Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act." Section 503B defines an outsourcing facility, in part, as "a facility at one geographic location or address." FDA has received questions from outsourcing facilities and other stakeholders about the meaning of this term, such as whether multiple suites used for compounding human drugs at a single street address constitute one or multiple facilities, or whether a single location where human drugs are compounded can be subdivided into separate operations compounding under different standards. FDA is issuing this guidance to provide the Agency's current thinking on these questions and related issues regarding how to ensure that the compounding of drugs in an outsourcing facility occurs only in accordance with section 503B.