Compounding pharmacies facing tough scrutiny by officials

In our last post we discussed one of the most recent recalls issued by a compounding pharmacy. The recall was announced by the Food and Drug Administration after inspectors found particles contaminating vials of the Massachusetts-based pharmacy’s products.

Compounding pharmacies are facing an increasing amount of product liability litigation as more consumers become sickened by contaminated products. NBC News recently reported that the problem with unsanitary compounding pharmacies is widespread. The FDA claims that it does not have enough power to control the compounding pharmacy market, but consumer advocates disagree.

The FDA is making some inroads to inspecting specialty compounding pharmacies. FDA commission Dr. Margaret Hamburg recently blogged about a new wave of inspections.

“We are currently deploying resources to work with states to inspect certain state-licensed pharmacies that produce sterile drug products that we believe may present the highest risk,” the commissioner wrote. “Over the past two months, we have inspected over 30 facilities and will continue to work to protect public health.”

Compounding pharmacies are only supposed to mix medicines when they have orders from specific patients. Several compounding pharmacies have increased their production to meet demand and now resemble small, unregulated drug manufacturers.

Although we have not seen another outbreak on the scale of last year’s fungal meningitis scandal, some experts believe that it is only a matter of time before another large group of patients are sickened by products made in the hundreds of unsanitary pharmacies across the country.