NEWS
The US Food and Drug Administration (FDA) has stopped short of mandating the use of RFID to trace pharmaceuticals in the supply chain - but the move could soon be on the agenda.
As part of new measures designed to prevent counterfeit drugs being passed off as real pharmaceuticals, the FDA is putting in place regulations that will force drug makers to make sure they can provide a 'pedigree' of how products have passed through the supply chain.
While the type of technology that will be put in place to keep the drugs legitimate has not been specified, the FDA appears to be steering the industry towards the use of RFID, referring to it as "a potential new measure to safeguard the drug supply".
The FDA had previously thought RFID was likely to see widespread adoption throughout the industry by 2007 and had delayed the 'pedigree' provisions to give pharmaceutical companies time to take up the technology in their own time.
Now, however, the FDA doesn't believe that timescale will be met and will be implementing the 'pedigree' proposals to ensure electronic tracking of pharmaceuticals takes place.
The FDA says it now believes "widespread use of e-pedigrees using electronic track and trace technology, including RFID, would provide an electronic safety net for our nation's drug supply", and has advised that RFID be tested first on drugs that are likely to be the most counterfeited.
The FDA's recommendations on which technology will be chosen are expected to be published in December.
Some US drug companies have already jumped the gun and initiated their own rollouts of RFID to track and trace their products, most notably Pfizer, maker of Viagra. No pharmaceutical rollouts of the technology are yet planned on this side of the pond, although a number of pharmacies have been trialling the technology from supplier Aegate.
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1. Dyfrig Wilson
I've been in the Pharmaceutical IT business for 10 years and it surprises me that the FDA would recommend a specific technology as a solution to a problem.
Typically through their history the FDA issues guidelines and regulations (enforceable laws) when problems arise with Pharma products.
In 1997 the FDA issued 21 CFR Part 11 - the regulations governing e-Records and e-Signatures. This was in response to the industry that had requested rules governing the use of electronic records in lieu of paper records. Part 11 has undergone a number of changes since then.
However, at no time has the FDA recommended any technology, as their philosophy was that the industry knows best how to solve their problems, the FDA just provides the rules.