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Evelyn Orona, Associate Microbiology Supervisor Just as crucial as the sterile production of drug products is ensuring those same products are free of dangerous pyrogens – contaminants that induce febrile reactions in patients if introduced at high levels. Relative to patient safety, the most concerning and common pyrogen is bacterial endotoxins. Pyrogens can be removed or

Drug components differ in purity, specifications and quality. According to FDA draft guidance, it’s important for compounding pharmacies and outsourcing facilities to verify drug components purchased from suppliers. Pharmacists verify drug components by: The FDA draft guidance for 503B outsourcing facilities states that “in lieu of testing each shipment of each ingredient, a COA can