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FDA Begins Review Of E-Pedigree Options Just As California Delays Its Plan

Executive Summary

With testimony that fewer than one in seven pharmaceutical manufacturers could be ready for California's planned implementation of electronic pedigree rules on Jan. 1, 2009, the State Board of Pharmacy decided to delay implementation for another two years

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FDA To Unveil Drug Identifier System Soon, Short On Enforcement Authority

FDA is preparing to release guidance on a system for uniquely identifying units of prescription drugs

FDA To Unveil Drug Identifier System Soon, Short On Enforcement Authority

FDA is preparing to release guidance on a system for uniquely identifying units of prescription drugs

Next step toward track and trace requirements taken

FDA's recently issued draft guidance on what should be included as part of a package-level standardized numerical identifier serves "an initial step to facilitating other measures for securing the drug supply chain" based on requirements included in the FDA Amendments Act. The agency is seeking comment on guidance that describes the SNI as being composed of the National Drug Code "that reflects each corresponding manufacturer or repackager, combined with a unique eight-digit numerical serial number generated by the manufacturer or repackager for each individual package." FDA says this identification "can in turn facilitate authentication and tracking and tracing of the prescription drugs." FDAAA requires the implementation of an SNI no later than 30 months after its Sept. 27, 2007 enactment. FDA's guidance does not address technologies that would be used to read the identifier. In March 2008 FDA requested public input on the status of e-pedigree technology and standards development (1"The Pink Sheet," March 31, 2008, p. 20). Comments on the draft guidance are due April 16

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