Posts Tagged ‘GS1 U.S.’

For the application of unique serial numbers, or Standard Numerical Identifiers (SNIs), to packages as part of compliance with the California Pedigree Law in 2015-2017 , GS1′s Electronic Product Code (EPC), particularly in barcode form, is the clear winning standard.  But there seems to be a very common misconception going around that for pedigree data management, all you need to do to comply with that law is to deploy a system that is based solely on the GS1 Electronic Product Code Information Services (EPCIS) standard.  The  misconception assumes that there is a formula that can be followed to achieve compliance and that EPCIS is the whole formula.

In truth, EPCIS will almost certainly be an important component in the compliance formula but exactly how it fits, and whether there are other necessary components, has not yet been determined.

There are probably several reasons that this misconception persists.  First, GS1 US continues to promote their 2015 “Readiness” Program as if it is that formula.  The program documentation strongly implies that, if you simply follow their program, you will “be ready” to comply with the law; but it stops short of actually saying that you will be compliant.

Second, it seems like people are either able to understand the law well but not the technical standards, or they are able to understand the technical standards well but not the law.  The legal folks are left to trust what the technical people say about EPCIS, and the technical people assume that as long as the data elements identified in the law are present somewhere then EPCIS must comply.

Now I am not a legal expert but I’ve been looking at the text of the California Pedigree Law for a few years now and I think I understand it at a level that allows me to estimate how various technical approaches might fill its requirements.  Let me show you how Read the rest of this entry »

For the first time in over two years the topic of pedigree appears on the agenda of the California Board of Pharmacy for their upcoming meeting on September 7.  Earlier this year in a presentation at the FDA Track & Trace Workshop Board Executive Office Virginia Herald mentioned that the Board would take up the topics of inference, drop shipments, decommissioning and linkage between shipping orders and invoices at a future meeting in 2011.  It’s hard to tell if those will be the actual topics discussed in next week’s meeting because they aren’t called out explicitly.  Here is the item as it actually appears on the agenda: Read the rest of this entry »

At the end of my last essay I said I had recently concluded that the jump to a fully automated pharma supply chain upstream visibility system is too big and complex to be achievable by every company in the U.S. supply chain by the California dates.  I want to explain that statement in a future essay (soon), but before I do I want to explore some of the track and trace models that are being considered by both GS1 and the FDA.  I particularly want to look at the viability of each model because I think we will find that some just aren’t (viable), and that will help narrow the search.

I’ll look at the three basic models that the FDA mentioned in their recent workshop:  Centralized, Semi-Centralized and Distributed (or Decentralized as the FDA called it).  There are others, but it seems that they can all be either based on, or reduced to, one of these three basic models.

In this essay I am looking at track & trace models from a global viewpoint, which is something that GS1 is doing but the FDA may not.  Attacks on the pharma supply chain are a global problem and global problems demand global solutions or gaps will be left for criminals to exploit.

GS1′s goal is to develop standards that apply globally as much as possible and the FDA will likely find that Read the rest of this entry »

In this essay, I’m not going to discuss the attributes of a track & trace system from a regulator’s point of view.  I’m not going to discuss input into the FDA’s Track & Trace workshop that occurs this week and I’m not going to speculate on the outcome of that meeting.  Instead, I’m going to talk about the attributes of a track & trace application from the viewpoint of any global pharma manufacturer who is facing the regulatory mandates for serialization and traceability in a growing list of countries around the world, and from the viewpoint of any solution provider who is thinking about what they need to include in their solution offering so that those global pharma companies find it attractive enough to buy.  

To those kinds of companies, the potential for new non-binding guidance from the U.S. is important, but perhaps less so than an increasing number of binding regulations from around the world.  Whatever the FDA—and especially the U.S. Congress—may do in the future will be important when selecting a track & trace solution, but the U.S. is only one of the countries in the world and pharma companies that do business in those other countries do not have time to wait for the U.S. to figure out their approach before making investments. 

The goal is to make investments today that will be Read the rest of this entry »

I’ve been involved in a number of conversations lately that included differing opinions about what will be necessary to “certify” a drug pedigree in California after their pedigree law goes into effect (2015-2017, depending on your role in the supply chain).  It’s a contentious issue, especially for those who wish that a distributed pedigree model would comply. 

The California Law is fairly clear that the pedigree must contain, “A certification under penalty of perjury from a responsible party of the source of the dangerous drug that the information contained in the pedigree is true and accurate.”  And that, among a list of other things, it must include “…the name and address of each person certifying delivery or receipt of the dangerous drug.”

In the California language, a “dangerous drug” is Read the rest of this entry »

GS1 US is dedicated to expanding the adoption of GS1 Global’s standards for supply chain interaction in the U.S. market.  Almost every country in the world has a GS1 “Member Organization” (M.O.) that is dedicated to the same thing within their borders.  With the local M.O.’s primary focus on driving adoption, their most valuable tool is that country’s government.  If they can get the government to reference GS1 standards in their laws, their work is much easier. 

This isn’t unique to GS1, or course.  All standards organizations know this and they all have various approaches to getting the attention of each country’s government.  There is nothing wrong with this.  In fact, it makes perfect sense since, unlike standards organizations themselves, countries always have very large enforcement wings.

But what happens when those governments are too big to sway easily?  What if it costs too much and takes too long to get them to see the light?  This is when a standards adoption organization needs to get creative.  In my opinion, that’s what has led GS1 Healthcare US to create the “2015 Readiness Program”.  It was out of frustration with the California State Government and with the U.S. Food and Drug Administration (FDA) and their, so far, unwillingness to create laws and regulations that mandate the use of GS1 standards.  Let me explain. Read the rest of this entry »