The U.S. Food and Drug Administration (FDA) has introduced a proposed rule that, if finalized, would establish a simplified drug manufacturing registration pathway for distributed manufacturing establishments operating as a single establishment through a “hub-and-spoke” model. The proposal also seeks to clarify drug manufacturing registration requirements for certain foreign establishments that manufacture drugs, including active pharmaceutical ingredients, which indirectly enter the U.S. drug supply. This initiative represents another step in the FDA’s broader effort to help ensure Americans have dependable access to safe, quality medicines by strengthening domestic pharmaceutical manufacturing while ensuring regulatory frameworks continue to keep pace with innovation.
Under the proposed framework, distributed manufacturing establishments would continue operating with a central quality oversight hub connected to multiple equivalent manufacturing units across different locations. Existing regulations require every manufacturing unit within such a network to complete a separate registration, resulting in administrative complexity. Through the proposed drug manufacturing registration changes, these distributed manufacturing establishments could instead register as a single establishment. The proposal would also allow manufacturing units to be added, relocated or removed using a streamlined update process. In addition, companies would be required to notify the FDA before relocating any manufacturing unit, addressing a gap in the agency’s 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 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,” he added.
Proposal Clarifies Foreign Registration Requirements and Supply Chain Visibility
Beyond domestic manufacturing, the proposed rule also addresses drug manufacturing registration and drug listing obligations for certain foreign drug manufacturing establishments. At present, some foreign establishments that manufacture drugs, including components of drugs such as active pharmaceutical ingredients, exclusively for distribution to other foreign establishments may not be registered with the FDA.
According to the agency, this limits visibility into upstream supply chains. By aligning the regulations with statutory requirements, the proposed rule would make it clear that these establishments are required to register with the FDA and report the drugs they manufacture. The agency says this would improve its ability to identify and respond to potential safety concerns affecting the supply chain.
If the proposed rule is finalized, the FDA expects it to lower registration costs for distributed manufacturing companies while creating long-term efficiencies for both the pharmaceutical industry and the agency. The proposal also builds on a series of administration actions focused on revitalizing American pharmaceutical manufacturing, strengthening supply chain transparency, and reducing vulnerabilities across the drug supply chain.
