The FDA has proposed a rule to streamline drug manufacturing registration for hub‑and‑spoke, or distributed manufacturing, models, allowing these networks to register as a single establishment instead of each unit registering separately.
The proposed rule would reduce administrative burden on companies, enable easier addition, relocation, or removal of manufacturing units via a streamlined update process, and require advance notification to the FDA of any unit relocation.
The rule would also clarify registration and drug listing requirements for certain foreign establishments manufacturing drugs or active pharmaceutical ingredients that indirectly enter the U.S. drug supply, enhancing FDA visibility into upstream supply chains.
Comments on the proposed rule are due by September 11, 2026.
Sources:
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