{"abstract":"On October 11, 2019, the U.S. Food and Drug Administration approved a new drug application for Reyvow (lasmiditan) tablets for oral use. Lasmiditan is chemically known as [2,4,6-trifluoro-N-(6-(1- methylpiperidine-4-carbonyl)pyridine-2-yl-benzamide]. Thereafter, the Department of Health and Human Services provided the Drug Enforcement Administration (DEA) with a scheduling recommendation to place lasmiditan in schedule V of the Controlled Substances Act (CSA). In accordance with the CSA, as revised by the Improving Regulatory Transparency for New Medical Therapies Act, DEA is hereby issuing an interim final rule placing lasmiditan, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule V of the CSA.","action":"Interim final rule with 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/2020/01/31/2020-01957.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"1308","title":21}],"citation":"85 FR 5557","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The effective date of this rulemaking is January 31, 2020. Interested persons may file written comments on this rulemaking in accordance with 21 U.S.C. 811(j)(3) and 21 CFR 1308.43(g). Electronic comments must be submitted, and written comments must be postmarked, on or before March 2, 2020. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period.","disposition_notes":null,"docket_ids":["Docket No. DEA-558"],"dockets":[],"document_number":"2020-01957","effective_on":"2020-01-31","end_page":5562,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/01/31/2020-01957.xml","html_url":"https://www.federalregister.gov/documents/2020/01/31/2020-01957/schedules-of-controlled-substances-placement-of-lasmiditan-in-schedule-v","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-01957?publication_date=2020-01-31","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-01-31/2020-01957/mods.xml","not_received_for_publication":null,"page_length":6,"page_views":{"count":2062,"last_updated":"2026-09-20 10:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-01-31/pdf/2020-01957.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-01957.pdf?1580391942","publication_date":"2020-01-31","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/01/31/2020-01957.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Lasmiditan HHS ltr and 8 Factor Analysis 10-23-2019","document_id":"DEA-2020-0003-0012"},{"title":"8F Lasmiditan 08062020","document_id":"DEA-2020-0003-0011"},{"title":"DEA 8-factor review Lasmiditan 01232020 pdf","document_id":"DEA-2020-0003-0009"},{"title":"8F Lasmiditan 06102020","document_id":"DEA-2020-0003-0008"},{"title":"Lasmiditan HHS ltr and 8 Factor Analysis","document_id":"DEA-2020-0003-0007"}],"comments_count":5,"agency_id":"DEA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=DEA-2020-0003","supporting_documents_count":5,"docket_id":"DEA-2020-0003","document_id":"DEA-2020-0003-0001","regulation_id_number":null,"title":"Schedules of Controlled Substances: Placement of Lasmiditan in Schedule V","checked_regulationsdotgov_at":"2021-05-26T03:30:11Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":5557,"subtype":null,"title":"Schedules of Controlled Substances: Placement of Lasmiditan in Schedule V","toc_doc":"Placement of Lasmiditan in Schedule V","toc_subject":"Schedules of Controlled Substances:","topics":["Administrative practice and procedure","Drug traffic control","Reporting and recordkeeping requirements"],"type":"Rule","volume":85}