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FDA Allows Import of Injectable Nutritional Drugs Due to Product Shortage
FDA will allow the import of injectable drugs used in total parenteral nutrition (TPN) due to a critical shortage of the products. The agency stated it was exercising regulatory discretion to temporarily allow Fresenius Kabi USA, LLC, of Lake Zurich, IL, to import trace elements and phosphate injections from its facility in Norway. The shortage of these products is related to a decision by American Regent/Luitpold to temporarily shut down its operations to address quality issues, according to FDA.
