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FDA addresses IV fluids, saline bag shortage

November 21, 2017

Silver Spring, Md. — The Food and Drug Administration announced Nov. 17 that hospitals are reporting shortages of IV fluids, particularly small saline solution bags, stemming from destruction caused by Hurricane Maria in Puerto Rico in September.

“The medical products industry has a significant presence in Puerto Rico, and the disruption to this industry has had ramifications for patients both on the island and throughout the U.S,” said FDA Commissioner Scott Gottlieb, M.D. “The FDA has been working closely with federal and Puerto Rican authorities to help stabilize the medical products manufacturing sector. We’re taking steps to mitigate or avert product shortages but we’ve still seen shortages of certain medically important products, some of which are sourced primarily or only in Puerto Rico.”

FDA’s efforts to mitigate the shortage include:

  • Temporarily allowing the importation of IV saline products from facilities outside of the U.S.
  • Encouraging the expansion of production at existing facilities to meet shortfalls.
  • Expediting its review of new product applications that will help address this shortage.
  • Working with federal and local government partners to prioritize a small number of critical facilities based on public health needs.
  • Encouraging hospitals to consider clinical recommendations for managing the shortage of these IV fluids, including recommendations by the American Society of Health-System Pharmacists and the University of Utah.
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