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FDA And States Meet About Regulation Of Drug Compounders


On Wednesday (December 19), the FDA met with health delegates from all 50 states to discuss tighter regulations on drug compounders.

According to the federal agency, the central government needs greater oversight of compounding pharmacies; the state health delegates, in response, say that they need better communication with the federal government in order to better control drug compounding.

"Our concern is that if we don't act explicitly it will continue to be in that gray area without adequate oversight," FDA Commissioner Margaret Hamburg, MD, told reporters Wednesday.

Under current law, says the New York Times, compounders are not required to allow the FDA access to their books, a situation which has resulted in a flurry of court orders from the agency to pharm compounders.

The meeting came as a result of the meningitis outbreak, linked to a compounding pharmacy in Framingham, Massachusetts, that infected over 600 patients in 19 states.

by RTTNews Staff Writer

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