Editor’s note: For more coverage of drug, immunization and medical device supply shortages, visit https://bit.ly/AAPNewsDrugShortages.
Baxter International has restarted manufacturing some intravenous (IV) solutions at a critical North Carolina facility flooded by Hurricane Helene, and health officials are allowing extended use dates on some of the company’s products produced before the storm.
Baxter’s North Cove plant in North Carolina, which produces a significant portion of the country’s IV fluid and peritoneal dialysis (PD) solutions, closed in late September due to flooding. Supply disruptions caused by the closure came on top of existing shortages of several IV solutions and have led hospitals to postpone surgeries, according to news reports.
Baxter announced Thursday it has restarted an IV solutions manufacturing line that represented about 25% of the site’s total production and about half of the site’s production of one-liter IV solutions. While the restart is ahead of expectations, the company noted it still will not be ready to ship the products until late November. Health officials said they will be monitoring the products for quality and safety.
“Recovery progress at our North Cove site continues to be very encouraging,” Baxter Chairman, President and CEO José (Joe) E. Almeida said in a statement. “In a matter of weeks, our team has advanced from the depths of Hurricane Helene’s impact to restarting our highest-throughput manufacturing line. This is a pivotal milestone, but more hard work remains as we work to return the plant to full production.”
Baxter is continuing to work on site remediation and equipment assessment so the North Cove plant can restart additional production as quickly as possible. The U.S. Department of Health and Human Services recently invoked the Defense Production Act to help with these efforts.
The company has moved more than 885 truckloads of products produced at the North Cove site before the hurricane and has been working with federal officials to import products from its international facilities. Baxter projects about 18,000 tons of products from Europe and Asia will be imported by the end of the year.
The Food and Drug Administration (FDA) also announced this week it would extend the expiration dates on more than 50 of Baxter’s products, providing up to 12 months of additional use time.
The FDA previously released guidance that increases flexibility around compounding certain parenteral drug products. The guidance does not require use of the products within 24 hours and does not include provision about distribution beyond a one-mile radius.
Baxter is aiming to return to 90% to 100% allocation of certain IV solution products by the end of the year. In the meantime, the company and health officials are urging health care providers to continue to conserve these products.
Resources
- Information from Baxter on IV fluid and peritoneal dialysis solution supply disruptions related to Hurricane Helene
- Information on extended expiration dates for Baxter products
- Centers for Disease Control and Prevention health advisory on conservation of IV and peritoneal dialysis solutions
- Information from the FDA on product importation and compounding
- Oct. 18 update from HHS regarding IV fluid supply shortages
