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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. OxyContin, which is a controlled substance, has been subject to abuse, theft, and diversion. Based on the availability of sufficient RFID tags, Purdue also plans to tag bottles of Palladone (hydromorphone), a newly approved product to treat persistent moderate-to-severe pain.
The FDA considers electronic pedigrees to be a type of "electronic safety net," which allows illicit drug transactions to be rapidly identified and potentially transmitted to the FDA. This could improve the agency's ability to conduct investigations of suspected counterfeiting or the diversion of prescription drugs.
The FDA believes its compliance guide will clear the way for more pilot programs that involve RFID tagging of all packages of certain products, especially those that are highly likely to be counterfeited. The FDA hopes that more firms will use RFID technology and gain experience with transferring, storing, and securing data that RFID provides.
The scope of the compliance guide is based on information the FDA obtained concerning RFID feasibility studies examining the use of this technology for various business purposes, including inventory control and tracking and tracing of drugs. To encourage these studies, the guide announces the FDA's intention to exercise enforcement discretion if certain studies trigger regulatory requirements.
The FDA's actions are key steps in implementing a major recommendation of the agency's report, "Combating Counterfeit Drugs." That report recommended that RFID technology be in widespread use throughout the pharmaceutical industry by 2007.