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FDA comment periods: GMP / manufacturing

3 open comment periods and 1 upcoming effective dates tagged GMP / manufacturing. Subscribe (iCal).

Open for comment

Closes	Document
closes in 10 days Oct 27, 2026	Agency Information Collection Activities; Proposed Collection; Comment Request; Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers Notice · published Aug 28, 2026 · FDA-2026-N-8691 GMP / manufacturing Food & dietary supplements
closes in 13 days Oct 30, 2026	Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act and Associated Fees Notice · published Aug 31, 2026 · FDA-2026-N-8690 GMP / manufacturing
closes in 41 days Nov 27, 2026	Compounding Animal Drugs From Bulk Drug Substances: Compounding Under CGMP in Federally-Registered Facilities; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request Notice · published Aug 28, 2026 · FDA-2018-D-4533 GMP / manufacturing

Upcoming effective dates

Effective	Document
effective in 348 days Sep 30, 2027	Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2027 Notice · published Jul 30, 2026 · FDA-2026-N-7896 GMP / manufacturing Food & dietary supplements

Recently closed

Closes	Document
closed 33 days ago Sep 14, 2026	Establishment Registration and Product Listing for Tobacco Products Proposed Rule · published Jun 29, 2026 · FDA-2025-N-7130 GMP / manufacturing Tobacco
closed 36 days ago Sep 11, 2026	Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments Proposed Rule · published Jul 13, 2026 · FDA-2025-N-6075 GMP / manufacturing
closed 82 days ago Jul 27, 2026	Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act Notice · published May 26, 2026 · FDA-2026-N-5128 GMP / manufacturing
closed 89 days ago Jul 20, 2026	Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements Notice · published Jun 18, 2026 · FDA-2026-N-0686 GMP / manufacturing Food & dietary supplements
closed 89 days ago Jul 20, 2026	Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles and Medicated Feeds Notice · published Jun 18, 2026 · FDA-2026-N-0496 GMP / manufacturing
closed 109 days ago Jun 30, 2026	List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act Notice · published May 1, 2026 · FDA-2018-N-3240 GMP / manufacturing
closed 117 days ago Jun 22, 2026	Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice (CGMP): Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals (Including Active Pharmaceutical Ingredients) and the Advanced Manufacturing Technologies Designation Program Notice · published May 21, 2026 · FDA-2026-N-0746 GMP / manufacturing
closed 162 days ago May 8, 2026	Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: Draft Guidance for Industry; Availability Notice · published Mar 9, 2026 · FDA-2025-D-1504 GMP / manufacturing Vaccines / biologics
closed 169 days ago May 1, 2026	List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Extension of Comment Period Notice · published Jun 26, 2026 · FDA-2018-N-3240, FDA_FRDOC_0001 GMP / manufacturing
closed 173 days ago Apr 27, 2026	Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements Notice · published Feb 24, 2026 · FDA-2026-N-0686 GMP / manufacturing Food & dietary supplements
closed 173 days ago Apr 27, 2026	Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice Regulations for Medicated Feeds Notice · published Feb 25, 2026 · FDA-2026-N-0496 GMP / manufacturing
closed 179 days ago Apr 21, 2026	Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practice (CGMP): Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals (Including Active Pharmaceutical Ingredients) and the Advanced Manufacturing Technologies Designation Program Notice · published Feb 20, 2026 · FDA-2026-N-0746 GMP / manufacturing
closed 179 days ago Apr 21, 2026	Agency Information Collection Activities; Proposed Collection; Comment Request; Approved Organizations for Wholesale Drug Distributors and Third-Party Logistics Providers Notice · published Feb 20, 2026 · FDA-2026-N-0684 GMP / manufacturing

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