Top Takeaways From GS1: Healthcare Packaging

What will it take for the pharma industry to survive the National Drug Code (NDC) Rule?

Editor-in-Chief Liz Cuneo recaps top takeaways from GS1 Connect, where industry leaders unpacked the FDA's coming shift to a standardized 12-digit National Drug Code and its ripple effects across barcoding, labeling, and supply-chain systems. The conversation also covered the expanding role of RFID and connected-product technology, and why strong data governance is becoming essential to compliance, traceability, and patient safety.

This is an AI-generated episode. Read the full featured article on Healthcare Packaging.

Transcript

SPEAKER_03 0:03

Welcome to Through the Line, a podcast exploring innovations and information across the packaging and processing landscape. From topics impacting consumer packaged goods and healthcare packaging to the latest technologies in food processing operations.

SPEAKER_02 0:22

Hi, Liz Cunio here, editor-in-chief of healthcare packaging. What follows is an AI-generated podcast from a recent article I wrote all about the recent GS1 Connect event. Learn why data quality, global standards, and connected technology are becoming critical to regulatory compliance.

SPEAKER_01 0:38

In this deep dive, we examine key takeaways from GS1 Connect, focusing on the upcoming national drug code overhaul, the expanding role of 2D barcodes and RFID in traceability, and the future of data-driven supply chains.

SPEAKER_00 0:52

Yes, and welcome. Our mission today is to thoroughly unpack the insights shared by industry leaders at the recent GS1 Connect event.

SPEAKER_01 1:00

Exactly. The goal here is to help those of you operating within the packaging and processing industry understand exactly how data quality, global standards, and connected technologies are becoming absolutely critical to regulatory compliance.

SPEAKER_00 1:14

And not just compliance, but end-to-end traceability and ultimately patient safety.

SPEAKER_01 1:18

Okay, let's unpack this. I think we need to begin with the most urgent regulatory hurdle that was discussed at the event. It's something that fundamentally alters how pharmaceutical products are identified across the entire supply chain.

SPEAKER_00 1:30

Oh, you're talking about the impending overhaul of the National Drug Code or the NDC?

SPEAKER_01 1:34

Aaron Powell Yeah, that looming giant.

SPEAKER_00 1:36

It is a giant. For necessary context for you all listening, the Food and Drug Administration has historically utilized a variable 10-digit format for the NDC.

SPEAKER_01 1:45

So depending on the manufacturer, that 10-digit code could be configured in different segment lengths.

SPEAKER_00 1:49

Exactly. You might see a 4-4-2 layout or maybe a 5-4-1 layout. But the FDA's new final rule standardizes this identifier into a uniform 12-digit format.

SPEAKER_01 2:03

And it specifically mandates a strict 6-4-2 segment structure, right?

SPEAKER_00 2:08

Trevor Burrus, Jr. Yes, a very strict format. And the enforcement deadline for this mandate is March 7, 2033.

SPEAKER_01 2:14

Aaron Powell Which sounds far away, but really isn't in manufacturing timeline.

SPEAKER_00 2:17

No, not at all. To manage this architectural shift, regulators have established a three-year transition period leading up to that deadline.

SPEAKER_01 2:24

So it's crucial for you to understand that only during this specific three-year window will both the 10-digit and 12-digit formats be acceptable within supply chain software systems.

SPEAKER_00 2:34

Exactly. And when Urb Wong, who is the chief customer officer at Amteri's Vision Group, spoke at the event, he captured the severity of this mandate perfectly. He stated that the NDC rule will be bigger than the Drug Supply Chain Security Act and harder than Y2K.

SPEAKER_01 2:51

Aaron Powell, which is a massive statement. When evaluating that specific comparison to Y2K, my first thought goes directly to data silos. Y2K was an operational nightmare because changing just two digits and date codes broke millions of interconnected back-end systems.

SPEAKER_00 3:05

Oh, absolutely.

