{"abstract":"On July 1, 2016, the U.S. Food and Drug Administration (FDA) approved a new drug application for Syndros, a drug product consisting of dronabinol [(-)-delta-9-trans-tetrahydrocannabinol (delta-9-THC)] oral solution. Thereafter, the Department of Health and Human Services (HHS) provided the Drug Enforcement Administration (DEA) with a scheduling recommendation that would result in Syndros (and other oral solutions containing dronabinol) being placed in schedule II 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 FDA-approved products of oral solutions containing dronabinol in schedule II 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/2017/03/23/2017-05809.html","cfr_references":[{"chapter":null,"citation_url":null,"part":1308,"title":21}],"citation":"82 FR 14815","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The effective date of this rulemaking is March 23, 2017. Interested persons may file written comments on this rulemaking in accordance with 21 CFR 1308.43(g). Electronic comments must be submitted, and written comments must be postmarked, on or before April 24, 2017. 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-344"],"dockets":[],"document_number":"2017-05809","effective_on":"2017-03-23","end_page":14820,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2017/03/23/2017-05809.xml","html_url":"https://www.federalregister.gov/documents/2017/03/23/2017-05809/schedules-of-controlled-substances-placement-of-fda-approved-products-of-oral-solutions-containing","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2017-05809?publication_date=2017-03-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2017-03-23/2017-05809/mods.xml","not_received_for_publication":null,"page_length":6,"page_views":{"count":7442,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2017-03-23/pdf/2017-05809.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2017-05809.pdf?1490186769","publication_date":"2017-03-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2017/03/23/2017-05809.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"HHS Syndros recommendation","document_id":"DEA-2017-0003-0003"},{"title":"Dronabinol 8 factor_","document_id":"DEA-2017-0003-0002"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=DEA-2017-0003","supporting_documents_count":2,"docket_id":"DEA-2017-0003","regulation_id_number":null,"title":"Schedules of Controlled Substances:  Placement of FDA-Approved Products of Oral Solutions Containing Dronabinol [(-)-delta-9-trans-tetrahydrocannabinol (delta-9-THC)] in Schedule II.","checked_regulationsdotgov_at":"2017-04-25T05:00:46Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":14815,"subtype":null,"title":"Schedules of Controlled Substances: Placement of FDA-Approved Products of Oral Solutions Containing Dronabinol [(-)-delta-9-trans-tetrahydrocannabinol (delta-9-THC)] in Schedule II","toc_doc":"Placement of FDA-Approved Products of Oral Solutions Containing Dronabinol [(-)-delta-9-trans-tetrahydrocannabinol (delta-9-THC)] in Schedule II","toc_subject":"Schedules of Controlled Substances:","topics":["Administrative practice and procedure","Drug traffic control","Reporting and recordkeeping requirements"],"type":"Rule","volume":82}