Resources for Food and Drug Administration (FDA)

All Eyes on FDA for Drug E-Pedigree

www.rfidjournal.com

With 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).

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