Health Law Daily Wrap Up, DRUGS AND BIOLOGICS—PROPOSED RULES: FDA seeks to modernize registration for distributed drug manufacturing, (Jul 16, 2026)

By WK Editorial Staff

FDA proposed a single-establishment registration pathway for qualifying distributed manufacturing operations and clarified registration and listing duties for foreign drug establishments whose products indirectly entered the U.S. drug supply.

FDA proposed changes to its drug establishment registration and drug listing rules to address two gaps it identified in the existing framework: registration requirements that did not fit distributed manufacturing models and uncertainty over the obligations of certain foreign establishments in the upstream drug supply chain. The agency said distributed manufacturing could use advanced manufacturing technology to support more flexible production, but the current definition of an establishment generally tied registration to one management structure at one general physical location. FDA also said some foreign establishments that made drugs or drug components for distribution only to other foreign establishments had not registered or listed those drugs even when the products ultimately were imported or offered for import into the United States, limiting the agency’s visibility into the drug supply chain (Proposed Rule, 91 Fed. Reg. 42888 (July 13, 2026)).

The proposal addressed distributed manufacturing through a hub-and-spoke model. A distributed manufacturing establishment would consist of a distributed manufacturing hub and one or more distributed manufacturing units. The units would be equivalent in design and operation, manufacture the same drug or drugs at one or more physical locations, and operate under the oversight and control of a single quality unit. The quality unit would have a management structure located at the hub and would implement a unified pharmaceutical quality system to direct, monitor, and control manufacturing across the establishment.

FDA explained that this model differed from traditional manufacturing because the manufacturing activity did not reside at one general physical location. Under current regulations, the hub and each manufacturing unit would need separate registrations if they performed manufacturing activities, even though they operated collectively as one establishment. FDA said that multiple separate registrations would impose unnecessary burdens, could hinder adoption and implementation of distributed manufacturing, and could limit the agency’s understanding of the relationship between the hub and the units. The proposed pathway would allow a qualifying distributed manufacturing establishment to register as a single drug manufacturing establishment while still providing FDA with information about the number, location, and operations of individual distributed manufacturing units.

The proposed definition of a distributed manufacturing establishment included significant limits. The hub and all units would need to operate under one management pursuant to a decentralized manufacturing strategy. They also would need to have been subject to a preapproval inspection in connection with an approved application that described the use of a decentralized manufacturing strategy for at least one drug in each profile class manufactured by the establishment. FDA said the pathway would not cover a structure in which multiple unaffiliated contract manufacturing organizations operated units for the same drug, because those entities would operate under different management and different quality units rather than a unified pharmaceutical quality system.

The proposed registration requirements would require information tailored to the distributed model. Registrants would provide basic ownership, name, contact, registration number, and unique facility identifier information, and would identify the hub’s name, physical address, and telephone number. For each distributed manufacturing unit, the registrant would provide the unit identifier assigned by FDA and the unit’s location, either as a physical address or GPS coordinates. Registrants also would identify the types of operations performed at the hub and at the units and, when foreign hubs or units were involved, provide information on U.S. agents and import-related entities.

FDA also proposed update requirements that reflected the mobility of distributed manufacturing units. A registrant would update registration information when it added a new unit, removed a unit, changed the name of the establishment, changed the hub’s physical address, closed or sold the establishment, or changed official contact or U.S. agent information. For a mobile unit, the registrant would provide advance notice before relocation. FDA proposed at least 30 calendar days’ notice for a move within or to the United States and at least 120 calendar days’ notice for a move within or to a foreign country. The notice would include the unit identifier, departure and destination locations, expected departure and arrival dates, and the anticipated date manufacturing would resume at the new location.

The proposed rule separately addressed foreign establishment registration and drug listing. FDA proposed to align 21 CFR part 207 with section 510 of the Federal Food, Drug, and Cosmetic Act as amended by section 2511 of the PREVENT Pandemics Act. The amendments would clarify that registration and listing requirements applied to a foreign establishment that manufactured, prepared, propagated, compounded, or processed a drug that was imported or offered for import into the United States, even if the drug first underwent further manufacturing, preparation, propagation, compounding, or processing at another foreign establishment. FDA used the example of a foreign active pharmaceutical ingredient manufacturer that distributed an API only to foreign finished-product manufacturers, where the finished drug was later imported or offered for import into the United States.

FDA said the foreign-establishment clarification was necessary because the absence of registration and listing for upstream foreign sources had hindered oversight of a growing sector of the supply chain. Registration information served as the agency’s primary source for including establishments in its drug establishment site selection model for routine quality-related surveillance inspections. Listing information also helped FDA enhance visibility into foreign sources of drugs and components, which could support more targeted responses to safety concerns. If an establishment required to register failed to do so, FDA stated that a drug manufactured, prepared, propagated, compounded, or processed there would be considered misbranded under section 502(o) of the FD&C Act.

FDA estimated that the proposal would impose annualized net costs of approximately $583,958 at a seven percent discount rate and $533,771 at a three percent discount rate, with unquantified benefits from greater supply chain visibility. The agency also estimated additional paperwork burdens for distributed manufacturing respondents and foreign manufacturing establishment registration and listing respondents. FDA proposed that any final rule become effective 30 calendar days after publication in the Federal Register.

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