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U.S. Department of Health and Human Services

Drugs

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Combating Counterfeit Drugs May 2005 Update - Technology: Securing the product, packaging, and movement through the supply chain

In the Report, we stated that it is critical to implement new technologies to better protect our drug supply. We concluded that a combination of rapidly improving track and trace technologies and product authentication technologies could be used to provide a greater level of security for drug products. These technologies are intended to secure the product, packaging, and movement of the product as it travels through the drug supply chain.

Track and Trace Technology

In the Report, we stated that adoption and wide-spread use of reliable track and trace technology is feasible by 2007. This would help secure the integrity of the supply chain by providing an accurate drug "pedigree," a record documenting that the drug was manufactured and distributed under secure conditions. We particularly advocated for the implementation of electronic track and trace mechanisms and noted that radio-frequency identification (RFID) is the most promising technology to meet this need. RFID technology uses a tiny radio frequency chip containing essential data in the form of an electronic product code (EPC). Implementation of RFID will allow supply chain stakeholders to track the chain of custody (or pedigree) of every package of medication. By tying each discrete product unit to a unique electronic serial number, a product can be tracked electronically through every step of the supply chain.

Over the last year stakeholders have made tremendous progress in the development and implementation of EPC/RFID. This is a huge endeavor that requires close collaboration among all constituents of the pharmaceutical distribution system. We have observed and supported this collaboration, and we continue to support it today.

A critical piece of this undertaking is the development of standards for the type of technology to be used and the systems for storing and sharing pedigree information. This activity will ensure that the electronic track and trace technologies adopted are comprehensible and data communication systems are interoperable. We have been present at and actively participated in many industry, standard-setting, and government meetings and workshops where implementation issues have been discussed. We appreciate the opportunities we have been given to participate in the discussions and provide input when needed.

We received a number of questions over the past year regarding RFID and regulatory issues from members of the supply chain. In response to these common questions, on November 15, 2004, we issued a Compliance Policy Guide (CPG) for implementing RFID feasibility studies and pilot programs as an important and essential step in moving this technology forward. The CPG presents FDA's current thinking regarding several labeling, current Good Manufacturing Practices (GMP), and other regulatory issues that may arise by affixing an RFID tag to a drug product for a feasibility study or pilot program. Several members of the supply chain simultaneously announced their intention to move forward with pilot programs (joint programs across the supply chain or within an individual company) that will involve the tagging of products susceptible to counterfeiting. In fact, three major pharmaceutical companies said that they will incorporate an RFID tag into at least one of their products by the end of 2005. We have been in close communication with participants in these and other pilot studies and provided input when appropriate.

Also in November, we announced the creation of an internal, cross-agency "RFID Workgroup." This group is charged to monitor adoption of RFID in the pharmaceutical supply chain, pro-actively identify regulatory issues raised by the use of this new technology, and develop straightforward processes for handling those issues. We believe that the workgroup will improve communication with members of the supply chain on RFID related issues and will facilitate both the performance of pilot studies and the collection of data needed to formulate policy.

It is important to gain a better understanding of the effects of RFID on drug products, particularly biological products because they may be more susceptible to change in their environment. In the past year, we developed a protocol for the Product Quality Research Institute (PQRI) (a collaboration of FDA, academia, and industry) to evaluate the effects of radio-frequency on specific biological protein-based products. This study is in its very early stages. Also, a laboratory within FDA's Center for Devices and Radiological Health is conducting analyses of the heating and the radio-frequency field strengths induced in certain liquid pharmaceuticals by some RFID systems. We are encouraged by the response of individual companies informing us that they are conducting studies. In addition, the Health Research Initiative of the Auto-ID Laboratories is conducting additional studies on the effects of radio-frequency on various drug products and storage conditions. We look forward to the results of such studies.

Next Steps: FDA will continue to play an active role in public and private sector efforts toward developing an "electronic safety net" for our drug supply, including the adoption and widespread use of reliable track and trace technology by 2007. We will continue to facilitate and monitor standard-setting activities, including efforts by epcGlobal (an entity that has taken a lead role in developing standards) to establish standards for numbering systems, chip frequency, electronic pedigree, and data-sharing and security. In addition, we will continue to encourage and foster research on the use and potential impact of RFID on drug and biological products. Finally, we will regularly review the extent and pace at which RFID is being adopted.