The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend the drug establishment registration and drug listing requirements with respect to establishments engaged in distributed manufacturing and foreign drug establishments. This action, if finalized, will provide a pathway for a distributed manufacturing establishment that manufactures drugs at multiple different physical locations to register as a single drug manufacturing establishment and align drug establishment registration and drug listing regulations applicable to foreign drug establishments with statutory changes made by the Preparing for and Responding to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act).
US Federal Register - FDA Rules · July 13, 2026
Proposed amendments to drug establishment registration and drug listing requirements for distributed manufacturing and foreign establishments
Original title: Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
FDA proposes to amend drug establishment registration and listing rules to enable distributed manufacturing facilities to register as single establishments and align foreign establishment requirements with the PREVENT Pandemics Act.
Published by US Federal Register - FDA Rules. HealthSignal links to the original document; the summary above is extracted from the source text.