{"abstract":"The Food and Drug Administration is proposing to establish criteria for the lists of drug products or categories of drug products that present demonstrable difficulties for compounding (Demonstrable Difficulties for Compounding Lists or DDC Lists) under certain sections of the Federal Food, Drug, and Cosmetic Act. Additionally, the Agency is proposing to identify the first three categories of drug products on both DDC Lists. Drug products or categories of drug products that appear on the DDC Lists cannot qualify for certain statutory exemptions, and therefore may not be compounded under, either section 503A or section 503B, respectively.","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/2024/03/20/2024-05801.html","cfr_references":[{"chapter":null,"citation_url":null,"part":216,"title":21}],"citation":"89 FR 19776","comment_url":null,"comments_close_on":"2024-06-18","correction_of":null,"corrections":[],"dates":"Either electronic or written comments on the proposed rule must be submitted by June 18, 2024.","disposition_notes":null,"docket_ids":["Docket No. FDA-2023-N-0061"],"dockets":[{"supporting_documents":[{"title":"Reference 10a PCAC briefing Nov 20-21 2017","document_id":"FDA-2023-N-0061-0013"},{"title":"Reference 09 PCAC briefing May 8-9 2017","document_id":"FDA-2023-N-0061-0012"},{"title":"Reference 08 PCAC briefing Nov 3 2016","document_id":"FDA-2023-N-0061-0011"},{"title":"Reference 07b PCAC briefing March 8-9 2016 errata and addendum","document_id":"FDA-2023-N-0061-0010"},{"title":"Reference 07a PCAC briefing March 8-9 2016","document_id":"FDA-2023-N-0061-0009"},{"title":"Reference 06 PCAC briefing June 17-18 2015","document_id":"FDA-2023-N-0061-0008"},{"title":"Reference 05 PCAC transcript Nov 21 2017","document_id":"FDA-2023-N-0061-0007"},{"title":"Reference 04 PCAC transcript May 8-9 2017","document_id":"FDA-2023-N-0061-0006"},{"title":"Reference 03 PCAC transcript Nov 3 2016","document_id":"FDA-2023-N-0061-0005"},{"title":"Reference 02 PCAC transcript March 9 2016","document_id":"FDA-2023-N-0061-0004"}],"agency_name":"FDA","documents":[{"comment_count":30,"comment_start_date":"2024-03-20","updated_at":"2024-09-03T16:48:26.387-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-N-0061-0001","allow_late_comments":false,"id":"FDA-2023-N-0061-0001","comment_end_date":"2024-06-19","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":12,"id":"FDA-2023-N-0061","title":"Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act"}],"document_number":"2024-05801","effective_on":null,"end_page":19788,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/03/20/2024-05801.xml","html_url":"https://www.federalregister.gov/documents/2024/03/20/2024-05801/drug-products-or-categories-of-drug-products-that-present-demonstrable-difficulties-for-compounding","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-05801?publication_date=2024-03-20","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-03-20/2024-05801/mods.xml","not_received_for_publication":null,"page_length":13,"page_views":{"count":4261,"last_updated":"2026-04-04 22:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-03-20/pdf/2024-05801.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-05801.pdf?1710852315","publication_date":"2024-03-20","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/03/20/2024-05801.txt","regulation_id_number_info":{"0910-AI31":{"issue":"202310","html_url":"https://www.federalregister.gov/regulations/0910-AI31/drug-products-or-categories-of-drug-products-that-present-demonstrable-difficulties-for-compounding-","title":"Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202310&RIN=0910-AI31&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AI31"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 10a PCAC briefing Nov 20-21 2017","document_id":"FDA-2023-N-0061-0013"},{"title":"Reference 09 PCAC briefing May 8-9 2017","document_id":"FDA-2023-N-0061-0012"},{"title":"Reference 08 PCAC briefing Nov 3 2016","document_id":"FDA-2023-N-0061-0011"},{"title":"Reference 07b PCAC briefing March 8-9 2016 errata and addendum","document_id":"FDA-2023-N-0061-0010"},{"title":"Reference 07a PCAC briefing March 8-9 2016","document_id":"FDA-2023-N-0061-0009"},{"title":"Reference 06 PCAC briefing June 17-18 2015","document_id":"FDA-2023-N-0061-0008"},{"title":"Reference 05 PCAC transcript Nov 21 2017","document_id":"FDA-2023-N-0061-0007"},{"title":"Reference 04 PCAC transcript May 8-9 2017","document_id":"FDA-2023-N-0061-0006"},{"title":"Reference 03 PCAC transcript Nov 3 2016","document_id":"FDA-2023-N-0061-0005"},{"title":"Reference 02 PCAC transcript March 9 2016","document_id":"FDA-2023-N-0061-0004"}],"comments_count":30,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2023-N-0061","supporting_documents_count":12,"docket_id":"FDA-2023-N-0061","document_id":"FDA-2023-N-0061-0001","regulation_id_number":null,"title":"Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act","checked_regulationsdotgov_at":"2024-06-21T01:00:06Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":19776,"subtype":null,"title":"Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act","toc_doc":"Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act","toc_subject":null,"topics":["Drugs","Prescription drugs"],"type":"Proposed Rule","volume":89}