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The history behind the Drug Supply Chain Security Act (DSCSA)

The latest DSCSA exemptions and what that means for trading partners

How this piece of legislation and AI are able to intertwine

Nicholas Saraceno offers an overview of the legislation and how it impacts the pharma supply chain.

Nov. 27 is Here: What Does That Mean for DSCSA?

 interview, Dave DeJean, Systech’s VP of global strategic accounts, dives into:

The valuable lessons he’s learned along the way, given his three and half decades of experience at Systech

An overview of the Drug Supply Chain Security Act (DSCSA), including its three main pillars

How he would interpret this “Stabilization Period” that the FDA provided this past summer, and what he pharma industry do now during this period in order to avoid penalties later

Whether or not he anticipates the FDA implementing any other sort of delays in the near future in order to help remedy these issues/challenges surrounding the enactment of DSCSA

Podcast is available directly on SoundCloud.

Dave DeJean provides his expert insight on lessons he’s learned from his plethora of time in the industry, along with an outlook on where the pharma supply chain stands in adhering to the Drug Supply Chain Security Act (DSCSA). 

Complying With the DSCSA

This serialization system represents a business imperative that yields significant competitive advantages.

Serialization 2.0: Why It’s Time to Upgrade, and What’s at Stake

When delays and disruptions threaten not only product integrity but patient
well-being, thorough risk assessment and mitigation are essential.

Reducing Risk in the Pharmaceutical Cold Chain

Why taking proactive steps—and combing the right data sources—is critical to informed decision-making in risk management.

What Your Data Can Tell You About Illicit Trade Risk

Ensuring that essential treatments reach patients safely and efficiently is an increasing imperative in today's pharma landscape.

Strategies to Modernize, Future-Proof, and Secure the Healthcare Supply Chain

Introducing a new Pharma Commerce column focused on combating illicit trade and protecting product integrity—and ultimately patients.

Welcome to the 'Dark Side'

What Is Smart Pharma Packaging?

, Kirsten Newquist, Identiv’s CEO, defines "smart pharma packaging" as the integration of technology into pharmaceutical packaging to enhance product identification, tracking, and patient engagement. She explains that packaging primarily involves embedding technologies such as RFID radio-frequency identification (RFID) or Bluetooth low energy (BLE) into pharmaceutical containers. These technologies assign a unique digital ID to each package, enabling serialization, which is critical for tracking and traceability across the global supply chain.

This digital ID allows stakeholders—from manufacturers to pharmacists and patients—to verify a drug’s authenticity at every step of its journey. This significantly reduces the risk of counterfeit drugs entering the system, as products can be authenticated upon delivery or administration. Newquist emphasizes that this kind of smart packaging not only strengthens supply chain security but also fosters better patient engagement, offering real-time data that can support dosage verification and proper usage.

Additionally, she notes a secondary dimension of smart packaging: smart drug delivery systems. These include technologically enhanced devices like auto-injectors, smart pillboxes, or connected syringes, which offer further layers of verification and ensure patients receive the correct medication and dosage. While this may go beyond traditional packaging, it aligns with the broader goals of improving safety, compliance, and confidence in the pharmaceutical supply chain.

Overall, smart pharma packaging plays a crucial role in combating drug counterfeiting by improving transparency and traceability from production to patient use. By embedding intelligence into packaging and delivery systems, the pharmaceutical industry is better equipped to protect product integrity and ensure patient safety in an increasingly complex global supply chain.

Newquist also comments on the role embedded product intelligence plays in maintaining cold chain integrity, and why is this so critical for pharmaceutical safety and efficacy; how regulatory mandates, such as the Drug Supply Chain Security Act (DSCSA), influence the adoption of smarter packaging technologies across the industry; some of the biggest challenges pharmaceutical companies face in implementing this infrastructure, and much more.

How would you define “smart pharma packaging,” and how is it helping to combat the growing threat of counterfeit drugs in today’s global supply chain?

In my mind, what that really means is the integration of intelligence or technology into the packaging—in this case, putting an identification on the smart packaging. In the case of radio-frequency identification (RFID) or Bluetooth low energy (BLE) technology—which is a type of technology that my company develops—it's really giving everything a unique digital ID. It enables serialization of the product, which helps with tracking of the product through the supply chain. It helps with enabling traceability. It helps with engagement, once the patient or the pharmacist actually receives the product. It's really about adding this technology and intelligence to the packaging that's used for the pharmaceutical. That’s my primary definition.

