The US Food and Drug Administration is to enforce regulations requiring electronic tracking and tracing of pharmaceutical...
products throughout the supply chain, as part of a crackdown on counterfeit medicines.
The FDA wants the pharmaceutical industry to use track and trace technology, such as radio frequency identification (RFID), to document the chain of custody of drug products, creating an “e-pedigree” for them.
A RFID-based e-pedigree would provide “an electronic safety net” for medicine supplies, the agency said.
Three years ago, the FDA put some regulations arising from the 1987 Prescription Drug Marketing Act of 1987 on hold to give the industry time to adopt the new technology.
But in a statement following a report by its Counterfeit Drug Task Force, the FDA said, “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.”
The FDA will focus its enforcement of the pedigree regulations on the products most susceptible to counterfeiting, and implementation of RFID technology should begin with these products, it said.