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NHIA Response to Manufacturing Disruption of Intravenous Solutions due to Hurricane Helene

NHIA has developed resources and is urging HHS action in response to the recent operational disruption at Baxter’s North Cove, NC facility due to Hurricane Helene. See the latest resources in NHIA’s IV Fluid Shortage Resource Center.

Guidance for Addressing Product Shortages during Disruptions in Manufacturing
NHIA has developed a new guidance document to provide healthcare organizations with a structured approach for managing product shortages, particularly of diluents, parenteral nutrition (PN) products, and small and large volume parenteral solutions. The document outlines recommendations and considerations to help clinicians and healthcare professionals maintain patient care during these shortages.

Letter to HHS RE: Imminent Intravenous Solution Shortage
In a letter to HHS, NHIA has urged the agency take several measures to minimize the impact on patient care and ensure equitable access to life-saving IV therapies. NHIA has requested HHS declare a shortage of sterile IV solutions to allow 503B compounding facilities to fill gaps in the supply chain; fast-track approval of products approved in the EU; take steps to ensure allocations/distributions of IV fluids go to hospitals and pharmacies that use them for life-saving and medically necessary treatments; and temporarily suspend certain documentation requirements in the PN LCD to allow flexibilities in formulation.

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