Search Results for: GS1

California Pedigree Law

California Board of Pharmacy Clarifies Use Of GS1 EPCIS

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As I indicated last week, I wanted to write about a specific dialog that occurred at the December 4, 2012 California Board of Pharmacy Enforcement Committee meeting.  The important exchange came at the end of the meeting during the catchall agenda item called “General Discussions” when topics that are not on the agenda can be … Continue reading California Board of Pharmacy Clarifies Use Of GS1 EPCIS →

standards

Can HIBCC Withstand The GS1 Tide In Medical Device Identification?

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I was recently asked to help a small medical device manufacturer switch all of their medical device-related product codes from Health Industry Business Communications Council (HIBCC) Universal Product Numbers (UPN) to GS1 Global Trade Item Numbers (GTIN).  Historically, the pharmaceutical supply chain has used GS1 GTINs but the medical device supply chain has predominantly used … Continue reading Can HIBCC Withstand The GS1 Tide In Medical Device Identification? →

GS1

Should GS1 Continue Developing ePedigree Standards?

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For the first time since GS1 produced the Drug Pedigree Messaging Standard (DPMS) standard in 2005, GS1 has just published a call-to-action for the formation of a new standards development group to focus on a new pedigree-related standard.  The new group will be called the “Pedigree Security, Choreography and Checking Service (PSCCS) Mission Specific Work … Continue reading Should GS1 Continue Developing ePedigree Standards? →

GS1 Company Prefix

Your GS1 Company Prefix: An Enterprise Resource

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Any company wishing to make use of GS1 standards—including their barcodes, identifiers and data exchange standards—must first obtain a GS1 Company Prefix, or “GCP”.  Normally you would obtain a GCP by applying to the GS1 Member Organization (M.O.) in the country where your company headquarters resides, but if you are a pharmaceutical company that makes … Continue reading Your GS1 Company Prefix: An Enterprise Resource →

FDA, standards

Should FDA Cede All Standards Development To GS1?

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Back in 2007 the U.S. Congress passed the Food and Drug Administration Amendments Act (FDAAA) and it was signed into law by President Bush.  One of the provisions of that law was an instruction to the FDA to “…develop standards and identify and validate effective technologies for the purpose of securing the drug supply chain … Continue reading Should FDA Cede All Standards Development To GS1? →

Pedigree models, standards, Uncategorized

GS1 Standards – Betcha Can’t Use Just One!

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The title is a paraphrase of a TV commercial from the 1960’s, ’70’s and ’80’s for Lay’s Potato Chips but the sentiment is the same.  You really can’t get away with using only a single GS1 standard.  That’s why they are sometimes referred to as “The GS1 System of Standards“.  It’s a “system” of standards.  … Continue reading GS1 Standards – Betcha Can’t Use Just One! →

Pedigree models

Why GS1 EPCIS Alone Won’t Work For California Pedigree, Part 2

There are more than one reasons why you shouldn’t expect to use GS1’s EPCIS by itself to comply with the California pedigree law.  Part 1 of this series showed that the traditional distributed network of EPCIS repositories in the U.S. pharma supply chain doesn’t work.  But that analysis assumed the use of the “vanilla” EPCIS … Continue reading Why GS1 EPCIS Alone Won’t Work For California Pedigree, Part 2 →