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

Government Seizes Contaminated Heparin STILL in the US Supply Chain?

In a news report, the Federal Agents seized contaminated Heparin a full seven months following the recall. Read the full story.

It seems shocking that after confirmed deaths of over 250 people that this type of product would still be in the domestic supply chain. “I think that this is an illustration of how many gaps that remain in the process and the system that leaves the US consumer at risk,” stated Alan Clock, SVP of XStream Systems. “Those within the supply chain that believe that they are not vulnerable or that the burden of product safety lay elsewhere are in for a rude awakening when not if the next counterfeit or adulterated products hit their warehouse or store shelves.”

To learn more about XStream Systems revolutionary materials analysis solution to counterfeit, contaminated or adulterated products please visit us at www.xstreamsystems.net.

How do Recalls Affect Consumer Loyalty?

A new study release by Deloitte shows that safety issues costs companies millions of revenue dollars. The study shows that when consumers hear of product safety and/or quality issues, more than half of them switch products for nine months or more, increasing the likelihood that they would discontinue the brand use entirely.

Modern consumers are less tolerant of recalls and over 49 percent are extremely concerned with product safety. Those population segments with the greatest concern are women (53%) and seniors (56% of those over the age of 55).

In addition, recent recalls from China have left the public with a distrust of items manufactured there. Over 73 percent stated they were extremely apprehensive about items manufactured in China.

To see how loyalty is affected, just look at last year’s recall issue where thousands of pets died from tainted products resulting in the largest recall of pet food in US history. Today, pet owners, even in this economic downturn, are reluctant to change to a cheaper pet food. ….

A recent article by the associated press stated “That's because many pet owners, who upgraded their kibble after contaminated pet food killed or sickened thousands of animals last year are leery of switching back…..”

So what can companies do to assure their customers that their products are safe? Consumers want safety information on the package, on the company website, and from the government. Furthermore, testing materials for consumer safety is a necessity.

Build and they shall come – But, test and assure and they will stay.

Obama and McCain Both Support Drug Re-Importation

As the 2008 Presidential Campaign heads into its inevitable heated conclusion and the individual campaigns separate themselves on the issues, it may be time to reflect briefly on an issue that both Barrack Obama and John McCain seem to be in agreement.

Both Barrack Obama and John McCain have publically stated their support of drug re-importation as a way to curb the high price of pharmaceuticals.

Given this seemingly rare consensus it is important to realize that there is a significant possibility that drug re-importation may become a reality once the new administration comes into power.

There are certainly many pros and cons to the issue and many reasons why there is significant support for this stance by both candidates. It is important however to understand the considerable danger that re-importation magnifies if it becomes law.

As we all know by now, the issue of counterfeit, adulterated and contaminated drugs has been proliferating both domestically and globally dramatically in recent years. To date the United States has little in the way of regulations or solutions in place to adequately protect the domestic pharmaceutical supply chain from this threat, outside of weak state pedigree laws which attempt to track the transaction of drugs from the manufacturer to the drug store.

If the re-importation of drugs becomes a reality, the potential threat of even more counterfeit, adulterated and contaminated medications reaching the American consumer will automatically triple given the supply chain’s inability to adequately track and authenticate the actual contents of the medication.

This is where XStream Systems technology can save the day. XStream’s XT250 system has the ability to authenticate and verify the contents of a sealed container in a non-destructive manner. Authenticating the contents of the imported pharmaceuticals will be critical in making certain that pharmaceuticals imported from other countries are clinically safe and efficacious.

Please visit XStream Systems website at www.xstreamsystems.net for more information on this technology.