Sunday, January 15, 2017
Interim Policy on Compounding Using Bulk Drug Substances
www.fda.gov/downloads/drugs/.../guidances/ucm469120.pdf15 hours ago - The bulk drug substance cannot be used in compounding. under section 503A of the FD&C Act. A drug compounded. using the bulk drug substance is subject to regulatory action. The bulk drug substance appears in 503A Category.