The Food and Drug Administration (FDA) aims to mitigate a shortage of intravenous (IV) fluids by approving saline products from additional countries and working with manufacturers to import more IV fluid from foreign facilities, FDA Commissioner Scott Gottlieb, MD, said in a statement.
The shortage is due to the effects of Hurricane Maria on Puerto Rico, where much IV fluid is produced, and has been exacerbated by the severity of this year’s flu season. Small-volume saline bags typically are used to deliver medication, while larger bags are used for hydration.
FDA has worked with manufacturers, including Baxter and B. Braun, to import products from other countries, such as Brazil, and has approved IV saline bags from additional manufacturers to remedy the shortage. The agency also asks companies to submit data demonstrating that expiration dates for IV bags can safely be extended.
FDA encourages health care organizations to contact the agency if they are not receiving needed products and to follow the American Society of Health System Pharmacists’ guidance for managing the shortage. Product availability information is available on the FDA drug shortage website.
Contact Director of Policy Erin O’Malley at firstname.lastname@example.org or 202.585.0127 with questions.