Track-and-Trace System in Limbo as Final Details Debated in PDUFA

June 7, 2012
The Senate-passed omnibus FDA user fee bill includes a proposed track-and-track system, but lawmakers need to hammer out details with the agency and stakeholders or risk seeing the proposal jettisoned from a final bill. As currently proposed, the track-and-trace system, dubbed RxTEC, would force drugmakers to implement a 2-D barcoding system to monitor products to the lot level. The requirement would start in early 2017.
International Pharmaceutical Regulatory Monitor