Drug Enforcement Administration April 2021 – Federal Register Recent Federal Regulation Documents

In this rule, the Drug Enforcement Administration places 10 specified fentanyl-related substances permanently in schedule I of the Controlled Substances Act. These 10 specific substances all fall within the definition of fentanyl-related substances set forth in a February 6, 2018, temporary scheduling order. Through the Temporary Reauthorization and Study of the Emergency Scheduling of Fentanyl Analogues Act, which became law on February 6, 2020, Congress extended the temporary control of fentanyl-related substances until May 6, 2021. The regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess), or propose to handle any of these 10 specified fentanyl-related substances will continue to be applicable permanently as a result of this action.

Rhodes Technologies has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.

Cardinal Health has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.

The applications for exempt chemical preparations received by the Drug Enforcement Administration (DEA) between July 1, 2018, and December 31, 2020, as listed below, were accepted for filing and have been approved or denied as indicated.

Research Triangle Institute 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.

Scottsdale Research Institute has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.

With the issuance of this final rule, the Acting Administrator of the Drug Enforcement Administration removes samidorphan (3- carboxamido-4-hydroxy naltrexone) and its salts from the schedules of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. Prior to the effective date of this rule, samidorphan was a schedule II controlled substance because it can be derived from opium alkaloids. This action removes the regulatory controls and administrative, civil, and criminal sanctions applicable to controlled substances, including those specific to schedule II controlled substances, on persons who handle (manufacture, distribute, reverse distribute, dispense, conduct research, import, export, or conduct chemical analysis) or propose to handle samidorphan.

Royal Emerald Pharmaceuticals Research and Development DBA: Royal Emerald Pharmaceuticals has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.

Sharp Clinical Services, Inc., has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.