Tag Archives: GS1

California ePedigree Uncertainty

Pedigree law approaches CaliforniaImportant 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.A lot of things related to ePedigree in the U.S. supply chain are cooking right now but they seem to be happening a little too slowly, so it will be interesting to see where it all ends up in the next few years.  After developing the Drug Pedigree Messaging Standard (DPMS) in 2006-2007, GS1 is now taking only the initial steps toward adding network-centric ePedigree capabilities to their EPCIS and related standards.  The California Board of Pharmacy says they would like to be able to accept a semi-centralized network centric approach as long as it includes all the stuff listed in their pedigree lawFor nearly 18 months, GS1 U.S. has been “nearing publication” of a draft guideline—six years in the making—that is supposed to help companies who want to use EPCIS to meet the California law.  Congress considered passing a Federal track & trace regulation that would have preempted the California law last year but failed from lack of agreement between the parties.  Some companies are making good progress on meeting the serialization requirement but the number who have the pedigree part figured out are those who have settled on DPMS.  All the while the California pedigree deadlines are rushing toward us like a bus-sized asteroid heading straight toward Earth.  Not surprisingly, the asteroid is moving faster than the efforts to divert or absorb it.

I’ve written about my theory that the date of impact won’t be pushed out again, no matter what happens (for a full explanation of that theory, see “Will The California ePedigree Dates Slip Again?”).

What can be done?  In my view, it’s going to be determined by Continue reading California ePedigree Uncertainty

Data Ownership In The Track & Trace Cloud

Cloud over IllinoisImportant 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.Who will own the data that supply chain trading partners store in some future cloud-based, semi-centralized Network Centric ePedigree (NCeP) data repository?  I met one potential future repository service provider who seemed to think that they would own that data.  Imagine their excitement.  All the data about where drugs go throughout the supply chain!  Think of the value they could mine from that.

Well, that’s never going to happen because companies in the supply chain won’t sign up for handing over all of their supply chain data to some third-party just so they can comply with regulations, especially when there exists an alternative approach that would allow them to avoid using a third-party and still comply (by using DPMS).  And regulatory agencies are Continue reading Data Ownership In The Track & Trace Cloud

“The Shadows Of Things That MAY BE, Only” : EPCIS and California Compliance

Magoo_christmas_futureImportant 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.Currently, we know that companies can use GS1’s Drug Pedigree Messaging Standard (DPMS) to comply with the California pedigree law.  That’s been known for a long time now.  But many companies have been hoping to use GS1’s more general purpose Electronic Product Code Information Services (EPCIS) standard instead for almost as long.  For just as long, it has been known that a number of problems arise when you try to figure out exactly how to apply EPCIS to California compliance.

The problem is, EPCIS was originally envisioned by its creators to share supply chain “visibility” data.  That is, event data that was to be collected automatically based on Radio Frequency IDentification (RFID) reads picked up by readers that were to be spread around the supply chain by each of its members.  The collection of RFID readers were to form a kind of “visibility” of each RFID tag applied to the products in the supply chain.  From this visibility would come benefits.  One of those benefits was to be Continue reading “The Shadows Of Things That MAY BE, Only” : EPCIS and California Compliance

California Board of Pharmacy Clarifies Use Of GS1 EPCIS

“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

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

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

Can HIBCC Withstand The GS1 Tide In Medical Device Identification?

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 HIBCC UPNs, so a switch like that seemed to be against the grain.  I asked them, “Why are you abandoning HIBCC codes for GS1 codes?”

The answer was a little startling Continue reading Can HIBCC Withstand The GS1 Tide In Medical Device Identification?

We Should Be Ashamed Of The U.S. Approach To Pharma Recalls

Flicker / Akulawolf

That’s right.  We should all be ashamed of the way our supply chain handles drug recalls and we should do something about it.  I will explain, but first, what is a drug recall?

Today, when the manufacturer decides that a recall is necessary—either on their own or through a request by the FDA—they issue a recall for it.  The FDA website is a great resource for learning about what a recall is (see “What is a recall?”, and “FDA 101: Product Recalls – From First Alert to Effectiveness Checks” and their recalls homepage at “Drug Recalls”).

Recalls can be issued for a number of reasons including Continue reading We Should Be Ashamed Of The U.S. Approach To Pharma Recalls

InBrief: RFID and Barcode Interoperability

There is a new and valuable resource available for anyone who needs to make use of both GS1 RFID and GS1 barcodes–or even just one or the other–on any product or shipping container and in any supply chain.  It is called “RFID Bar Code Interoperability, GS1 Guideline” and it is available as a free PDF download here on the GS1 website.

This is a guidance document, which means that it isn’t a standard itself but draws contents from GS1 standards documents to better explain the subject.  In this particular case it draws primarily from the GS1 General Specifications and the Tag Data Standard.  Both of those source documents are huge and so you will find this new guidance document a relative joy to read if you need this kind of information.

Even if you are already familiar with GS1’s RFID and barcode standards, intermingling them so that they are fully interoperable in a single application isn’t Continue reading InBrief: RFID and Barcode Interoperability