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# FDA Proposed Rule Changes Facility Registration
- URL: https://www.fdaweb.com/fda-proposed-rule-changes-facility-registration/
- Published: 2026-07-30T12:00:00.000Z
- Updated: 2026-09-14T13:44:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161552

A 7/13 FDA proposed rule would fundamentally change how certain drug manufacturers register their facilities and list their products with the agency. Attorneys **Abha Kundi** and **Shoshanna Golden** (Argent Fox Schiff) write in an online [post](https://www.afslaw.com/perspectives/alerts/reinventing-the-wheel-fdas-hub-and-spoke-fix-drug-manufacturing-registration?ref=fdaweb.com) that the proposal is consistent with recent agency initiatives intended to strengthen U.S. drug manufacturing, improve supply chain resilience, and encourage earlier engagement between FDA and companies building domestic manufacturing capacity.

In practical terms, Kundi and Golden write, the proposed rule would make it easier for certain distributed manufacturing networks to register as one establishment, while also requiring more visibility into some foreign manufacturers whose ingredients or products ultimately enter the U.S. They say such companies should review whether the rule would require updates to FDA registrations, product listings, supplier records, import records, Drug Supply Chain Security Act compliance, or state license files, among other items.

Kundi and Golden write that the proposed rule addresses two areas where FDA feels it does not have adequate visibility into the drug manufacturing supply chain:

- distributed manufacturing, which generally refers to a model where a company uses a central hub and multiple manufacturing units in different locations; and
- foreign manufacturing, with the agency concerned that some foreign manufacturers, including upstream active pharmaceutical ingredient manufacturers, may not be registered even though their products ultimately become part of drugs imported into the U.S.

Under the proposal, the post says, the timing of registration would depend on whether the distributed manufacturing network includes U.S. or foreign components. A distributed manufacturing network would need to register if it includes a U.S. hub or unit, or if a foreign hub or unit makes a drug that is imported or offered for import into the U.S. For U.S. units, it says, FDA proposes that registration generally be submitted within five calendar days after the first unit begins manufacturing for commercial distribution. For foreign units, registration would generally be required before the drug made at that unit is imported or offered for import into the United States. FDA also contemplates that a U.S. hub could serve as the importer for drugs made by a foreign unit in the same distributed manufacturing network. 

The attorneys say the proposal is open for public comment until 9/11, and companies that may be affected should consider submitting comments if the proposed rule creates uncertainty or operational burden.