FDA released a statement in October explaining that since Hurricanes Irma and Maria devastated the island of Puerto Rico, the agency “has been working closely with Baxter and other companies to reduce the risk of shortages of critically important drugs.” Concern was expressed, in particular, about Baxter’s sodium chloride 0.9% injection bags. The agency is also expediting reviews and approvals of other dosage forms and generic versions of products as alternate sources of critical products. In November, FDA published an update on its efforts to address IV fluid shortages exacerbated by Hurricane Maria with advice for hospitals in managing the shortage. FDA continues to work with Baxter in helping restore operations and move critical ingredients onto and off the island, and has recently approved IV solution products from Fresenius Kabi and Laboratorios Grifols.
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