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The FDA, Drugs, and RFID Technology for Pharmaceutical Industry |
FDA, Drugs, and RFID |
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Combating Counterfeit Drugs with RFID Technology. A Progressive Food and Drug Administration Endorses RFID for Tracking, Tracing, and Pedigree Enablement… The US Food and Drug Administration
completed a report titled "Combating Counterfeit Drugs: A
Report of the Food and Drug Administration" this month
(February, 2004), describing specific examples where RFID technology
can play a key strategic role. In this report, they discuss how
counterfeiting of currency and consumer products are common problems
that confront governments and manufacturers globally. Currently, America has an extremely low rate of drug counterfeiting, however the FDA detects an increasing trend by counterfeiters to target the American pharmaceutical marketplace. This report was created by a task force, whose mission is to respond to this emerging threat. The recommendations support the creation of a comprehensive system of modern protections, such as RFID technology, against counterfeit drugs. The FDA task force recommends the implementation of new technologies, specifically RFID, to better protect our drug supply. A combination of RFID technologies, such as track and trace, identification and authentication, etc., will provide a higher level of security for drugs in the near term. The FDA plans to facilitate the rapid development and deployment of these RFID applications. Radio frequency identification, or RFID, tagging of products through the pharmaceutical value chain - by manufacturers, wholesalers and retailers - is the best approach for reliable product tracking and tracing at this time. Feasibility studies and technical improvements are underway to validate RFID technology in this drug application. The FDA is working with RFID manufacturers and implementers to ensure that regulations facilitate the safe and secure use of RFID technology. RFID technology is also recommended for use in providing the electronic pedigree of a drug, at a lower cost than the manual processes in place today. The FDA expects to stay its regulations regarding specific pedigree requirements to enable the adoption of RFID-enabled pedigree solutions. The RFID-enabled pedigree is expected to be implemented at the case, pallet, and package level over time. The FDA recognizes that there are risks with RFID technology that must be addressed, such as the need to create standards for RFID and to focus on RFID information management.
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Discussion |
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Radio frequency identification (RFID) is an enabler of tracking processes in the extended value chain. Roadblocks could slow RFID Radio frequency identification has become a hot concept promising to streamline how businesses track and stock inventory. But companies may need to rethink their software infrastructures in order to make RFID work as advertised say analysts and technology makers. RFID tags which combine chips that carry descriptive information and radio frequency technology to track inventory could make it easier for businesses to track products and raw materials and therefore reduce their operating costs over time. Globetechnology E-Insider, Feb 19, 2004 Commentary: Filling a void for RFID Companies experimenting with radio frequency identification tags and readers are learning that they need new software to get the most out of their efforts. CNET News.com, Feb 19, 2004 FDA Backs RFID Tags to Track Prescription Drugs February 19 2004 - News Prescription drug manufacturers in general back the plan with key manufacturers distributors and the National Association of Chain Drug Stores settling on Accenture Ltd. to serve as their RFID program manager. The FDA in a report released Wednesday on combating counterfeit drugs called RFID tags the most likely technology to bring about mass serialization of prescription drugs. Bio-IT World, Feb 19, 2004 Exel: RFID on trial GMT Datamonitor Exel EXL.L is embarking on a project with House of Fraser HOF to trial RFID in the retailer's international supply chain. RFID is capturing the imagination of several leading retailers in Europe and the US who see it as a potentially revolutionary supply chain tool. Although the technology is neither proven nor perfected Exel is gearing itself to meet the challenge. Comment Wire, Feb 19, 2004 Data Synchronization Fundamental to RFID Success According to Latest GMA/FMI/NACDS Report; Action Plan Based on Input from 100 Executives at 80 Global Companies 19 U.S. Newswire Retail and consumer products companies must continue to drive implementation of data standards item registry and data synchronization if they are to take full advantage of advanced collaborative technologies such as the Electronic Product Code EPC and Radio Frequency Identification RFID according to a new action plan for electronic collaboration in the industry. US Newswire, Feb 19, 2004 Sierra Atlantic seeks RFID applications market ... Having built a strong expertise in manufacturing sector we are working with a manufacturing customer in evaluating new emerging technologies like RFID. One of the core areas for RFID applications is the manufacturing sector and we are in the early stages of developing RFID applications Mr Joga Ryali Sierra Atlantic s CTO told ET. The India Times - InfoTech, Feb 19, 2004 MeadWestvaco Launches RFID Inventory Solution That Meets FDA Anti-Counterfeiting Recommendations Over the last several months MWVIS has been assisting the FDA's Task Force in its efforts to understand fully the value of RFID technology for both consumer safety and in creating greater efficiencies in the manufacturing and distribution of prescription drugs. Task Force recommendations include the deployment of authentication and track and trace technology to guarantee that drugs delivered to consumers are those produced by pharmaceutical manufacturers. PR Newswire via iWon, Feb 19, 2004 Paxar RFID printing solutions approved for use with Manhattan Associates supply chain execution systems ... a provider of supply chain execution SCE solutions. Paxar's Monarch brand 9855 RFID printer encoder has been tested and approved by Manhattan Associates to work with its supply chain execution solutions. Frontline Today, Feb 19, 2004 P&G EPC Leader Takes New Role Larry Kellam who helped to lead Procter Gamble's EPC efforts has retired and will offer consulting services. Feb. 19 2004 As director of B2B supply chain innovation at Procter Gamble Larry Kellam was a leader in promoting Electronic Product Code EPC technology. In December Kellam retired from P G after 35 years. RFID Journal, Feb 19, 2004 AIM expands mission to include mobile computing RFID focus AIM the global trade association representing the automatic identification industry is expanding its charter to emphasize mobile computing and radio frequency identification. AIM s broadened mission is reflected in the association s proposed name change. Upon ratification by members in March the organization will be known as AIM The Association for Automatic Identification and Mobility. Frontline Today, Feb 19, 2004 NTT DoCoMo tests cell phones with RFID cards INNOVATIVE NEW PACKAGING IN JAPAN via NewsEdge Corporation NTT DoCoMo has begun testing cell phones with RFID cards built to Sony's FeliCa standard. The phones can be used as a credit card. Twenty seven companies including All Nippon Airways Pia and am pm Japan are taking part in this experiment which runs through summer 2004. Wireless Week Regions, Feb 19, 2004 Leading regional networking distributor sees strong adoption of Zebra desktop label printers in healthcare and warehousing Zebra Technologies is one of the leading global providers of thermal bar code label and receipt printers card printers RFID smart label printer encoders supplies label design integration software and the widest range of thermal printer connectivity and networking solutions. Zebra Technologies Corporation Invites You to Join Its 2003 Fourth Quarter And FY 2003 Analyst Conference Call on the Web More than 90 percent of Fortune 500 companies use Zebra R printers. A broad range of applications benefit from Zebra-brand thermal bar code smart label card and receipt printers resulting in enhanced security increased productivity improved quality lower costs and better customer service. The company has sold more than 3 million printers including RFID printer encoders and wireless mobile solutions and also offers software connectivity solutions and printing supplies.
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Particularly, the counterfeiting of drugs has become endemic, in
some countries.