There's a secondary one as well, where there's also smart drug delivery packaging. Maybe that goes beyond what your question is, but there is also technology that can be embedded into drug delivery devices, like syringes, auto injectors, or pill boxes that also enable patients to be ensured that they've got the right drug, that they've got the right dose, etc.

First and foremost, it's around true pharmaceutical packaging. Then secondly, I think there's also this pharmaceutical packaging concept that's really more around drug delivery, and in both cases, it really does help with counterfeiting, because it enables you to track the drug through the supply chain and trace it through the supply chain, but also when it gets to the patient or the pharmacist, doctor, or whoever is delivering the drug, they can verify that it is the actual drug, that it is not counterfeit. They can authenticate it and really make sure that it's not a counterfeit drug.

In the first part of her Pharma Commerce video interview, Kirsten Newquist, Identiv’s CEO, defines the term, and explains how it is helping to combat the growing threat of counterfeit drugs in today’s global supply chain.

Preparing for DSCSA Deadlines 

, Jody Hatcher, CEO of Morris & Dickson and chair of HDA’s board of directors

 outlines his vision for the future of the organization and the key priorities he hopes to drive during his tenure. He expresses a strong sense of privilege and responsibility in succeeding Kirk Kaminsky and looks forward to collaborating closely with Debbie Weitzman of Cardinal Health to strengthen connections across the pharmaceutical supply chain.

Hatcher emphasizes the often-overlooked value that distributors bring to the healthcare ecosystem. Representing more than 1,200 manufacturers and serving around 330,000 pharmacies and care providers, he describes distributors as being part of an "irreplaceable network" that plays a vital, behind-the-scenes role in ensuring the availability of medications and healthcare products across the country.

He outlines three main priorities for his leadership. First, he aims to enhance engagement within the distribution community—bringing together pharmacies, manufacturers, and distributors around their shared mission. Second, he highlights the critical importance of implementing the Drug Supply Chain Security Act (DSCSA) across the supply chain. With an extension recently granted, Hatcher underscores the need to meet the updated deadlines to maintain the reliability and integrity of the distribution network.

Lastly, he stresses the importance of storytelling—articulating the value and sophistication of the distribution sector to external audiences. He notes that while distributors are often discussed in various contexts, it's essential to clearly communicate their indispensable role in maintaining a secure and efficient healthcare supply chain.

Overall, Hatcher's vision centers on strengthening collaboration, ensuring compliance, and raising awareness of the distribution sector’s critical contributions.

Hatcher also comments on his day-to-day workflow at Morris & Dickson, including how it supports the efficiency and reliability of the company’s operations; steps that should be taken to ensure DSCSA compliance; types of implications that the potential 25% tariffs on pharmaceuticals can cause; and much more.

With the DSCSA implementation deadlines for pharma supply chain stakeholders fast approaching, what steps should be taken to ensure compliance? Are there any technological or operational adjustments that can help?

DSCSA is a mission-critical priority for every member of HDA. We've had work groups that have had daily and weekly meetings around the HDA table, and HDA has been working deliberately with the FDA on the traceability issues for probably two decades.

At the end of the day, DSCSA fundamentally means that we want to ensure the safe and effective implementation for our customers and for the products that they buy from us. Obviously, the most critical deadline is May 27, when pharmaceutical manufacturers and the repackagers need to meet the criteria in terms of the data at the package level, or have their waivers or exemptions in place, so it's important. It's an important indicator of readiness, not only for the manufacturers, but also for distributors and dispensers, and then for the distributors, for all of us, by Aug. 27, 2025, we've got to be able to receive and trace product from the manufacturers and provide data to our dispensers. We've got to receive and provide EPCIS data at the product unit level. This requires review of processes, such as the practices for returns—which is complicated—product quarantines, testing, and communication.

At the end of the day, I think the message here for all constituents is this has to be a priority, and it involves the technology you've deployed, it involves your systems. I think for all of us, it's really just a shift in the way we work. Our intent, our aim here at Morrison & Dixon, and I think with the rest of HDA, is to make sure that DSCSA is fully integrated into what we do. It's just not optional. And again, I'd like to hope that everybody involved with implementation feels the exact same way.

In the third part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Jody Hatcher, CEO of Morris & Dickson and chair of HDA’s board of directors, comments on the steps needed to achieve Drug Supply Chain Security Act compliance.

