Guidance issued by FDA on compounding outsourcing facilities

FDA issues additional guidance for outsourcing facilities that compound sterile human drugs

11/21/2014 03:30 PM EST

Today, the U.S. Food and Drug Administration issued three additional policy documents to assist entities that compound sterile human drugs with registering as outsourcing facilities. The policy documents will also assist entities with complying with provisions of the Drug Quality and Security Act (DQSA), which was enacted in November 2013.