Sterile Compounding

CHA Comments on Revised FDA Draft Compounding Guidance

CHA has submitted comments to the Food and Drug Administration (FDA) on its revised draft guidance on hospital and health system compounding under Section 503A of the Federal Food, Drug, and Cosmetic Act.  In the letter, CHA applauds the agency for revising its earlier 2016 draft guidance to eliminate the previously proposed policy that would have established a one-mile radius requirement as criteria for medication distribution by a hospital or health […]

FDA Revises Draft Guidance on Hospital and Health System Drug Compounding

The Food and Drug Administration (FDA) has issued revised draft guidance on hospital and health system compounding under section 503A, updating draft guidance released in 2016.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.