FDA to Lift Mandate on Prescription Drug Pedigrees

FDA to Lift Mandate on Prescription Drug Pedigrees
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RFID is being studied and recommended to not only comply with e-pedigree, but for so-called track and trace efficiencies as well. However, there remain issues to overcome.On Dec. 1 the Federal Drug Administration is expected to lift its stay on its Prescription Drug Marketing Act, which mandates that wholesale pharmaceutical distributors show a paper or electronic "pedigree," or trail, for every drug that touches their company by 2007.

The upcoming mandate comes as no surprise to the manufacturers, distributors and retailers in the pharmaceutical supply chain, they say—most are already complying with an e-pedigree mandate in Florida with bar-code systems that can be applied on a national basis. But those systems are often considered a stopgap at best.

Whats being looked at in pilot projects—and recommended by the FDA—is the use of RFID technology to not only comply with e-pedigree, but for so-called track and trace efficiencies as well.

But before that can happen, there remain issues to overcome with RFID.

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Cardinal Health, one of the worlds "big three" wholesale pharmaceutical distributors (Cardinal also manufacturers drugs and medical supplies) announced Nov. 14 the long-awaited results from an RFID pilot that tests the technologys capabilities in an end-to-end supply chain scenario from the manufacturer to the retailer.

The study concludes that while RFID technology using UHF (ultra-high frequency) at the unit, case and pallet levels is feasible for track and trace, challenges remain before it can be adopted industry-wide.

To read more about the pharmaceutical industrys adoption of RFID, click here.

"While our pilot demonstrated that using UHF RFID technology at the unit, case and pallet level is feasible for track and trace purposes, a great deal of additional work needs to be undertaken by stakeholders across the industry to address significant challenges including global standards, privacy concerns and the safe handling of biologics," said Renard Jackson, vice president and general manager of global packaging services for Cardinal Health, in Dublin, Ohio.

"Until those challenges are addressed, direct distribution of medicine continues to be the best near-term approach to maintain the highest levels of security and efficiency in the pharmaceutical supply chain."

There are both technology and process challenges to overcome, according to a statement released by the company.

Those include getting to case and unit level read rates that exceed 99 percent at all reading stations—an issue thats been marked by other industries piloting RFID—and allowing unit level "inference" where read rates are unreliable.

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