On July 10, 2026, the U.S. Food and Drug Administration issued a proposed rule to update drug manufacturing establishment registration requirements. If finalized, the rule would create a streamlined registration pathway for distributed manufacturing establishments operating as a single establishment under a “hub-and-spoke” model. It would also clarify registration requirements for certain foreign establishments that manufacture drugs, including active pharmaceutical ingredients, that indirectly enter the U.S. drug supply.
Registration for distributed manufacturing
Distributed manufacturing establishments use a central quality oversight hub and multiple equivalent manufacturing units at different locations. Under current regulations, each manufacturing unit in such a network must register separately. The FDA said this creates unnecessary administrative burdens. Under the proposed rule, the network could register as a single establishment, while units could be added, relocated or removed through a streamlined update process.
Companies would be required to notify the FDA in advance of any unit relocation. The agency said this requirement would address a gap in its real-time oversight. “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.”
Foreign establishments and supply-chain visibility
The proposal would also clarify registration and drug listing requirements for certain foreign drug manufacturing establishments. Some foreign establishments that manufacture drugs, including components such as active pharmaceutical ingredients, only for distribution to other foreign establishments may currently not be registered with the FDA. The agency said this can limit its visibility into upstream supply chains.
By aligning the regulations with statutory requirements, the proposed rule would make clearer that these establishments must register with the FDA and report on the drugs they produce. The FDA said this would give it greater ability to detect and respond to potential safety concerns. “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.”
If finalized, the proposed rule is expected to reduce registration costs for distributed manufacturing companies and generate long-term efficiencies for industry and the FDA. The agency described the proposal as part of coordinated efforts to strengthen domestic pharmaceutical manufacturing, improve supply chain transparency and reduce vulnerabilities in the drug supply chain. The proposed rule is available through the FDA’s announcement.