FDA Guidance for Industry: Current Good Manufacturing Practice - Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act
Title:
FDA Guidance for Industry: Current Good Manufacturing Practice - Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act
Origin/Publisher:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM403496.pdf
Content:
This guidance describes FDA’s policies regarding compliance with current good manufacturing practice (CGMP) requirements for facilities that compound human drugs and register with FDA as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).