FDA proposes streamlined registration rule for hub-and-spoke drug manufacturing networks

The FDA released a proposed rule that would let distributed drug manufacturing facilities using a hub-and-spoke model register as a single establishment.

Under current regulations each site must register separately, creating administrative burdens. The new approach would allow companies to add, move, or close satellite sites through a streamlined update process.

The proposal also clarifies registration requirements for foreign manufacturers that produce active pharmaceutical ingredients that enter the U.S. supply indirectly.

The agency says the change is meant to modernize the regulatory framework, support domestic manufacturing capacity, and improve real-time oversight of site relocations.