Tuesday, July 22, 2014

Compounding crackdown

After tainted drugs from a Massachusetts-based compounding pharmacy killed 64 people and sickened hundreds more, lawmakers went to work. Last year, Congress passed legislation improving federal oversight of these businesses. This month, Gov. Deval Patrick went still further, signing a law that greatly enhances the state’s regulatory involvement. Together, these actions should help improve the safety of combined medications.
Compounding pharmacies mix drugs together for an array of purposes. Today, they often ship the drugs in bulk to hospitals. But originally, the practice emerged as a way of tailoring pharmaceuticals to individual patients. Compounding pharmacies were never governed by the same safety standards as large drug manufacturers, partly because it was unclear who had authority over them. Small batches of individually tailored drugs tended to be regulated by state boards.
In 2012, a Framingham, Mass.-based company, the New England Compounding Pharmacy, shipped out a batch of tainted steroids, causing a lethal outbreak of meningitis across the country. It had received some warnings about its practices from the federal Food and Drug Administration but, before the outbreak, had generally been left alone. The company has since been shut down.
A law signed by President Obama last year set up a voluntary system for compounding pharmacies to register with the FDA. In doing so, they agree to meet certain safety standards and allow federal inspections. Registering presumably makes them more attractive to purchasers.
The Massachusetts law sets new, stricter licensing standards for compounding pharmacies in the state. It gives the state Board of Registration in Pharmacy power to conduct surprise inspections and requires it to take part in national reporting systems. The state Department of Public Health will also develop a website that offers consumers more information on compounding pharmacies.
These are reasonable steps to ensure that Massachusetts compounding operations are committed to public safety. While they are no guarantee, they should diminish the likelihood of new disasters.

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