Tuesday, September 27, 2022
HomeLatest NewsAcute radarSen. Rounds and Thune support IV solution letter to FDA

Sen. Rounds and Thune support IV solution letter to FDA

South Dakota Sen. Rounds and Sen. Thune have joined dozens of colleagues in signing a letter to the Food & Drug Administration (FDA) asking for support to improve the IV saline solution shortage that is impacting many health care facilities in South Dakota and across the nation.  In addition, Sen. Thune and Rep. Noem are considering lending their names to the letter, as well.

Baxter Healthcare is a major supplier of IV saline solution bags in the U.S., however their manufacturing facilities in Puerto Rico were shut down in Sept. when Hurricane Maria struck and have only recently reopened.  This has resulted in a severe shortage of small saline IV bags across the U.S.

On Jan. 15, Baxter was granted regulatory discretion for the temporary importation of small saline bags from its plant in Brazil. Now, to help meet demand, Baxter is bringing additional large-volume saline bags to the U.S. market through a recent approval from the FDA for large-volume products from one of its plants in Mexico. This is expected to improve hospital shortages. Additionally,  Baxter reported earlier this week that power has been restored to its facilities in Puerto Rico and they are once again operating at pre-hurricane levels.

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