The US Food and Drug Administration has issued a proposed rule, which if finalized, would create a streamlined registration pathway for distributed manufacturing establishments that operate as a single establishment using a “hub-and-spoke” model. The proposed rule would also clarify registration requirements for certain foreign establishments that manufacture drugs, including active pharmaceutical ingredients, that indirectly enter the US drug supply. 

Distributed manufacturing establishments operate using a “hub-and-spoke” model, with a central quality oversight hub and multiple equivalent manufacturing units at different locations. Currently, regulations require each manufacturing unit in such a network to register separately, creating unnecessary administrative burdens, according to FDA. Under the proposed rule, distributed manufacturing establishments could register as a single establishment. Units could be added, relocated, or removed through a streamlined update process, and companies would be required to notify FDA in advance of any unit relocation, closing a gap in the agency’s real-time oversight. 

The proposed rule would also clarify registration and drug listing requirements for certain foreign drug manufacturing establishments. Currently, some foreign establishments that manufacture drugs (including components of drugs, such as active pharmaceutical ingredients) only for distribution to other foreign establishments may not be registered with FDA, limiting the agency’s visibility into upstream supply chains. By aligning its regulations to the statutory requirements, FDA says this proposed rule would make it clearer that these establishments must register with FDA and report on the drugs they produce, giving the FDA greater ability to detect and respond to potential safety concerns. 

If finalized, the proposed rule is expected to reduce registration costs for distributed manufacturing companies and generate long-term efficiencies for both industry and the agency, according to FDA. The proposed rule is open to public comment through September 11, 2026.  

Source: US Food and Drug Administration