Human Drug Compounding Outsourcing Facilities

The U.S. FDA has issued a new draft guidance document: “Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry.”

The guidance reflects further consideration of how CGMP requirements should be applied in light of the size and scope of an outsourcing facility's operations.

The document can be found here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/current-good-manufacturing-practice-guidance-human-drug-compounding-outsourcing-facilities-under

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)