Enhancing Pharma Supply Chain Transparency and Trust

, Laura Johnson, senior director of sales, life sciences, Loftware, discusses how supply chain collaboration is becoming increasingly important, particularly in the life sciences and pharmaceutical sectors. According to Johnson, the adoption of cloud-enabled collaborative supply chains is crucial for improving real-time data sharing. This enhances visibility and coordination among internal stakeholders, external suppliers, co-manufacturers, and co-packers, who all play a role in the complex supply chain process.

This collaboration leads to faster decision-making and reduces operational costs, resulting in greater agility. Pharmaceutical organizations are better able to respond to market changes, regulatory updates, label changes, and potential disruptions. In addition, cloud-based systems facilitate regulatory compliance and advanced analytics, enabling more accurate demand forecasting. These systems also optimize inventory management, which directly contributes to improving patient outcomes and accelerating the time to market for new therapies.

Ultimately, cloud-based collaborative supply chains help streamline operations, reduce costs, and improve the overall efficiency of the pharmaceutical industry, benefiting both companies and patients.

companies are exploring new ways to ensure that their products and shipments are protected, why the demand for supply chain transparency is continuing to gain momentum, and much more.

Why is the demand for supply chain transparency continuing to gain momentum, and what role are track-and-trace initiatives playing in that effort?

I've been in the industry for a while, so I was around doing and providing solutions to support, track and trace way back in the beginning. You mentioned RFID was certainly a hot topic, and it continues to be. I think that companies are continuing to embrace track and trace. There's a better understanding that the technology has certainly improved immensely over the past 10 to 15 years, so I think it's easier for them to adopt and get the support, and the funding and things that might be needed to deploy these types of systems.

In general, the adoption of track and trace in life sciences certainly enhances the supply chain transparency. It provides that real-time monitoring of products across the network, from production all the way to patient delivery. I think that's really what the intent of it was back when we started focusing on it, deploying sterilized product, as well as the tagging in different ways, whether it's RFID or two-dimensional barcodes, which are a little bit harder to counterfeit than a standard linear barcode. Getting back to track and trace, it certainly improves regulatory compliance as well, and if needed, it can lead to the ability for brand owners or manufacturers to be able to act very swiftly or quickly, should a recall or something else be needed.

In my opinion, by leveraging technology, organizations can improve data accuracy. They reduce inefficiencies often seen when a brand owner is working with a co-packer or another trading partner, and having track and trace across the entire network certainly helps to build trust with these different stakeholders and eventually the consumer.

In the third part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Laura Johnson, senior director of sales, life sciences, Loftware, discusses why the demand for supply chain transparency is continuing to gain momentum, while also explaining the role that track-and-trace initiatives are playing in that effort.

Peer Exchange: The Future of RFID and Supply Chain Management (Episode 6)

 roundtable discussion, Nicholas Saraceno, editor of 

 and the peer exchange’s moderator, alongside a panel of experts, discussed the role of radio frequency identification (RFID) technology in the pharmaceutical and healthcare sectors. RFID is a technology that utilizes radio waves to automatically collect and transfer data, providing efficient tracking and tracing of products. This discussion covers the potential and challenges of RFID in the industry.

The panel consisted of Matt Campasano, Managing Director, Criterion Consulting; Sean O’Hearen; Founder & Principal Consultant, 1

 Line Partners; Tim Marsh, Founder & Head of Strategy, MDB; and Bahar Aliakbarian, PhD, Associate Professor, Sr. Director of R&D, Axia Institute (at Michigan State University).

Each expert brought unique perspectives on RFID’s applications, including brand protection, traceability, and supply chain efficiency.

Campasano highlighted RFID’s value in pharmaceutical traceability, particularly in relation to the Drug Supply Chain Security Act (DSCSA). RFID offers significant operational efficiencies in warehousing, as it eliminates the need for line-of-sight scanning and speeds up product verification, saving both time and resources.

The discussion also explored the fluctuating adoption of RFID over the past two decades. Marsh provided historical context, explaining that while RFID technology showed promise for improving supply chain operations and patient safety, it faced challenges, particularly in the early 2000s. High costs and reliability issues led to disillusionment, with many RFID installations being dismantled. Furthermore, the lack of widespread adoption of RFID by wholesalers, who required the majority of products to be tagged for it to be effective, hampered progress.

Today, RFID is making a gradual comeback in the pharmaceutical industry, primarily driven by regulatory compliance needs and the growing need for improved product traceability. However, its widespread adoption remains limited by cost concerns and the lack of clear, immediate value for all stakeholders.

