One of the most recent improvements that California made to their drug pedigree law was to spread out the compliance dates by supply chain segment. Previously, all segments had to comply with the regulation by January 2011. Now drug manufacturers will need to comply with half of the products (or sales) by January 2015 and the remainder one year later, distributors must comply by mid-2016 and the pharmacies by mid-2017. As I understand it, this spread was intended to help the industry fully prepare for the new requirements in their businesses. Companies would now have time to adjust to the changes implemented by their upstream trading partners according to their earlier deadlines.
This staggered start pleased a lot of people—particularly distributors and pharmacies. However, to me, the staggered start of the current California regulation doesn’t address the issue of complexity very well and a different kind of ramp up to full operation would be more practical and have better odds for success.
I discussed complexity in my last essay, “U.S. Pharma Supply Chain Complexity”. I tried to show what it is about the supply chain that leads to difficulty in the setup and execution of a drug pedigree system. On its own, the U.S. pharma supply chain is naturally complex. A truly workable and protective pedigree system needs to deal with that natural complexity without exploding in its own complexity and cost. As I pointed out in that essay, the problem with the more popular pedigree models (like DPMS and the various distributed pedigree models) is the large number of the point-to-point data connections that are necessary to reflect the natural complexity of the supply chain. That adds a lot of complexity.
THE PLATEAUS OF SECURITY
No matter which model the industry implements, starting it up will have its own complexities. In my view, regulators and industry should Continue reading Plateaus of Pharma Supply Chain Security