FDA: National IV saline shortage over after years of strained supply

Editor's Note

The Food and Drug Administration (FDA) officially declared the nationwide shortage of sodium chloride 0.9% injection products over, saying a critical supply line for hospitals and surgical teams is restored. According to an August 8 statement from FDA Commissioner Martin A. Makary, MD, MPH, the resolution marks a major milestone for public health and reflects coordinated action across federal agencies and the industry to stabilize access to this essential IV saline solution.

As detailed in the statement, the shortage’s resolution followed intensive collaboration between the FDA, the Administration for Strategic Preparedness and Response, and manufacturers. Efforts focused on expanding production capacity, streamlining supply chain operations, and leveraging regulatory measures to bridge gaps in availability. The FDA conducted expedited assessments to enable temporary importation of IV solutions, fast-tracked manufacturing expansions, and approved extensions to product expiration dates when appropriate, all to ensure hospitals could meet patient needs during the shortage.

Sodium chloride 0.9% injection products will be removed from the FDA’s Drug Shortage Database. Hospitals and clinics are encouraged to use FDA-approved formulations whenever possible. While this particular shortage is over, the FDA notes some IV fluids remain in limited supply. Ongoing collaboration with manufacturers and real-time monitoring of production levels will continue as part of the agency’s broader strategy to safeguard the drug and medical supply chain.

Per the announcement, the FDA’s approach reflects a larger push under the Trump Administration to bolster the resilience of US medical product manufacturing and distribution systems.