RFID Drug Pedigree Accelerates ...

FDA accelerates the use of RFID technology to support the electronic pedigree for drugs. ...

... "Among other new measures, FDA 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. FDA had placed on hold certain regulatory provisions because of concerns raised at the time about the impact on small wholesalers. 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. Further, FDA has not heard that the concerns raised in the past regarding the impact on small wholesalers remains, and in fact, FDA was encouraged by most drug stakeholders to allow the hold to expire. Doing so would also provide clarity in the drug supply chain regarding who is and is not required to pass a pedigree. Continuing the hold would perpetuate the current confusion and further allow opportunities for counterfeit and diversionary practices. FDA has, therefore, determined that it can no longer justify not implementing these regulations. Accordingly, the hold, which will expire in December, will not be continued.

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. " ...

RFID Drug Pedigree Accelerates: Via FDA: FDA Announces New Measures to Protect Americans from Counterfeit Drugs