E-pedigree delay till 2015 in California

12 October 2008

The biggest US state, California, has passed new legislation on securing the prescription drug distribution chain using an electronic pedigree system (e-pedigree). However, in signing the bill into law, Governor Arnold Schwarzenegger (Republican) has also been credited by both the Generic Pharmaceutical Association (GPhA) and the National Community Pharmacists' Association, for extending the deadline to 2015 for manufacturers and 2017 for pharmacists.

Previously, California had introduced a requirement to adopt e-pedigree systems by the beginning of 2011, a timetable considered too short by some industry groups. The basic problems facing firms attempting to comply with the new rules has been the cost of new equipment and the lack of a national standard, raising the fear that duplication at the federal level might follow (Marketletters passim).

The GPhA's president, Kathleen Jaeger, said that the reforms are "common sense," noting that counterfeiters rarely target unbranded drugs, due to their low cost. Radio-frequency identification (RFID) tagging, which was the subject of another bill supported by Gov Schwarzenegger, is one technology proposed for e-pedigree compliance. However it is considered too costly for use, except in the case of the more expensive and counterfeiter-targeted agents. A report in March this year, by research firm Kalorama, estimated the total pharmaceutical RFID market in 2012 at about $600.0 million.

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