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Sterility Standards in Compounding

Meaning

Sterility Standards in Compounding are the rigorous procedural, environmental, and quality control requirements mandated for the preparation of sterile pharmaceutical products, which include injectables, ophthalmic solutions, and intrathecal medications. These standards, primarily defined by pharmacopeial chapters like USP , ensure the final compounded drug product is entirely free from viable microorganisms, bacterial endotoxins (pyrogens), and particulate matter. Strict adherence to these standards is an absolute necessity for patient safety, especially when the route of administration bypasses the body’s natural defense mechanisms.