Tag Archives: California Pedigree Law

California Pedigree Law

California Board of Pharmacy Clarifies Use Of GS1 EPCIS

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“The Californians”

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.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 raised by Board members or the general public in attendance.

As soon as the Chair opened that agenda item, Michael Ventura of GlaxoSmithKline rose and strode to the microphone.  The exchange that followed was captured on the meeting video.  I transcribed the exchange below as it happened because I think it provides a number of important clarifications about  Continue reading California Board of Pharmacy Clarifies Use Of GS1 EPCIS →

Board of Pharmacy

How To Make The Semi-Centralized Track & Trace Model A Reality

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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.Last week I attended the Enforcement Committee meeting of the California Board of Pharmacy.  The value of attending these meetings is hard to extract.  It helps to have a solid knowledge of the language of the pedigree law, understanding of the standards and technology being considered to meet it, and the history of how we got where we are today.  Even with all that on your side it takes a lot of concentration during the meeting and after it is over to put it all into perspective and find the value.

I will provide you with my thoughts on what Continue reading How To Make The Semi-Centralized Track & Trace Model A Reality →

Network Centric ePedigree Models

The Significance of the Abbott, McKesson and VA Pilot

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Last month I had the opportunity to see the presentation by Abbott Labs, McKesson, the U.S. Department of Veterans Affairs (VA) and GHX about their recent and ongoing Network Centric ePedigree pilot.  [NOTE:  GS1 removed the PDF file from their website after my essay was published.  See the comments below this essay for more. – Dirk.]  I see that a presentation on the same topic is on the agenda for this week’s HDMA Track & Trace Technology Seminar.  If you are attending that event, don’t miss that presentation because this pilot is an important one.  I normally like to attend the HDMA event but I won’t be there this year due to a long-scheduled vacation.

The pilot implemented a “Centralized” Network Centric ePedigree (NCeP) system. Continue reading The Significance of the Abbott, McKesson and VA Pilot →

California Pedigree Law

Will The California ePedigree Dates Slip Again?

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Coastline near Laguna Beach California, November 2009. Photo by Dirk.
Click to enlarge image.

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.Everywhere I go lately I am asked “Do you think the California ePedigree dates will slip again?”.  I don’t have any special or inside knowledge but, as usual, I do have a theory about that.  I offer it to you here as one possible outcome.  You can decide for yourself if you think it is dubious, merely plausible, fully probable, or somewhere in-between. Continue reading Will The California ePedigree Dates Slip Again? →

Congress, Federal Pedigree

Congressional Legislation Development: Mad Libs Edition!

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I’ve now finished studying the latest Congressional Discussion Draft to Improve Drug Distribution Security.  As promised last Thursday, here is my analysis.  Overall I’d say it is a very serious attempt to develop a raw text that everyone can agree on.

But the only reason everyone can agree on it is that there are literally hundreds of multiple-choice options (they call them “policy choices”) built in–kind of like Mad Libs.  Anyone can use a marker to go through and cross out all the choices that they don’t like and they would end up with a bill that their constituency would probably accept.  The problem is Continue reading Congressional Legislation Development: Mad Libs Edition! →

IBM, track and trace

Could It Be The Cloud? More Thoughts On IBM’s Divestiture Of Its EPCIS And E-Pedigree Suite

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At times like these I often think of an old movie from 1981 called “Modern Problems” which starred Chevy Chase as a hapless air traffic controller who faced problem after problem, some of which wouldn’t even have existed 20 years earlier.  For some reason I can’t explain, I sometimes think of that movie when I’m about to click the “Publish” button on an essay.  As soon as that button is clicked, my thoughts are instantly transmitted to the world (hundreds of people in the case of RxTrace) in a neat little package.

Almost immediately after clicking the Publish button on last Friday’s essay, “IBM Divests EPCIS and ePedigree Suite” I had thoughts of another possibility that IBM’s recent action might explain.  Too late.  My thoughts were already being read by people.  A “modern problem”.  Fortunately I can send this follow-up.

Like a commenter to my Friday essay, I wondered why IBM would chuck their entire traceability repository product if the problem were simply that ePedigree only makes sense for boutique solution providers?  They could have just sold off the ePedigree application and kept the more generally marketable ITS product.  There has to be more to it than that. Continue reading Could It Be The Cloud? More Thoughts On IBM’s Divestiture Of Its EPCIS And E-Pedigree Suite →

pedigree software

IBM Divests EPCIS and ePedigree Suite

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According to the IBM website, IBM has sold its Infosphere Traceability Server (ITS) product to Frequentz, a company based in Los Altos, CA.

The IBM ITS webpage now states:

“Frequentz acquired the IBM InfoSphere Traceability Server in Oct 2, 2012. All future information regarding the InfoSphere Traceability Server products will be available from Frequentz.”

No other information about the sale was included.

This is stunning news considering the history of the ITS product, and because Continue reading IBM Divests EPCIS and ePedigree Suite →

GS1

Should GS1 Continue Developing ePedigree Standards?

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Photo by immrchris

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.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 Group (MSWG)”.  According to the call-to-action:

“This group will develop standards to allow pharmaceutical supply chain parties striving to meet pedigree regulation requirements, by gathering and checking pedigree event data.  Standards will also address data confidentiality and security.  This MSWG will create

        A) standard for security framework applicable to EPCIS and,

        B) pedigree checking services.”

This group’s output will not be a self-contained pedigree standard, per se, but Continue reading Should GS1 Continue Developing ePedigree Standards? →