FDA Compounding Guide Excludes Physicians From Enforcement Action

By Kelly Lienhard / November 9, 2020 at 3:53 PM
In a final compounding guidance released Friday (Nov. 6), FDA maintains that it will not take regulatory action against physicians who compound products in a physician’s office for in-office administration, despite previous pushback from a key pharmacy organization that had argued safe compounding practices should not differ based on the setting in which the drugs are compounded. The guidance, “ Insanitary Conditions at Compounding Facilities ,” describes the types of insanitary conditions FDA has found at compounding facilities so that...

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