Compounders must keep clean

Friday, October 12, 2012
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A national meningitis outbreak linked to a large specialized pharmacy in Massachusetts that found a niche by essentially combining two (or more) approved drugs to make a third has called much-deserved attention to the practice known as drug compounding.

The problem with the injectable painkiller, made this May by the New England Compound Center of Framingham, Mass. and shipped to doctors in 23 states, apparently wasn’t with the drug’s formulation; it was the less-than-sanitary conditions under which the steroid was concocted. Federal health officials suspect that a fungal contamination is responsible for the 119 cases of noncommunicable meningitis so far, 12 of which have proven fatal.

Though the regulations for so-called compounding pharmacies — especially those that prepare injectable medications — are tougher than for regular retail pharmacies, they aren’t as tough as those for actual drug manufacturers. According to Rep. Edward Markey (D-Mass.), who serves on the House Energy and Commerce Committee, compounding pharmacies “fall into a regulatory black hole” because the primary responsibility for their oversight belongs to states, which have limited resources and varying standards.

Markey said in a New York Times story Wednesday that he would soon sponsor a bill requiring large-scale compounding pharmacy operations to be regulated by the federal Food and Drug Administration. That seems a reasonable enough place to start in improving standards for this growing cottage industry.

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