Compounding Reform: Reconsidering the Draft Safe Drug Compounding Act of 2007 in Light of the Ongoing Fungal Meningitis Outbreak

Compounding is the act of combining, mixing or altering ingredients to create a drug tailored to the needs of an individual patient, such as a child who needs a less potent dose, an elderly patient who has trouble swallowing, or an individual with a severe allergy to a drug component. Compounding pharmacies, which engage in large-scale drug compounding, have come under the microscope recently because of the ongoing deadly outbreak of fungal meningitis that began in 2012. Fungal meningitis “occurs when the protective membranes covering the brain and spinal cord are infected with a fungus.” The recent outbreak was caused by steroid shots contaminated with so much fungus that in some cases the fungus particles were visible to the naked eye. A single compounding pharmacy in Framingham, Massachusetts, the New England Compounding Center, “shipped 17,676 vials of . . . potentially contaminated [steroid] solution to 75 clinics in 23 states.” As of March 4, 2013, the Centers for Disease Control and Prevention (CDC) had linked 720 cases of meningitis or other complications, including forty-eight deaths, in twenty states to the epidural steroid injections that all originated from the New England Compounding Center