SPEAKER_01 3:06

So here the FDA is adding two digits to the NDC. I have to assume the ripple effect across interconnected healthcare and manufacturing software is essentially identical to that, correct?

SPEAKER_00 3:15

What's fascinating here is that the complication actually stems from the uncoupling of deeply entrenched data structures. Historically, manufacturers have relied entirely on directly embedding the 10-digit NDC within the global trade item number, or DTI N14.

SPEAKER_01 3:30

The GTIN 14. And as a reminder to you listening, the GTIN 14 is the standard 14-digit data container the industry uses globally to wrap and recognize product data.

SPEAKER_00 3:39

Aaron Powell Precisely. But because the length of the labeler code is inherently increasing to 12 digits under this new rule, the NDC simply will no longer fit.

SPEAKER_01 3:48

It it physically cannot be directly embedded within that GTIN 14 structure anymore.

SPEAKER_00 3:54

That direct translation is becoming completely obsolete. And that triggers a massive data architecture challenge across three distinct system categories.

SPEAKER_01 4:03

So let us examine the mechanics of those three categories, starting with the physical infrastructure on the packaging line itself.

SPEAKER_00 4:09

Aaron Powell Sure. So first you have the physical barcoding systems. That means the printers and scanners operating on your production floors will require comprehensive hardware and software updates to process the new formatting.

SPEAKER_01 4:20

Aaron Powell Because if a legacy printer is programmed to encode a GTI N14 containing an embedded 10-digit NDC, pushing a 12-digit sequence to it will just generate a hard error.

SPEAKER_00 4:30

Aaron Powell Exactly. It breaks down right on the line. Second, we have to look at the internal systems utilized by organizations throughout the broader healthcare industry.

SPEAKER_01 4:37

Aaron Powell Like warehouse inventory management software.

SPEAKER_00 4:40

Yeah, that. And even hospital electronic health records, all of it must be re-engineered. A database field configured strictly for 10 characters will just reject a 12-character input, freezing the inventory logging process entirely. Trevor Burrus, Jr.

SPEAKER_01 4:53

Which means every single node in the supply chain where data is exchanged represents a potential failure point if those internal databases are not perfectly synchronized.

SPEAKER_00 5:14

That is a perfect analogy. And that actually leads to the third and perhaps most complex category, which is the digital interfaces and communication protocols between different organizations.

SPEAKER_01 5:23

Aaron Powell The Business to Business Data Exchange.

SPEAKER_00 5:25

It relies on strict formatting rules. If a manufacturer transmits a shipping manifest, utilizing the new 12-digit standard to a wholesale distributor, but that distributor systems are still operating on the legacy 10-digit logic.

SPEAKER_01 5:38

That data payload will be rejected during transfer.

SPEAKER_00 5:40

Exactly. The physical pallets of medication might arrive at the loading dock, but digitally, the distributor will not be able to process or receive the inventory.

SPEAKER_01 5:49

That paints a stark picture of the required data synchronization. However, Ulrich Mayevsky, the community engagement director for healthcare at GS1 US, did provide some important parameters regarding what is not changing.

SPEAKER_00 6:03

Yes, he offered some much needed relief there.

SPEAKER_01 6:05

Yeah, this should offer a degree of operational relief for those of you actively managing these compliance timelines. He clarified that there will be no retroactive updates required for legacy data currently housed in your systems.

SPEAKER_00 6:17

Which is huge.

SPEAKER_01 6:18

Yeah.

SPEAKER_00 6:18

Furthermore, there is no mandate for the immediate relabeling of existing inventory that is currently in commercial distribution.

SPEAKER_01 6:25

And there will be no requirement for the resubmission of current product approvals to the FDA.

SPEAKER_00 6:29

Those parameters are vital for strategic planning. The operational challenge you face is entirely focused on upgrading future data architecture and labeling infrastructure to seamlessly generate, transmit, and accept the new 12-digit standard moving forward.

