I attended the Healthcare Distribution Management Association (HDMA) Track and Trace Seminar held in Crystal City, VA on November 11-13, 2013. I was particularly interested in the session called “Distributor Case Studies and Updates”, as were a lot of other people. The speakers were:
Chris J. Anderson, Director, Quality Systems,
Cardinal Health, Inc. Steve Tadevich, Director, Product Serialization Technologies,
McKesson Corporation Heather Zenk, PharmD, Vice President, Business Integration,
Each speaker gave a brief presentation about their current serialization and pedigree programs before taking questions as a panel. As you would expect, all of the preparation these companies have done up to this point has been aimed squarely at the California pedigree law which would have gone into effect for wholesalers in California in mid-2016. But,
Continue reading DQSA: Will U.S. Pharma Distributors Mandate Aggregation Data In Phase 1?
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
Rumors 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
Last 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”
Over 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?
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 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
The 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
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of
Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer. The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating the positions of any company, organization or individual other than Dirk Rodgers.
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