United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2026_register executive 2026-07-11 article Proposed Rules D09002ee1e4c96acf D09002ee1e4c96b83 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency 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). 91 FR 42888 https://www.govinfo.gov/app/details/FR-2026-07-13/2026-14073 2026-14073 fr13jy26-8 RIN 0910-AI94 4164-01-P Docket No. FDA-2025-N-6075 https://www.govinfo.gov/app/details/FR-2026-07-13/2026-14073 https://www.govinfo.gov/content/pkg/FR-2026-07-13/html/2026-14073.htm https://www.govinfo.gov/content/pkg/FR-2026-07-13/pdf/2026-14073.pdf Drugs Reporting and Recordkeeping Requirements 19 p. 42888 42906 91 FR 42888 Title 21 Part 207 21 CFR Part 207 RIN 0910-AI94 Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments; Federal Register Vol. 91, Issue PRORULE 2026-14073 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2026-09-11 Docket No. FDA-2025-N-6075 4164-01-P 2026-14073 Proposed rule.

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).

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. With regard to the proposed rule: Ashley Boam, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301- 796-6341, ashley.boam@fda.hhs.gov. Drugs Reporting and Recordkeeping Requirements Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments, ashley.boam@fda.hhs.gov PRAStaff@fda.hhs.gov https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cders-framework-regulatory-advanced-manufacturing-evaluation-frame-initiative https://www.fda.gov/about-fda/economics-staff/regulatory-impact-analyses-ria https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations https://www.fda.gov/drugs/news-events-human-drugs/fdapqri-workshop-regulatory-framework-distributed-and-point-care-pharmaceutical-manufacturing#event-information https://www.fda.gov/industry/structured-product-labeling-resources/business-operation https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/investigations-operations-manual https://www.fda.gov/media/173449/download?attachment https://www.fda.gov/media/188153/download?attachment https://www.fda.gov/media/89926/download https://www.fda.gov/news-events/congressional-testimony/safeguarding-pharmaceutical-supply-chains-global-economy-10302019 https://www.federalregister.gov/documents/2022/10/14/2022-22386/discussion-paper-distributed-manufacturing-and-point-of-care-manufacturing-of-drugs-request-for https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.reginfo.gov/public/do/PRAMain https://www.regulations.gov reginfo.gov Vol. 91, no. 132 Office of the Federal Register, National Archives and Records Administration 2026-07-13 continuing daily deposited born digital 189 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2026-07-13 P0b002ee1e4c8c034 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr13jy26 https://www.govinfo.gov/app/details/FR-2026-07-13 https://www.govinfo.gov/content/pkg/FR-2026-07-13/pdf/FR-2026-07-13.pdf https://www.govinfo.gov/content/pkg/FR-2026-07-13/xml/FR-2026-07-13.xml fdlp 42845 43024 DGPO 2026-07-11 2026-07-11 FR-2026-07-13 machine generated eng FR FR-2026-07-13 91 132