Data / Federal rules / 2026-14073
Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The Food and Drug Administration published this proposed rule in the Federal Register on July 13, 2026. Comments closed on September 11, 2026.
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What the agency says
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).
Key facts
- Document number
- 2026-14073
- Type
- Proposed rule
- Action
- Proposed rule
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- July 13, 2026
- Comments due
- September 11, 2026
- 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.
- Docket
- Docket No. FDA-2025-N-6075
- Regulation ID (RIN)
- 0910-AI94
- Code of Federal Regulations
- 21 CFR 207
- Topics
- Drugs; Reporting and recordkeeping requirements
- Significant
- Yes, under Executive Order 12866
- Pages
- 19
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on drugs · Rules on reporting and recordkeeping requirements · Published in July 2026
Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.