All posts by Dirk Rodgers

Dirk is the founder of RxTrace where he writes regularly on the intersection between the pharmaceutical supply chain, track and trace technology, standards and regulatory compliance. He has written hundreds of essays on those specific topics. A logical thinker, Dirk is skilled at making complex technical topics understandable to non-technical readers and listeners. An Electrical and Computer Engineer by education, Dirk has worked as a consultant, software architect and automation engineer during a career spanning 30 years. Overall, Dirk's thought leadership has helped to expose hidden complexities and reveal surprising consequences and implications of drug serialization and pedigree laws around the world. Dirk is the author of "The Drug Supply Chain Security Act Explained". View Dirk's LinkedIn Profile Follow Dirk on Twitter

Most Companies Will Do DSCSA Verification Wrong

A lot has been written about the concept of “verification”, here in RxTrace and elsewhere.  It’s all good, but I still don’t think the critical point has been made yet by anyone—including me (see “What’s So Hard About Unique Identifier Verification?”)—and until it is, companies are going to do it wrong.  Less than an hour after I posted my essay last Wednesday (see “GS1’s Messaging Standard For Verification Of Product Identifiers”) I received an email from a subscriber who had questions about it, the essay was referenced in a post on LinkedIn by a reader in Europe, and I found a great link to a brand new essay about verification by Scott Pugh that had just been posted about the same time.  So here is my new take on why most companies are going to get it wrong.

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GS1’s Messaging Standard For Verification Of Product Identifiers

Verification%20messaging.png

For companies in the US pharma supply chain, 2019 is going to be the year of an important milestone of the Drug Supply Chain Security Act (DSCSA).   In November, wholesale distributors will be required to begin issuing verification requests to manufacturers, at the Standardized Numerical Identifier (SNI) level, for any returned drug that is still saleable, before they resell it.  I’ve written a lot about this change in the past.  

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FMD: Denmark Moves To Solve FMD Dilemma

Beginning in less than two weeks, all packages of prescription drugs entering the EU pharma supply chain must contain a 2D barcode encoding the EU serialized ‘Unique Identifier’ (see “The ‘Unique Identifier’ in the EU Delegated Act”).  More importantly, all drugs that have an FMD unique identifier on them at the point of dispense after February 9, 2019 must be “verified” and decommissioned through the National Medicines Verification System (NMVS) (see “What’s So Hard About Unique Identifier Verification?” and “Decommissioning Under the FMD/EUDR”).  It looks like my prediction of FMD delays was wrong (see “How Will They Delay The FMD?”) but at least Denmark has just moved to solve a serious FMD dilemma with a kind of delay.  Let me explain.

Continue reading FMD: Denmark Moves To Solve FMD Dilemma

EPCIS Explained

At a recent GS1 discussion group meeting one of the moderators acknowledged that they need to create a clear explanation for exactly what EPCIS is.  I’ve never been very impressed with GS1’s ability to explain their own standards at a high-level for non-technical readers.  They do a great job of explaining them at the minutia-level, but that’s the problem.  Non-technical people who must make decisions about GS1 standards probably get bogged down in that minutia and end up not really understanding what it is, why it is significant, and why they should use it.  Too much technical documentation exists on how to apply EPCIS, and not enough documentation on the why.

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My Comments Regarding The New NDC Format

Happy New Year!

A few hours before the end of the comment period, I submitted my comments to FDA’s docket on Regulations.gov for the new NDC format. By the time your read this, the docket will be closed. The agency that operates that web site often takes a few days to post submissions, but because of the government shutdown, I doubt if anyone will be working on it until after the government re-opens (assuming the furloughed workers haven’t gotten a better job by then…In that case, it could be even longer).

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More Details On The Russian Crypto-Code

Since my last essay about the Russia Crypto-Code (a.k.a., Crypto-Tail) (see “New Direction For Pharma Serialization In The Russian Federation”), Russia has published little of value in document form about the requirements or the technology.  I have heard rumors that the pilots conducted with the Crypto-Code have failed.  Interestingly, according to the Center for Research in Perspective Technologies (CRPT), the Russian 50-50 public-private company now under contract with the government there to define and implement the technology, those same pilots were a smashing success.  I am skeptical of that reported success, but let’s take a look at some of the details they have provided. Continue reading More Details On The Russian Crypto-Code

GS1 Blockchain Discussion Group Kickoff Meeting

Stock photo of actors reenacting the GS1 US discussion group meeting.

I attended the GS1 US Blockchain Discussion Group kickoff meeting on November 28-29 out of curiosity.  Fortunately it was held in Chicago so I didn’t need to travel very far.  Just a simple commuter train ride from home each day.  Any farther and I might not have attended, but I was glad I did.  It was great to have the opportunity to Continue reading GS1 Blockchain Discussion Group Kickoff Meeting

FDA Gets Comments On Their Draft Q&A on DSCSA Product Identifiers

Over the weekend I skimmed through the many responses the FDA has received for their ‘Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers’ draft guidance (see “FDA Posts Two Final DSCSA Guidances And A Draft Product Identifier Q&A Document” and “FDA’s Late Recommendation On Human Readable”).  As usual, the most specific, most detailed and most interesting response comes from the Healthcare Distribution Alliance (HDA).  In fact, a few of the other respondents refer to the HDA’s work in the areas covered by the Q&A.  Many of the respondents—even those who did not credit HDA—agreed with the HDA’s positions they covered.  There were a few different opinions, however.  Let’s take a look. Continue reading FDA Gets Comments On Their Draft Q&A on DSCSA Product Identifiers