FDA Instructs Pharma Companies to Watch for Melamine

Pharmaceutical-Technology.com reported in its August 7, 2009 on-line edition on FDA guidance and instructions on protection to the pharmaceutical supply chain, specifically as it relates to Melamine. Melamine is a synthetic chemical with a variety of industrial uses including the production of resins and foams, cleaning products, fertilizers and pesticides.

Here are some highlights from the article:

• The US Food and Drug Administration (FDA) warned drug companies to scrutinize certain pharmaceutical ingredients for the presence of melamine and has issued industry guidance on how to protect against contamination.


• The FDA has stressed that there is no evidence that melamine, which if ingested in significant amounts can lead to kidney failure or death, has entered the pharmaceutical chain but that recent contaminations in pet food and in infant milk in China have proven the need to be vigilant.


• The FDA has released guidance as an initial measure with pharmaceutical manufacturers, re-packers, other suppliers and pharmacists to conduct melamine testing.


• The FDA identified specific pharmaceutical ingredients recommended for screening, and has also recommended specific FDA-published methods for this testing.


• "The FDA urges the implementation of appropriate controls to assure consumers that melamine contamination will not happen in the pharmaceutical supply chain," Hamburg said.

XStream’s authentication and verification technology tests the product inside its sealed, unit-of-sale container and can protect the pharmaceutical supply chain by screening inventories at the point of production, distribution and dispense without destroying the medication or disrupting the container by opening.

To learn more about XStream Systems, visit us at www.xstreamsystems.net.

To read the article in full, follow the link below:
http://www.pharmaceutical-technology.com/news/news61460.html?WT.mc_id=DN_News

XStream Systems Stories and News for the Week of November 28, 2008

Here are a few of stories that we at XStream Systems think are noteworthy as it relates to the safety of our supply chain. Recent incidents such as the adulteration of heparin and the discovery of melamine in baby formula have heightened consumer’s awareness of safety risks to our food and drug supply.

U.S. pays millions for unapproved drugs
The availability of unapproved prescription drugs to the public may create a dangerous false sense of security. Dozens of deaths have been linked to them.
The medications date back decades, before the Food and Drug Administration tightened its review of drugs in the early 1960s.

Republican Lawmaker Asks GAO to Review FDA Handling of Heparin
The FDA may not have used all available postmarket surveillance tools when determining the likelihood that contaminated heparin caused patient fatalities, according to a Republican congressman. “Based on the available information … there is a serious and potentially troubling question about whether FDA availed itself [of] all of its tools to conduct comprehensive surveillance of heparin deaths,” Rep. Joe Barton (R-Texas), ranking member of the House Energy and Commerce Committee, says in a letter to the Government Accountability Office (GAO).

FDA Finds Melamine Traces In U.S. Infant Formula
Bloomberg News reported that the industrial chemical melamine was found in U.S. infant formula in trace amounts that pose no health concern, according to FDA. Since September, some 50,000 children in China were sickened by melamine-tainted milk and several died.

We at XStream Systems believe that molecular pharmaceutical authentication will play a major role in the coming years to protect us from contaminated, adulterated and counterfeit products. To learn more about how this can be done, please visit www.xstreamsytems.net.

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.