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.