary to avoid imminent hazard to the public safety. As a result of this order, the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances will 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.

On July 22, 2016, the Comprehensive Addiction and Recovery Act of 2016 became law. One provision of the Comprehensive Addiction and Recovery Act of 2016 amended the Controlled Substances Act to allow for the partial filling of prescriptions for schedule II controlled substances under certain conditions. The Drug Enforcement Administration (DEA) is amending its regulations to conform to this statutory provision, as well as to provide direction on gaps not addressed by legislation. DEA will also be amending its regulations to update a cross-reference in a paragraph that will be redesignated with this final rule.

Biopharmaceutical Research Company has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.

Aurobindo Pharma USA, Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.