FDA Draft Guidance on Compounding at Outsourcing Facilities

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Does your company compound drugs at outsourcing facilities? To address the use and qualification of bulk substances in compounding, the FDA issued the draft guidance document: Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry (March 2018).

The proposed rules identify outsourcing facilities as its own category, which is separate from traditional compounders. This draft guidance is an extension of The Drug Quality and Security Act (DQSA), which was passed in November 2013. It asserts that Active pharmaceutical ingredients (APIs) must be accompanied by a monograph from an appropriate governing party (if one exists), must be made in a facility that has prior approval, and have a certificate of analysis to prove they been characterized.

Download the guidance here.