The U.S. Food and Drug Administration (“FDA”) issued a proposed rule to update drug establishment registration and listing requirements for distributed manufacturing (“DM”) and certain foreign drug establishments. If finalized, the rule would create a streamlined registration pathway for qualifying distributed manufacturing establishments (“DMEs”) that manufacture drugs at multiple physical locations, while also aligning the FDA’s foreign establishment registration and listing regulations with statutory changes made by Section 2511 of the PREVENT Pandemics Act. Comments on the proposed rule are due by September 11, 2026. See 91 Fed. Reg. 42888, 42888-89 (July 13, 2026).
The proposal addresses two issues in the FDA’s current registration framework. First, existing regulations generally tie an “establishment” to one management at one general, physical location, which can require separate registrations for multiple manufacturing locations even where those locations function as part of an integrated manufacturing network. Second, the FDA has expressed concern regarding visibility into upstream foreign drug supply chains, including certain foreign establishments that manufacture active pharmaceutical ingredients (“APIs”) or other drug components that may ultimately enter the U.S. drug supply. See 91 Fed. Reg. at 42891-92, 42904-05.
The proposed rule may be particularly relevant for companies pursuing advanced or decentralized manufacturing models because it would allow qualifying distributed manufacturing networks to register as a single establishment rather than maintaining separate registrations for each manufacturing location. The proposal also reflects the FDA’s continued focus on supply chain transparency and oversight of upstream foreign suppliers.
Distributed Manufacturing Establishments
The FDA describes distributed manufacturing as a decentralized manufacturing strategy that uses advanced manufacturing technologies to allow drug manufacturing activities to occur across multiple coordinated locations, which may help manufacturers respond more flexibly to demand or supply chain needs. Under the proposed framework, a DME would operate through a hub-and-spoke model consisting of a distributed manufacturing hub (“DM Hub”) and one or more distributed manufacturing units (“DMUs”).
Physical manufacturing activities would occur at DMUs located at one or more geographic locations under the oversight and control of a single quality unit located at the DM Hub and operating under a unified pharmaceutical quality system (“UPQS”). To qualify as a DME, the DMUs would be required to remain equivalent in design and operation and manufacture the same drug or drugs. See 91 Fed. Reg. at 42889.
The FDA explains that the current location-based registration framework could require separate registrations for each DMU, the hub (if it engages in manufacturing activities) and any newly added or relocated DMU, even where those locations collectively function as a single manufacturing operation. According to the FDA, the current location-based registration framework may create unnecessary administrative burdens and limit the FDA’s ability to understand the relationship between a DM Hub and its associated DMUs. See 91 Fed. Reg. at 42891-92.
Eligibility for the DME pathway would be limited. Among other requirements, the DM Hub and DMUs would need to:
- Operate under one management pursuant to a decentralized manufacturing strategy;
- Remain equivalent in design and operation;
- Operate under a single quality unit and UPQS; and
- Have been subject to a preapproval inspection associated with an approved application describing the decentralized manufacturing strategy for at least one drug in each profile class manufactured by the DME.
See 91 Fed. Reg. at 42893-94, 42903.
The FDA states that the DME pathway would not be available to unaffiliated contract manufacturing organizations making the same drug at different locations or to third-party repackers, relabelers or salvagers that do not operate under the manufacturer’s ownership or control. However, qualifying DMEs could manufacture certain non-application products, such as over-the-counter monograph drugs, if each product is in the same profile class as one or more approved drugs manufactured under the decentralized manufacturing strategy. See 91 Fed. Reg. at 42893-94.
To implement the new framework, the FDA proposes to revise 21 C.F.R. Part 207 by modifying the definition of “establishment” and adding new definitions for “distributed manufacturing establishment,” “distributed manufacturing hub” and “distributed manufacturing unit.” If finalized, qualifying DMEs would be permitted to register as a single establishment, with additions, relocations or removals of DMUs managed through DME-specific registration updates.
For mobile DMUs, the FDA proposes advance notice requirements of:
- At least 30 calendar days before relocation within or to the United States; and
- At least 120 calendar days before relocation within or to a foreign country.
The FDA states that these notice periods are intended to facilitate inspection planning and regulatory oversight. See 91 Fed. Reg. at 42897, 42906.
Foreign Establishment Registration and Listing Requirements
The proposed rule would revise Part 207 to align the FDA’s regulations with Section 510 of the Federal Food, Drug, and Cosmetic Act (“FD&C Act”), as amended by Section 2511 of the PREVENT Pandemics Act. As amended, Section 510 clarifies that foreign establishments must register and list drugs if they manufacture, prepare, propagate, compound or process a drug that is imported or offered for import into the United States, regardless of whether the drug undergoes additional manufacturing or processing at another foreign establishment before importation. See 91 Fed. Reg. at 42889, 42892-93, 42897, 42902.
The FDA does not view these provisions as creating new statutory obligations. Rather, the FDA states that the Section 2511 amendments were self-implementing and that the proposed rule is intended to conform Part 207 to the amended statutory requirements and eliminate perceived inconsistencies between Section 510 of the FD&C Act and the FDA’s regulations. See 91 Fed. Reg. at 42892, 42897, 42902. According to the FDA, these amendments would improve the FDA’s visibility into upstream foreign supply chains, including foreign establishments that manufacture APIs and other drug components that may ultimately be incorporated into finished drug products imported into the United States. The FDA further explains that failure by a covered foreign establishment to register or list drugs could cause the affected drug, including an API used in an imported finished product, to be deemed misbranded and could create import consequences for downstream products. See 91 Fed. Reg. at 42891-92, 42893, 42898.
Although the FDA characterizes these revisions as conforming amendments, the proposal highlights the importance of supplier compliance throughout the drug supply chain. Drug manufacturers and importers may wish to evaluate whether key upstream foreign suppliers satisfy applicable registration and listing requirements, particularly where those suppliers manufacture APIs or other critical drug components.
Practical Takeaways
- Manufacturers operating hub-and-spoke manufacturing models should assess whether their operations satisfy the proposed eligibility criteria, including centralized management, equivalent DMUs, a single quality unit and implementation of a UPQS.
- Manufacturers utilizing mobile DMUs should consider the operational impact of the proposed advance-notice requirements for relocations.
- Drug manufacturers and importers should recognize that upstream foreign supplier registration and listing obligations already apply under amended Section 510 of the FD&C Act and that failures by covered suppliers may create misbranding or import consequences for finished products offered for import into the United States.
- Although the foreign establishment provisions are largely intended to conform FDA regulations to existing statutory requirements, the proposal underscores the FDA’s continued focus on supply chain transparency and visibility into upstream foreign manufacturing activities.
Comments are due by September 11, 2026. Submissions should reference Docket No. FDA-2025-N-6075. Electronic comments may be submitted through regulations.gov and will be posted publicly without change, including any attachments. Companies wishing to submit confidential business information should use the FDA’s written/paper confidential submission process rather than the electronic portal.
If you have any questions or would like assistance evaluating how the proposed rule may affect your distributed manufacturing operations, drug establishment registration and listing obligations, foreign supplier compliance or FDA regulatory strategy, please contact:
- Carolina Wirth at (202) 780-2989 or cwirth@hallrender.com;
- Will Wurster at (317) 977-1494 or wwurster@hallrender.com; or
- Your primary Hall Render contact.
A special thanks to Summer Associate Christian Merrill and Intern Meron Dawit for their assistance with the preparation of this article.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.
