FDA issues guidance to prevent newborn nutrition supply gap

The U.S. Food and Drug Administration announced it is taking action to address a potential supply gap of neonatal starter parenteral nutrition, which provides essential IV nutrients to premature and critically ill newborns.

The issue was raised after two outsourcing facilities that produced standardized starter PN products announced permanent shutdowns, prompting children’s hospitals to express concerns about continued access.

Acting FDA Commissioner Kyle Diamantas said the agency will deploy every regulatory tool available and is working closely with healthcare providers and industry partners to ensure vulnerable patients receive needed care.

To mitigate the risk, the FDA is issuing an immediately effective guidance called Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates, outlining steps to prevent a disruption in supply.