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Understanding the Conflicts Between FDA’s Insanitary Conditions Guidance for Industry and USP 797 Webinar

Wednesday, December 16, 2020  |  1:00PM - 2:00PM
$ | 100 seats remaining

On November 6, 2020, the FDA released the final version of Insanitary Conditions at Compounding Facilities Guidance for Industry. This document applies to both 503A compounding pharmacies, which follow USP 797, and 503B outsourcing facilities, which must comply with Current Good Manufacturing Practices (CGMPs). This difference in regulatory standards and guidance can lead to instances of insanitary conditions being in direct conflict with what is allowed by USP 797. In this webinar, we will present the areas where these conflicts exist and provide insight and best practice recommendations for 503A entities to manage these conflicts.