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
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