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October 18, 2019

Packaging Sterility for Compounding Pharmacies (503Bs)

With the May 21, 2019 meeting to review the FDA draft guidance governing 503B compounding pharmacies, it has become evident that sterility of drugs produced at such facilities is a major focus of the U.S. Food and Drug Administration (FDA).<sup>1</sup> The meeting discussed the importance of qualifying container closure systems and was aimed at providing more context on what compounding pharmacies need to do.
Amy Kim

Amy Kim

Sr. Specialist, Scientific Communications, SA & TS

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