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It all started with California

While a few of the major pharmaceutical manufacturers jumped in early in order to create a system flexible enough to do business in multiple foreign countries, California’s announcement in 2004 really got the attention of industry.

Due to extensive delays enforcing the 1988 Prescription Drug Marketing Act (PDMA) and a lack of specific traceability requirements in the PDMA, the State of California presented the industry with the concept of electronic pedigree and chain-of-ownership tracking. In 2004, the California Board of Pharmacy passed legislation aimed at more aggressive consumer protection due to the growth of counterfeit and diverted drugs.

The law required all pharmaceutical supply chain partners, from manufacturer through pharmacy, to pass along an electronic pedigree detailing the movement and transfer of ownership of a pharmaceutical product at the smallest salable item level.

With California comprising what some have said is the ninth largest economy in the world, industry had to step up and take notice.

This mandate was initially supposed to take effect January 1, 2007 and was later pushed out to 2009, then again to 2011. In 2008, after continued meetings with industry stakeholders, the California Legislature and the California Board of Pharmacy agreed to again push out the effective dates to 2015 through 2017.

These initial delays, and target date “creep,” have unfortunately set the scene for industry to hold off on implementing, in the hopes that further delays (or a federal override) may occur.

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