FDA declares end to IV saline shortage

The Food and Drug Administration has declared that the nationwide shortage of sodium chloride 0.9% injection, for IV saline, is now over.

The FDA credited the end of the shortage on its collaboration with the Administration for Strategic Preparedness and Response, as well as industry partners, who worked “swiftly and strategically” to expand manufacturing capacity and restore stability to the supply chain, the agency said.

The FDA also used available regulatory tools to help increase the supplies that were available to hospitals, the agency said. For example, the FDA conducted scientific and regulatory assessments to help facilitate the temporary importation of intravenous solutions, and expedited reviews to increase manufacturing capacities and extend product expiry.

With the shortage now resolved, the products will be removed from the FDA list of Current Shortages in the Drug Shortage Database on the FDA website. The agency is recommending that hospitals, health systems and clinics use the FDA-approved drug when available.

Other IV fluids are still in shortage. The FDA said it’s working closely with manufacturers and will continue to monitor the supply to help ensure patients have access to needed medications.

“Addressing this shortage has been a top priority for the FDA and aligns with the Trump Administration’s broader commitment to strengthening the U.S. drug and medical supply chain,” the agency wrote.

The FDA maintains that it’s still working to monitor supply levels, anticipate potential disruptions, and support a robust and transparent supply chain.

Last October, American Hospital Association President and CEO Rick Pollack sent a letter to President Biden urging immediate action to increase the supply of IV solutions for hospitals and other providers.

The IV solution shortage was due to the closure of a Marion, North Carolina, manufacturing plant that was damaged by Hurricane Helene.