FDA Cuts 1-Mile Distribution Limit From Hospital Compounding Draft Guide

By Beth Wang / October 6, 2021 at 12:15 PM
FDA on Wednesday (Oct. 6) revised its 2016 hospital compounding draft guidance to remove a contentious policy that would have prevented hospital pharmacies from distributing compounded drugs to health care facilities located outside of a 1-mile radius of the compounding pharmacy, unless those pharmacies registered as outsourcing facilities. “We believe the revised policy being proposed today will assist hospitals and health systems in their approach to appropriate medical treatments for patients,” Donald Ashley, director of the drug center’s Office of...

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