"There is no reason pharmaceuticals should be recalled for bacterial reasons with all the high quality sterilization equipment now available,” expressed Jeb Supple,Sales Manager Carometec Inc.
Peosta, IA (PRWEB) October 07, 2013
The US Food and Drug Administration (FDA), on August 9th, confirmed products supplied by yet another compounding pharmacy, this time in Texas, are indeed contaminated with bacterial growths. Significant scrutiny by the FDA has resulted in investigated pharmacies receiving recalls, Form 483s, and warnings to health care providers and consumers nationwide.
The increased attention is a direct result of an incident in 2012 that involving a Massachusetts compounding pharmacy whose contaminated products were responsible for a massive outbreak of fungal meningitis. An investigation was led by FDA and state regulators that determined insufficient sanitation practices were one of the causes of the outbreak and could be responsible for the troubling pattern they are now seeing industry wide.
The majority of the sterility concerns identified by the FDA are associated with the manufacturing process. It has become very apparent that the compounding pharmacy industry is not meeting the Hazard Analysis and Critical Control Point standards required by the FDA, a situation that could be corrected with upgrades to facilities and sanitation equipment.
“There is no reason pharmaceuticals should be recalled for bacterial reasons with all the high quality sterilization equipment now available,” expressed Jeb Supple,Sales Manager Carometec Inc. “Carometec has been meeting the pharmaceutical industry’s sanitation equipment needs by supplying the highest quality sole washers and all-in-one sanitation machines and we are very excited for the opportunity to help compounding pharmacies find sanitation solutions that are within their budget.”
The FDA in conjunction with Centers for Disease Control and Prevention (CDC) has continued to be on the lookout for any additional contamination cases, being wary of any compounding pharmacy product that may have the potential to adversely affect the nation’s health. Based on a CBS News report issued on May 24, 2013 their vigilance was justified when in May of this year the FDA announced that compounds produced by a pharmacy in Tennessee were responsible for seven adverse incidents that included one fungal infection, prompting a voluntary recall by the company.
With the significant media coverage and ongoing case load requiring investigation by the FDA and CDC, the U.S. Government has been forced into action. Congress is currently considering legislation that will set increased standards for the FDA regarding the regulation of compounding pharmacies and their sanitation practices.
About Carometec: Carometec strives to meet the ever changing sanitation equipment needs of manufacturers worldwide with state of the art customizable sanitation systems. Utilize the number-one system for preventing and eliminating bacteria and germs from any work environment, for more information visit: http://www.carometecusa.com.