WASHINGTON-The Food and Drug Administration launched a new initiative to study the use of radio frequency identification technology to improve the safety and security of drugs, an effort with major implications for high-tech vendors and systems integrators that parallels plans of major retailers and manufacturers to integrate the wireless technology into supply-chain management in coming years.
The FDA published a Compliance Policy Guide for implementing RFID feasibility studies and pilot projects, actions intended to foster use of the technology in the U.S. drug supply chain by 2007.
“Radio frequency identification technology is an innovative response to the challenge of counterfeit drugs,” said Tommy Thompson, secretary of the Department of Health and Human Services. “It is our goal to ensure that the drugs available in the United States are among the safest in the world. However, we still must continue to be on guard against those who would exploit patients by selling counterfeit drugs.”
The FDA also announced it is creating an internal workgroup whose charge is to monitor adoption of RFID in the pharmaceutical supply chain, identify regulatory issues raised by the use of this new technology and develop processes for handling those issues. FDA said it believes that the workgroup will improve communication with members of the supply chain on RFID-related issues and should facilitate both the performance of pilot studies and the collection of data needed to formulate policy.
RFID technology uses electronic tags on product packaging to precisely track products as they move through the supply chain.
The FDA applauded efforts by pharmaceutical companies Pfizer, GlaxoSmithKline and Purdue Pharma to leverage use of RFID technology. Outside the pharmaceutical industry, top retailers-led by Wal-Mart-are championing RFID technology. RFID is also being employed for homeland security and defense applications as well as for livestock tracking. RCR
