The agency published the guidance for immediate implementation, citing the expected market exit of the predominant source of certain starter parenteral nutrition drug products.
Washington, 9 September 2026 — The Food and Drug Administration announced the availability of a guidance for industry titled "Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates".
The notice states that the guidance describes the agency’s regulatory and enforcement priorities regarding the compounding of certain starter parenteral nutrition drug products for neonates by outsourcing facilities, and by State-licensed pharmacies and Federal facilities that are not registered with the agency as outsourcing facilities.
The notice records that the guidance is being published for immediate implementation, and gives as the reason the expected market exit of the predominant source of certain starter parenteral nutrition drug products.
Source documents
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Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates; Guidance for Industry; Availability
- Identifier
- Federal Register document 2026-18368
- As the record states
- The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a guidance for industry titled "Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates." This guidance describes the FDA's regulatory and enforcement priorities regarding the compounding of certain starter parenteral nutrition drug products for neonates by outsourcing facilities and by State-licensed pharmacies and Federal facilities that are not registered with FDA as outsourcing facilities. This guidance is being published for immediate implementation due to the expected market exit of the predominant source of certain starter parenteral nutrition drug products for neonates in the United States.
- Document number
- 2026-18368