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EPCglobal US Supports FDA Initiative to Protect U.S. Drug Supply Chain from Counterfeit Drugs
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            Nov 17, 2004 12:28 IST  
Addressing significant challenges facing the health and life sciences industries, such as counterfeiting, the EPCglobal Inc(TM) Healthcare and Life Sciences Business Action Group....

Addressing significant challenges facing the health and life sciences industries, such as counterfeiting, the EPCglobal Inc(TM) Healthcare and Life Sciences Business Action Group has made the tracking and tracing of pharmaceutical pedigree a top priority in the development of Electronic Product Code(TM) (EPC) technology.
Today’s announcement by EPCglobal US, an affiliate of EPCglobal serving subscribers in the United States to help foster the adoption of the EPCglobal Network(TM) and leverage radio frequency technology (RFID) in the supply chain, comes on the heels of the U.S. Federal Drug Administration’s (FDA) announcement of a new initiative designed to protect the U.S. drug supply chain from counterfeit products.


Pharmaceutical pedigree is a record of a drug’s chain of custody, from the point of manufacture to the point of dispensing. Using EPC-based RFID to improve pharmaceutical pedigrees will allow wholesalers and retailers to rapidly identify, quarantine, and report suspected counterfeit drugs, a significant global issue.

The FDA published its Compliance Policy Guide (CPG), which outlines parameters by which Radio Frequency Identification (RFID) feasibility studies and pilot programs can proceed. According to the FDA, the CPG will allow for a more rapid deployment of pilot programs, as companies can consult the policy guidelines rather than requesting individual permission to begin piloting. The FDA said it will look to standards-making bodies such as EPCglobal to assist in efforts to help secure the nation’s drug supply chain.

Charged with supporting members to help comply with pedigree laws worldwide, the EPCglobal Healthcare and Life Sciences Business Action Group has outlined three key priorities: defining requirements for meeting pedigree laws and then ensuring that the EPCglobal Network can support those requirements; enabling trading partners to effectively track prescription drugs through the EPCglobal Network; and deploying EPC technology in a way that can be used effectively and safely in the hospital environment.

The FDA initiative is an important step in the development of a safe and secure drug supply chain in the United States. Now, more companies can evaluate how RFID and EPC will bring significant safety and cost benefits to their supply chains through new pilot implementations and testing, said Mike Meranda, president of EPCglobal US. Top healthcare industry firms in the United States are helping to lead the EPCglobal Healthcare and Life Sciences Business Action Group and will work with the FDA to build community-based standards that enable low-cost, efficient EPC implementations and ensure authentic pharmaceuticals pedigree for their customers.

Since July 2004, 16 of the world’s top pharmaceutical companies, leading medical device manufacturers, patient service providers, distributors, wholesalers, and retailers have joined EPCglobal. More than 200 company representatives from 98 companies worldwide are participating.
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