The U.S. Food and Drug Administration announced on September 4, 2026, that it is taking steps to address a potential supply gap for neonatal starter parenteral nutrition (PN). These products provide essential nutrients through an IV to premature and critically ill newborns who cannot receive nutrition by mouth or through a feeding tube. The agency became aware of the potential gap after children’s hospitals raised concerns regarding the discontinuation of certain standardized neonatal starter PN products made by two outsourcing facilities that are permanently shutting down.
In response, the FDA issued an immediately-in-effect guidance titled "Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates." This guidance outlines the agency’s temporary regulatory and enforcement priorities for certain state-licensed pharmacies, federal facilities, and outsourcing facilities that compound specified parenteral drugs under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.
The guidance is intended to help address potential supply gaps and support hospitals in continuing to access critical nutrition drug products while longer-term solutions are identified. Acting FDA Commissioner Kyle Diamantas stated, "The FDA is committed to deploying every regulatory tool available to prevent critical supply chain gaps from threatening patient care." Acting Center Director of the FDA’s Center for Drug Evaluation and Research, Michael Davis, M.D., Ph.D., added, "Starter parenteral nutrition is especially important for premature and critically ill newborns who need nutrition soon after birth. These temporary policies are intended to help hospitals maintain access to this life-saving nutrition during this transition."
The FDA stated that it will continue to monitor current and expected supply needs and assess if additional action is needed as the situation develops.
