FDA stepping up efforts to replenish U.S. saline solution supplies

The FDA said it's stepping up its efforts to address the shortage of saline solution for humans and animals by increasing the importation of intravenous fluids from producers not previously approved by the regulatory agency.

The agency said it's coordinating with drug companies to specifically increase the availability of 3- to 5-liter intravenous fluids intended for use with large animals. The FDA is also temporarily exercising its enforcement discretion over the importation of large-volume saline solutions currently being marketed overseas and that carry labeling appropriate to those countries.

Saline solution has been in short supply for about a year now. The FDA has been working with Baxter ($BAX), Hospira ($HSP) and B. Braun Medical to boost their U.S. production to help relieve the situation. It has also allowed imports from three European plants that were not approved to ship saline to the U.S.: a Fresenius Kabi plant in Norway, a Baxter plant in Spain and more recently from a B. Braun plant in Germany. But manufacturing problems have led to more recalls, which have kept the U.S. supply chain from getting fully replenished.

Several factors are behind the shortage for large animals, the agency said, including increased demand combined with reduced manufacturing of the sizes typically used in large animals. Because of a shortage of IV fluids used both for humans and animals, some manufacturers have focused production on the smaller sizes for humans and small animals, which created a decrease in 3-liter and 5-liter sizes used on large animals.

- see the FDA announcement