Tag Archives: GS1 Healthcare US

GS1 Healthcare US, track and trace, Uncategorized

The New GS1 Healthcare US Track & Trace Guidance

 

GS1 Healthcare US
GS1 Healthcare US

Important Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.GS1 Healthcare US, an arm of GS1 US the member organization (MO) of the global GS1 standards organization, has just published the “preliminary version” of a track & trace implementation guide.  The full title is “Implementation Guideline, Applying GS1 Standards to U.S. Pharmaceutical Supply Chain Business Processes To Support Pedigree And Track & Trace, Release 1.0”.

This document contains the accumulation of thought and best practices generated over the last nine years within various working groups of GS1 Healthcare US and from pilots conducted by its members (including the Abbott Labs, McKesson, VA and GHX pilot that I wrote about in “The Significance of the Abbott, McKesson and VA Pilot”).  Pulling it all together into a single coherent document turned out to Continue reading The New GS1 Healthcare US Track & Trace Guidance →

HDMA

Standards and Guidance For U.S. Pharma Supply Chain Technology

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[This essay is one of two long lost essays that have now been restored on RxTrace.  It was originally published on November 22, 2010.  See “Return Of Two Classics” for an explanation.]

In my last essay, “Who Will Decide Which Pedigree Model You Will Invest In?” I pointed out how easy it is to get confused about pedigree technology because of varying claims made by certain companies who have interests that don’t align well with yours.  So where can you get better information?  I can provide you with a few good sources, and I will also tell you about a missing ingredient that I see in the current guidance landscape that will need to be addressed in the next couple of years. Continue reading Standards and Guidance For U.S. Pharma Supply Chain Technology →

GS1 Healthcare US

Before You Participate in The GS1 US 2015 Readiness Program, Read This

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Important Notice To Readers of This Essay On November 27, 2013, President Barack Obama signed the Drug Quality and Security Act of 2013 into law. That act has many provisions, but one is to pre-empt all existing and future state serialization and pedigree laws like those that previously existed in California and Florida. Some or all of the information contained in this essay is about some aspect of one or more of those state laws and so that information is now obsolete. It is left here only for historical purposes for those wishing to understand those old laws and the industry’s response to them.

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. Continue reading Before You Participate in The GS1 US 2015 Readiness Program, Read This →