In the final part of this roundtable discussion, a panel of subject matter experts discuss what the future holds for this technology, why end-to-end visibility is necessary in healthcare, and the opportunities for greater RFID adoption that lie ahead.

The Gap in DSCSA Readiness 

, Joe Lipari, direct of product management for Systech, dives into how the Drug Supply Chain Security Act (DSCSA), signed into law by President Obama in 2013, has actually been in development for nearly two decades, with earlier state-level efforts like California’s e-Pedigree push. Initially, the full implementation deadline was set for Nov. 27, 2023, marking the completion of serialization and traceability across the pharmaceutical supply chain. However, due to industry readiness issues, the FDA introduced a “stabilization period” to allow for testing and system adjustments. The stabilization period, meant to iron out bugs, turned into a series of delays, and the implementation date has been pushed back multiple times.

In October 2023, the FDA announced another delay, introducing a phased approach to DSCSA compliance. Manufacturers now have until May 2025 to meet requirements, wholesale distributors until August 2025, and mid-to-large dispensers until November 2025. Small dispensers, defined as those with 25 or fewer employees (including pharmacists and pharmacy technicians), have an extended deadline of November 2026. This phased approach allows different parts of the supply chain to comply gradually, but the full implementation will not be realized until at least 2026.

The FDA’s latest exemption allows eligible trading partners that have either completed or documented efforts to complete data exchange connections to be given some leeway in enforcement. This continues the trend of delays and phased compliance, highlighting ongoing challenges in fully implementing the DSCSA across the industry.

Lipari also explains the penalty for non-compliance, the likelihood that these deadlines put forth by the FDA will be met, and more.A transcript of Lipari’s conversation with

What do you believe the likelihood is that these deadlines put forth by the FDA will be met?

The funny thing is, we were having this conversation back in August and September. The HDA [Healthcare Distribution Allinace] does their Traceability Seminar in DC every year. You have the FDA there and a lot of different legal entities there, and that question continues to be asked of, what are you guys going to do? The answer was, no, there will not be any more delays. And a month later, we have the announcement. History has sort of shown us that any dates within the DSCSA implementation framework are subject to change.

If I was a betting man. I’d have to look at the track record of this implementation and say that I'm not sure if any of the dates will hold. But I mean, from my experience with Systech, we are more on the manufacturing side. A majority of our serialization customers are Big Pharma, mid-, mid-tier pharma. With our traceability platform, we have manufacturers, we have distributors, we have repackagers, CMOs. There is whole breadth of trade partners, but the manufacturers, for the most part, are ready. They've been serializing product for quite some time. They have systems in place to do verification. They have systems in place to handle tracing requests. They have systems in place to electronically share data. You hear from the wholesale distributor—from a KPI perspective—the wholesale distributors ramping up their enablement across their DCs.

In the beginning, you heard numbers and by the end of the stabilization period, definitely those numbers all went in the right direction, as far as how much was enabled, and then furthest downstream, you get to the dispensers. That's really where I think the main problem with readiness lies, and it's a tough space.

In the US, there's something to the tune of 90,000 different dispense locations. That ranges from the CVS and Costcos of the world—which are massive corporations—all the way to your mom and pops, those little pharmacies. I have one in my town, and they're independently owned, a single location, but that doesn't mean they're not exempt from DSCSA. They are the same prescription serialized drugs that are flowing through those facilities, just like CVS. It’s a tough space because of how many different types and the wide range of business types that exist in that space. There was a clear message that the dispense side was not going to be ready. If this thing did get pushed through, [there may have been] calls for patient safety, and what happens with quarantine product if you can't meet the letters of the law? I get that side of it, but there's a piece of me that feels we've been talking about this since 2013, and so how much further can we kick this can down the road?

In the final part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Joe Lipari, director of product management, Systech, predicts the probability that these DSCSA compliance deadlines put forth by the FDA will be met.

Consequences of Non-Compliance 

Lipari also explains the penalty for non-compliance, the likelihood that these deadlines put forth by the FDA will be met, and more.

A transcript of Lipari’s conversation with

What is the penalty for stakeholders who don’t comply with the DSCSA?

The FDA does take action against supply chain trade partners. There’re implications of non-conformance to disciplinary action. There’re warning letters—they publicly post those warning letters on websites, so there's some negative press that comes along with that for the trade partner. You could have products that could quarantine. You could have seizures. You could have court-ordered injunctions; civil, criminal penalties if it got really far down the line. There’s sort of a full range of disciplinary actions that the FDA can take.