SPEAKER_01 6:44

So you do not need to look backward at historical inventory, but you must ensure your forward-facing infrastructure is structurally sound before that transition window closes.

SPEAKER_00 6:53

And because the 12-digit NDC breaks the old GTIN 14 container, the industry can no longer rely on legacy linear barcodes to meet these compliance demands.

SPEAKER_01 7:04

No, we are fundamentally forced to adopt data carriers capable of handling much larger, more complex data payloads.

SPEAKER_00 7:10

Exactly. This operational necessity directly fuels the widespread shift toward two-dimensional barcodes.

SPEAKER_01 7:17

And during the event, Josh Thorpe, who is the head of global sales development at Loftware, highlighted that the enablement of the two-dimensional barcode allows the industry to capture, pass, and consume significantly more data.

SPEAKER_00 7:28

Aaron Powell He did, and he emphasized something really crucial. He said the most important thing to consider is that this shift is a true transition and not merely a change.

SPEAKER_01 7:37

Okay, I have to stop you there because I want to push back on Thorpe's terminology a little bit. What is the practical difference for industry professionals between making a change to a label versus undergoing a full transition in data management? Isn't buying a new printer to stamp a square code essentially a change?

SPEAKER_00 7:55

The distinction between those two terms is critical for long-term operational success. Swapping a traditional linear barcode for a two-dimensional barcode on a folding carton is a change. It's a tactical, isolated event.

SPEAKER_01 8:08

Okay, so the physical packaging looks different.

SPEAKER_00 8:10

But if your back-end systems remain siloed and only extract the basic product identifier, you have not actually altered your operational capability. A transition, however, means establishing a comprehensive data governance framework that treats the two-dimensional barcode as a dynamic, scalable data carrier.

SPEAKER_01 8:27

Let me make sure I am translating that into practical terms for the professionals listening right now. My assumption is that a change is just a hardware swap, like buying a new printer head to stamp a square two-dimensional code instead of vertical lines. But a transition means you are entirely restructuring your back-end data architecture so that the two-dimensional code can hold a vast amount of dynamic information. Is that the functional difference we are discussing?

SPEAKER_00 8:53

You have identified the exact functional difference. When you commit to a full transition, you build a digital infrastructure where that single two-dimensional barcode ensures your compliance with current FDA regulations today, while retaining the agility to seamlessly adjust to entirely new regulatory frameworks as they emerge tomorrow.

SPEAKER_01 9:12

And that flexibility is massive.

SPEAKER_00 9:14

It is. And this is particularly relevant because data standardization is no longer strictly isolated to pharmaceutical compliance and the Drug Supply Chain Security Act. It is now deeply intertwined with global sustainability initiatives.

SPEAKER_01 9:26

Specifically, extended producer responsibility, or EPR, compliance. Let us expand on the mechanics of extended producer responsibility because it represents a massive shift in how packaging is regulated.

SPEAKER_00 9:38

It really does.

SPEAKER_01 9:39

Yeah, EPR legislation essentially shifts the financial and physical burden of waste management back to you, the packaging producers.

SPEAKER_00 9:46

So to comply, manufacturers must meticulously track and report the exact material composition and end-of-life environmental impact of their packaging materials.

SPEAKER_01 9:55

Which is where a true data transition proves its return on investment. If you have built robust data governance, you can utilize the exact same standardized data architecture to track a pharmaceutical product's secure chain of custody for the FDA and simultaneously report the specific polymer recyclability metrics of its blister pack to a local environmental agency.

SPEAKER_00 10:17

Exactly. And recognizing this significant regulatory overlap, GS1 US recently released a dedicated playbook designed specifically to help packaging companies format and report their data to meet these complex EPR environmental mandates.

SPEAKER_01 10:30

That dual functionality aligns perfectly with the insights shared by Josh Macy, the senior sales manager at Maxim Label and Packaging.

SPEAKER_00 10:37

Yeah, he had some great points.

