The US 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.

Details of the Proposal

The proposed rule would allow manufacturers using a “hub-and-spoke” model to register as a single facility. In such a model, a central site oversees quality operations across multiple units producing the same products at different locations.

Under current regulations, each manufacturing unit in such a network must register separately with the U.S. Food and Drug Administration. The proposed rule would enable units to be added, relocated or removed through a streamlined update process.

Companies would 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 make active pharmaceutical ingredients.

Original reporting: Appleton, WI News Feed (HLL/CB) — read the source article.