Recent Regulatory Actions: Focus on Quality in Compounding

by Craig A. Boyce , RPh Over the past month, a number of regulatory changes have occurred surrounding aseptic and sterile compounding.  Some of the significant regulatory actions include:  FDA release of the cGMP Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act (7-1-2014)  Massachusetts passage and signing of... Read more

Categories: Blog | Regulatory | Safety
Tags: Aseptic | cGMP | FDA | IV compounding | Manual Compounding | QbD | Quality by Design | Sterile Compounding | USP 795 | USP 797