SPEAKER_01 10:39

He noted that government regulations across all sectors are increasingly demanding transparency and visibility all the way through the supply chain. He explained that packaging companies are achieving this required transparency by helping brands uniquely identify their products.

SPEAKER_00 10:54

And they're doing that through the deployment of two-dimensional barcodes, near-field communication, or NFC, and radio frequency identification, or RFID.

SPEAKER_01 11:04

By doing this, you are essentially future-proofing your supply chain against disjointed regulatory audits.

SPEAKER_00 11:10

It creates a unified architecture of trust. However, generating this rich data does not merely satisfy government regulators and sustainability auditors. It fundamentally transforms what happens to the packaging once it physically reaches the hospital floor or the consumer's hands.

SPEAKER_01 11:25

Diego May, the founder of Forge Stop, pointed out during his session that the packaging industry has already adopted many of these connected technologies.

SPEAKER_00 11:32

The immediate challenge is figuring out how to reuse those exact same technologies to break free from old constraints.

SPEAKER_01 11:38

Yeah, he explained that tying serialization data to an NFC or RFID tag allows brands to move away from traditional batch or lot management.

SPEAKER_00 11:48

Which is a huge shift. This shift from batch management to item level management is a significant operational leap. Instead of tracking a pallet of 10,000 units as a single entity, you gain granular individual control over every single product.

SPEAKER_01 12:01

Precisely. And while the underlying radio frequency technology for RFID and NFC has existed in the industry for over two decades, the operational landscape is entirely different today.

SPEAKER_00 12:12

Yeah, the catalyst that transforms this 20-year-old technology into a modern game changer is the fact that virtually every consumer, nurse, and clinician is now carrying an advanced computing device in their pocket in the form of a smartphone.

SPEAKER_01 12:25

Here's where it gets really interesting. To conceptualize this shift, it is like upgrading your packaging from a silent cardboard box to an interactive digital assistant that speaks directly to the patient.

SPEAKER_00 12:34

That's a great way to put it.

SPEAKER_01 12:36

Simply by tapping a smartphone against the NFC-enabled product, a consumer can instantly access critical statutory product information.

SPEAKER_00 12:44

So this includes exact expiration dates, highly specific LOT information, provenance, and exact details regarding where the active pharmaceutical ingredients were manufactured.

SPEAKER_01 12:54

But at the same time, that exact same tap provides a secondary interface for non-statutory information. This allows brands to deliver rich, dynamic content directly to the user's screen.

SPEAKER_00 13:06

We are talking about step-by-step video usage instructions, promotional materials, targeted coupons, and immediate access to customer support.

SPEAKER_01 13:14

Which is incredible for brand engagement.

SPEAKER_00 13:17

It is. And if we examine the operational value of that digital interaction, it reveals a profound shift in end-to-end supply chain visibility. Historically, supply chain data tracking stopped abruptly at the warehouse loading dock.

SPEAKER_01 13:30

Once the product was shipped out to retail or a medical facility, visibility was essentially lost. The manufacturer was effectively blind to the product's journey until the moment of sale, assuming that sale was even accurately recorded and shared back up the chain.

SPEAKER_00 13:43

Exactly. But now, because the packaging acts as an interactive node, that visibility extends all the way into the specific hospital bed or the consumer's living room.

SPEAKER_01 13:54

Which closes a critical feedback loop. When a user interacts with that package at home, they can contact support and receive assistance specific to the exact serialized product they're holding.

SPEAKER_00 14:04

They do not have to read off complex lot numbers over a phone call because the tap authenticates the exact unit.

SPEAKER_01 14:11

Simultaneously, brands instantly get that interaction data sent right back to them. They can verify that a specific product is authentic post-supply chain, gaining visibility into where that product is moving and how it is being used for the very first time after it enters the hands of the consumer.

SPEAKER_00 14:27

And this level of direct communication vastly improves patient safety and brand engagement, all by utilizing technology that, as Diego may pointed out, may already be implemented within your current warehouse tracking operations.

