FDA statement on ongoing efforts to mitigate impact of saline shortages during flu season

As flu activity remains widespread across the United States, FDA continues to monitor this situation closely and in coordination with CDC. The agency has taken steps to help ensure that people with the flu have access to critical medical products, including antivirals, saline, and other supportive care drugs and devices. Across the country, there remains a shortage of IV saline bags, which have long faced supply issues. These supply issues were worsened by the impact of Hurricane Maria on the medical products manufacturing sector in Puerto Rico, which impacted small volume IV bags. Although the saline shortage is improving, this year’s worse-than-normal flu season and workarounds deployed by health care providers in the wake of this shortage have increased demand for saline and other products. FDA is actively working to improve the large and small IV bag shortage and tracking potential shortages of critical medical products, such as the empty IV containers. The agency also continues to work closely with the companies that manufacture saline to limit and improve the shortage issues. Recently, FDA was able to extend the expiration dates of certain products, including some 500 ml size saline bags, after examining the data submitted by the company to ensure that it meets FDA's quality and safety standards.