Monday, September 9, 2013

A Primer on Compounding Pharmacies and Regulation by Congress


Senators hope that they will soon get a chance to quickly pass legislation that would give the Food and Drug Administration more authority over compounding pharmacies. For months, lawmakers in both chambers have been working on the best way to respond to last year’s fatal fungal meningitis outbreak linked to a contaminated compounded drug.
Although the House has yet to produce a full bill, sponsors are hoping that negotiations will smooth the path to compromise — and that continued problems with the drugs will bring urgency to the cause.
Following are answers to some questions about the problems that have cropped up in connection with compounding pharmacies, current regulatory policy, the fatal outbreak and the solutions for better oversight that are under consideration.
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