Primary source: Download the Final Guidance Document
Translated From Spanish
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The FDA published guidance for immediate implementation regarding compounding of certain starter parenteral nutrition drug products for neonates.
This guidance facilitates compounding by outsourcing facilities and licensed pharmacies, addressing potential shortages due to the market exit of the predominant source for these products.
Regulatory Affairs must implement the new compounding policies immediately to ensure compliance and mitigate risks associated with product availability.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Regulatory Affairs must implement the new compounding policies immediately to ensure compliance and mitigate risks associated with product availability.
This guidance outlines the FDA's regulatory and enforcement priorities related to compounding certain starter parenteral nutrition drug products for neonates by outsourcing facilities and state-licensed pharmacies. With an effective date of September 4, 2026, this policy is prompted by the expected market exit of the primary source of these products.
What changed: The FDA published guidance for immediate implementation regarding compounding of certain starter parenteral nutrition drug products for neonates.
Why it matters: This guidance facilitates compounding by outsourcing facilities and licensed pharmacies, addressing potential shortages due to the market exit of the predominant source for these products.
Practical implication: Regulatory Affairs must implement the new compounding policies immediately to ensure compliance and mitigate risks associated with product availability.
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