The US Food and Drug Administration (FDA) announced it is taking action, consistent with the Trump administration’s commitment to protecting vulnerable patients and maintaining access to critical medical products, to help address a potential supply gap of 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 FDA became aware of the potential supply gap after children’s hospitals raised concerns about continued access to neonatal starter parenteral nutrition. The concerns were based on the discontinuation of certain standardized neonatal starter PN products made by two outsourcing facilities that are permanently shutting down.
“The FDA is committed to deploying every regulatory tool available to prevent critical supply chain gaps from threatening patient care,” said Acting FDA Commissioner Kyle Diamantas, J.D. “We are working closely with healthcare providers and industry partners to help ensure that vulnerable populations continue to have access to the care they need.”
In response, the FDA assessed the situation and identified ways to help prevent a disruption in supply. As part of that effort, the agency is issuing an immediately-in-effect guidance, Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates, describing the agency’s temporary regulatory and enforcement priorities regarding certain compounded starter parenteral nutrition drug products. 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.
“Starter parenteral nutrition is especially important for premature and critically ill newborns who need nutrition soon after birth,” said Michael Davis, M.D., Ph.D., Acting Center Director of FDA’s Center for Drug Evaluation and Research. “These temporary policies are intended to help hospitals maintain access to this life-saving nutrition during this transition.”
The guidance describes 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 FDA will continue to monitor current and expected supply needs and assess if additional action is needed as the situation develops.
The FDA, an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.
