Over the past three months, the U.S. Food and Drug Administration inspected 31 compounding facilities and found numerous problems including dirty work spaces, poor storage of drugs, contaminants in the drugs and inadequate safety testing.
New York, N.Y. (PRWEB) May 03, 2013
Pharmacies that compound drugs in 49 states are not required to report how much drugs they produce or where they send them, an April 15 news article in the Boston Globe states. A recent outbreak of fungal meningitis and other serious infections that were traced to contaminated injectable steroids made at a Massachusetts compounding pharmacy killed 53 people and sickened more than 700 nationwide, the report states. This tragedy prompted Congressman Edward J. Markey and other lawmakers to study such problems further and call for federal oversight of these pharmacies, which are going largely unregulated or untracked, according to the article.
Only two states – Mississippi and Missouri – require specific licensing for compounding pharmacies, Markey's office reports. The Congressman's website states that over the past three months, the U.S. Food and Drug Administration inspected 31 compounding facilities and found numerous problems including dirty work spaces, poor storage of drugs, contaminants in the drugs and inadequate safety testing. Markey has called for compounding pharmacies to operate like drug manufacturers so they are also subject to federal oversight, the report announced.
Any facility that manufactures drugs must be subject to stringent regulation, says New York personal injury lawyer Kenneth A. Wilhelm. "It is shocking to learn that these types of facilities are operating under subnormal standards. Any lack of oversight in this regard is likely to put more lives at risk."
The results of Markey's report are shocking, Wilhelm says. "There can be no ambiguity when it comes to the law and the makers of these drugs must be held liable for their products. Until there is proper federal oversight, it is not a matter of if, but when these outbreaks occur again."
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