The FDA found unsanitary conditions and sloppy procedures at 60 specialty pharmacies. Behind each one of these pharmacies, known as compounders, independent testing laboratories were affirming that the drugs were safe, sterile and mixed at the proper strength, FDA records show.
The FDA cited five labs for more than 70 safety problems, including one case in which the repeated appearance of bacteria in a so-called clean room where sterile drugs were being tested called into question the integrity of the testing procedures.
The five laboratories conduct testing for about 90 percent of the nation’s large-scale specialty pharmacies, which mass-produce custom-mixed drugs and other medical solutions for doctors, clinics and hospitals.
Dozens of types of medications, packaged in thousands of IV bags, syringes and vials, have been recalled as a result of FDA inspections at the compounding pharmacies and the laboratories they use.
One of the labs, Oklahoma-based Analytical Research Laboratories (ARL), reported favorable test results for medications for the now-shuttered NECC, which produced the steroids that federal health officials say killed 64 people and sickened 686 other people last fall.
Another facility, DynaLabs in Missouri, tested and reported that a calcium gluconate solution, made by Texas-based Specialty Compounding, was safe and effective. Federal authorities said they believe the solution supplied by Specialty Compounding was contaminated with bacteria. Dozens of batches of that solution, commonly used to stabilize calcium levels in heart patients, were recalled by the pharmacy in August after the Centers for Disease Control and Prevention linked it to two deaths and 13 illnesses at two Texas hospitals.
The FDA has not assigned blame for the contaminated medications exclusively to the labs but said they must play an essential role in ensuring public safety.
“They were supposed to be a safety net, but no one has been policing the labs,” said Eric Kastango, a national expert on compounding and compounding industry consultant.
Unlike small pharmacies that custom mix medications based on an individual patient prescription, large-scale compounding firms make their custom-mixed products in sizable quantities and often ship them across state lines.
These large firms, like NECC, began routinely turning to independent laboratories for outside validation a decade ago. The move followed a series of scandals, including one in 2001 where thousands of cancer patients were given chemotherapy treatments by a Kansas City compounder who had diluted them to 40 percent below their prescribed strength.