Some countries mandate the use of GS1 standards for drug product identification and package and case barcodes. The European Commission seems to tolerate GS1 standards, leaving it up to each member state to decide. Most use them, a few held onto their own national codes as long as they could. China is taking their time warming up to the GS1 Global Trade Item Number (GTIN) but it seems to be happening. That is, I think it’s happening. The United States has always had its own national numbering system for identifying drugs, known as the National Drug Code (NDC) (see “Anatomy Of The National Drug Code”). Because they are running out of numbers to identify new manufacturers (labelers), they are considering changes to the NDC that could break the ability to encode an NDC within a GTIN (see “How To Properly Define GTINs For Your NDCs”, “FDA New NDC Format Public Meeting” and “An Open Letter To The FDA: New NDC Format Public Meeting”). The USA is not the only country to be considering a break with GS1 standards. Indonesia will allow QR Codes on drug packages, and now there is a movement in the India government to move away from GS1 standards. What’s going on here? Can GS1 hold onto drug identification around the world? Let’s take a look.
CRPT, the company authorized to conduct the development, piloting and operation of the Russian government pharmaceutical serialization and tracing system, posted an important document last week. The document is intended “…to unify the process of testing printing on the packaging of medicinal products of identification features using the verification code and electronic signature with the content in it of a different number of characters and the aggregation process of drug manufacturers to obtain comparable test results and their applicability in the framework of industrial implementation.” Will it help you?
India has recently made moves to impose a new barcoding requirement for all drugs procured by state and federal governments for domestic public consumption. The new requirements are part of the preference to “Make In India” program that is intended to “…promote manufacturing and production of goods and services in India with a view to enhancing income and employment.”
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.
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.
Almost everyone agrees that GS1’s Electronic Product Code Information Services (EPCIS) standard will be used by drug manufacturers and the large wholesale distributors in the United States for compliance with the serialization requirement of the Drug Supply Chain Security Act (DSCSA). Even I think that (see “Will EPCIS Event Exchange Replace EDI ASNs for DSCSA Someday?”). But there is a problem that could kill its use beyond the internal uses of today, keeping it from being used for data exchange or the data repositories that will eventually become the way data is “exchanged” in 2023 as part of the Enhanced Drug Distribution Security (EDDS) phase of the DSCSA.
As serialization mandates sweep the world you would think that drug manufacturers and repackagers would just deploy one generic “serialization application” and simply turn it on for any drugs that requires it, and turn it off for any that do not. That’s probably what the legislatures and regulators who create the requirements think. RxTrace readers know it’s not nearly that easy.
The problem is that every regulation requires something different. The only common thread is that there is always a “serial number” requirement in there somewhere (thus the name). But the serial number itself is usually defined differently and everything else that surrounds the serial number is often not the same. It’s not a matter of just turning it on and off, it’s a matter of changing a bunch of parameters, which result in significantly more complexity in the setup, testing and validation of the system for each market. Continue reading Meeting U.S. and E.U. Drug Serialization Requirements With A Single Solution→
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
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.
After November 27, 2017 the U.S. 
Almost everyone agrees that GS1’s 
As serialization mandates sweep the world you would think that drug manufacturers and repackagers would just deploy one generic “serialization application” and simply turn it on for any drugs that requires it, and turn it off for any that do not. That’s probably what the legislatures and regulators who create the requirements think. RxTrace readers know it’s not nearly that easy.