The FDA proposed a rule to streamline establishment registration for distributed manufacturing networks using a hub-and-spoke model. Under the proposal, multiple equivalent manufacturing units under a single quality oversight hub could register as one establishment, reducing administrative friction while improving the agency’s visibility into upstream supply chains. The draft rule would also clarify registration and drug listing requirements for certain foreign establishments making APIs or drug components that indirectly enter the U.S. drug supply. FDA said it is aiming to “reflect how distributed manufacturing actually works,” including a notification process ahead of unit relocations. For industry, the immediate impact is potential rework of registration workflows and readiness planning around unit additions, relocations, and governance documentation. The policy also signals continued FDA focus on supply-chain integrity without slowing innovative manufacturing models. Key watch items include how FDA will define “equivalent manufacturing units,” the extent of required transparency around quality oversight, and how quickly companies can transition to the streamlined registration pathway if finalized.