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Import Controls Imposed on Solriamfetol

The U.S. Drug Enforcement Administration has issued a final rule that effective 7 January permanently places solriamfetol (2-amino-3-phenylpropyl carbamate), including its salts, isomers and salts of isomers whenever their existence is possible, into schedule IV of the Controlled Substances Act.

This substance was previously temporarily placed in schedule IV; as a result, this rule continues on a permanent basis the regulatory controls and administrative, civil and criminal sanctions applicable to schedule IV controlled substances on persons who import, export, manufacture, distribute, reverse distribute, dispense, possess or engage in research, instructional activities or chemical analysis with respect to this substance. These include the following:

  • all importation and exportation of these substances must continue to be in compliance with 21 USC 952, 953, 957 and 958 and in accordance with 21 CFR part 1312;
  • any activity involving this substance that is not authorised by, or is in violation of, the Controlled Substances Act or its implementing regulations continues to be unlawful and may subject the person to administrative, civil or criminal sanctions;
  • any person who handles or desires to handle this substance must be registered with the DEA to conduct such activities; and
  • all labels, labelling and packaging for commercial containers of this substance must comply with 21 USC 825 and 958(e) and be in accordance with 21 CFR part 1302.
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