FDA Releases Final Guidance on Outsourcing Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act

Summary

The Food and Drug Administration (FDA) has issued a final guidance to clarify the definition of an outsourcing facility under Section 503B of the Federal Food, Drug, and Cosmetic Act, addressing questions from outsourcing facilities and stakeholders about the meaning of the term 'facility' and how to ensure compliance with the law.