After a long delay, the Florida Department of Health wants to fix a gap in the law that made it powerless over out-of-state compounding pharmacies.
Hear Health News Florida’s audio story on the outbreak and its aftermath.
When tainted injections from New England Compounding Pharmacy caused a fungal meningitis epidemic in 2012, the state discovered it had licensed hundreds of such facilities to send drugs into Florida. It also found that Florida law gave DOH no authority over those located in other states.
DOH could have asked the legislature to fix the gap in the law during the 2013 session in the spring, but did not, as Health News Florida reported last June (see Who Forgot to Fix Compounding Law?). It was never made clear who dropped the ball.
In any event, DOH now has a proposed bill – approved by the Board of Pharmacy in October – that would plug the gap. It would allow Florida to send or hire inspectors to an out-of-state licensee and bill that pharmacy for the cost.
It would also require the pharmacy to provide a toll-free number that patients in Florida could call and maintain clear records of who got which drugs so that if there were a problem, those at risk could be contacted.
The outbreak caused by contamination of the steroid injectable liquids shipped from New England Compounding Pharmacy killed 64 people, including seven in Florida, according to the Centers for Disease Control and Prevention.
The pharmacy that made the tainted drugs was shut down soon after the outbreak was discovered in September 2012, and was later declared bankrupt. Other Florida-licensed compounding pharmacies based in and out-of-state have also triggered outbreaks or been found to have dangerous conditions by DOH or the Food and Drug Administration.
(more to come)
quoted from here
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