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California Track-and-Trace Law Is Good Model, EMD Serono Says

 
• By Cathy Dombrowski

The company has been tracking shipments of its growth hormone agent Serostim since 2002 to forestall counterfeiting and fraudulent claims and backed a full track-and-trace system during a forum sponsored by Pew Health Group. But while the system makes good business sense for a specialty firm, the acknowledgement could complicate the existing political picture for industry.

While FDA and an alliance of stakeholders debate the best way to implement a track-and-trace system for pharmaceuticals, EMD Serono has in place an electronic pedigree system for its specialty products and says a California requirement for an e-pedigree to accompany individual drug packages through pharmacy dispensing is reasonable.

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