The Food and Drug Administration (FDA) on Oct. 11 issued new temporary guidance relaxing manufacturing requirements for IV solutions following the temporary closure of Baxter International Inc.’s North Cove, N.C. facility due to damages from Hurricane Helene.
Citing the low supply of Dextrose 70% IV solution, Lactated Ringers IV solution, and Peritoneal Dialysis solution commercially available to meet national demand, the agency clarified that it does not intend to penalize pharmacies that provide IV solutions to hospitals without first obtaining a patient-specific prescription.
FDA also shares guidance on compounding parenteral drugs and is considering policy changes to extend the shelf life of these drugs. The agency advises hospitals not to dispose of expiring or expired products.
Baxter announced Oct. 10 that it would increase IV fluid allocations from 40 to 60 percent for most hospitals and up to to 100 percent for designated children’s hospitals. The company plans to update its website every Monday and Thursday with supply shortage information.
Association Action
America’s Essential Hospitals on Oct. 10 sent a letter urging the administration to use all available tools to increase IV fluid supply and ensure supplies are available to essential hospitals.
The association also seeks federal action to mitigate the resulting financial challenges essential hospitals face.
In the letter, the association urged the federal government to allow advance payments in Medicare and Medicaid as a first step to mitigate cash flow issues at essential hospitals due to the shortage. America’s Essential Hospitals also encouraged policymakers to consider additional policy levers to help essential hospitals offset the increased cost of procuring IV solutions and the lost revenue from deferred care. The association echoed these concerns in an Oct. 11 letter to congressional leadership.
If you are experiencing severe supply shortages, contact Director of Policy Rob Nelb, MPH, at rnelb@essentialhospitals.org or 202.585.0127. He may be able to connect you directly with Baxter leadership. Baxter also has encouraged hospitals facing acute challenges to email the company directly at hurricanehelenesupport@baxter.com.
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