It’s time to think about what is likely to happen in 2016 with regard to pharma serialization and traceability. As part of that, let me remind you right off the top to fill out the 2016 RxTrace U.S. Pharma Traceability Survey, sponsored by Frequentz. You don’t have to be a subscriber to respond and the results will also be open to everyone in the coming months.
I would be willing to bet that almost every regular reader of RxTrace knows who Bob Celeste is, and most of you have probably already heard that he is ending his long tenure with GS1 US. Last fall that organization announced that Bob would continue into the new year as a consultant, and shortly after that, he would transition his GS1 Healthcare US work group facilitation work to others. Bob reminded everyone on his weekly industry calls of that schedule about two weeks ago and by the end of this month he will no longer fill that role.
I often write about the fact that drug manufacturers and repackagers that sell into the U.S. market must put “serial numbers”, or “serialize” their drug packages and homogeneous cases before November 27, 2017, but what exactly does that mean?
The term ‘product identifier’ means a standardized graphic that includes, in both human-readable form and on a machine-readable data carrier that conforms to the standards developed by a widely recognized international standards development organization, the standardized numerical identifier, lot number, and expiration date of the product.” (Section 581)
It is pretty clear that there is not much interest in the use of Radio Frequency IDentification (RFID) in the pharmaceutical supply chain because every time I publish an essay in RxTrace about some aspect of it, there is a drop in readership. So at the risk of taking another hit in readership, let’s take a look at the case against the use of RFID in the pharma supply chain.
Over the next two weeks I have a very special treat for RxTrace readers. It is an interview with Ken Traub, GS1 standards expert and independent consultant. The subject is GS1 serial number randomization, something so important that I think pharma companies ought to give deep thought to it before they turn on their serial number applications.
Pharma manufacturer who sell into the E.U. and/or Brazil markets will be forced to randomize their serial numbers because of regulatory requirements, but even those who only sell into the U.S. market should strongly consider randomization. I’ll have more to say about why in a follow-up essay after this series is over.
Because the interview with Ken covers the topic so thoroughly, it is long. That’s good, because it provides readers with an easy to understand explanation of everything they need to know about randomizing. But it also makes for a very long essay, so I have broken the interview down into five RxTrace essays. Read sequentially, they contain the complete interview. The subtopics covered by those essays include:Continue reading Randomization—An Interview with Ken Traub—Part 1: GS1 Serial Number Considerations→
Let’s take a brief pause from our in-the-moment work on meeting today’s healthcare supply chain security needs and consider what the supply chain will look like in the future. Because of regulations and laws enacted in 2012 and 2013 in the U.S., and expected in 2014 in the E.U., we know more today about how healthcare supply chain security will work In 2024 than looking forward in any previous 10 year period. In the last two years the U.S. and the E.U. have enacted legislation and introduced regulations that will have a profound impact on the security of these major supply chains in ten years. These include:
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer. The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating the positions of any company, organization or individual other than Dirk Rodgers.