Federal Register #2026-18368

FDA Guidance on Compounding Neonatal Parenteral Nutrition Drug Products

The Food and Drug Administration (FDA), under the Department of Health and Human Services, has released guidance for industry regarding compounding starter parenteral nutrition drug products for neonates. - Government Buyer: - Food and Drug Administration (FDA) - Department of Health and Human Services - Context: - Guidance issued due to anticipated exit of the main supplier of neonatal parenteral nutrition drug products in the U.S. - Aims to ensure continued access to essential neonatal nutrition products for patients - Scope: - Applies to outsourcing facilities, State-licensed pharmacies, and Federal facilities not registered as outsourcing facilities - Products/Services: - No specific products, part numbers, or quantities are mentioned - No OEMs or vendors identified - Unique Requirements: - Policy update for immediate implementation - Focuses on regulatory and enforcement priorities for compounding neonatal nutrition drug products - Not a procurement opportunity or award; informational guidance only

Description

The Food and Drug Administration (FDA) is announcing the availability of guidance for industry titled "Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates." This guidance outlines FDA's regulatory and enforcement priorities regarding the compounding of certain starter parenteral nutrition drug products for neonates by outsourcing facilities, State-licensed pharmacies, and Federal facilities not registered as outsourcing facilities. It is published for immediate implementation due to the expected market exit of the predominant source of these drug products in the United States. The guidance aims to ensure patient access to essential neonatal nutrition products during this transition.

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