Recent Adulteration of Heparin Drives Newly Proposed USP Standards

This month the U.S. Pharmacopeia (USP) proposed a second revision to their standards for the blood thinner, Heparin. This measure is to increase patient safety particularly because adulterated heparin resulted in the reported deaths of more than 200 patients worldwide in 2007 - 2008.

Most standards tests are generated to ensure manufacture quality and not equipped to look at unknown contaminants that may be added deliberately—as was the case with heparin. In the recent heparin recall the drug was adulterated with over-sulfated chondroitin sulfate and was not detected by current methods available then.

While we applaud the USP for answering this new threat to our citizen’s health, it does indicate that our pharmaceutical security measures need to be more proactive rather than reactive. Current science now offers methods to scan products to alert the user of unknown contaminants through the use of EDXRD technology. For more information on this revolutionary solution, visit: www.xstreamsystems.net.

To read more on the proposed USP revisions visit: http://www.usp.org/pdf/EN/aboutUSP/heparinStatement.pdf

For more information on specific changes to the monograph standards, visit www.usp.org or contact mediarelations@usp.org.

Will the FDA’s China Office Protect US Consumers?

The Washington Post, New York Times, Bloomberg News and a variety of other media outlets all have stories today announcing the Food and Drug Administration (FDA) deploying staff and opening its first office in Beijing, China.

This is the FDA’s reaction to China’s increasing role as a major exporter to the United States in food, drug and consumer products. Unfortunately China is also the world leader in exporting counterfeit, adulterated and contaminated products and the FDA is attempting to slow down the dangerous impact to US consumers. Recent high profile examples of counterfeit, adulterated and contaminated products include the recent heparin contamination which resulted in over 250 deaths in the US, the pet food contamination with melamine and the huge issue over lead paint on children’s toys. Most experts agree that these examples of toxic products within our consumer supply chain represent only a fraction of the dangerous products that are reaching our shores on a daily basis.

Apparently the FDA has plans this year to open up other offices throughout China and certify third-party inspectors who can approve and qualify the safety of exports to the United States.

The question is when will the FDA deploy a materials analysis technology that can look inside product packaging to inspect and protect the US consumer instead of throwing bodies at a high expense to attempt to catch the problem before it gets into our supply chain?

Stay tuned, we at XStream Systems are trying our best to introduce our revolutionary technology as a solution to catching the problem before it impacts our nations health.