The adulteration of compounded drugs at a compounding pharmacy—Advanced Specialty Pharmacy d/b/a Meds IV—led to 12- and 10-month prison sentences for two Alabama pharmacists. According to a Department of Justice (DOJ) release, the pharmacists compounded an intravenous drug known as Total Parenteral Nutrition (TPN) that contained the bacteria Serratia marcescens (S. marcescens).
Meds IV compounded various drugs for human use. The pharmacy’s TPN drug is an intravenous liquid nutrition for patients who cannot or should not receive their nutrition through eating. An information, filed on January 28, 2016, alleged that, beginning in 2011, Meds IV compounded its own amino acid solution, which was mixed with other ingredients to form TPN. According to the charges, the amino acid was prepared by the pharmacy outside a laminar airflow workbench, unrefrigerated, in a room that was not sterile, and in a large pot sitting on the floor. In some cases, the amino acid was stored that way—overnight—before it was sterilized and used.
Between March 5 and 15, 2011, nine patients died at various Birmingham-area hospitals as a result of bloodstream infections caused by S. marcescens. Additional patients developed bloodstream infections and survived. All of the infected patients had been given TPN compounded and distributed by Meds IV. A Centers for Disease Control and Prevention (CDC) inspection at Meds IV on March 22, 2011 found a strain of S. marcescens that could not be distinguished from the outbreak strain on a tap-water faucet, in an open container of amino acid powder, and on the surface of TPN mixing equipment. The information charged the pharmacists with compounding adulterated TPN because it was contaminated with S. marcescens and was prepared, packed, or held under insanitary conditions.
One of the pharmacists was responsible for reviewing and approving TPN formulations and filling individual TPN prescriptions. The other pharmacist was responsible for overseeing the day-to-day operations of Meds IV. Both pharmacists plead guilty to two misdemeanor counts related to two lots of TPN that were adulterated in violation of the federal Food, Drug, and Cosmetics Act (FDC Act) ) (21 U.S.C. §301 et seq.). In addition to the prison terms, each of the pharmacists was sentenced to one year of supervised release and a $5,000 fine.