The Food and Drug Administration issued immediately effective guidance on Friday to head off a national shortage of the intravenous nutrition given to premature and critically ill newborns within hours of birth. The agency acted after children's hospitals raised concerns about continued access, prompted by the discontinuation of standardized neonatal starter products made by two outsourcing facilities that are permanently shutting down.
For families with a baby in a neonatal intensive care unit, this is not a product that can be swapped for something on a store shelf. Starter parenteral nutrition delivers essential nutrients through an IV line to infants who cannot take anything by mouth or through a feeding tube. There is no consumer substitute and no home version. When it is unavailable, hospital pharmacies must compound each bag individually, which takes longer at exactly the moment when time matters most.
