Fourteen individuals from the New England Compounding Center in Framingham, MA have been arrested in connection to a meningitis outbreak in 2012 due to contaminated injections of preservative-free methylprednisolone acetate (MPA). Co-founders Barry Cadden and Gregory Conigliaro, pharmacist Glenn Adam Chin, and others are facing charges including mail fraud and the introduction of adulterated and misbranded drugs into interstate commerce. In the indictment, Cadden, Chin, and others are being accused of using expired ingredients into drugs, failing to properly sterilize drugs, and failing to test drugs for sterility. Cadden and Chin have also been accused in a federal indictment of “acting in wanton and willful disregard of the likelihood” that their actions would cause death or great bodily harm. In the fall of 2012, the contaminated medication was discovered along with unsanitary conditions at the plant, including standing water, mold, water droplets, and dirty equipment. Over 750 patients became ill and 64 died due to fungal meningitis and other illnesses contracted from the contaminated injections; the company filed for bankruptcy protection and surrendered its license after being inundated with hundred of lawsuits filed by victims and their families.
On December 16th 2014, the FDA announced the membership of the Pharmacy Compounding Advisory Committee. The committee is comprised of 14 members who will provide advice on scientific, technical and medical issues concerning drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, acknowledged this was a key step toward implementing the compounding provisions of the Drug Quality and Security Act.