USA – Current Good Manufacturing Practice—Guidance for Human Drug 2 Compounding Outsourcing Facilities 3 Under Section 503B of the FD&C Act

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). Under section 501(a)(2)(B) of the FD&C Act, a drug is deemed to be adulterated if it is not produced in accordance with CGMP. FDA’s regulations regarding CGMP requirements for the preparation of drug products have been established in 21 CFR parts 210 and 211. FDA intends to promulgate more specific CGMP regulations for outsourcing facilities. Until these final regulations are promulgated, outsourcing facilities are subject to the CGMP requirements in parts 210 and 211. This guidance provides for conditions under which FDA generally does not intend to take regulatory action against an outsourcing facility regarding certain CGMP requirements in parts 210 and 211 during this interim period. This guidance applies to drugs compounded in accordance with section 503B. In addition, this guidance generally applies to drugs that outsourcing facilities repackage and biological products that outsourcing facilities mix, dilute, or repackage in accordance with relevant guidance for outsourcing facilities.

This guidance reflects FDA’s intent to recognize the differences between outsourcing facilities and conventional drug manufacturers, while maintaining the minimum standards necessary to protect patients from the risks of contaminated or otherwise substandard compounded drug products…