Schedules of Controlled Substances: Placement of Serdexmethylphenidate in Schedule IV

On March 2, 2021, the United States Food and Drug Administration approved a new drug application for AZSTARYS capsules for oral use, a combination drug product containing serdexmethylphenidate chloride and dexmethylphenidate hydrochloride, for the treatment of Attention Deficit Hyperactivity Disorder in patients six years of age or older. The Department of Health and Human Services provided the Drug Enforcement Administration with a scheduling recommendation to place serdexmethylphenidate and its salts in schedule IV of the Controlled Substances Act. In accordance with the Controlled Substances Act, as amended by the Improving Regulatory Transparency for New Medical Therapies Act, Drug Enforcement Administration is hereby issuing an interim final rule placing serdexmethylphenidate, including its salts, isomers, and salts of isomers, in schedule IV of the Controlled Substances Act, thereby facilitating the commercial distribution of AZSTARYS as a lawful controlled substance.