FDA allows TPN importation for premature infants

May 30, 2013

FDA announced May 29 its plans to permit importation of total parenteral nutrition injectable drugs that are in short supply from Norway. The drugs are used to treat premature infants, cancer patients, and gastrointestinal surgery patients who are not able to eat or drink by mouth.

FDA announced May 29 its plans to permit importation of total parenteral nutrition (TPN) injectable drugs that are in short supply from Norway. The drugs are used to treat premature infants, cancer patients, and gastrointestinal surgery patients who are not able to eat or drink by mouth.

Fresenius Kabi USA, LLC, based in Lake Zurich, Ill., has been allowed to import trace elements and phosphate injectables from its Norwegian facility to meet patients’ needs this week, according to an FDA statement.

“While we have made progress on the critical issue of drug shortages, we remain extremely concerned about all current and potential drug shortages, and we are vigilant in our efforts so patients have access to the medicines they need, when they need them,” said FDA Commissioner Margaret A. Hamburg, MD.

U.S. hospitals have been having trouble obtaining enough of the intraveneous food solution following the shutdown of American Regent, a major manufacturer of TPN, in late 2012.

Other manufacturers of TPN, such as Hospira Inc. of Lake Forest, Ill., are also trying to produce more of the drugs that are at critically low levels, FDA said.