EU FMD

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 →
Russia

Mixed Signals From Russia

I’m not talking about the mixed signals from Russia in your daily political newsfeed, I’m talking about the mixed signals we see between the Russian Federation decrees for their pharma serialization and traceability mandate, and the announcements of the government’s designated technology contractor to develop that system:  CRPT, LLC.  Considering how short the deadlines are, these mixed signals are counterproductive because they cause companies to pause while they figure out what they should do.  Let me explain.

Continue reading Mixed Signals From Russia →
EPCIS

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.

Continue reading EPCIS Explained →
NDC

My Comments Regarding The New NDC Format

6 Comments

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).

Continue reading My Comments Regarding The New NDC Format →
Russia

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 →

Blockchain

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 →

DSCSA

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 →

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