White House reviewing FDA proposed rule on distributed manufacturing, foreign facility registration

By Laura DiAngelo, MPH and Ned Pagliarulo

The White House is reviewing a proposed FDA rule that could update registration and listing requirements for entities involved in distributed drug manufacturing as well as certain foreign establishments. The proposal comes as regulators increasingly examine how emerging manufacturing models and globalized supply chains fit within existing regulatory frameworks.

The rule could clarify how distributed manufacturing facilities register with the FDA and codify statutory changes affecting foreign establishments involved in producing drugs imported into the United States.

This AgencyIQ analysis examines how the proposed rule could reshape regulatory oversight of distributed manufacturing and international drug supply chains.

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