The US FDA has declared an end to the national shortage of sodium chloride 0.9% injection products, a form of intravenous (IV) saline.
RT’s Three Key Takeaways:
- Shortage Resolved: The nationwide shortage of sodium chloride 0.9% IV saline has officially ended and will be removed from the FDA’s Current Shortages list.
- Collaborative Response: Resolution was achieved through expanded manufacturing capacity, temporary importation, and expedited regulatory reviews, in partnership with federal agencies and industry.
- Ongoing Monitoring: The FDA will continue to address other IV fluid shortages and focus on preventing future supply disruptions to strengthen the US medical supply chain.
FDA commissioner Marty Makary, MD, MPH, says a combination of expanded manufacturing, imports, and expedited regulatory processes have prompted removal of 0.9% sodium chloride saline from the FDA’s Current Shortages list.
The FDA added prefilled 0.9% sodium chloride IV saline flush syringes to its medical device shortage list and device discontinuance list on March 21, 2022.
The shortage had multiple contributing factors, including the COVID-19 pandemic, supply chain disruptions, and natural disasters including Hurricane Helene’s impact on production facilities in North Carolina in 2024.
Makary issued the following statement on the development:
I am pleased to announce that the nationwide shortage of sodium chloride 0.9% injection products, a form of intravenous (IV) saline, has officially ended. This marks a significant milestone for public health and reinforces the FDA’s commitment to ensuring Americans have consistent access to life-saving medical products.
This success is the result of close collaboration between the FDA, the Administration for Strategic Preparedness and Response, and our industry partners, who worked swiftly and strategically to expand manufacturing capacity and restore stability to the supply chain. Their responsiveness and innovation have been vital to this achievement. In addition, the FDA used its available regulatory tools to help increase supplies available to hospitals to help meet patient needs. 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.
The shortage of sodium chloride 0.9% injection products has resolved, and therefore these products will be removed from the FDA list of Current Shortages in the Drug Shortage Database on the FDA website.
We generally recommend hospitals, health systems, and clinics use the FDA-approved drug when available.
For other IV fluids still in shortage, the FDA is working closely with manufacturers and will continue to monitor the supply to help ensure patients have access to the medicines they need. The availability of reliable medical products is essential to patient care and the overall resilience of our healthcare system. Addressing this shortage has been a top priority for the FDA and aligns with the Trump Administration’s broader commitment to strengthening the US drug and medical supply chain.
The FDA remains focused on doing all we can to help mitigate shortages and prevent them from occurring. We will continue working diligently to monitor supply levels, anticipate potential disruptions, and support a robust, secure, and transparent supply chain for medical products.
