October 1, 2008
Issue 2

INTRO

Welcome to Countdown, our periodic newsletter for keeping you up to date on legislation and standards surrounding electronic drug pedigrees and serialization.

In California, Governor Arnold Schwarzenegger has signed SB 1307, Senator Mark Ridley-Thomas's "Pharmacy E-Pedigree" bill. Expected to become law by many industry stakeholders and observers, the legislation gives pharmaceutical manufacturers and its supply-chain partners more time to develop an end-to-end electronic pedigree system.

"I applaud the governor for seeing the wisdom of signing my legislation that once and for all addresses important issues all vested parties can agree upon," said Ridley-Thomas.  "SB 1307 resolves a number of ePedigree implementation issues that were not addressed in the original legislation.  I am confident California will now be able to move forward with a reliable tracking system that guarantees the highest pharmaceutical safety standards."

The Healthcare Distribution Management Association (HDMA) supports the move. "HDMA and our primary healthcare distributor members applaud the legislature and the governor for working together to enact this important legislation that makes necessary improvements to California's current pedigree law to further preserve patient safety, value, and access to medicines," said John M. Gray, HDMA President and CEO. " California is a pioneer in the area of track and trace for prescription medications, and SB 1307 allows the state to continue in that leadership role, while at the same time encouraging the U.S. Congress to enact a uniform, federal requirement for pedigree."

The California State Board of Pharmacy will be discussing pending requirements for electronic pedigrees next week. While the pharmaceutical industry will continue to monitor the board's progress, its attention will mostly likely turn toward FDA's efforts, which could include standards as early as March 2010. Read on for coverage.

Daphne Allen
Editor

 

More Resources

Layering for Protection

California's Electronic Pedigree Law Delayed to 2011: Now What?

Tracking & Tracing Pharmaceutical Products Supplement

ePackage Newsletter Archives

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FEDERAL

FDA is still busy drafting standards for unique identifiers, for both drugs and medical devices. Work is well under way on unique device identification (UDI), which could very well guide the agency's policies on drug identification.

Making identification standards all the more urgent are two breaking news stories: more counterfeiting cases and more melamine troubles. In August, more than a dozen potential counterfeit drugs were discovered at two Baltimore branches of The Medicine Shoppe. FDA reports that the products "were either expired or suspected counterfeit." (FDA continues to investigate, but the agency nor The Medicine Shoppe would comment on how or why these products were suspected.) More

 

 

CALIFORNIA

Pharmaceutical manufacturers now have more than six years to comply with California's electronic pedigree rules. Governor Arnold Schwarzenegger has signed into law SB 1307—Senator Mark Ridley-Thomas's Pharmacy E-Pedigree bill.

The law gives drug manufacturers until January 1, 2015, and beyond to comply with California electronic pedigree requirements. Before January 1, 2015, manufacturers will need to designate a minimum of 50% of their drug products that will be subject to the pedigree requirements. Before January 1, 2016, manufacturers shall designate the remaining 50%. More

 FEDERAL DEADLINE
 
 CALIFORNIA DEADLINE
 

March 30, 2010

January 1, 2015

 
 
 

IMPLEMENTATION brought to you by Nosco

Despite delay, many people believe the Federal Legislature will use this opportunity to enact a National Pedigree Law in some shape or form. We believe the opportunity is now to begin preparing for ePedigree and serialization with a pilot to build your learning curve.

Learn how with 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. You can download the entire 50+ page e-book here.


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