There’s been a lot of confusion about product identifiers in the pharmaceutical industry since the DSCSA was passed. In my own work with clients I get these kinds of questions quite often:
“Which standard should we use, NDC or GTIN?”
“Do you need to be a GS1 member to use GTIN?”
“Is a GTIN going to be enough, even if I’m doing business globally?”
GTIN is, of course, GS1’s Global Trade Item Number, a well-known identification system used in many industries, including healthcare. And because the questions above all touch on important aspects of the DSCSA’s product identifier issue, I’d like to tackle each of them, and also provide a recommendation for manufacturers.
NDC or GTIN?
Much of the confusion can be traced back to the DSCSA’s vague wording. Here’s the actual text, from page 15:
‘‘(14) PRODUCT IDENTIFIER.—The term ‘product identifier’ means a standardized graphic that includes, in both human-readable form and on a machine-readable data carrier that conforms to the standards developed by a widely recognized international standards development organization, the standardized numerical identifier, lot number, and expiration date of the product.”
Who is this “widely recognized international standards development organization”? They don’t tell us, so we’ve been left to wonder: Can I just use my NDC? Will the FDA step in and create a new system? What about the IEEE, GS1, or HIBCC?
Technically, an NDC number – when it’s accompanied by a serial number – would meet the DSCSA’s standard.
But while the NDC/serial number combination provides sufficient compliance coverage (labeler code, product code, and package code in the NDC; plus the lot number and expiration number in the serial code), it has some major deficiencies, especially if you do business globally: the NDC only covers U.S. companies.
The FDA knew this, of course, but they left it to the industry to find a solution. In that void, manufacturers have collectively come to the realization their best course of action was to turn to the closest thing they have to an international product identification standard: GS1 and the GTIN.
GS1 Membership and GTIN
Adopting GTIN (plus a serial number to form sGTIN) as a serialization identification standard seems like a natural fit in many ways. But, for companies unfamiliar with how the GS1 organization works, there are still some kinks to work out.
The biggest misconception is around how one acquires a GTIN. Given that it’s only a fourteen-digit number (in the U.S.) that identifies the manufacturer’s product, many businesses mistakenly believe that they can simply add a few digits to their NDC and call it a day – voila, GTIN! Not so. You may be able to get away with that for a while, but eventually your self-made GTIN will catch up with you, causing confusion with partners, and possibly rendering your drug products unacceptable to distributors.
The bottom line is you need to register with GS1 to acquire a GTIN. You might be put off by the fee they charge, but don’t let that prevent you from becoming a member: As of April, 2016, GS1 has lowered their fee from $10,500 to $2,100 per labeler code. Given the complexities of serialization, that’s a small price to pay for peace of mind.
The process is pretty simple: 1) You become a GS1 member by registering your labeler code with them. 2) GS1 turns your labeler code into a company prefix – the base to generate GTINs.
The image below illustrates the serialized Numerical Identifier (SNI) format.
Is GTIN Enough?
Given all the unknowns that still await us after November 27, 2017, and all the complications around implementing serialization – including getting it right across all parts of your company, and keeping your businesses from being disrupted – GTIN is essential in the U.S. market. Here’s why LSPediA is recommending that all manufacturers register with GS1:
- The big three wholesale distributors have aligned to the GS1 standard.
- Not all countries with a serialization requirement use the GS1 standard, but a significant portion do – including the European Union, Korea, Saudi Arabia, and now the U.S. If you are selling to these markets, you need to get on board now.
There are undoubtedly wrinkles in global serialization – there is no real global standard. From the perspective of a global pharmaceutical company, GTIN is one of the product identifiers, but not the only product identifier. We can only hope that these wrinkles get ironed out over time through international harmonization. Until then, I recommend sensible investment in master data management. By managing your master data with accuracy and integrity today, you’ll avoid data problems and recalls tomorrow.
Meet Serialization Compliance Standards, With LSPediA
Securing your product identifiers is just one piece of a much bigger puzzle called DSCSA serialization. By working with LSPediA, you can ensure all those elements come together while maintaining complete control over the process. Whether you purchase a Serialization Toolkit, or sign up for our Services starting for as little as $1000 a month, we can provide you with:
- More efficient business processes
- A better return on technology investments
- Improved regulatory compliance
- Higher customer satisfaction
Contact us today to get started.
LSPediA helps pharmaceutical manufacturers and distributors implement serialization and aggregation processes to meet global regulations, DSCSA requirements, and future track-and-trace mandates. Our services include URS, RFQ, gap analysis, serialization toolkits and solutions, DSCSA strategies, management consulting, and more.
We value long-term relationships and work with our clients’ internal teams to properly define roadmaps, create architectures, and implement systems that align to vital business goals, ultimately helping them derive maximum value from their investments, both now and well into the future.