Even After 53 Deaths In MA Outbreak, Only 2 States Routinely Track Number Of Compounding Pharmacies
State authorities who are supposed to oversee the type of specialized pharmacy at the heart of last fall’s deadly meningitis outbreak lack the most basic information about the companies they are supposed to regulate, according to a congressional report to be released Monday.
State boards of pharmacy generally don’t know which pharmacies in their state engage in compounding, the custom mixing of medications for individual patients. Nor do they know how much medication they make, how much of it is sterile or whether any products are sold across state lines. Only two states, Mississippi and Missouri, routinely track the number of compounding pharmacies in their states.
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Republicans are expected to question FDA Commissioner Margaret Hamburg about why the agency didn’t take more forceful action against NECC before the outbreak. Democrats on the panel want executives of the International Academy of Compounding Pharmacists, a major industry group, to testify about their two decades of lobbying Congress to limit FDA authority over compounders.
Last week, FDA officials released initial results of a targeted inspection of 30 compounding pharmacies that mix sterile drugs, considered the most high risk because any breakdown in the process can result in contamination. Federal inspectors found dozens of potentially dangerous safety problems, including unidentified black particles in vials of sterile solution, rust and mold in “clean rooms,” and workers wearing torn gloves.
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http://www.washingtonpost.com/national/health-science/report-compounding-pharmacies-go-untracked/2013/04/14/bfef7974-a3b2-11e2-be47-b44febada3a8_story.html
