FDA Proposes Changes to Foreign Drug Manufacturer Rules

The Food and Drug Administration has issued a proposed rule that would amend the drug establishment registration and drug listing requirements with respect to establishments engaged in distributed manufacturing as well as foreign drug establishments. Comments on this rule are due no later than Sept. 11.

According to the FDA, distributed manufacturing establishments operate using a hub-and-spoke model, with a central quality oversight hub and multiple equivalent manufacturing units at different locations. Current FDA regulations require each manufacturing unit in such a network to register separately, but under the proposed rule distributed manufacturing establishments could register as a single establishment. Units could be added, relocated, or removed through a streamlined update process, and companies would be required to notify the FDA in advance of any unit relocation.

The proposed rule would also clarify registration requirements for certain foreign establishments that manufacture drugs, including active pharmaceutical ingredients, that indirectly enter the U.S. drug supply. Currently, the FDA explains, some foreign establishments that manufacture drugs (including components such as APIs) only for distribution to other foreign establishments may not be registered with the FDA, limiting the agency’s visibility into upstream supply chains. The proposed rule would align the FDA’s regulations with statutory changes made by the Preparing for and Responding to Existing Viruses, Emerging New Threats, and Pandemics Act and make it clearer that these establishments must register with the FDA and report on the drugs they produce.