{"abstract":"The Food and Drug Administration (FDA or Agency) is proposing a regulation to identify an initial list of bulk drug substances that can be used to compound drug products in accordance with certain compounding provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), although they are neither the subject of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph nor components of FDA-approved drugs. Specifically, the Agency proposes to place six bulk drug substances on the list. This proposed rule also identifies four bulk drug substances that FDA has considered and proposes not to include on the list. Additional substances nominated by the public for inclusion on this list are currently under consideration and will be the subject of a future rulemaking.","action":"Proposed rule.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2016/12/16/2016-30109.html","cfr_references":[{"chapter":null,"citation_url":null,"part":216,"title":21}],"citation":"81 FR 91071","comment_url":null,"comments_close_on":"2017-03-16","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the bulk drug substances list by March 16, 2017. See section VI for the proposed effective date of a final rule based on this proposed rule.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-N-3464"],"dockets":[{"supporting_documents":[{"title":"Reference 16 - Food and Drug Administration Supplemental Review of Topical Tranilast, April 25, 2016.","document_id":"FDA-2016-N-3464-0033"},{"title":"Reference 10 - Food and Drug Administration Supplemental Review of Oxitriptan, November 2018.","document_id":"FDA-2016-N-3464-0032"},{"title":"Reference 4 - Letter from the United States Pharmacopeia to FDA, October 7, 2016.","document_id":"FDA-2016-N-3464-0031"},{"title":"Reference 3 - Memorandum to File on Food and Drug Administration Consultations with United States Pharmacopeia, September\n26, 2016.","document_id":"FDA-2016-N-3464-0030"},{"title":"Reference 14 - Economic Analysis of Impacts","document_id":"FDA-2016-N-3464-0016"},{"title":"Reference 13 - Case Series  The Effectiveness of Fatty Acids From Pracaxi Oil in a Topical Silicone Base for Scar and Wound Therapy","document_id":"FDA-2016-N-3464-0015"},{"title":"Reference 12 - Treatment of Keloid and Hypertrophic Scars by Iontophoretic Transdermal Delivery of Tranilast","document_id":"FDA-2016-N-3464-0014"},{"title":"Reference 11 - FDA Supplemental Review of Topical Tranilast, April 25, 2016","document_id":"FDA-2016-N-3464-0013"},{"title":"Reference 10 - Results of Prevention of REStenosis with Tranilast and its Outcomes (PRESTO) Trial","document_id":"FDA-2016-N-3464-0012"},{"title":"Reference 9 - Piracetam in the Treatment of Different Types of Myoclonus","document_id":"FDA-2016-N-3464-0011"}],"agency_name":"FDA","documents":[{"comment_count":13,"comment_start_date":"2016-12-16","updated_at":"2023-02-28T15:49:12.492-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2016-N-3464-0001","allow_late_comments":null,"id":"FDA-2016-N-3464-0001","comment_end_date":"2017-03-17","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":19,"id":"FDA-2016-N-3464","title":"List of Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act"}],"document_number":"2016-30109","effective_on":null,"end_page":91082,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/12/16/2016-30109.xml","html_url":"https://www.federalregister.gov/documents/2016/12/16/2016-30109/list-of-bulk-drug-substances-that-can-be-used-to-compound-drug-products-in-accordance-with-section","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-30109?publication_date=2016-12-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-12-16/2016-30109/mods.xml","not_received_for_publication":null,"page_length":12,"page_views":{"count":11543,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-12-16/pdf/2016-30109.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-30109.pdf?1481809540","publication_date":"2016-12-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/12/16/2016-30109.txt","regulation_id_number_info":{"0910-AH29":{"issue":"201810","html_url":"https://www.federalregister.gov/regulations/0910-AH29/list-of-bulk-drug-substances-that-can-be-used-to-compound-drug-products-in-accordance-with-section-5","title":"List of Bulk Drug Substances That Can Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act\n","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201810&RIN=0910-AH29&operation=OPERATION_EXPORT_XML","priority_category":"Substantive, Nonsignificant"}},"regulation_id_numbers":["0910-AH29"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 16 - Food and Drug Administration Supplemental Review of Topical Tranilast, April 25, 2016.","document_id":"FDA-2016-N-3464-0033"},{"title":"Reference 10 - Food and Drug Administration Supplemental Review of Oxitriptan, November 2018.","document_id":"FDA-2016-N-3464-0032"},{"title":"Reference 4 - Letter from the United States Pharmacopeia to FDA, October 7, 2016.","document_id":"FDA-2016-N-3464-0031"},{"title":"Reference 3 - Memorandum to File on Food and Drug Administration Consultations with United States Pharmacopeia, September\n26, 2016.","document_id":"FDA-2016-N-3464-0030"},{"title":"Reference 14 - Economic Analysis of Impacts","document_id":"FDA-2016-N-3464-0016"},{"title":"Reference 13 - Case Series  The Effectiveness of Fatty Acids From Pracaxi Oil in a Topical Silicone Base for Scar and Wound Therapy","document_id":"FDA-2016-N-3464-0015"},{"title":"Reference 12 - Treatment of Keloid and Hypertrophic Scars by Iontophoretic Transdermal Delivery of Tranilast","document_id":"FDA-2016-N-3464-0014"},{"title":"Reference 11 - FDA Supplemental Review of Topical Tranilast, April 25, 2016","document_id":"FDA-2016-N-3464-0013"},{"title":"Reference 10 - Results of Prevention of REStenosis with Tranilast and its Outcomes (PRESTO) Trial","document_id":"FDA-2016-N-3464-0012"},{"title":"Reference 9 - Piracetam in the Treatment of Different Types of Myoclonus","document_id":"FDA-2016-N-3464-0011"}],"comments_count":13,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2016-N-3464","supporting_documents_count":19,"docket_id":"FDA-2016-N-3464","document_id":"FDA-2016-N-3464-0001","regulation_id_number":null,"title":"List of Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act","checked_regulationsdotgov_at":"2023-02-28T20:49:11Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":91071,"subtype":null,"title":"List of Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act","toc_doc":"List of Bulk Drug Substances that can be used to Compound Drug Products","toc_subject":null,"topics":["Drugs","Prescription drugs"],"type":"Proposed Rule","volume":81}