FDAnews
www.fdanews.com/articles/204730-fda-revises-compounding-guidance-for-hospital-pharmacies

FDA Revises Compounding Guidance for Hospital Pharmacies

October 7, 2021

The FDA has released revised draft guidance saying that the agency is rethinking its enforcement policy for hospital pharmacies that distribute compounded drugs to other healthcare facilities.

Since 2016, the FDA has been considering giving hospital pharmacies greater flexibility when distributing compounded drugs within their own health systems. A former draft proposed that the agency would not enforce compliance for a drug distributed within a one-mile radius of hospital pharmacies.

Donald Ashley, director of the FDA’s Office of Compliance within the Center for Drug Evaluation and Research, said the agency will prioritize enforcement against hospital pharmacies with poor compounding practices or lack of sterility assurance and those that produce nonpatient-specific compounded drugs distributed for interstate commerce.

View today's stories