New Heparin Potency Test Leads to Drug Shortage

Heparin manufacturers are having trouble getting their product past a new test established after the contamination scandal, creating a shortage of heparin nationwide. The batches are failing to pass the test, in use since last fall, because it is more specific and gives potency readings for the drug that are 10 percent greater than the older test, Baxter spokeswoman Kellie Hotz said. Baxter has asked for guidance from the FDA and is working with the U.S. Pharmacopeia to determine what variance is acceptable and how to manage the issue.
Drug Industry Daily