Tag Archives: serialization

Global Alignment

Sponsored: Transatlantic Alignment

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Happy Martin Luther King day!  Today we have a special guest blog essay by Mark Davison of Blue Sphere Health in the U.K..   Mark is the author of the book, “Pharmaceutical Anti-Counterfeiting”, published by Wiley in 2011. – Dirk.

BPH.logo-lrg2Pharmaceutical traceability (in its various nuances of serialization, aggregation, track and trace, epedigree etc) has been proposed, debated, boosted and resisted for a very long time. The labyrinthine twists and turns have been examined in near real time on RxTrace and I won’t revisit them here. However, the passing of the Drug Quality and Security Act (DQSA) late last year opens a new chapter.  It means greater transatlantic clarity of future compliance requirements and (whether intentional or not) it also brings near synchrony of some key deadlines. Continue reading Sponsored: Transatlantic Alignment →

DQSA of 2013

DQSA: Will U.S. Pharma Distributors Mandate Aggregation Data In Phase 1?

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worker with stacker at warehouseI 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:

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? →

DQSA of 2013

DQSA: Getting To Electronic Transaction Data Exchange

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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 →

Federal Pedigree

All Eyes On The U.S. Senate Tonight

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U.S. Capitol building, Senate wing. The flag above the wing indicates that the Senate is in session.
U.S. Capitol building, Senate wing. The flag above the wing indicates that the Senate is in session.  Photo by Dirk.  Click to enlarge.

The effort to enact a nationwide pharmaceutical serialization law that would preempt all state laws has been going on for four or five years now, and this evening could be the culmination of all of those efforts.  The U.S. Senate calendar for today makes the passage of H.R. 3204, the Drug Quality and Security Act a top priority.  It finally looks like it is going to happen.

The official Senate calendar for today includes the following as the first order of business:

“                         CALENDAR OF BUSINESS

Monday, November 18, 2013

SENATE CONVENES AT 2:00 P.M.

PENDING BUSINESS

H.R. 3204 (ORDER NO. 236)

An act to amend the Federal Food, Drug, and Cosmetic Act with respect to human drug compounding and drug supply chain security, and for other purposes. Continue reading All Eyes On The U.S. Senate Tonight →

exemptions

Drug-Device Combo Products Under State And Federal Pedigree Laws

Metered dose inhaler drug-device combination product
Metered dose inhaler drug-device combination product

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.Both the California ePedigree law and the potential federal pedigree law that currently exists within the womb that is H.R. 3204 contain an exemption for drug-device combination products.  This is an expanding category of products so this exemption is worthy of a closer look.

The drug-device combo product exemption language included in the California Business and Professions Code, 4034(g)(9), is almost identical to the language in H.R. 3204, 581(24)(B)(xii).  There is a reason for that.  They are both based on part of the FDA’s definition for a drug-device combination product, found in 21 CFR 3.2 (e). Continue reading Drug-Device Combo Products Under State And Federal Pedigree Laws →

serialization

Eli Lilly: “Serialization Needs Standardization”

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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” →

EPCIS

Will Use Of EPCIS Force Everyone To Use GS1 Identifiers?

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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 Pedigree Law, Federal Pedigree

California, Congress and The Choices We Are Forced To Face

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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 →