FDA Guidance Affecting cGMP Compounding Pharmacies (503Bs)

Since the 2012 New England Compounding Center tragedy that linked a deadly fungal meningitis outbreak to a failure to use current good manufacturing practices (cGMP),¹ compounding pharmacies have faced increasing scrutiny and regulation by the U.S. Food and Drug Administration (FDA). While registering with the FDA is still voluntary, only compounding pharmacies that register, and pass inspection, will be granted “503B” status as compounding outsourcing facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act.²