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Understanding the “Compounding Pharmacy” Industry

The recent meningitis outbreak has led many to hear, for the first time, the term “compounding pharmacy.” This is the term used to describe the business which is allegedly at the heart of the latest outbreak. As blog readers know, the fungal meningitis problem was connected to a spinal steroid product at a New England compounding pharmacy.

Since the issue was discussed, investigators have further learned that the facility in question has a few other alleged problem in the past. A complaint was lodged against the company in 2002 which resulted in a 2006 consent decree authorizing detailed facility investigations by regulators. In addition, a 2004 lawsuit was filed by a woman who claims that her husband developed meningitis and died as a result of a contaminated spinal steroid injection–just as in this latest outbreak. That lawsuit was settled confidentially in 2005.

So what are these compounding pharmacies and what can they learn from this latest incident?

In the most basic sense, compounding pharmacies take material made elsewhere and alter them so that they can be used for different purposes. A recent Forbes article on the story explain that, in it quaintest form, these companies are like the old-time local pharmacists of the past–taking products make elsewhere and mixing and dosing so that they are useful for patient.

However, since this fungal meningitis outbreak–and actually before it–many have raised calls for concern about the safety of products created by these compounding companies. That is because products released by the compounding companies do not undergo the rigorous screening by the FDA. Instead, there is mostly only state oversight.

Yet there is a glaring problem with only state oversight of these operations–companies can always move to states with more lenient rules to avoid any onerous regulations aimed at ensuring that the products are actually safe. That is why, according to one law professor interviewed for the Forbes article, “For states to try to regulate this is really difficult. It has to be done nationally”

However, it remains unclear if any changes will be made in the aftermath of this latest controversy. Right now the focus remains on helping those affected by the problem. Well over a hundred people have already been identified as having the fungal meningitis, with at least 12 deaths. The CDC notes that, considering the thousands of spinal steroid injections from this batch given to patients between July and September of this year, they expect more cases to be found in the coming days and weeks.

Legal Help for Meningitis Outbreak in Illinois
The attorneys at our firm continue to work on the legal issues implicated by this event. Many community members in Chicago and nearby communities may have been affected by this recalled steroid product. If you or someone you know may be in that group, please consider giving our office a call to see how we can help.

As a reminder, the Illinois Department of Public Health explained that at least three APAC Pain Clinics gave local patients doses of the contaminated steroids. They include APAC Lincoln Park, the facility in the Thorek Hospital Building, and the Prairie Medical Building in Westchester.

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