Baxter, a medical technology and healthcare company, has provided an update on its North Cove, North Carolina, injectables manufacturing facility, which was flooded and severely impacted by the rain and storm surge from Hurricane Helene, which struck parts of the Southeast, including Western North Carolina, where the facility is located, on September 26, 2024.  

The facility produces IV solutions, irrigation fluids, and peritoneal solution, among other products. The facility’s shutdown is further contributing to current industry-wide drug shortages of normal saline IV fluids, normal saline irrigation fluid, sterile water irrigation, and dextrose 5% IV fluids that pre-dated Hurricane Helene, according to information from the US Department of Health and Human Services (HHS). 

Baxter provides update  
Baxter reported that as of October 9, 2024, its North Cove facility is still offline and that it is continuing to advance multiple paths to manage inventory and minimize supply disruption as it works to fully restore manufacturing operations. This includes implementing allocations, which limit what a customer can order based on historical purchases and medical necessity as well as available and projected inventory.  

Based on efforts to increase manufacturing capacity at its other sites and the anticipated timing of inbound products and air shipments, Baxter increased its current US allocation levels of its highest-demand IV fluids for direct customers from 40% to 60%, and for distributors from 10% to 60%, effective October 9, 2024.  It is also increasing high concentration dextrose and sterile water for injection allocations and expects to be in a position to make additional increases for certain product codes by early November (November 2024). Allocations for IV solutions and nutrition products for designated children’s hospitals were increased to 100%. 

In addition, the company also says it is actively working to deliver supplies to current peritoneal dialysis (PD) patients, and it is working with partners to conserve and identify alternate sources of supply across all PD product categories and is monitoring stock levels and working with partners and professional bodies to optimize utilization of PD supplies. 

“Our goal continues to be to restore customers to 100% allocation levels as soon as possible,” said the company in its October 9, 2024, update. “This would be achieved through a combination of importing products from other Baxter facilities and the resumption of operations and scale up of production at our North Cove facility.“ 

Baxter says it continues to scale production across its global locations and is working with the US Food and Drug Administration (FDA) on temporary importation of products to increase available inventory. FDA reported on October 9, 2024, that this applies to some products already in shortage industry wide and which were further impacted by the recent facility’s shutdown and include:  

• Dextrose 5% IV solution – (shortage posted on 2/14/22)  

• Dextrose 10% IV Solution – (shortage posted on 2/14/22)  

• Sodium Chloride 0.9% IV Solution (Normal Saline) – (shortage posted on 6/21/18)  

• Sodium Chloride 0.9% for Irrigation – (shortage posted on 4/28/23)  

• Sterile Water for Injection – (shortage posted on 11/23/21)  

• Sterile Water for Irrigation – (shortage posted on 4/28/23)  

FDA says additional products may be added to the FDA shortage list if FDA were to determine that the total supply, including importation of product from other Baxter facilities outside the US, dips below national demand. 

In its October 9, 2024, update, Baxter says its goal is to restart North Cove production in phases and return to 90% to 100% allocation of certain IV solution product codes by the end of 2024, based on its current status of its remediation efforts, its expectations regarding its ability to reallocate capacity from other Baxter facilities, and initiation of temporary importation on certain products.   

HHS provides update on US government response 
Meanwhile, HHS Secretary Xavier Becerra also provided an update on October 9, 2024, to say that that HHS is coordinating a US government-wide response to address supply-chain disruptions and is working with public and private partners to support the supply chain while the Baxter facility is brought back to full operational capacity. He says FDA, which  is part of HHS, will continue working with Baxter to identify both potential products already in their system and alternative manufacturing sites, including for potential temporary imports. As alternatives are identified, the HHS Secretary says FDA is expediting assessments of those options. He says FDA will also expedite consideration of any shelf-life extension requests manufacturers submit for short-dated products and will continue to work with Baxter as it bring their plant back online and with other suppliers to increase supply. 

Lastly, he said that the Administration for Strategic Preparedness and Response, which is part of HHS, is working with Baxter and other US government partners to support infrastructure repairs and ensure the facility can resume operations as quickly as possible. 

Source: Baxter, HHS, FDA