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A reprieve from California e-pedigree?

House and Senate serialization bills could push back packaging line expenditures, but wouldn’t do much to counter pharmaceutical counterfeiting.

BD recently entered the pharmaceutical industry with a new line of generic prefilled injectable products called BD Simplist. One of the first two drugs launched is BD Simplist™ Metoclopramide Injection, USP. Both its outer package and the inner container are printed with a 2D barcode and with the NDC, serial number, lot number, and expiration date 'human readable.'
BD recently entered the pharmaceutical industry with a new line of generic prefilled injectable products called BD Simplist. One of the first two drugs launched is BD Simplist™ Metoclopramide Injection, USP. Both its outer package and the inner container are printed with a 2D barcode and with the NDC, serial number, lot number, and expiration date "human readable."

Fast-moving congressional legislation on drug package bar coding gives pharmaceutical manufacturers a short-term reprieve from what they view as an impending California e-pedigree death sentence. But the timeline for manufacturers spending millions on packaging line upgrades will likely be pushed back only three or four years. At that point they will have to print on the packages of the smallest salable units 2D bar codes containing a product's National Drug Code, a unique serial number, lot number, and expiration date.

Very few manufacturers are doing that today despite the fact the California deadline to put those 2D labels on half of all products coming into that state is January 1, 2015. The other half would have to be 2D-bar-coded one year later.

Given their petty pace on serialization, the entire brand-name and generic industry has pressed hard to pre-empt the California deadline. Both House and Senate bills do that by substituting a national standard.

Justin Schroeder, senior director, Marketing and Development Services, Packaging Coordinators, Inc., says, "I don't think you should be surprised that U.S. companies have not made more progress on serialization. Most are waiting to see how the regulations play out. It is a substantial investment in time, resources, and capital expense with very few standards in place due to the evolving state, national, and international requirements. I don’t think people appreciate the scale of the investment required."

PCI is one of the world’s major pharmaceutical and biotech packaging contractors. In May, Frazier Healthcare and PCI acquired AndersonBrecon from its parent company Amerisource Bergen Corp. AndersonBrecon now merged with and operates as PCI.

PCI is currently commercially serializing one multi-SKU product apiece for each of two top 10 global pharmaceutical manufacturers. Given the fact that PCI has 100-plus clients, the scale of adoption from manufacturers has been limited, and again reflects how far from complying with California U.S. companies are. Schroeder notes that many pilot programs and full-scale rollouts are being implemented in 2013 as a select group of companies aggressively look to implement serialization programs now. Many other clients have begun active discussions, but look to implement in 2014 or beyond. 

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