USP Reminds Levothyroxine Makers of Updated Monograph

摘要

The U.S. Pharmacopeia (USP) is urging manufacturers outside the U.S. to adopt the new monograph for levothyroxine sodium, which tightens potency specifications. USP released the new monograph in January. The new potency requirement, which takes effect October 2009, is 95 percent to 105 percent throughout a product's shelf life. It was tightened from 90 percent to 110 percent. The FDA revised the specification last year after evaluating data from all levothyroxine sodium products. It found variable stability profiles and shelf lives for different versions of the drug, a concern for patients who use the thyroid replacement therapy and may get prescription refills made with different potencies by different manufacturers.