FDA Expands Access to IV and PD Solutions Following Hurricane Helene Disruptions

1 minute read

FDA Expands Access to IV and PD Solutions Following Hurricane Helene Disruptions

In response to supply disruptions caused by Hurricane Helene’s damage to Baxter International Inc.’s North Cove facility in Marion, North Carolina, the FDA has implemented several measures to support healthcare providers in maintaining access to critical IV drugs and peritoneal dialysis (PD) solutions. Acting swiftly, the FDA conducted comprehensive scientific and regulatory assessments to enable the temporary importation of 40 IV and PD fluids from seven Baxter facilities worldwide. These imports, along with increased production from other manufacturers, are expected to help bridge supply gaps over the coming weeks.

Additionally, on October 28, the FDA announced extended use dates for specific lots of parenteral drug products, following a stability review submitted by Baxter International. This extension will allow providers and patients to continue using stock they already have on hand, reducing immediate supply pressures.

Earlier, on October 11, the FDA issued immediately-in-effect guidance allowing new flexibilities for compounding IV solutions, aimed at empowering hospitals and healthcare facilities to produce these solutions on-site as needed. These efforts are part of the FDA’s broader strategy to stabilize the supply chain and ensure ongoing patient access to essential IV and PD solutions during the recovery period.