FDA Addressing the Shortage of Large Volume Intravenous Solutions

The U.S. Food and Drug Administration’s Center for Veterinary Medicine is coordinating with drug companies to increase the availability of three- to five-liter intravenous (IV) fluids intended to provide large animals with IV fluid replacement therapy.

The current shortage has been triggered by several factors, including increased demand combined with reduced manufacturing of the sizes most suitable for use in large animals. Because of a shortage of IV fluids for use in both human and veterinary medicine, some manufacturers have focused on manufacturing the smaller sizes for humans and small animals, which has contributed to a decrease in the availability of the three-liter and five-liter sizes that are used in large animals.

The FDA is working with drug companies to address the current shortage and meet the long-term demand for IV fluids. To address the immediate need, the FDA will temporarily exercise enforcement discretion over the importation of large volume IV solutions that are currently marketed in foreign countries and carry labeling appropriate for those countries. Several companies are currently preparing to import five-liter fluids into the U.S. As products become available, we will update our drug shortages – IV Fluids page with additional information.

The FDA is working to ensure continued, long-term availability of these products, as well as ensuring that the products are produced and marketed in a manner that is consistent with Compliance Policy Guide, CPG Sec. 635.100 Large Volume Parenterals (LVP’s) for Animal Use.

For manufacturing and availability updates on IV fluids (≤1L) for use in people, please see: http://www.fda.gov/Drugs/DrugSafety/ucm382255.htm.

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