Radiofrequency Identification Technology: Protecting the Drug Supply

FDA Consumer, March-April 2005 | Go to article overview

Radiofrequency Identification Technology: Protecting the Drug Supply


The FDA has stepped up its efforts to improve the safety and security of the nation's drug supply by encouraging use of a state-of-the-art technology that tags product packaging electronically. The technology, called radiofrequency identification, or RFID, allows manufacturers and distributors to more precisely track drug products through the supply chain.

RFID makes it easier to ensure that drugs are authentic, and it also creates an electronic pedigree--a 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.

In November 2004, the FDA published a compliance policy guide for industry on implementing RFID studies and pilot programs. Acting FDA Commissioner Dr. Lester M. Crawford says the agency's actions were designed with one main goal: "to increase the safety of medications consumers receive by creating the capacity to track a drug from the manufacturer all the way to the pharmacy."

The FDA acknowledged the leadership of Johnson & Johnson in establishing standards for RFID technology and participating in RFID pilot studies. The agency also applauded initiatives announced by Pfizer, GlaxoSmithKline, and Purdue Pharma.

Pfizer announced its plans to place RFID tags on all bottles of Viagra (sildenafil) intended for sale in the United States in 2005. GlaxoSmithKline has announced that it intends to begin using RFID tags on at least one product deemed susceptible to counterfeiting.

Purdue Pharma announced that it is placing RFID tags on bottles of the pain reliever OxyContin (oxycodone) to make it easier to authenticate, as well as to track and trace the medication. …

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