SPEAKER_01 14:40

We also see this granular control completely revolutionizing internal environments, particularly within the complex healthcare sector.

SPEAKER_00 14:47

Oh, definitely.

SPEAKER_01 14:48

One compelling session at GS1 Connect detailed exactly how RFID labels are currently being utilized in modern hospital networks to overhaul inventory management.

SPEAKER_00 14:58

The mechanics of that hospital inventory overhaul are fascinating. By attaching passive RFID tags to both high-value assets and everyday consumables, and installing continuous overhead RFID scanners throughout the hospital corridors and supply rooms.

SPEAKER_01 15:14

Administrators are completely eradicating the need for manual inventory counts.

SPEAKER_00 15:18

The packaging itself becomes an active automated participant in the hospital's network.

SPEAKER_01 15:22

Let us walk through a practical application of that technology. Because the continuous scanners provide real-time visibility into exact stock levels across the entire facility, a nurse no longer has to physically search through supply cabinets to locate a specific device or medication.

SPEAKER_00 15:38

Exactly. The system knows exactly which room the asset is in at all times.

SPEAKER_01 15:41

Furthermore, this automated scanning dramatically accelerates product recalls. If a specific batch of medication is recalled by the manufacturer, the hospital system instantly locates every affected vial within the building down to the specific shelf.

SPEAKER_00 15:55

And beyond recall acceleration, it proactively manages inventory health. The continuous scanning automatically flags expiring medications before they become a patient safety hazard or a total financial loss.

SPEAKER_01 16:07

It actively prevents the loss or theft of expensive mobile medical equipment by triggering alerts if an asset moves past a designated threshold.

SPEAKER_00 16:16

Ultimately, this granular data reduces the hours clinicians spend searching for equipment, minimizes inventory waste caused by blind overpurchasing, prevents critical out-of-stock scenarios and emergency situations, and ensures that expired medications never reach a patient.

SPEAKER_01 16:32

Once you have turned every individual package into an interactive digital node within a hospital network, you have essentially laid the technological groundwork for the next 20 years of supply chain evolution.

SPEAKER_00 16:42

It really does set the stage for the future.

SPEAKER_01 16:44

Which directly ties into what the GS1 U.S. innovation team sees as the long-term trajectory for the industry. At the event, they hosted an interactive installation called the Road to 2050 wall, where attendees posted sticky notes predicting future industry trends.

SPEAKER_00 16:59

Yes, and the insights clustered around three dominant themes.

SPEAKER_01 17:01

The first theme centered on the concept that advanced identification and traceability now rival artificial intelligence as a headline trend.

SPEAKER_00 17:10

The professionals in attendance predicted a complete shift away from simple product tracking toward continuous item-level verification against a digital twin.

SPEAKER_01 17:20

And to understand the mechanism of a digital twin, you really must view it as a dynamic cloud replica of the physical product.

SPEAKER_00 17:27

So when they talk about verification against a digital twin, they mean that every time a physical vial of medication is scanned or moved, that event data instantly pings a cloud-based replica to ensure the physical location, the environmental temperature, and the chronological timestamp perfectly match its intended authorized journey.

SPEAKER_01 17:45

For instance, if an RFID scan on a loading dock in Miami registers a temperature of 20 degrees Celsius, but the digital twin dictates the product must remain at four degrees, the twin instantly flags the anomaly and automatically invalidates the physical product for clinical use.

SPEAKER_00 18:00

Exactly. This future state includes the ubiquitous use of RFID across all medical supplies. Establishing these identification standards is the foundational trust layer for everything from local retail safety to advanced off-planet supply chains.

SPEAKER_01 18:15

Wow, off-planet supply chains, that is a massive scope.

SPEAKER_00 18:18

It is. But the second dominant theme from the 2050 wall focused directly on the role of artificial intelligence in managing these massive data flows.

SPEAKER_01 18:26

While AI remains the dominant force and is already viewed as an active participant in the supply chain, the wall revealed a distinct split personality in how the industry views its trajectory.

