Today, the FDA has issued an immediately-in-effect guidance, Temporary Policies for Compounding Certain Parenteral Drug Products, for compounders to help fill the gaps from the impact of Hurricane Helene on Baxter International’s North Cove facility.  The FDA also added three new drug products to the Drug Shortages Database as a result of Hurricane Helene. The agency now considers Dextrose 70% IV solution, Lactated Ringers IV Solution, and Peritoneal Dialysis Solution to not be commercially available in adequate supply to meet national demand.

The FDA is working continuously to address the shortages and supply disruptions to ensure patients have access to certain parenteral drugs, including IV solutions. For the most recent information on drug and biologic products that were impacted by Hurricane Helene, please see FDA’s Baxter Recovery webpage.