FDA to e-track popular drugs

By Mary Mosquera

Connecting state and local government leaders

| November 17, 2004

The Food and Drug Administration will use RFID technology to track the nation's drug supply to reduce counterfeiting.

The Food and Drug Administration launched an effort this week to use radio frequency identification technology to track the nation's drug supply from manufacturer to pharmacy to reduce counterfeiting. FDA, an agency of the Health and Human Services Department, wants pharmaceutical companies and their supply chain to adopt RFID by 2007 to improve drug safety and security.

The agency published a Compliance Policy Guide for implementing RFID studies and pilot programs.

RFID uses electronic tags on product packaging to allow manufacturers and distributors to more precisely track drug products as they move through the supply chain, similar to that used for tollbooth and fuel purchasing passes.

FDA anticipates that its initiative will accelerate RFID standard-setting activities and applied research in such areas as tag numbering, optimal frequency use and database management. The agency is creating an internal "RFID Workgroup" to monitor RFID adoption, identify regulatory issues it raises and the processes for handling those issues. The workgroup should promote the performance of pilot studies and the collection of data needed to formulate policy.

RFID technology creates an electronic pedigree, or record of the chain of custody, from the point of manufacture to the point of dispensing. Electronic pedigrees will improve patient safety and protect the public health by allowing wholesalers and retailers to rapidly identify, quarantine and report suspected counterfeit drugs and conduct efficient, targeted recalls.

FDA considers electronic pedigrees to be a type of "electronic safety net" which utilizes technology that allows illicit drug transactions to be rapidly identified and, potentially, transmitted to the FDA, thereby improving FDA's ability to conduct investigations of suspected counterfeiting or diversion of prescription drugs.

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