RFID FDA

Whether a pedigree for all drug products can be achieved by phasing in track and trace technology (i.e., electronic pedigree) starting at a case and pallet level for products likely to be counterfeited and progressively including all products at the case, pallet, and package level; and whether, as an interim measure, prior to widespread adoption of track and trace technology all drugs and biologics likely to be counterfeited should be tracked and traced either by limiting the number of transactions of the product or by using available track and trace technology, identifying the drug at the case and pallet level, and preferably at the product level, throughout the distribution system using RFID FDA technology.

There was universal support for the adoption of electronic track and trace technology RFID FDA. 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.

FDA was also informed that some companies are planning feasibility studies concerning business uses of RFID for early this year and that other activities related to creating standards, business rules, and migratory pathways for RFID FDA are also ongoing.

Let’s see some useful discussion about RFID FDA initiatives: Use of mass serialization to uniquely identify all drug products intended for use in the United States is the single most powerful tool available to secure the U. S. drug supply. Mass serialization involves assigning a unique number (the electronic product code or EPC) to each pallet, case, and package of drugs and then using that number to record information about all transactions involving the product, thus providing an electronic pedigree from the point of manufacture to the point of dispensing. This unique number would allow each drug purchaser to immediately determine a drug's authenticity, where it was intended for sale, and whether it was previously dispensed.

Although there is general agreement that widespread use of mass serialization is inevitable, several important issues remain unresolved, including the migratory path(s) that participants in the drug distribution system will follow as they begin to serialize their products, and the most likely timeline for widespread commercial use.

It currently appears that the technology most likely to bring mass serialization into widespread commercial use by the pharmaceutical industry is RFID, although two-dimensional bar codes may be used for some products. RFID FDA technology includes not only the silicon tags containing the EPC, but also antennas, tag readers, and information systems that allow all users to identify each package of drugs and its associated data. This data can be used not only to authenticate drugs but also to manage inventory, conduct rapid, targeted recalls, prevent diversion, and ensure correct dispensing of prescriptions.

Acquiring and integrating RFID technology into current manufacturing, distribution, and retailing processes will require considerable planning, experience, and investment of resources. Currently, some manufacturers, wholesalers, and retailers are developing business plans and testing mass serialization using RFID while others are taking a wait and see approach. Due to rapid technologic advancements, the lack of significant market place experience with it in the pharmaceutical supply chain, each participant is best situated to determine his optimal path(s) to adopting it.

Therefore, FDA has identified near term actions, described below, for it to take in order to facilitate the performance of mass serialization feasibility studies using RFID, and to assist stakeholders as they migrate towards the use of RFID technology.

In the long term, after there is significant market place experience with RFID, FDA plans to propose or clarify, as necessary and appropriate, policies and regulatory requirements relating to the use of RFID. Labeling, electronic records, product quality, and Current Good Manufacturing Practices (cGMP) requirements are issues that have arisen in connection with RFID. However, regulatory or policy determinations regarding these, or other, issues should not be made until they can be informed by sufficient data and significant marketplace experience with RFID FDA has also identified a series of actions, discussed below, that would help industry stakeholders and standard-setting organizations achieve this goal.

FDA Pushes Drug Industry to Adopt RFID: The Food and Drug Administration is asking pharmaceutical makers and distributors to adopt radio-frequency identification technology within the next three years to combat drug counterfeiting. RFID is the most-promising track-and-trace technology for providing an accurate electronic "pedigree" for pharmaceuticals. It can ensure that drugs are manufactured and distributed under secure conditions and that counterfeit drugs introduced into the supply chain aren't mistaken for valid ones. Electronic drug pedigrees can be more reliable, authentic, and cost-effective than old-style paper records.

In its report, the FDA anticipates drugmakers and distributors will conduct RFID feasibility studies this year and next year begin attaching RFID chips to pallets, cases, and packages of costly pharmaceuticals and other drugs that are popular among counterfeiters. Use of the chips should permeate high-risk drugs in 2006, with some tagging occurring among pallets of less-valuable drugs. The FDA expects that by the following year, all pallets, cases, and most individual packages of the drugs it regulates will be tracked using RFID. The agency stopped short of setting mandatory implementation guidelines.

These expectations likely won't come as a surprise for most in the pharmaceutical industry, which has been largely receptive to the value and use of RFID tagging. The FDA expects large manufacturers, wholesalers, and drugstore chains to be the first on board with RFID, while it will take a few years for smaller retailers to implement systems and processes.

Several issues must be addressed before RFID FDA can work for the industry, the FDA acknowledges, including the need to develop standards and business rules and address database-management challenges. Adopters also will have to comply with the Health Insurance Portability and Accountability Act.