Solutions for: • Distributors • Regulatory • Reverse Distributors •

Promoting Peace of Mind in the Global Supply Chain

XStream Systems designs authentication solutions  … for the challenges you face.

The Challenge

The World Health Organization (WHO) now estimates that global sales of counterfeit prescription medicines are up to $40 billion annually with the prediction that the numbers will reach over $75 billion by 2010. While the supply chain in the U.S. is among the safest in the world, a great deal more must be done to improve overall security.

Current regulations, including pedigree laws, provide some level of protection for the public. While pedigree laws help with issues such as diversion, drugs may still be counterfeited, adulterated, dosage changed, or contaminated and still have a valid pedigree. The recent heparin episode was a clear demonstration of that, where adulterated product, with valid pedigrees, killed several people and hospitalized many more.

The Solution

Overview

Authentication is the next layer in supply chain security and is rapidly evolving as an alternative to track and trace and pedigree. The FDA has identified three layers of authentication that need to be implemented by the pharmaceutical industry. The first two, overt and covert, deal primarily with authenticating the packaging while only forensic authentication actually detects and verifies the contents being processed.

The most effective method of authenticating drugs is rapid and accurate analysis of the drug itself, whether that drug is sealed in the manufacturer’s original packaging or repackaged for dispensing, the true solution is authentication of the drug, not add-on to the packaging or labeling.

Authentication technology, like our XT250 system, complement current pedigree legislation by validating the material inside the bottle. Now, not only do you know where a bottle of drugs came from, but more importantly, what's inside it.

We have a proven, unique and innovative solution to eliminate the record number of counterfeit and adulterated pharmaceutical products entering the global marketplace.

As the industry leader, XStream Systems has the knowledge that will assist you with your “beyond pedigree” decisions and is passionate about pharmaceutical authentication as the ultimate solution to prevent counterfeits.