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Compounding pharmacy regulations put in place

By Tim Sandle     Jul 11, 2014 in Business
Boston - Two years after a deadly nationwide meningitis outbreak linked to a compounding pharmacy in Massachusetts, Governor Deval Patrick has signed a law aimed at addressing a "gray area" between state and federal oversight of pharmacies.
In 2012 Digital Journal was one of the first news outlets to break a major drugs contamination story. This centered on the recall of a steroid medication that was manufactured by the New England Compounding Center (NECC), and which was then distributed across the U.S. The drug, intended to be sterile, was contaminated with fungi. When injected there was a high risk of causing patient harm and, in some cases, due to meningitis.
Since the NECC case, a spate of other compounding pharmacies were required to recall different types of medications, the vast majority of these were covered by Digital Journal.
The problems were widely linked to a lack of regulation. For example, international contamination control expert Barry Friedman was of the view that the issue threw up wider questions about the control and regulation of compounding pharmacies. Dr Friedman said with regard to drug compounding:
"Unfortunately, this is not the first case in recent months of Pharmaceutical Compounding facilities producing contaminated parenteral product. Franck’s Compounding Lab, Ocala, Florida recently was issued a Warning Letter (7/9/12) for Fusarium contaminated BBG as was InfuPharma, LLC, Hollywood, Florida (7/30/12) for Streptococcus. Both of these companies were found by the FDA to have been repacking sterile injectable vials into sterile injectable syringes which were then being shipped to various end users. The products were found to cause a variety of illnesses because of the contamination. Please visit the Warning Letters for additional information."
Slowly the view that tighter regulation was required permeated through federal and state policy makers. In November 2013 President Barack Obama signed into law a bill that grants the Food and Drug Administration (FDA) more regulatory powers over drug compounding pharmacies.
Now, in place where the first and most serious incident happened — Massachusetts — Deval Patrick has signed a new law, according to the Boston Herald. The measure includes new licensing and labeling requirements and steps up fines for violations of state rules. The law also reorganizes the board that oversees pharmacies and requires the board's inspectors to be trained in sterile and non-sterile compounding practices.
In terms of penalties, pharmacies could be fined up to $25,000 per violation, with an additional $1,000 for each day a violation continues after it was supposed to be corrected.
More about Health, Pharmacy, compounding, Drugs, Regulation
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