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December’s New To-Do List: E-Pedigree and Track and Trace

November 30, 2011 – 10:45 am

daphne_102610If pharmaceutical electronic pedigrees and track and trace are on your radar, December will be a busy month for you. California’s State Board of Pharmacy (CA BoP) has announced that it will discuss implementation of the state’s electronic pedigree requirements during its board meeting on December 6. In addition, GS1 Healthcare US is seeking feedback from U.S. industry stakeholders by December 15 on its emerging pharmaceutical traceability models, Chain of Custody and Chain of Ownership. We encourage you to participate in both–and the good news is that you can right from your desk!

According to CA BoP’s agenda, Connie T. Jung, FDA’s acting associate director for policy and communications in the Center for Drug Evaluation and Research, will kick off the discussion with a presentation. Jung will be followed by presentations and questions from the pharmaceutical supply chain and then discussion about future rule makings to implement California’s requirements. You should be able to access the meeting via a Webcast. For details, visit the CA BoP’s agenda online.

We also encourage you to watch GS1′s videos on its technical models for Chain of Custody and Chain of Ownership and provide feedback by Dec. 15. According to GS1, Chain of Custody is defined as “a record of organizations, entities, and locations that have had or currently has physical possession of the product, while Chain of Ownership records the legal title of the product. The objective in both Chains is for trading partners to be able to document the product attributes and all other trading partners involved in the Chain of Custody/Ownership.”

“For more than seven years, we’ve been working to help pharmaceutical manufacturers, distributors, retailers, and hospitals understand the business and technical aspects of tracking and tracing serialized product through the supply chain,” says Bob Celeste, director of healthcare, GS1 US. “The launch of this video is part of that overall effort, as it paints a picture of how stakeholders can leverage pedigree information to increase supply chain security and visibility up and down the distribution chain.”

I’ve given you a lot to do in the next few weeks, but your participation is needed. You’ve got just over three years to serialize 50% of your prescription drugs to meet CA’s law. And there is movement toward federal activity . . .

Daphne Allen

  1. One Response to “December’s New To-Do List: E-Pedigree and Track and Trace”

  2. I have found that clients are reluctant to employ methods to prevent counterfeiting and diversion for several reasons, most of which are unfounded. I feel that there has been quite a lot of misinformation regarding new technologies and it is up to the new media to dispel some of the myths and promote some of the advances in this important field.

    By vincent hatty on Jan 27, 2012

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