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All Eyes on FDA for Drug E-Pedigree

Now that California has extended its electronic-pedigree deadline to 2011, the U.S. Food and Drug Administration could become the first governing body to issue e-pedigree requirements for protecting the pharma supply chain—assuming it meets its goal.
By Claire Swedberg
Apr 10, 2008With the deadline for California's electronic-pedigree (e-pedigree) requirement for pharmaceuticals moved from Jan. 1, 2009, to Jan. 1, 2011, the push for a drug-authenticating e-pedigree system now seems to have shifted to the federal rather than state level. The U.S. Food and Drug Administration (FDA) has set a deadline of January 2010 to put in place a pedigree system that would protect the pharmaceutical supply chain "against counterfeit, diverted, subpotent, substandard, adulterated, misbranded or expired drugs." While the FDA is not considering only electronic solutions—other paper-based identification systems that do not use RFID or bar coding are being discussed as well—the agency has shown an interest in RFID technology, which would make the pedigree solution electronic.

An e-pedigree is an electronic record for tracking the movement of prescription drugs through the supply chain to combat counterfeit or adulterated prescription drugs. California was the first state to set a deadline for e-pedigree compliance that could include a $5,000 fine for every violation (each sellable unit found not in compliance).

Doug Farry
Nevada and Virginia also have e-pedigree systems on a limited scale. In Nevada, a pharmaceutical wholesaler must create e-pedigrees for any pharmaceutical items it ships, then send all of the electronic records once a month to the Nevada State Board of Pharmacy.

Both California's and the FDA's pedigree system are comprehensive, and would begin with tracking items earlier, at the point of manufacture, and then follow them to the point of sale. The state of Florida issued its own pedigree requirement in 2006, but that is document-based, with participants manually recording data about pharmaceutical shipments. In addition, the California e-pedigree system calls for tracking additional details, such as product volume and dosage.

But on March 25, the California State Board of Pharmacy issued a decision to delay implementation of its e-pedigree law. After the board set the 2009 deadline two years ago, some industry members have since been more successful than others in putting their own e-pedigree systems in place. In its March 25 decision, however, the board wrote that a large percentage of industry members have indicated they will be unable to meet the deadline by 2009, but could do so by 2011.

Because the implementation delays among some industry members would affect the efficacy of systems that other members already set in operation, the board determined the industry as a whole would not be able to meet the 2009 deadline. An imperfect or non-uniform implementation of an e-pedigree system, the board wrote, could cause unnecessary delays in the supply chain, or unneeded expenses.

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