March 24, 2014


By Peter Mantius


The U.S. Food and Drug Administration sent warning letters in February to pharmacy boards in four states to alert them to drug-compounding pharmacies that appeared to violate sterile practice standards. Since a new federal law specifically designates the states, not the FDA, as the regulator of traditional pharmacies, the letters to Florida, Kansas, New Jersey and Oklahoma appear to be a bid by the agency to assert influence over a regulatory grey area between corner drug stores and drug manufacturers. The Quality Compounding Act gives pharmacies the option of registering as “outsourcing facilities” to be regulated by the FDA. But it also gives pharmacies that dispense compounded drugs to individually identified patients the right reject federal registration and remain entirely under state jurisdiction. “It is important for pharmacies that dispense for individually identified patients to maintain a strict jurisdictional line,” Melissa Gilmore, a pharmaceutical attorney for the law firm Polsinelli wrote in a recent blog.


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