{"abstract":"On August 4, 2023, the United States Food and Drug Administration approved a new drug application for ZURZUVAE (zuranolone) capsules for the treatment of post-partum depression. The Department of Health and Human Services provided the Drug Enforcement Administration (DEA) with a scheduling recommendation to place zuranolone and its salts in schedule IV of the Controlled Substances Act (CSA). In accordance with the CSA, as amended by the Improving Regulatory Transparency for New Medical Therapies Act, DEA is hereby issuing an interim final rule placing zuranolone, including its salts, in schedule IV of the CSA. This action facilitates the public availability of zuranolone as a schedule IV controlled substance.","action":"Interim final rule; request for comments.","agencies":[{"raw_name":"DEPARTMENT OF JUSTICE","name":"Justice Department","id":268,"url":"https://www.federalregister.gov/agencies/justice-department","json_url":"https://www.federalregister.gov/api/v1/agencies/268","parent_id":null,"slug":"justice-department"},{"raw_name":"Drug Enforcement Administration","name":"Drug Enforcement Administration","id":116,"url":"https://www.federalregister.gov/agencies/drug-enforcement-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/116","parent_id":268,"slug":"drug-enforcement-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2023/10/31/2023-23982.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"1308","title":21}],"citation":"88 FR 74347","comment_url":null,"comments_close_on":"2023-11-30","correction_of":null,"corrections":[],"dates":"This rule is effective October 31, 2023. Comments must be submitted electronically or postmarked on or before November 30, 2023.","disposition_notes":null,"docket_ids":["Docket No. DEA1258"],"dockets":[{"supporting_documents":[{"title":"ASH to DEA Letter and 8FA Zuranolone 12Jul2023","document_id":"DEA-2023-0149-0003"},{"title":"DEA1258 Zuranolone Eight Factors of Analysis September 2023","document_id":"DEA-2023-0149-0002"}],"agency_name":"DEA","documents":[{"comment_count":1,"comment_start_date":"2023-10-31","updated_at":"2023-12-01T00:01:19.222-05:00","comment_url":"https://www.regulations.gov/commenton/DEA-2023-0149-0001","allow_late_comments":null,"id":"DEA-2023-0149-0001","comment_end_date":"2023-12-01","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":2,"id":"DEA-2023-0149","title":"Placement of Zuranolone in Schedule IV (DEA1258)"}],"document_number":"2023-23982","effective_on":"2023-10-31","end_page":74352,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/10/31/2023-23982.xml","html_url":"https://www.federalregister.gov/documents/2023/10/31/2023-23982/schedules-of-controlled-substances-placement-of-zuranolone-in-schedule-iv","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-23982?publication_date=2023-10-31","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-10-31/2023-23982/mods.xml","not_received_for_publication":null,"page_length":6,"page_views":{"count":2058,"last_updated":"2026-06-27 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-10-31/pdf/2023-23982.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-23982.pdf?1698670002","publication_date":"2023-10-31","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/10/31/2023-23982.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"ASH to DEA Letter and 8FA Zuranolone 12Jul2023","document_id":"DEA-2023-0149-0003"},{"title":"DEA1258 Zuranolone Eight Factors of Analysis September 2023","document_id":"DEA-2023-0149-0002"}],"comments_count":1,"agency_id":"DEA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=DEA-2023-0149","supporting_documents_count":2,"docket_id":"DEA-2023-0149","document_id":"DEA-2023-0149-0001","regulation_id_number":null,"title":"Placement of Zuranolone in Schedule IV (DEA1258)","checked_regulationsdotgov_at":"2023-12-01T05:01:18Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":74347,"subtype":null,"title":"Schedules of Controlled Substances: Placement of Zuranolone in Schedule IV","toc_doc":"Placement of Zuranolone in Schedule IV","toc_subject":"Schedules of Controlled Substances:\n","topics":["Administrative practice and procedure","Drug traffic control","Reporting and recordkeeping requirements"],"type":"Rule","volume":88}