The U.S. Food and Drug Administration has issued a proposed rule that would streamline registration for drug manufacturers using distributed manufacturing models and clarify registration requirements for foreign facilities whose products indirectly enter the U.S. drug supply.
Distributed manufacturing uses a hub-and-spoke model in which manufacturing activities occur at multiple equivalent units under the oversight of a single quality hub. Under current regulations, each unit must register separately, creating unnecessary administrative burdens. The proposed rule would allow distributed manufacturing establishments to register as a single entity, with units added, relocated, or removed through an expedited update process. Companies relocating mobile units would need to notify the agency in advance — 30 days for domestic moves and 120 days for international moves.
“The FDA is proposing changes to our establishment registration regulations that would reflect how distributed manufacturing actually works — as one single establishment,” said Michael Davis, M.D., Ph.D., Acting Director of FDA’s Center for Drug Evaluation and Research. “The proposed changes would make it easier for innovative manufacturers to operate efficiently, and give the FDA a clearer, more accurate picture of how and where drugs are being made.”
The proposed rule also addresses a transparency gap in the foreign drug supply chain. Section 2511 of the PREVENT Pandemics Act, signed into law in December 2022, amended the FD&C Act to require registration of foreign establishments whose drugs are imported or offered for import into the United States, even if the drug first undergoes further processing at another foreign establishment. Currently, some foreign API manufacturers that distribute only to other foreign manufacturers have not registered, limiting FDA visibility into upstream supply chains. The proposed rule would align the regulations with this statutory requirement.
“When an active ingredient in a medicine reaches an American patient, the FDA should be able to trace exactly where it came from,” said Dr. Davis. “Closing this registration gap for foreign establishments is a concrete step toward increasing the supply chain transparency that patients deserve.”
The proposed rule addresses two distinct areas of the drug supply chain. For distributed manufacturing, it creates a registration framework that recognizes the hub-and-spoke model as a single establishment, reducing duplicate filings and enabling mobile units that can be rapidly deployed during emergencies. For foreign facilities, it closes a registration gap that has left upstream suppliers outside FDA visibility, bringing the regulations in line with the PREVENT Pandemics Act and giving the agency a more complete picture of where drugs and their components originate.
Source: FDA Press Release
