Tag Archives: GS1

DQSA: Getting To Electronic Transaction Data Exchange

Files transfer.While we wait for President Obama to sign the Drug Quality and Security Act of 2013 (DQSA, a.k.a. H.R. 3204) we can be confident it will become law in the next week or so.  This President has been presented with over 740 bills so far in his Presidency and he has signed all but two.  He has 10 days to sign the bill or it becomes law anyway but there might be some delay in the process between passage by the Senate and when the President is presented with the bill.

My interest in the DQSA of 2013 is only the Drug Supply Chain Security Act (DSCS) which is Title II within the overall bill.  I’m going to keep referring to it as the DQSA of 2013 but be aware that I probably won’t ever write about the compounding part, Title I.  If that is what brought you here, sorry, look elsewhere.

It is not law yet, but we can now be 100% sure it will be very soon.  Even before the bill was Continue reading DQSA: Getting To Electronic Transaction Data Exchange

The Flaw That Must Be Addressed in H.R. 3204, The Drug Quality and Security Act

DQSA ePedigree timeline.ZoomRumors abound that the Drug Quality and Security Act (DQSA), H.R. 3204 will be debated and voted on in the Senate any day now (see “Waiting For The Senate To Act On A Track & Trace Bill, Again”).  It already passed the House of Representatives back in September and the text is a compromise between the bill managers in both the House and the Senate, so everyone expects it to pass and be signed into law by President Obama.  No one (except maybe some folks who don’t like the compounding part) wants to see its progress slowed, but there is a problem with the track and trace part that must be addressed before it is adopted or its implementation will quickly run into difficulties. Continue reading The Flaw That Must Be Addressed in H.R. 3204, The Drug Quality and Security Act

Eli Lilly: “Serialization Needs Standardization”

David Colombo of Eli LillyLast month, Eli Lilly posted a video about their serialization initiative on YouTube.  It features Grant Lindman, Manager of Lilly’s Global Anti-Counterfeiting Operations, and David Colombo, Commercial Implementation Leader of Lilly’s Global Serialization Program talking about their global serialization program.  It is worth a listen. Continue reading Eli Lilly: “Serialization Needs Standardization”

Will Use Of EPCIS Force Everyone To Use GS1 Identifiers?

EPCISOver the last five years the larger companies in the U.S. pharmaceutical supply chain have increasingly aligned around GS1’s Electronic Product Code Information Services (EPCIS) standard for holding and communicating serialization-based events.  The hope and expectation by many of these manufactures and others in the supply chain is that EPCIS will be the standard that ensures supply-chain-wide interoperability in any future track and trace or ePedigree system that the federal government might impose.  On its surface it appears that EPCIS is designed around GS1’s family of serialized identifiers, which are based on GS1’s GS1 Company Prefix (GCP) (see “Anatomy of a GTIN” and “Your GS1 Company Prefix: An Enterprise Resource“).  This includes Continue reading Will Use Of EPCIS Force Everyone To Use GS1 Identifiers?

California, Congress and The Choices We Are Forced To Face

The Thinker statueImportant 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.Another week has gone by with no official movement in the Senate on the compromise pharmaceutical compounding and track & trace bill, H.R. 3204, the Drug Quality and Security Act (DQSA) (see “Waiting For The Senate To Act On A Track & Trace Bill, Again”).  With the focus of the Congress rightly on reopening the government I think we should expect to wait a little longer.  You can bet that the supporters and the opposition are both developing their strategy as time goes by.

I attended the GS1 Global Healthcare Conference in San Francisco last week and it was a great opportunity to reconnect with a lot of people I have worked with over the years on defining workable standards for healthcare supply chain data exchange.  Some of us are Continue reading California, Congress and The Choices We Are Forced To Face

UDI And The Approaching End Of The NDC

UDI Barcode Cake
UDI Barcode Cake from last week’s UDI Conference

To be honest, I was somewhat surprised when Jay Crowley announced during last week’s UDI Conference that the U.S. FDA had published the final rules for Unique Device Identification (UDI).  Its publication starts the clock on a host of new requirements designed to identify most medical devices in the U.S. market with the same standard approach.  That is expected to result in the reduction of errors made by medical professionals and also increase the accuracy and efficiency of the supply chain.  I’ve become a little jaded about healthcare Automatic Identification and Data Capture (AIDC) deadlines lately and so the fact that one actually happened caught me slightly off-guard.  Of course, UDI was Continue reading UDI And The Approaching End Of The NDC

What The UDI Date Format Says About FDA’s Direction

Jay CrowleyThe U.S. FDA is poised to publish their final Unique Device Identification (UDI) rule any day now.  The publication was due earlier in the summer but has apparently been held up in the review by the Office of Management and Budget (OMB) without any kind of accurate timeline.  The organizers of this year’s UDI Conference are hoping the FDA will be able to announce its publication at their event this Thursday and Friday in Baltimore.  I understand that not everyone is looking forward to its publication, but some are kind of tired of waiting for it.  I’ll bet Jay Crowley and his team Continue reading What The UDI Date Format Says About FDA’s Direction

FDA Chooses DUNS For Unique Facility Identifier

The DUNS NumberLast week the FDA published draft, non-binding guidance for their recommended unique facility identifier (UFI) for use in registering foreign and domestic drug  establishments.  Last year, Congress passed the FDA Safety and Innovation Act (FDASIA) to address safety concerns induced by inspection gaps of facilities outside the United States and other issues (see “The Supply Chain Provisions Of The FDA Safety & Innovation Act”).  In that law, Congress required the FDA to come up with some way of uniquely identifying all foreign and domestic facilities that are involved in the manufacture and importation of drugs.  This new guidance is the response. Continue reading FDA Chooses DUNS For Unique Facility Identifier