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Home » FDA Clarifies the Term ‘Outsourcing Facility’ and Requirements for 503A Compounders

FDA Clarifies the Term ‘Outsourcing Facility’ and Requirements for 503A Compounders

May 10, 2018
Pharmaceuticals Regulatory Affairs
As part of its increased focus on drug compounding, the FDA issued a final guidance clarifying the term “outsourcing facility” and detailing requirements for compounders operating under 503A that are next to an outsourcing facility.

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