WEEKLY UPDATE: 10/31/24
The U.S. Food and Drug Administration (FDA) on Monday, October 28 announced its approval to extend the shelf life of more than 50 intravenous (IV) and irrigation solutions produced by Baxter International. This week, Baxter also restarted production at its North Carolina plant for the highest-throughput IV solutions, including one-liter IV solutions, which are the most commonly used by hospitals, and aims to begin distribution of the products by late November at the earliest. The company continues to make significant progress in remediation efforts to restore the facility, which shut down in September due to damage from Hurricane Helene.
The recent FDA authorization provides up to an additional 12 months of expiry — a total 24-month expiry period from the date of manufacture — and only applies to products manufactured before the end of September 2024. Hospital pharmacies and outsourcing pharmacies are still permitted temporary flexibility to manufacture the fluids on the FDA’s official shortage list.
To help meet domestic demand, the federal government has established a coordinated effort to airlift IV solutions from several global Baxter sites to the U.S., and the first product shipments arrived on October 19. Additional deliveries will be imported over the coming weeks and filtered through normal distribution channels.
Allocations for hospitals across the country remain at 60% of normal shipment volumes. Connecticut hospitals and health systems continue to employ alternative hydration and medication delivery methods, as conservation of IV and peritoneal dialysis (PD) remains crucial to preserving quality of patient care. The Connecticut Hospital Association (CHA) is monitoring impacts on operations throughout the state in collaboration with healthcare providers and the Connecticut Departments of Public Health (DPH) and Consumer Protection (DCP). This week, CHA met with Connecticut congressional delegation staff to elevate member feedback and address concerns. CHA is also continuing to advocate for the federal government to incentivize manufacturers to expand production of materials and goods needed to produce sterile IV and PD solutions and containers.
Click here for more information on the shortage, including local and national IV solution shortage updates, CHA’s advocacy efforts to mitigate impacts of the supply chain disruption in Connecticut, and resources to inform conservation strategies.
Baxter’s major manufacturing plant located in Marion, North Carolina provides approximately 60% — or 1.5 million bags — of the IV solutions used every day in the U.S., making the facility the top supplier of hospital IV fluids and PD solutions in the country. Baxter does not have a timeline for when production at the North Cove facility will be fully restored to pre-hurricane levels but estimates a return to 90-100% allocation of certain IV solution product codes by the end of the year.
