FDA Extends Shelf Life of IV Solutions

To ensure the adequate availability of IV solutions that may be in high demand during the flu season, the Food and Drug Administration (FDA) extended the expiration dates of some IV products after Baxter, a major IV solution manufacturer, submitted safety data that indicated that extended expiration dates meet FDA safety standards.

The FDA noted that while it expects the production of IV solutions and related products to increase over the next month, having adequate supplies during this year’s widespread flu is critical to public health.

The FDA is not requiring that the shelf life of IV fluids listed in an extension of shelf life table are extended but is providing this option when IV solutions are unavailable or are in short supply. The shelf life table lists the product codes of IV solutions and current shelf life and extended shelf life. In many cases, the shelf life has been extended 6 months or more. The FDA notes that if IV solutions listed in the table become available during the extension period, the product codes and their shelf lives will be updated.

The FDA advises nurses and pharmacists to squeeze IV fluid bags with extended dating prior to use to ensure that they do not leak. For more information, read the statement issued by the FDA.