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Product safetyFDAUnited StatesImports

Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates; Guidance for Industry; Availability

9 September 2026

In plain English

FDA issued guidance setting temporary enforcement and regulatory priorities for compounding certain starter parenteral nutrition drug products for neonates by outsourcing facilities, State-licensed pharmacies and Federal facilities.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
9 September 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

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
The full text is at the source

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