Two Pharmacists Sentenced to Prison for Adulteration of Drugs

On June 21, 2016, the Department of Justice announced that two Alabama pharmacists were sentenced to prison terms of 12 and 10 months for their roles in the distribution of adulterated drugs. The drugs in question were compounded at the now-defunct compounding pharmacy Advanced Specialty Pharmacy (dba: Meds IV.)

Meds IV allegedly compounded numerous drugs for human use, including intravenous drugs known as Total Parenteral Nutrition (TPN) which is a liquid nutrition for patients who cannot or should not receive medications orally, without taking the legally required precautions to ensure the sterility of its products.

Allegedly, in early 2011, Meds IV began compounding its own amino acid solution which was then mixed with other intravenous medications to create patient specific TPNs. The amino acids used in compounding the TPNs were adulterated as  the amino acids were found to be contaminated with the highly resistant bacteria Serratia marcescens (S. marcescens) which can cause bloodstream infections if introduced into the bloodstream through contaminated medications.

According to documents, the amino acid was prepared by Meds IV outside a laminar airflow workbench and kept unrefrigerated in a non-sterile room in a large pot sitting on the floor before it was sterilized and used.

Nine patients, with other serious underlying medical conditions, who developed bloodstream infections caused by S. marcescens died while many others developed infections but survived.

David Allen of McCalla, Alabama, the former pharmacist-in-charge of Meds IV, was responsible for reviewing and approving TPN formulations, and William Timothy Rogers, of Hoover, Alabama, the former president of Meds IV, pleaded guilty in March 2016 to two misdemeanor violations of the Federal Food, Drug and Cosmetic Act (FDCA). Allen and Rogers received 12 month and 10 month prison terms, respectively, and also received a one year of supervised release following their imprisonment and a $5,000 fine.

The Department of Justice and the Food and Drug Administration continue to work aggressively to protect consumers from drugs compounded under insanitary conditions.