With the FDA now urging hospitals to acquire all their outsourced compounded sterile products (CSPs) from facilities registered with the agency under Section 503B of the Food, Drug, and Cosmetic Act, it may be tempting to assume that all FDA-designated 503B compounders are created equal. After all, the section requires that these facilities must observe Current Good Manufacturing Practices (CGMPs) and provide the FDA with certain information about the products they compound; they’re also
APRIL 16, 2018