The FDA says the recent import alert imposed on 0.9% sodium chloride made at a Baxter International ($BAX) plant in Canada was issued because an "importer/consignee" tried to ship some into the U.S. The problem is, the saline made at that plant is not approved for sale in the U.S.
In an emailed statement, the FDA said that the product made at the Baxter plant in Mississauga, Ontario, that "the consignee tried to ship into the United States" is not approved for sale here. Therefore, "the agency issued an import alert in order to notify our field offices to help prevent unapproved drug shipments from crossing the border."
The agency explained that while there are some allowances for personal importation of unapproved new drugs, those don't come into play if the products are for business use. "In this particular situation, the unapproved Baxter drug consignee attempted to import the 0.9% sodium chloride for business use and thus was in violation of the" Food, Drug, and Cosmetic Act.
The agency pointed out that the import alert had nothing to do with manufacturing problems at the plant, often the impetus for import bans. It also said there was no reason the import alert would affect the availability of saline in the U.S., where hospitals have been dealing with a shortage of saline. Baxter made the same points.
A Baxter spokesman said in an email: "Because saline solution produced at Baxter's facility in Canada is not approved for use in, or imported by Baxter, to the U.S., we do not anticipate any impact to Baxter's saline supply in the U.S. We have reiterated this point with U.S. customers while assuring them that we continue to produce at maximum capacity to help meet patient needs for this product."
Baxter has emphasized that it has been the one continuous supplier of saline during the shortage and that it has been working with the FDA on efforts to expand production in the U.S. "We are producing at maximum capacity to meet patient and customer needs," a spokesman said last week. "We increased production 3% in 2013 year over year, and are investing to increase production another 9% in 2014."
The FDA has been working with Baxter, Hospira and B. Braun Medical to boost production of saline since the shortage got serious. Baxter has also been ramping up production of nitroglycerin to help the FDA deal with a shortage of that product. The FDA has also has been scouting outside the U.S. for additional capacity of both of those products. Last month, the agency agreed to let German drugmaker Fresenius Kabi temporarily import to the U.S. saline solution made at a plant in Norway that is not currently approved for sale here.
- find the alert here