SPEAKER_00 18:37

Yeah, there was a very clear divide. On one hand, AI is viewed optimistically as a massive value creator and an unparalleled engine for rapid personalization at scale.

SPEAKER_01 18:46

But on the other hand, it is viewed with deep caution as a potential replacement of humanity within the workforce. The consensus at the event was that determining which of these two paths we steer toward is the defining operational question of 2050.

SPEAKER_00 18:59

It absolutely is.

SPEAKER_01 19:00

So what does this all mean for the professionals listening right now who are actively designing these production facilities and might be worried about automation replacing their roles? If artificial intelligence and automated digital twins eventually take over the verification and routing of all physical goods, what does this analysis actually mean for the future of their strategic roles?

SPEAKER_00 19:20

If we connect this to the bigger picture, we find a highly strategic answer in the third theme that emerged from the 2050 wall. The attendees predicted that physical production will inevitably become distributed, proximate, and sovereign.

SPEAKER_01 19:35

What does that mean practically?

SPEAKER_00 19:36

Concepts such as regional microfactories, advanced biomanufacturing, and on-demand 3D printing fundamentally reimagine the traditional linear supply chain.

SPEAKER_01 19:45

So instead of relying on massive centralized production facilities that span vulnerable global shipping routes, the industry is moving toward agile point-of-need manufacturing.

SPEAKER_00 19:55

Exactly. This distributed model is deeply tied to national security, operational resilience, and material sovereignty.

SPEAKER_01 20:01

Because in a world of frequent global disruptions, the winning principle for manufacturing is no longer just maximizing lean efficiency, it is maximizing localized resilience.

SPEAKER_00 20:12

Exactly. And that required resilience is what secures the human element. While AI and digital twins will undoubtedly manage the immense autonomous data flows and handle the routine verification processes, human strategy, complex problem solving, and adaptability will remain the absolute core of these sovereign manufacturing networks.

SPEAKER_01 20:32

So the artificial intelligence will handle the autonomous data execution, but human professionals must be kept at the center to design, govern, and continuously adapt the localized supply chains that ensure true material sovereignty.

SPEAKER_00 20:44

It highlights a critical evolution in the responsibilities of our listeners.

SPEAKER_01 20:47

Yeah.

SPEAKER_00 20:48

You are no longer simply managing the physical movement of corrugated boxes and glass vials, you are actively managing the architecture of trust, data integrity, and operational resilience.

SPEAKER_01 20:59

The physical product and its digital data identity are becoming completely inseparable.

SPEAKER_00 21:03

To summarize our analysis of the GS1 Connect event for you, surviving the incoming wave of complex regulations requires a fundamental shift in perspective.

SPEAKER_01 21:12

From executing the NDC 12-digit transition to managing the vast data requirements of the Drug Supply Chain Security Act to navigating emerging environmental compliance laws, you must fully embrace data standardization.

SPEAKER_00 21:26

Technologies such as two-dimensional barcodes and RFID continuous scanning must be viewed not merely as compliance hurdles to clear, but as the foundational strategic tools required for achieving total supply chain visibility and future-proofing your manufacturing operations.

SPEAKER_01 21:42

Which leaves us with one final provocative concept for you to consider as you evaluate your own packaging strategies and data architecture moving forward. If every individual package you produce eventually acts as a secure, interactive digital twin that communicates directly and continuously with AI systems, local consumers, and global hospital networks, will the data generated by the packaging soon become just as valuable as the physical product it protects?

SPEAKER_00 22:06

That is definitely something to think about.

SPEAKER_01 22:08

Thank you for joining us for this deep dive.

SPEAKER_03 22:12

Thank you for listening to Through the Line Packaging and Processing. You can listen to more episodes on all streaming platforms. Be sure to visit us at packworld.com, profoodworld.com, and healthcarepackaging.com for more packaging and processing news. This podcast was edited by Brady Gunn.