The U.S. Food and Drug Administration (FDA) has proposed a rule to streamline registration for certain distributed drug manufacturing sites and clarify reporting requirements for some foreign production facilities, as part of its efforts to improve supply-chain transparency.

If finalized, the rule, proposed on Friday, would allow manufacturers using a "hub-and-spoke" model to register as a single facility. In this model, a central site oversees quality operations across multiple units producing the same products at different locations.

Under current regulations, each manufacturing unit within such a network must register separately with the FDA. The agency said the proposed rule would instead allow distributed manufacturing establishments to register as a single establishment, while enabling manufacturing units to be added, relocated or removed through a streamlined update process. Companies would also be required to notify the FDA before relocating a manufacturing unit.

The proposal would also clarify registration and drug-listing requirements for certain foreign facilities, including those that manufacture active pharmaceutical ingredients. The FDA said some foreign establishments that manufacture drugs or drug components solely for distribution to other foreign facilities may not currently be registered with the agency, limiting its visibility into upstream supply chains.

Under the proposed rule, those facilities would be more clearly required to register with the FDA and report the drugs they produce, improving the agency's ability to trace products and respond to potential safety concerns.

The FDA said the rule, if finalized, is expected to reduce registration costs for distributed manufacturing companies and generate long-term efficiencies for both the industry and