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Meningitis Epidemic Raises Quality Control Questions

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The deadly meningitis outbreak linked to contaminated spinal injections is spurring calls for FDA oversight of compounded drugs. These are medications that are created or repackaged outside of the usual pharmaceutical manufacturing process.

Historically, pharmacists actually formulated many of the medications they dispensed. But by the middle of the 20th century drug companies had taken over the manufacturing of most drugs in the U.S. There has been a resurgence in compounding over the last few decades, however. Such pharmacies supply bio-identical hormones, unusual doses or special formulations that doctors request. Such drugstores serve their local communities. But there has also been a expansion of larger-scale compounding pharmacies. They advertise on the web and supply products all over the country to doctors' offices, clinics, surgical centers and even directly to patients. Unlike pharmaceutical firms, such mini-manufacturing centers are largely immune from FDA oversight.

Because of the unfolding tragedy involving contaminated steroid spinal injections, there are calls for new regulations. States rarely have the expertise or the resources to monitor manufacturing in compounding pharmacies the way the FDA oversees drug companies. As a result there have been previous problems with drug quality. The latest public health calamity underscores the need for better consumer protection.

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It is a tragedy that this tainting of the drug happened. However, I do not want the FDA to have any more control over the compounding pharmacies. Pharmaceutical produced drugs that are used as prescribed are responsible for over a hundred thousand deaths each year. The FDA needs to worry about those drugs and not try to run the compounding pharmacies out of business.

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