FDA Compounding Guide Excludes Physicians From Enforcement Action

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...