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FDA proposes updated registration and drug listing requirements for distributed manufacturing and certain foreign establishments
Today, FDA published the proposed rule, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments. The proposed rule, if finalized as proposed, would amend the registration requirements described in 21 CFR 207 to provide a streamlined registration pathway for certain drug manufacturing establishments engaged in distributed manufacturing, a decentralized drug manufacturing strategy that uses advanced manufacturing technologies. It also clarifies registration and listing requirements for certain foreign drug manufacturing establishments.
Distributed manufacturing is a focus of FDA’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) initiative, which aims to prepare a regulatory framework to support the adoption of advanced manufacturing technologies. This rule, if finalized, creates a streamlined registration pathway specific to certain distributed manufacturing establishments that would allow them to register as a single establishment comprising one or more distributed manufacturing units and a distributed manufacturing hub responsible for quality oversight. Under the model proposed in the rule, the establishment could add, remove, or relocate a distributed manufacturing unit as an expedited update to the registration. This process would be less burdensome than treating each distributed manufacturing unit as a drug manufacturing establishment with its own registration requirement. Advanced manufacturing technologies, such as those that make distributed manufacturing approaches possible, require a skilled workforce, which can facilitate U.S.-based pharmaceutical manufacturing competitiveness as well as help to ensure a stable supply of drugs critical to the health of U.S. patients.  (May 5, 2025) and is a priority for the administration. Executive Order 14293 (May 5, 2025)
This proposed rule is part of FDA’s continued efforts to support the use of distributed manufacturing. FDA intends to publish guidance for industry on other key topics regarding the use of distributed manufacturing to facilitate its implementation. Specifically, the Agency intends to publish guidance in 2026 on the recommended information to include in drug applications when using distributed manufacturing, and approaches to complying with drug CGMP requirements.
This rule, if finalized, will also improve FDA’s supply chain visibility by clarifying the requirement that foreign establishments must register their facilities even if their products, including active pharmaceutical ingredients, will be further processed by another foreign establishment before being imported into the United States. Establishments would also have to provide drug listing information for such drugs.
To learn more, visit our webpage detailing FDA actions to support and strengthen domestic drug manufacturing, including our recently proposed rule to modernize drug manufacturing registration.
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