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Stakes Are High for Mexican Pharma RFID Mandate
To participate in Mexico's federal Seguro Popular health-insurance program, which currently serves 4 million families, drug manufacturers and distributors will use UHF and HF RFID tags to track pallets, cases and individual containers of pharmaceuticals.
Sep 26, 2006—Mexico may be forging ahead of the United States when it comes to using RFID to secure the pharmaceutical supply chain. The country has issued a mandate requiring manufacturers and distributors to affix RFID tags on drugs sold to individuals covered under Seguro Popular, a governmental health-care institution that operates similarly to an insurance company. Created in 2002, Seguro Popular expects to assist more than 5 million families by year's end.
The RFID requirement, part of Seguro Popular's Supply Chain Model, was first presented to the pharma industry in March, and is designed to help trace and authenticate drugs to improve drug safety, fight drug counterfeiting and help the Mexican government determine payments for the drugs, according to Jorge Morales, director of operations for ISCEA-Mexico. The International Supply Chain Education Alliance (ISCEA) provides supply-chain training and certification worldwide, with the Mexican branch of the ISCEA serving as RFID technical advisor to Seguro Popular.
U.S. Food and Drug Administration (FDA) has been investigating the use of RFID to protect the U.S. pharmaceutical supply chain against counterfeit drugs, but currently does not require the technology's use. Instead, the FDA has urged drug manufacturers, wholesalers, distributors and retailers to begin testing RFID as a way to comply with the Prescription Drug Marketing Act of 1987. That act requires drug distributors to document (via a pedigree, though not necessarily in electronic form) the chain of custody for drug products as they move through the distribution system (see FDA Issues New 'Counterfeit Drug Task Force' Report).
Under the Seguro Popular Supply Chain Model, the Mexican government will require manufacturers and distributors to affix UHF RFID tags on cases and pallets, and HF RFID tags on item-level containers of pharmaceuticals. The government has not specified a required air interface for UHF tags, though EPCglobal Gen 2-compliant tags are recommended. As for the HF tags, the model calls for ISO14443B-compliant tags, but more air-interface protocols may be added later.
The government has not set a specific date for compliance, but manufacturers and distributors will be expected to comply as the government rolls out the supply chain and RFID capability on its end. The HF RFID tags will be encoded with a serial number and the drug's name, as well as its manufacturer, distributor and expiration date; the UHF tags used on cases and pallets will include a serial number, drug's name, and manufacturer. Although HF tags are being used for items, 96-bit EPC data standards will be followed, with a special variation of the EPC serial number specially designed by EPCglobal Mexico and ISCEA Mexico, according to Morales. The GTIN information (header, filter, partition, company prefix and item reference) remains the same, but Morales says what has changed is the usage of the 38-bit serial number to accommodate the expiration date and distributor ID number. "A standard of usage for these memory locations was needed so that the whole industry would use them in the same way," he says.
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