According to Baxter International, the Food and Drug Administration (FDA) approved the change, allowing for fluids to be used up to two years after manufacturing instead of the typical one year.
“This extension only applies to products manufactured prior to the end of September 2024,” said Baxter’s statement. “Details have been communicated directly to customers.”
“We are encouraged to report that, barring any unanticipated developments, Baxter anticipated restarting the highest-throughput IV solutions manufacturing line this week,” Baxter added.
The company has said it didn’t expect to be at full capacity until the end of the year, but credited “the urgency, diligence and resiliency of the North Cove and broader Baxter teams” for exceeding expectations.
The U.S. health care system has been facing a nationwide shortage of IV fluids due to the temporary closure of Baxter’s North Carolina facility.
Fellow IV fluid manufacturers have ramped up their own production, and federal authorities have approved temporary imports of IV fluids products from abroad, all in an effort to mitigate the shortage.
Among the products manufactured at the Baxter plant were 50 percent of the country’s peritoneal dialysis (PD) fluids. These are used by patients with renal failure who perform dialysis at home.
These dialysis products manufactured by Baxter were not listed among those for which expiration dates have been extended. Kidney care specialists have warned that PD fluids are more complex in making and ensuring access will be critical for patients living with kidney failure.
