Compounding Pharmacists Imprisoned for Dispensing Adulterated Drugs

JUNE 29, 2016
Meghan Ross, Senior Associate Editor
Two compounding pharmacists from Alabama will spend a year in prison for distributing tainted drugs.
 
The adulterated drugs were compounded at Advanced Specialty Pharmacy, which did business as Meds IV, according to the Department of Justice (DOJ). 
 
David Allen, 60, of McCalla, Alabama, the former pharmacist-in-charge of Meds IV, and William Timothy Rogers, 48, of Hoover, Alabama, the company’s former president, pleaded guilty in March 2016 to 2 misdemeanor violations of the Federal Food, Drug and Cosmetic Act. 
 
In June 2016, the DOJ announced that the 2 men were sentenced to 12 months and 10 months in prison, respectively. They’ll also have 1 year of supervised release after they get out of prison, and they’ll each have to pay a $5000 fine. 
 
“Compounding pharmacies are entrusted with protecting the public’s health from any harm their drugs may impose and must comply with the law,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division, in a press release. “These cases demonstrate that the [DOJ] will continue to work aggressively with the FDA to protect consumers from drugs compounded under insanitary conditions.”
 
US Attorney Joyce White Vance noted in the press release that the pharmacy dispensed IV nutrition products that didn’t undergo legally required precautions. This lack of precaution led to serious infections in patients, and several individuals died. 
 
The DOJ maintained that Meds IV compounded a treatment called Total Parenteral Nutrition (TPN), which is given to patients who can’t receive their necessary nutrition through food. Starting around February 2011, the pharmacy compounded its own amino acid solution, then mixed it with other ingredients to create TPN.
 
The amino acid solution happened to be contaminated with Serratia marcescens, and the TPN was prepared, packed, or held in insanitary conditions, according to the DOJ. S. marcescnes can cause bloodstream infections, serious complications, and even death. 
 
“According to the charging document, the amino acid was prepared by Meds IV outside a laminar airflow workbench and was kept unrefrigerated, in a room that was not sterile, in a large pot sitting on the floor, sometimes overnight, before it was sterilized and used,” the DOJ press release stated. 
 
Nine patients developed bloodstream infections and died, while others developed S. marcescens bloodstream infections but survived. The DOJ noted that some of the patients who died had other underlying conditions, but the medical staff determined that the infection played a significant role in their deaths. 
 
 “Producing unsafe and contaminated drugs poses a serious threat to the US public health and cannot be tolerated,” said Director George Karavetsos, of the FDA’s Office of Criminal Investigations, in a press release.  “The FDA remains fully committed to aggressively pursuing those who place unsuspecting American consumers at risk by distributing adulterated drugs.”
 
Allen was responsible for supervising the compounding, and the TPN formulations in particular. Rogers, meanwhile, was “ultimately responsible for overseeing all of the day-to-day operations of Meds IV,” the DOJ noted. 
 
 


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