October 11, 2024- The U.S. Department of Health and Human Services (HHS) is coordinating a USG-wide response to address Hurricane Helene-related supply chain disruptions. HHS is also working with public and private partners to support the supply chain while the Baxter facility is brought back to full operational capacity. The FDA has continued working with Baxter to identify both potential products already in their system and alternative manufacturing sites, including for potential temporary imports. As alternatives are identified, the FDA is expediting assessments of those options. FDA will also expedite consideration of any shelf-life extension requests manufacturers submit for short-dated product, and will continue to work with Baxter as they bring their plant back online and with other suppliers to increase supply.
According to HHS, in the coming weeks, supply may continue to be constrained, and the organization understands that certain products are on allocation; however, Baxter reported that they have resumed shipments to hospitals and dialysis providers and patients after the temporary hold last week, based on allocations as previously communicated.
The inventory will be used to support current allocations in the short term, and they note that several of their global plants are scaling and ramping production to help meet U.S. needs. Other producers are expected to be able to continue to fulfill domestic orders within their allocation.