No Means No, US FDA Advises 503A Compounding Pharmacies

The US Food and Drug Administration meant what it said in a 19 February rule disallowing traditional pharmacies regulated under Section 503A of the Food, Drug and Cosmetic Act from compounding drugs from four bulk active substances – despite the small-business impact – the agency explained in a 24 May question-and-answer guidance document.

But there is a way to appeal that decision and others like it that are sure to occur as the agency evaluates substances nominated for its 503A bulks list, the FDA explains in the