What do you suppose a texas drug compounding company did after the Food and Drug Administration (FDA) told it repeatedly to recall all its potentially “life-threatening” drugs? Well, basically, NuVision Pharmacy told the FDA to fuck off.
“NuVision Pharmacy is not recalling all sterile injectables,” the company stated flatly on its website .
And the official FDA reaction? It admitted impotence. The agency wrote in an August 16 press release that it “cannot require NuVision to undertake such a recall.”
Congress, in its campaign-dollar-soaked wisdom, has not granted the FDA the power to recall any drug—whether manufactured by Big Pharma or compounded in a pharmacy. Even if the product is proven dangerous, or made in violation of federal laws, the agency can only request compliance.
America’s thousands of “compounding pharmacies” like NuVision slip through additional regulatory loopholes. The category was established under now-outmoded rules developed to regulate your local drug store. Barred from “manufacturing” drugs, a compounder, by FDA definition, just “combines, mixes, or alters ingredients in response to a prescription, to create a medication tailored to the medical needs of an individual patient”—someone who needs, say, a custom-tailored dosage or formula without an allergen.
But hospitals, veterinarians, alternative practitioners and traditional doctors bypass that definition by mass ordering compounded drugs in “anticipation” of need—without a specific prescription. Thus, compounding pharmacies have expanded to fill the same role—and sometimes prescriptions—as major drug manufacturers. Except they fall more under state than federal oversight and regulation, don’t need to register with the FDA or comply with its standards or labeling requirements, and don’t need to submit their drugs to the FDA for testing and approval processes before sale.
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