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Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
Read on FederalRegister.gov · Official PDF · Docket on Regulations.gov · Add to calendar (.ics)
Summary (from the Federal Register 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).
- Document type
- Proposed Rule
- Federal Register document number
- 2026-14073
- Published
- Jul 13, 2026
- Action
- Proposed rule.
- Docket
- FDA-2025-N-6075
- Comments posted on Regulations.gov (at last check)
- 33
- RIN
- 0910-AI94
- CFR parts
- 21 CFR 207
- DATES section (from the document)
- 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.
- Topics (auto-tagged)
- GMP / manufacturing
Source: Federal Register API, document 2026-14073. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.