Early last month we informed you about the IV saline solution shortage that was exacerbated by Hurricane Maria’s impact on Baxter’s manufacturing facility in Puerto Rico. Since then, the ACR advocacy team has been working with the Food and Drug Administration (FDA) in its ongoing efforts to resolve the fluid shortage.
Currently, the FDA has authorized temporary imports from Baxter facilities in Ireland, Australia, Mexico and Canada and B. Braun in Germany (even though B. Braun recently announced it was slowing production). It is important to note that when the FDA initiates importation from another country, the agency evaluates the foreign firms and drug products to ensure no significant risks to patients exist.
In addition to the temporary imports, the FDA is expediting their review of drug and recently approved Fresenius Kabi and Laboratorios Grifols saline products who reported they will have supplies soon. It is also reported that the Baxter Puerto Rico facilities are functioning fully and hope to be distributing the saline solution quickly. The FDA anticipates that availability of these products from various avenues will help address the shortage.
The ACR will continue to work with the FDA and monitor the saline shortage to avoid any disruption in patient care. For more information on the availability of sodium chloride 0.9% injections, including information provided by the companies on their production status, visit the FDA Drug Shortage website. For questions or additional information, contact the ACR practice department at [email protected].
