Improving the Quality of Compounded Sterile Drug Products

The term compounding generally refers to the practice of combining, mixing, or altering ingredients of a drug product to create a medication tailored to the needs of an individual patient. Compounding has long been a common activity within the practice of pharmacy. The scope of pharmacy compounding includes the compounding of sterile products, a practice that is especially prevalent within hospitals, home infusion pharmacies, and, more recently, outsourced compounding facilities. Reports of patient morbidity and mortality associated with compounded products have led many over the years, including the US Food and Drug Administration (FDA), to call for more stringent federal oversight of pharmacy compounding to ensure patient safety. A tipping point was reached in 2012 with the emergence of a multistate outbreak of fungal meningitis and other infections in patients who received contaminated steroid injections compounded by the New England Compounding Center in Framingham, Massachusetts. This article describes the history of the practice and regulation of pharmacy compounding, culminating in the passage by Congress of the Compounding Quality Act of 2014.