Executive Summary

that “Radiofrequency Identification (RFID) tagging of products by manufacturers, wholesalers, and retailers appears to be the most promising approach to reliable product tracking and tracing. ” The Agency, while clearly indicating in the same report (1) that none of the contemplated track and trace technologies, including RFID, represents a “magic bullet”, has encouraged regulated industry to consider RFID as a potential tool in anti-counterfeiting efforts. A concern has been raised about the potential impact on product quality due to exposure of drug products to radiofrequency radiation which would occur if RFID is adopted. This issue was assigned to the Drug Product Technical Committee (DPTC) of PQRI. The DPTC requested a study design for exposure of biological/biotech drug products to RF radiation; in the course of discussing the proposed study, the DPTC unanimously requested that a risk assessment for such exposure be done. This report is that assessment. There are three main components to the risk assessment performed: 1) a summary of the results from the industry sponsored, FDA reviewed Accenture Jumpstart test of th