The FDA has announced that it “will fully implement regulations related to the Prescription Drug Marketing Act of 1987, which requires drug distributors to provide documentation of the chain of custody of drug products — the so-called “pedigree” — throughout the distribution system.”
Most recently, in early 2004, FDA delayed the effective date of certain regulatory provisions regarding pedigrees to allow the industry time to adopt electronic technology for tracking drugs through the supply chain. Based on information from drug supply stakeholders, the FDA had expected this technology to be in widespread use in the drug supply chain by 2007, but it now appears that these expectations will not be met.
Accordingly, the hold, which will expire in December, will not be continued.
A paper pedigree? In the 21st century? Will this really be an effective deterrent in the battle to combat counterfeiters so sophisticated they can produce both packages and pills imperceptively different from the real McCoy? Do we really think the bad guys can’t produce their own paper pedigree documents?
This is a big problem — but it’s not the point. This is a signal from the FDA that industry cannot drag its feet when it come to developing and implementing more potent e-pedigree systems such as RFID.
According to the FDA’s announcement:
“A potential new measure to safeguard the drug supply is the use of electronic track and trace technology, such as radio-frequency identification (RFID), which creates an electronic pedigree (e-pedigree) for tracking the movement of the drug through the supply chain. The FDA had expected this technology to be in widespread use in the drug supply chain by 2007. In early 2004 FDA delayed the effective date of the regulatory provisions regarding pedigrees to allow the industry time to adopt this technology. However, it now appears that FDA’s expectations for adoption of the technology by 2007 will not be met. FDA therefore has determined it can no longer justify delaying implementation of the pedigree regulations.”