FDA proposes modernization of drug establishment registration and listing requirements

On July 10, 2026, FDA proposed amendments to 21 CFPR Part 207 to modernize drug establishment registration and drug listing requirements. The proposal addresses distributed manufacturing and certain foreign establishments involved in the US drug supply chain.

Distributed manufacturing is a decentralized manufacturing approach in which equivalent manufacturing units operate at different locations under the oversight of a single quality system. Under the proposed “hub-and-spoke” model, a central hub provides quality oversight, while multiple equivalent manufacturing units or “spokes” manufacture the same drug at different locations.

Currently, each manufacturing unit located at a different physical location generally requires a separate establishment registration. The proposal would allow qualifying distributed manufacturing networks to register as a single establishment, with a streamlined process for adding, relocating, or removing manufacturing units. Advance notification to FDA would be required for relocation or closure of a unit.

The proposal would also clarify that certain foreign establishments manufacturing drugs or APIs that ultimately enter the US market through another foreign establishment must register with FDA and submit applicable drug listing information. This is intended to improve FDA visibility into upstream drug supply chains.

If finalized, the changes could reduce duplicative registration requirements for qualifying distributed manufacturers while increasing supply-chain visibility and registration obligations for certain foreign establishments. The proposal is not currently effective. Follow us for more such updates.