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FDA revised the guidance after industry feedback and to clarify CGMP requirements for outsourcing facility operations.
On Jan. 22, 2020, FDA announced the publication of a revised draft guidance regarding compounders that are registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as outsourcing facilities and current good manufacturing practice (CGMP) requirements. The revisions were based on industry comments on the previous draft document and reflect the agency’s thoughts on the application of CGMP requirements to outsourcing facility operations. With the revised draft guidance, FDA intends to recognize the difference between outsourcing facilities and conventional drug manufacturers. The agency also, however, intends to ensure compounded drugs are safe for patients.
Specifically, the guidance details conditions under which the agency will not take regulatory action against an outsourcing facility while it continues to finalize CGMP requirements under parts 210 and 211 of the Code of Federal Regulations. The revised guidance includes considerations for non-sterile compounded drugs and distinguishes requirements between sterile compounded drugs and non-sterile compounded drugs. It also includes stability testing changes and release testing requirements.
The draft guidance applies to drugs that are compounded in accordance with section 503B of the FD&C Act. It also applies to drugs that outsourcing facilities repackage and biological products that outsourcing facilities mix, dilute, or repackage.