Baxter’s North Cove plant located in Marion, North Carolina was significantly impacted by rain and flooding from Hurricane Helene. The facility specializes in the production of intravenous (IV) and peritoneal dialysis solutions and is the leading US manufacturer of these products.
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Baxter’s North Cove plant located in Marion, North Carolina was significantly impacted by rain and flooding from Hurricane Helene. The facility specializes in the production of intravenous (IV) and peritoneal dialysis solutions and is the leading US manufacturer of these products.
On October 7, Baxter provided an infrastructure update on the North Cove plant, reporting no structural damage and anticipating engineering certification within two weeks. Power has been restored, the local water source is intact, and a temporary "rock bridge" supports transport, with a second bridge expected soon.
Baxter is continuing efforts to increase manufacturing capacity at its other sites. Their goal is to restart North Cove production in phases and return to 90% to 100% allocation of certain IV solutions by the end of the year.
On October 9, the Department of Health and Human Services (HHS) released a letter to health care stakeholders assuring that they are working with Baxter and other IV solutions manufacturers to address any potential gaps in the supply chain, mitigate impacts from Hurricane Helene and Hurricane Milton, and continuing to bolster the IV solutions supply chain.
This includes the FDA expediting assessments of alternative IV solutions and expediting shelf-life extension requests from manufacturers on short-dated products.
Impacts to Healthcare Supply Chain
The following products are currently in shortage (pre-dating Hurricane Helene) and could be further constrained until the Baxter North Cove facility resumes operations:
Dextrose 5% IV solution
Dextrose 10% IV Solution
Sodium Chloride 0.9% IV Solution (Normal Saline)
Sodium Chloride 0.9% for Irrigation
Sterile Water for Injection
Sterile Water for Irrigation
The FDA has provided information on compounding drugs when appropriate if a drug is not available.
As of October 9, Baxter stated that they are implementing allocations of their highest demand IV fluids for:
Braun’s manufacturing plant and distribution center in Daytona Beach, Florida, could be impacted by Hurricane Milton. The site primarily produces 0.9% Sodium Chloride for injection.
Both the plant and distribution center are currently closed, with plans to resume operations on Friday, October 11.
HHS ASPR is currently deploying assets to prepare for Hurricane Milton and move any IV solution products away from the projected path of the storm.
On October 7, the American Hospital Association (AHA) sent a letter to President Biden urging the Administration to take action to address the IV solution supply shortage caused by Hurricane Helene. AHA is requesting regulatory flexibility, an official shortage declaration, and measures to extend expiration dates or allow in-house mixing of IV fluids to support hospitals facing critical shortages.
On October 8, the American Society of Health-System Pharmacists (ASHP) sent a letter to HHS, ASPR, and FDA recommending expediting importation from foreign manufacturing sites, identifying alternative manufacturers, and ramping up additional domestic capacity. Additional recommendations on short-term and long-term resolutions and mitigation efforts can be found here.
It is anticipated that IV fluid shortages will remain or be further exacerbated during the next few months.
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