FDA appeals compounding ruling: Regulatory agency continues to send companies warning letters to stop the compounding of some drugs

摘要

Federal regulators want the U.S. Court of Appeals for the Fifth Circuit to overturn a trial court's ruling that limits the Food and Drug Administration's (FDA) jurisdiction over the production of some compounded drugs. The appeal, filed Dec. 1, is thelatest move by FDA, which has sent warning letters to two animal-health and seven human-health compounding companies since a U.S. District Court ruled Aug. 30 that compounding from bulk ingredients does not violate the Federal Food, Drug and Cosmetic Act (FDCA), as asserted by the regulatory agency.