Pharmaceutical Track & Trace Update: e-Pedigree 2012 — A Year In Review
By Michael Stewart, VP Track & Trace Projects, PharmTech Inc.
“The rule is, jam tomorrow and jam yesterday-but never jam today.”
“It must come sometime to jam today,” Alice objected.
“No it can't,” said the Queen. “It's jam every other day. Today isn't any other day, you know”
― Lewis Carroll, Alice in Wonderland
For many in the pharmaceutical industry involved in their companies Track & Trace and e-Pedigree initiatives, the year 2012 was filled with all the twists, turns, and head scratching of Alice in Wonderland.
The year began with the usual eye of the industry on the California Board of Pharmacy mandates for item-level serialization and electronic pedigree (e-Pedigree) beginning January 1, 2015. Concerns remained that, without intervention from the FDA or Congress, there would be a patchwork of state level pedigrees that would make it increasingly difficult to meet the matrix of potential state-level requirements as product moved across borders. Some in the industry hoped California would yet again delay and push back its timeline for enforcement, but hope was showered with reality by Virginia Herold, Executive Officer, California Board of Pharmacy, stating early and often that the dates for compliance will stand.