SAGINAW, MI — The topic of compounding pharmacies have been a touchy subject for government policy makers since a deadly outbreak of fungal meningitis in 2012 that was attributed unsanitary conditions at New England Compounding Center in Massachusetts.
In Michigan, Attorney General Bill Schuette and State Sen. Joe Hune, R-Hamburg, have proposed a new state law that will regulate compounding pharmacies in the state. Federal lawmakers are proposing federal oversight of compounding pharmacies.
Michael Collins is a prescription compounding specialist running Healthway Compounding in Saginaw Township. During a visit on Monday, Oct. 21, by State Sen. Roger Kahn, R-Saginaw Township, Collins explained that regulation is sorely lacking under the current system.
"All I had to do is fill out an application form and a self-inspection," he said.
Currently, Collins said there is no federal oversight of Michigan businesses like his, which produce custom medications for individual patients by combining medications or converting pill or tablet medicines to liquid or other preparations. State oversight is provided directly by the state attorney general's office, he said.
Collins said he and other pharmacists believe some oversight is a good thing, though he cautions people not to lump all compounding pharmacies into the same group as places like the now-defunct New England Compounding Center.
He explained that the Massachusetts facility had a variety of sanitation problems that contributed to the outbreak, which in Michigan reached 260 patients and caused 19 deaths.
"There was jut a recipe for disaster there," Collins said.
As proof that not all compounding pharmacies are created equal, he pointed to Healthway's certification through the Pharmacy Compounding Accreditation Board and his requirement for all his pharmacy technicians to be trained and accredited, despite the fact that it is not required by law.
After briefly discussing the issue with the state senator, Collins handed Kahn a sterile scrubs to wear and turned him over to his staff, who gave the state lawmaker a tour of their three compounding laboratories.
"I just want to show you what we do and let you make up your own mind," Collins said.
After the tour, Kahn said he understood the importance of following the procedures put in place to ensure the drugs are being handled in a safe and sterile way.
"It appears that is what you do," he said.
Collins explained that though there are fewer than 10 full-scale compounding pharmacies like his in Michigan, there are about 3,500 pharmacists in the state who say they are compounding drugs at some level.
Kahn pointed out that regulating so many individual pharmacists could be difficult for the state government.
Collins said that, though he supports what he believes is being proposed in the state legislation, he is much more concerned about the potential federal oversight of his business.
"I believe it's going to be much more restrictive," he said of the pending federal legislation. "We think the state should be the one regulating us, not the federal government.
"The fight at the federal level has always been with the FDA (Food and Drug Administration). It's a turf war. They want control over compound drugs."
Collins said compounding pharmacies often face opposition from large drug manufacturers because they take customers from them.
"There has been just this constant battle," he said.
Collins has been running Healthway since he bought it in 1985. The business was originally located in St. Charles.
http://www.mlive.com/news/saginaw/index.ssf/2013/10/saginaw_township_compounding_p.html
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