Compounding pharmacies express frustrations from incomplete FDA guidance

Some pharmacists are expressing frustration over the time it is taking for the FDA to finalize its guidance on various areas involving compounded drugs, according to a November 2016 report from the U.S. Government Accountability Office.

Nearly a quarter of stakeholder organizations said it is difficult for pharmacies to move forward without final guidance from the FDA about which drugs it considers difficult to compound. Adding drugs to a bulk drug list exempts them from stringent provisions of the Federal Food, Drug and Cosmetic Act and means that pharmacies can use those drugs as active ingredients in compounded medications. (more…)