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Pharmaceutical Supply Chain Compliance

FDA Proposes Distributed Manufacturing Registration Pathway and Aligns Foreign Establishment Registration and Listing Requirements With Current Law

[07/29/26]

Posted on July 29, 2026 in Health Law News

Published by: Hall Render

The U.S. Food and Drug Administration (“FDA”) issued a proposed rule to update drug establishment registration and listing requirements for distributed manufacturing (“DM”) and certain foreign drug establishments. If finalized, the rule would create a streamlined registration pathway for qualifying distributed manufacturing establishments (“DMEs”) that manufacture drugs at multiple physical locations, while also aligning... READ MORE

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