FDA Proposes Rule to Modernize Drug Manufacturing Registration Proposed rule would streamline registration for advanced distributed manufacturers and increase visibility into foreign drug supply sources

https://www.fda.gov/news-events/press-announcements/fda-proposes-rule-modernize-drug-manufacturing-registration?utm_campaign=42504259-FnB%2C%20Cosmetics%2C%20Med%20Dev%2C%20Drugs%20%7C%20Newsfeed%20%7C%20Global%20%7C%202026&utm_medium=email&_hsenc=p2ANqtz-9v44-EMHC3g_teh9_yvvYv0yZj1qx3NhhAgxhl4tgyoQNO9bSE3KDBGPN1NymexqZaA8uC2MnP4FCSRHHtx6QztuCNdw&_hsmi=430311558&utm_content=429969268&utm_source=hs_email FDA has proposed a new rule that would streamline registration for distributed drug manufacturing facilities operating under a ""hub-and-spoke"" model while clarifying registration requirements for certain foreign drug manufacturers, including facilities that produce active pharmaceutical ingredients (APIs). If finalized, the rule would reduce administrative burden for innovative manufacturers while giving FDA greater visibility into global drug supply chains and upstream manufacturing activities by expanding applicability of listing requirements to more foreign drug manufactures who are not directly importing its produced products into the United States. Companies should review the proposal closely, as it signals FDA's continued focus on supply chain transparency, advanced manufacturing, and stronger oversight of foreign drug establishments.