INTRO
    Welcome to Countdown, our periodic newsletter for keeping you up to date on legislation and standards surrounding electronic drug pedigrees and serialization.
    After a flurry of talks over the past year urging an e-pedigree delay and then getting that delay, the drug industry may be tempted to slow down serialization. Yet another delay is possible, thanks to California Senate Bill 1307. And FDA isn’t ready yet—it is still in think-tank mode after getting a healthy amount of comments from industry on unique identifiers and track and trace and authentication technologies.
    So with little movement in rules and standards, why not slow down? Because you have too much to do—and to lose. Getting your packaging lines, pedigree-data systems, and technology partners in place is formidable enough of a challenge. But that isn’t all you have to do. You also need to work closely with your supply-chain partners and arrive together at an interoperable solution for the entire U.S. pharmaceutical supply chain.
    After surveying its members, the Pharmaceutical Research and Manufacturers of America (PhRMA) reports that 21 responding members have 2000 prescription medicines and 431 packaging lines in 162 plants that are affected by pending item-level serialization. Pilots have taken three years to complete, and costs have ranged up into the millions.
    As you can see, a lot of work and investment remain. We will keep you informed along the way. We will be counting down toward some key dates in Federal and state activity, beginning with FDA's deadline for standards and California's (current) deadline for e-pedigree. These dates could very well change, and we may very well turn our focus toward other developments. Our mission is to keep you up to date and provide as much clarity as we can.

Daphne Allen
Editor

FEDERAL

FDA is working to comply with a March 2010 deadline for establishing standards for a unique standardized numerical identifier (SNI) for prescription drug packaging. The agency will also develop guidance on track and trace technologies, as it reviews comments submitted by supply chain participants earlier this year.
“We are in the process of analyzing the information provided and researching several options received,” says Karen Mahoney, an FDA spokesperson. “The agency wants to make sure that it is thorough in its review of the comments and standards that are available.” The Food & Drug Administration Amendments Act of 2007 imposes the March 2010 deadline for defining the SNI.  The act also directs the Health and Human Services Administration to “develop standards and identify and validate effective technologies for the purpose of securing the (prescription drug) supply chain.” More

CALIFORNIA

Could another delay in electronic pedigree rules be on the way?
California has led the country toward pedigrees much more vigorously than FDA has. Delayed in March to January 1, 2011, California’s pending mandate for electronic pedigrees has commanded continued industry attention, given the effort needed for salable-item serialization.
However, all eyes have turned recently toward the bill introduced by Senator Mark Ridley-Thomas, referred to as “SB 1307—Pharmacy E-Pedigree” on his Web site. The bill would allow drug manufacturers to phase in serialization for electronic drug pedigrees. A draft of the bill amended in June stated that “all drug manufacturers and repackagers are strongly encouraged to serialize drug products and initiate electronic pedigrees as soon as possible, and all participants in the supply chain are encouraged to immediately ready themselves to receive and pass electronic pedigrees.” More

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IMPLEMENTATION brought to you by Nosco

Nosco is pleased to bring you this email series to help you track legislative evolution. This Implementation section will focus on just that: The latest in “how.”
We are offering a series of education bytes in each newsletter issue. In this issue, we are offering the e-book, “Pedigree Like It’s 2011. Getting Ready for California ePedigree Law (or whatever comes next).” The focus is on: Serialization Roadmap, Package Engineering Considerations and Challenges, FAQs, Serialization Formatting Guide, and Success Stories. Download the entire 50-plus page e-book here.

Canon Communications LLC