News and Publications

News & Publications

News Details

U.S. Food and Drug Administration (FDA) Issues Draft Guidance Documents on Compounding

Aug 11, 2016
  • The FDA also issued a draft guidance on Insanitary Conditions at Compounding Facilities. This guidance aims to assist compounding facilities in identifying insanitary conditions that can result in patient harm, so that they can implement appropriate corrective actions. The guide will also assist state regulatory agencies in understanding some examples of what FDA considers to be insanitary conditions. Public comments are due by October 3, 2016.