The U.S. Food and Drug Administration has issued a proposed rule that would create a streamlined registration pathway for distributed drug manufacturing establishments operating under a hub-and-spoke model.
Under the current regulatory framework, each individual manufacturing unit within a distributed network is required to register separately with the FDA, creating significant administrative burdens for companies.
The proposed rule would allow distributed manufacturing establishments to register as a single unified establishment rather than filing multiple separate registrations across their network.
Individual units within those networks could be added, relocated, or removed through a simplified update process, reducing paperwork and compliance complexity for manufacturers.
Companies would also be required to notify the FDA in advance of any unit relocation, which the agency says closes a gap in its real-time oversight capabilities.
“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 are designed to support newer manufacturing approaches, including modular and continuous manufacturing operations that have emerged in recent years.
The rule would also address foreign establishments that manufacture drugs or active pharmaceutical ingredients that indirectly enter the U.S. drug supply, requiring them to register with the FDA.
A significant oversight gap the proposal seeks to close involves foreign factories producing raw drug materials that remain invisible to U.S. regulators by routing products through intermediate facilities overseas.
If finalised, the rule is expected to reduce registration costs for distributed manufacturing companies and generate long-term efficiencies for both the industry and the agency.
The FDA described the action as part of a broader coordinated effort to ensure Americans have reliable access to safe, quality medicines while strengthening domestic pharmaceutical manufacturing.
The agency also said the proposed changes would ensure that regulatory frameworks keep pace with ongoing innovation across the pharmaceutical manufacturing sector.