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FDA Announces Pharma RFID Recommendations

The US Food and Drug Administration today released a highly anticipated report with recommendations for combating the issue of countfeit pharmaceuticals. This article contains the need-to-know points.
Jun 09, 2006This article was originally published by RFID Update.

June 9, 2006—The US Food and Drug Administration today released a highly anticipated report with recommendations for combating the counterfeit of pharmaceuticals. Following are the need-to-know points:
  • The FDA did not actually mandate the use of RFID but did reinforce its belief in the technology as a key element in the fight against counterfeiting. The agency wants to see the pharma supply chain stakeholders "continue to work expeditiously" toward the realization of electronic pedigrees.
  • In 2004, the FDA had expected that RFID adoption in the pharmaceutical supply chain would be widespread by 2007. The report reiterates what the FDA has said publicly in recent months: its 2007 prediction was aggressive, and it does not expect to see widespread adoption next year.
  • All of the pedigree regulations outlined in the Prescription Drug Marketing Act of 1987 will be implemented. (Note: these regulations refer to paper pedigree, not RFID-enabled electronic pedigree.) Some of the regulations had been placed on hold because of their burden on smaller wholesalers and the FDA's expectation that RFID e-pedigree would have been widely adopted by 2007. But because the small wholesaler concerns have subsided, and e-pedigree will probably not meet the FDA's hoped-for schedule, the agency is effectively lifting the regulation hold by not extending it upon expiration in December. Enforcement of the regulations will initially apply to those drugs most susceptible to counterfeiting.
  • Four aspects of RFID adoption are cited as needing further development: the technical complexities of mass serializiation; the realization of a national pedigree regulation instead of a fractured group of regulations coming from individual states; privacy protections; and consumer education about RFID including full disclosure when purchased drugs contain RFID tags.

Read the FDA's announcement
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