Sterile Compounding

Parent Issue

FDA Revises Draft Guidance on Hospital and Health System Drug Compounding

The Food and Drug Administration (FDA) has issued revised draft guidance on hospital and health system compounding under section 503A, updating draft guidance released in 2016. As advocated for by CHA, the FDA has revised the 2016 guidance to remove a requirement that would have limited the distribution of compounded drugs to health care facilities located within a one-mile radius of the compounding pharmacy.