Now that the dust has begun to settle, it is becoming apparent that compounding pharmacies are not unregulated, just relatively lightly regulated, for all of the reasons offered by the Food and Drug Administration in its December 4, 2006 "Warning Letter" to New England Compounding Center (the "FDA has long recognized the important public health function served by traditional pharmacy compounding" as a matter of enforcement discretion).
The compounding pharmacy itself apparently tested very little, though touted its limited results as a safety selling point (http://online.wsj.com/article/SB10001424052970204076204578076891268537914.html?mod=googlenews_wsj).
We could look to Missouri as a place that does require sampled testing of compounding pharmacies . We could also look to Kansas as a state that co-sponsored the failed Safe Compounding Act of 2007, attempting to federalize inspection authority over compounding authorities, something traditionally left to the states by the FDA and by the courts.
What does Kansas know that the rest of us don't? That state resources to police compounding pharmacies are stretched thin. That safety concerns in compounding pharmacies can go undiscovered by state watch dogs for long periods of time. Missouri, after all, got interested in compounding pharmacy testing after its own compounding pharmacy tragedy. A compounding pharmacist in Kansas City, Mo., admitted diluting drugs –
including chemotherapy medications – for more than 4,200 patients
between 1990 and 2001.
Today, the New York Times reports that potency and accuracy problems in tested compounded medications were found to be rife in Missouri and elsewhere, involving as much as a quarter of all compounded medications in those places.
The conventional thinking is that food and drug purity outrage is cyclical, predictable, and contained. Hard questions remain unasked about the purity of out-sourced components for FDA approved drugs.