Schedules of Controlled Substances: Placement of Zuranolone in Schedule IV

Document 2024-18087 is a Final Rule published by the Department of Justice in the Federal Register on August 14, 2024, with an effective date of September 13, 2024. This final rule adopts, without change, an interim final rule with request for comments published in the Federal Register on October 31, 2023, placing zuranolone (chemically known as 1-[2- [(3R,5R,8R,9R,10S,13S,14S,17S)-3-hydroxy-3,13-dimethyl- 2,4,5,6,7,8,9,10,11,12,14,15,16,17-tetradecahydro-1H- cyclopenta[a]phenanthren-17-yl]-2-oxoethyl]pyrazole-4-carbonitrile) and its salts in schedule IV of the Controlled Substances Act. With the issuance of this final rule, the Drug Enforcement Administration maintains zuranolone, including its salts, in schedule IV of the Controlled Substances Act. View the original at https://www.federalregister.gov/documents/2024/08/14/2024-18087/schedules-of-controlled-substances-placement-of-zuranolone-in-schedule-iv.

No. Document 2024-18087 is not classified as economically significant under Executive Order 12866. Economically significant rules require OIRA review and are estimated to have impacts of $100 million or more per year.