Pharmaceutical Serialization

3 04 2010

It has been a month since I have added any counterfeit drug news to my blog.  I was doing some researching online and found a news article about Europe. This article is a discussion with HealthCare packaging and Cognex representative Robb Robles.

Cognex “is a complete identification and data verification solution for healthcare serialization.” This system is called In-Sight® Track & Trace. On their overview webpage it states; “Cognex Corporation is the world’s leading provider of vision systems, vision software, vision sensors and surface inspection systems used in manufacturing automation.  Cognex is also a leader in industrial ID readers.”

This article was found from Healthcare packaging. It was written on April 2, 2010. I really liked this question and answer article. Here is the article called “Europe Shows the way to Pharmaceutical Serialization.”

Here is a little overview…

  • Europe was the first to receive this technology because: “RR: Europe had the most urgency—they are ahead of the U.S. in terms of putting requirements in place for labeling pharmaceutical packages, particularly prescription medicines.”
  • In the U.S right now… “Right now California is the only state that has a compliance deadline for traceability. The California requirements are similar to Brazil in that they are pushing for full serialization, with a unique identifier on every individual package. Their deadline of 2015 gives companies more time to comply than most European countries have required.
    However, the FDA just issued new guidelines for labeling on prescription drug packaging in March of this year. These guidelines recommend inclusion of an sNDC (Serialized National Drug Code) on each package. Previous guidelines had already put in place the NDC, so the significant difference here is the addition of a serial number, which will enable item-level traceability of prescription drugs for the first time in the United States. The sNDC is compatible with the GS1 data standard.
    The guideline is not binding and has no compliance date attached, but generally companies don’t deviate from FDA guidelines so I would expect this to increase efforts of U.S. manufacturers and packagers to establish infrastructure for traceability compliance.”
  • Cognex will be marketing this to contract packagers.

The whole article is really valuable to learning about counterfeit drugs and what is happening now to help hault this widespread problem. I urge you to read the whole article.




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