Major developments are afoot in package coding and track and trace regulation, that prompt the question: Is supply chain security taking a back seat to efficiency?
Parties of interest have collaborated on a revision of the closely-watched Buyer- Matheson bill (H.R. 5839), that preempts state’s requirements for e-pedigree documentation of supply chain transactions.
The revision tosses out a schedule featured in the first draft for manufacturer tagging of high risk drugs, as it embraces deadlines for tagging and track and trace established by California’s relaxed Ridley-Thomas law.
And the revision follows California in allowing inference, which most likely spells dire consequences for the RFID industry, at least as far as the pharma market is concerned.
The Buyer bill would allow supply chain members to avoid e-pedigree requirements now standing in 27 states, as they embark on serialization. Ridley requires e-pedigree, but it doesn’t kick in until the 2015-16 timeframe, when marking and wholesaler and pharmacy tracking has to start.
With e-pedigree requirements out of the picture, supply chain security would rest on companies’ progress in developing serialization. Yet the pushed backed deadlines would be further incentive for companies to put off investment in track and trace while the technology and standards shake out.
While manufacturers and wholesalers see the Buyer and Ridley timelines as realistic, FDA has yet to establish final guidance or regulation. The agency has said that companies shouldn’t wait to explore serialization. Might this be a signal that it would favor stricter deadlines than are being proposed?