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FDA issues temporary guidance to support neonatal starter parenteral nutrition supply amid outsourcing facility closures
In response to concerns about potential supply gaps of neonatal starter parenteral nutrition (PN) due to the shutdown of two outsourcing facilities producing standardized neonatal starter PN products, the U.S. Food and Drug Administration issued immediately effective temporary guidance. This guidance outlines regulatory and enforcement priorities to help state-licensed pharmacies, federal facilities, and outsourcing facilities compound certain starter PN drug products for neonates under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act. The FDA's actions aim to maintain access to critical nutrition for premature and critically ill newborns who receive nutrients intravenously and cannot be fed by mouth or tube. The FDA will continue monitoring supply and may take further action as needed.
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Facts
- Established fact
The FDA announced actions to address a potential supply gap of neonatal starter parenteral nutrition.
- Established fact
Certain standardized neonatal starter PN products are being discontinued due to the permanent shutdown of two outsourcing facilities.
- Established fact
The FDA issued immediately effective guidance titled 'Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates' to describe temporary regulatory and enforcement priorities to prevent supply disruption.
- Established fact
The guidance is intended for state-licensed pharmacies, federal facilities, and outsourcing facilities compounding specified parenteral drugs under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.
- Established fact
Neonatal starter PN provides essential nutrients intravenously to premature and critically ill newborns who cannot receive nutrition by mouth or feeding tube.
- Established fact
The FDA will continue monitoring supply and assess if additional action is needed.
What changed
Issuance of temporary guidance to address potential supply gaps and support hospital access to compounded neonatal starter PN products.
Who is affected
Neonatal starter parenteral nutrition products and compounding facilities including state-licensed pharmacies, federal facilities, and outsourcing facilities.
What happens next
FDA will monitor supply needs and assess if additional measures are required.
Sources
1 SOURCE