Friday, December 7, 2012

State might further scrutinize compounding pharmacies after meningitis outbreak

Date Friday, December 7, 2012, 1:18pm EST

Reporter- Orlando Business Journal
 
If you’re a compounding pharmacy in Central Florida, be warned: The state may take a harder look at regulating the industry after a fungal meningitis outbreak killed three people in Florida.
The problem is this: In Florida, there is no separate permit for a pharmacy or a compounding pharmacy. So the state has no way to track or regulate the industry and, potentially, make sure outbreaks don’t happen.
A pharmacy sells bulk drugs (think Walgreens). A compounding pharmacy is designed to mix a special compound not commercially available.
Central Florida has a huge cluster of specialty pharmacy companies. According to the Metro Orlando Economic Development Commission, 70 percent of the country’s specialty pharmaceuticals are distributed through Central Florida.
According to Health News Florida, the Pharmacy Board sent out a survey in October to all of the state’s pharmacies, asking who compounds their own drugs. They got a paltry return rate of 20 percent.
So the board passed an emergency rule threatening to punish pharmacies that don’t return the survey, which is due Dec. 10.
According to the same article, Assistant Attorney General David Flynn told the Board of Pharmacy at an all-day hearing in Orlando that the state has no power to regulate companies selling drugs in Florida that aren’t located here.
“In short,” Flynn said, “we’re in a box. We need to get authority so we can get out of the box.”

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