ePedigree and Serialization – The January 1, 2015 Deadline

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The word on the street is that the California State Board of Pharmacy’s 2015 deadline for new regulations on drug product serialization and ePedigree will not be pushed back. How is your company preparing your supply chain to handle these new regulations?

The January 1, 2015 deadline requires that 50% of manufacturer’s drug product packages (at the smallest unit) be serialized and with ePedigree. The push for these regulations in recent years is primarily due to the increasing trend of counterfeit drugs entering the pharmaceutical supply chain and pharmacy inventories. Another significant reason for stricter track and trace capability is the issue of pharmaceutical product drug thefts, which often occur in the ‘last mile’ shipments from the distribution centers to the final dispensing facility (pharmacy, hospital, doctor’s office, etc.).

Track and Trace Approach: Your approach should be based on the established Product Security Lifecycle Model, shown below, and targeted to your company’s situation and requirements. This approach is designed to provide guidance and direction through a structured process. The approach relies on subject matter knowledge for product authentication strategy, design and planning, as well as, data management and technology to support the initiative across the organization.

ePedigree Diagram

ePedigree Diagram

Recent Update: The 45-day comment period for the California regulation for Pedigree Requirements ended on November 5, 2012. ….Did you get your comments in on time?!

**This will be the first blog post in a series relating to ePedigree, Serialization, and Product(Rx) Identity Management Systems.**

Julia Wiest

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