2015 – Meeting Serialization Challenges With Time, Resources & Strategy

The year 2012 has come to signify “the end of the world” in pop culture, a sentiment fueled by doomsday theorists. Despite scientific fact to the contrary, a feeling of uncertainty and unpreparedness lingers in the minds of the general population. If I were a betting man, I’d gladly take the odds of surviving on through the next calendar year. What keeps me awake at night is the far more likely – and significantly underappreciated –deadline that is approaching the pharmaceutical industry.

The year 2015 is widely considered the beginning of the end for sales of non-serialized drug products. The entire pharmaceutical supply chain will soon undergo a monumental transformation. Yet, despite this pending reality, many decision makers who discuss "2015" continue to do so hypothetically.

California is the largest U.S. state economy and represents roughly nine percent of the prescription drug market. On January 1, 2015, the California e-Pedigree mandate is scheduled to take effect, requiring manufacturers to serialize, at the unit level, 50 percent of the products they send to the state. The remaining 50 percent must be serialized a year thereafter. And according to Virginia Herold, Executive Officer for the California State Board of Pharmacy, “The serialization requirement is not easy; [it] takes time to perfect. There will be no further extensions of time.”