Disruption in Production of Intravenous (IV) Fluid due to Impacts from Hurricane Helene

Dear Colleague:

This letter provides an update to the Clinician Letter that the Virginia Department of Health (VDH) sent on October 21, 2024, regarding the disruption in production of IV solutions as a result of Hurricane Helene on the Baxter International Inc. North Cove manufacturing facility in Marion, North Carolina.

Per an update from Baxter on October 28, 2024, the manufacturer has received Food and Drug Administration (FDA) authorization to extend the use dates of 50+ IV and irrigation codes to provide up to an additional 12 months of expiry. Products now have a 24-month expiry period from the date of the manufacture. This extension only applies to products manufactured prior to the end of September 2024. Details have been communicated directly to customers per the manufacturer.  Please continue to monitor manufacturer notices or guidance related to expiration dates of products and imported solutions at your facility.

Baxter has information regarding the Peritoneal Dialysis (PD) allocations and support in the above update. For additional peritoneal dialysis questions or support in Virginia, please contact Quality Insights Renal Network at [email protected][email protected].

Conservative strategies and measures remain important and effective to mitigate the potential impacts of manufacturing disruption. VDH is requesting all health care providers continue to implement conservation measures and guidance from  FDA for  temporary policies for compounding parenteral drug product.  

The Centers for Disease Control and Prevention (CDC) issued a Health Alert Network (HAN) on October 12, 2024 with recommendations for healthcare providers, pharmacists, and healthcare facility administrators in healthcare facilities.  Current data indicates some supply stabilization with the use of conservation strategies.

VDH continues to work closely with the Virginia Hospital & Healthcare Association (VHHA), Virginia Health Care Association (VHCA), Quality Insights Renal Network, Virginia’s EMS Councils, and other health care organizations, alongside our federal partners, to closely monitor this situation and will continue to provide updates as soon as available.


IV Fluid Resources and Updates

https://www.baxter.com/baxter-newsroom/hurricane-helene-updates

https://meded.baxter.com/hurricane-helene-clinical-resources

https://emergency.cdc.gov/han/2024/han00518.asp

https://www.fda.gov/drugs/updates-2024-hurricane-season/hurricane-helene-baxters-manufacturing-recovery-north-carolina?mkt_tok=MzgxLU5CQi01MjUAAAGWWYbABpHEnn9cG8gVJV_nVutY1jYK7dRw9v2X-ImJsNVprSSy5oCwzp-4H3-WFpHZ9ofOHIFIEOqR7H8dQyQx7EZUNfVH6HOAIvVBs-yeVdZ9Qg

https://www.fda.gov/news-events/press-announcements/fda-roundup-october-11-2024https://www.vdh.virginia.gov/news/hurricane-helene-post-storm-response/#Clinician

https://www.hhs.gov/about/news/2024/10/24/statement-secretary-xavier-becerra-iv-fluid-increase.html

Fact Sheet: HHS Continues Taking Action to Increase Access and Supply of IV Fluids Following Hurricane Helene | HHS.gov

https://www.vdh.virginia.gov/news/hurricane-helene-post-storm-response/#Clinician

Dialysis Management and Conservation:
https://www.baxter.com/sites/g/files/ebysai3896/files/2024-10/10-1_RenalMedical%20Information%20Letter.pdf

List of Parenteral Drug Products in Shortage:
Hurricane Helene: Baxter’s manufacturing recovery in North Carolina | FDA

Products authorized for temporary importation:
https://meded.baxter.com/sites/g/files/ebysai4096/files/2024-10/Temporary%20Importation%20Report%2010.24.24_Final.pdf

Expiration Dating Extensions:
https://meded.baxter.com/sites/g/files/ebysai4096/files/2024-10/ExtendedExpDatesIVSolutions%20v2.pdf

Additional Resources:   

https://www.ashp.org/drug-shortages/shortage-resources/publications/fluid-shortages-suggestions-for-management-and-conservation?loginreturnUrl=SSOCheckOnly

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/temporary-policies-compounding-certain-parenteral-drug-products


Sincerely,
Karen Shelton, MD
State Health Commissioner