RFID Track and Trace Feasible for Drug Tagging ...

Combating Counterfeit Drugs: A Report of the Food and Drug Administration

From Combating Counterfeit Drugs: A Report of the Food and Drug Administration ...

... "The adoption and common use of reliable track and trace technology is feasible in 2007, and would help secure the integrity of the drug supply chain by providing an accurate drug pedigree, which is a secure record documenting the drug was manufactured and distributed under safe and secure conditions. Modern electronic technology is rapidly approaching the state at which it can reliably and affordably provide much greater assurances that a drug product was manufactured safely and distributed under conditions that did not compromise its potency. FDA has concluded that this approach is a much more reliable direction for assuring the legitimacy of a drug than paper recordkeeping requirements, which are more likely to be incomplete or falsified, and that it is feasible for use by 2007. Radiofrequency Identification (RFID) tagging of products by manufacturers, wholesalers, and retailers appears to be the most promising approach to reliable product tracking and tracing. Significant feasibility studies and technology improvements are underway to confirm that RFID will provide cost-reducing benefits in areas such as inventory control, while also providing the ability to track and trace the movement of every package of drugs from production to dispensing. Most importantly, reliable RFID technology will make the copying of medications either extremely difficult or unprofitable. FDA is working with RFID product developers, sponsors, and participants of RFID feasibility studies to ensure that FDA's regulations facilitate the development and safe and secure use of this technology. FDA is also working with other governmental agencies to coordinate activities in this area." ...

RFID was cited as being the technology with the strongest potential for securing the supply chain but that it was not ready for widespread commercial use with pharmaceutical products. Many costs, potential benefits, and unresolved issues related to RFID were cited. The potential benefits included the ability to control inventory and conduct rapid, efficient recalls, while costs that could hinder the adoption of RFID included purchase of tags and other hardware, integration into existing information systems, and compliance with regulatory requirements (e.g., labeling, electronic records). Important unresolved issues included the need to develop standards and business rules for RFID, the need to address database management issues, and the need to determine the effect of RFID on product quality.