{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend the drug establishment registration and drug listing requirements with respect to establishments engaged in distributed manufacturing and foreign drug establishments. This action, if finalized, will provide a pathway for a distributed manufacturing establishment that manufactures drugs at multiple different physical locations to register as a single drug manufacturing establishment and align drug establishment registration and drug listing regulations applicable to foreign drug establishments with statutory changes made by the Preparing for and Responding to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act).","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/2026/07/13/2026-14073.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"207","title":21}],"citation":"91 FR 42888","comment_url":"http://www.regulations.gov/commenton/FDA-2025-N-6075-0001","comments_close_on":"2026-09-11","correction_of":null,"corrections":[],"dates":"Either electronic or written comments on the proposed rule must be submitted by September 11, 2026. Submit comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 by September 11, 2026.","disposition_notes":null,"docket_ids":["Docket No. FDA-2025-N-6075"],"dockets":[{"supporting_documents":[{"title":"TAB C-2023-173-Drug Establishment-Proposed Rule-Final","document_id":"FDA-2025-N-6075-0028"},{"title":"TAB C-2023-173-Drug Establishment-PRIA-Final","document_id":"FDA-2025-N-6075-0027"},{"title":"TAB B-2023-173-Drug Establishment-Proposed Rule-TRACK CHANGE FROM ORIGINAL TO FINAL","document_id":"FDA-2025-N-6075-0026"},{"title":"TAB B-2023-173-Drug Establishment-PRIA-TRACK CHANGE FROM ORIGINAL TO FINAL","document_id":"FDA-2025-N-6075-0025"},{"title":"TAB A-2023-173-Drug Establishment-Proposed Rule-Original","document_id":"FDA-2025-N-6075-0024"},{"title":"TAB A-2023-173-Drug Establishment-PRIA-Original","document_id":"FDA-2025-N-6075-0023"},{"title":"Reference 6 - FDA PQRI Workshop","document_id":"FDA-2025-N-6075-0021"},{"title":"Reference 2 - Safeguarding Pharmaceutical Supply Chains in a Global Economy_Congressional Hearing","document_id":"FDA-2025-N-6075-0020"},{"title":"Reference 1 - CDER's FRAME Initiative","document_id":"FDA-2025-N-6075-0019"},{"title":"Reference 9 - PRIA","document_id":"FDA-2025-N-6075-0018"}],"agency_name":"FDA","documents":[{"comment_count":12,"comment_start_date":"2026-07-13","updated_at":"2026-08-20T01:56:37.673-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2025-N-6075-0001","allow_late_comments":false,"id":"FDA-2025-N-6075-0001","comment_end_date":"2026-09-12","regulations_dot_gov_open_for_comment":true}],"supporting_documents_count":26,"id":"FDA-2025-N-6075","title":"Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments"}],"document_number":"2026-14073","effective_on":null,"end_page":42906,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/07/13/2026-14073.xml","html_url":"https://www.federalregister.gov/documents/2026/07/13/2026-14073/drug-establishment-registration-and-drug-listing-requirements-for-establishments-engaged-in","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-14073?publication_date=2026-07-13","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-07-13/2026-14073/mods.xml","not_received_for_publication":null,"page_length":19,"page_views":{"count":8370,"last_updated":"2026-08-24 02:15:07 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-07-13/pdf/2026-14073.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-14073.pdf?1783687517","publication_date":"2026-07-13","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/07/13/2026-14073.txt","regulation_id_number_info":{"0910-AI94":{"issue":"202504","html_url":"https://www.federalregister.gov/regulations/0910-AI94/drug-establishment-registration-and-drug-listing-requirements-for-establishments-engaged-in-distribu","title":"Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202504&RIN=0910-AI94&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AI94"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"TAB C-2023-173-Drug Establishment-Proposed Rule-Final","document_id":"FDA-2025-N-6075-0028"},{"title":"TAB C-2023-173-Drug Establishment-PRIA-Final","document_id":"FDA-2025-N-6075-0027"},{"title":"TAB B-2023-173-Drug Establishment-Proposed Rule-TRACK CHANGE FROM ORIGINAL TO FINAL","document_id":"FDA-2025-N-6075-0026"},{"title":"TAB B-2023-173-Drug Establishment-PRIA-TRACK CHANGE FROM ORIGINAL TO FINAL","document_id":"FDA-2025-N-6075-0025"},{"title":"TAB A-2023-173-Drug Establishment-Proposed Rule-Original","document_id":"FDA-2025-N-6075-0024"},{"title":"TAB A-2023-173-Drug Establishment-PRIA-Original","document_id":"FDA-2025-N-6075-0023"},{"title":"Reference 6 - FDA PQRI Workshop","document_id":"FDA-2025-N-6075-0021"},{"title":"Reference 2 - Safeguarding Pharmaceutical Supply Chains in a Global Economy_Congressional Hearing","document_id":"FDA-2025-N-6075-0020"},{"title":"Reference 1 - CDER's FRAME Initiative","document_id":"FDA-2025-N-6075-0019"},{"title":"Reference 9 - PRIA","document_id":"FDA-2025-N-6075-0018"}],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0910-AI94/drug-establishment-registration-and-drug-listing-requirements-for-establishments-engaged-in-distribu","title":"Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments"},"comments_count":12,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2025-N-6075","supporting_documents_count":26,"docket_id":"FDA-2025-N-6075","document_id":"FDA-2025-N-6075-0001","regulation_id_number":"0910-AI94","title":"Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments","checked_regulationsdotgov_at":"2026-08-21T08:55:07Z"},"regulations_dot_gov_url":"http://www.regulations.gov/commenton/FDA-2025-N-6075-0001","significant":true,"signing_date":null,"start_page":42888,"subtype":null,"title":"Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments","toc_doc":"Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments","toc_subject":null,"topics":["Drugs","Reporting and recordkeeping requirements"],"type":"Proposed Rule","volume":91}