Drug Enforcement Administration April 19, 2021 – Federal Register Recent Federal Regulation Documents

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.