Judgment day was September 30, 2008.As expected, Governor Schwarzenegger finally signed SB1307, the California bill extending the implementation deadline for the state's serialized e-pedigree law. See CA E-Pedigree: Going to ... 2015 for background and implications.
On a related note, check out Pharmaceutical Commerce's Serialization Survey, which shows that most manufacturers plan to continue with serialization initiatives (based on responses from 82 pharma/bio manufacturers). At the time of the survey, about one-quarter are currently serializing product or conducting a production pilot, while 35 manufacturers (43%) were planning to get started within 12 months.
As I noted in September, “mass serialization” will become increasingly important for supply chain security efforts at multinational drug makers, especially given the new serialization requirements in countries such as
In contrast, I expect to be writing much less about pedigree in Drug Channels over the next 12 months.
I still can't fathom why a manu would not pedigree every shipment. Simple enough to do and the ability to crow about it is great. Can't wait for "real" serialization to begin! Wonder if the data will ever be shared?
ReplyDeleteAppreciate the updates, Adam.
ReplyDeleteTo the previous comment: No, serialization and pedigree are not the same thing. Manufacturers don't even have to pedigree anything is some states, but manufacturers are the only ones that can serialize their own products. And what's the value if they can't even get access to their own data from wholesalers?
It's not spinal tap, but good one anyway!
ReplyDeleteHow long ago was e-prescribing introduced to the industry and what is the current utilization? Expect the same for acceptance of track and trace technology.
ReplyDeleteSo for over 2 years CA BOP said every meeting "better show us progress for the next meeting" and pharma spent money and more money to show progress. Now CA BOP says "oh, never mind" we did not have the resources or budget to enforce it any way" and we think 2015 is much better (and hope it is all funded by the feds by then). I agree a longer date was needed (2012 or 2013) but they just wasted a lot of people's time and money. So CA BOP, where do you want the $200m+ reimbursement claim sent? (for all the companies that wasted money).
ReplyDeleteAdam -
ReplyDeleteYou are correct in the need for a continued and expanded focus on mass serialization by multinational drug makers due to the global regulations. Preparing the proper framework will also set the stage to meet future US - FDA requirements.
To clarify on the global requirements, Belgium and Italy have existing serialization initiatives. A Phase 2 for Italy is being planned that will require each Bollini to be recorded (versus only the range and destroyed numbers as it is required today).
Additional countries such as Turkey and China have new serialization requirements, some of which follow GS1 standards others that do not. Turkey is planned for 1/1/09 and China has serialization regulations for 10/31/08.
There will be a continued growth in serialization requirements globally with EFPIA being another serialization initiative to watch closely.
Dan Goodstein - SupplyScape