DSCSA doesn't change that. It just adds a few others to this list. The questionaround the industry is, because it's an enforcement discretion saying the law went into law, the law is the law, and the dates in the law are the dates in the law. We're choosing not to enforce some of the requirements on the specific dates. There's always that notion of, will the FDA make an example out of somebody? It hasn't happened.

Is it an option on the table? Sure. But in reality, I think you know the language that you have successfully completed, you have made documented [efforts]. It's really tough to enforce that. I think the general sort of feeling in the industry is that this is just a broad exemption. Here's some new dates, and take it for what it's worth.

In the second part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Joe Lipari, director of product management, Systech, comments on what the repercussions are for failing to comply with the DSCSA.

Navigating DSCSA Delays

Could you describe the latest state of DSCSA implementation guidelines?

Like you said, Obama signed it into law in 2013, so we're talking that far back. Even prior to that, we're talking mid 2000s, where, prior to it being federal law, there were individual states that were kind of doing their own thing. There was a big California e-Pedigree push where there was some serialization and aggregation, but very local at the state level. It’s been around coming up on almost 20 years, right of some sort of US serialization push. Originally, the goal line was Nov. 27, 2023. That’s when full implementation—soup, the nuts, everything—would have gone live. Obviously, what happened was, with the state of readiness in the industry, the FDA announced what they called a stabilization period, which was meant to be a time to where all of the trade partners were flexing and testing all the systems they had in place, and that's the key word. Stabilization has a very specific meaning.

You're supposed to be stabilizing the existing systems in place, working out the bugs. Well, you can't stabilize something if you don't have a system in place, so unfortunately, the stabilization period really wound up being a proverbial “kick the can down the road.” There’s been a few up to this point, so DSCSA implementation in general has seen its fair share of delays, whether that be enforcement or non-enforcement, whatever verbiage you want to use. There's been multiple delays in this thing since the beginning.

The stabilization period was really meant for a time when everyone was to work out the kinks in the system so that we could all go live the 27th of November. That didn't happen. We had the announcements back in October—which were the latest round of announcements—where the FDA came out and gave a broader exemption to the industry. This really applied to—this is the language in the exemption—eligible trading partners who have either successfully completed or made documented efforts to complete these connections and data exchange with their trade partners.

Now, we can have a conversation about that language, because how do you enforce something that, but what that really meant was that it was a phased approach. FDA came out and said, hey, listen, we're going to take a step back. We're going to do a phased approach, starting from the front of supply chain to the back of supply chain, where you have your manufacturers that now have until May of 2025, you have your wholesale distributors that now have until August 2025, and now you have your mid-to-large dispensers that have until next November of 2025, so a full year. You have this phased approach for those categories.

The other piece, which was in June, was the announcement about small dispensers, defined as 25 or fewer employees. There's language in there too, which was under some scrutiny within the industry, because it's the corporate entity. The corporate entity that owns the dispenser has a total of 25 or fewer full-time employees, licensed pharmacists, and pharmacy techs. Small dispensers now have until Nov. 27, 2026, so the full breadth of this thing, as it is today, is not going to be realized now for another two years for all the different personas in the supply chain. That's kind of the latest state of implementation timelines.

In the first part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Joe Lipari, director of product management, Systech, describes the latest state of DSCSA implementation guidelines.

Peer Exchange: RFID Technological Obstacles (Episode 2)

The panel consisted of Matt Campasano, Managing Director, Criterion Consulting; Sean O’Hearen; Founder & Principal Consultant, 1st Line Partners; Tim Marsh, Founder & Head of Strategy, MDB; and Bahar Aliakbarian, PhD, Associate Professor, Sr. Director of R&D, Axia Institute (at Michigan State University).

In the second part of this roundtable discussion, key opinion leaders discuss the potential technological challenges surrounding RFID, and the likelihood of not only utilizing this tech at the item level but for product security purposes as well. 

Peer Exchange: An Overview of RFID Within the Pharmaceutical Industry (Episode 1)

In the first part of this roundtable discussion, a panel of subject matter experts introduce themselves, while discussing why the pharma supply chain sees value in this technology and why its use has fluctuated over the past decade.

The Dangers Surrounding Bits and Bytes

, Jeffrey Bernstein, director of cybersecurity and data privacy for Kaufman Rossin’s risk advisory services, outlined the top mistakes healthcare organizations make in software development and maintenance from a security standpoint, including a lack of incident response plan; inadequate data encryption; absence of multi-factor authentication; neglecting security development lifecycle (SDL) practices; infrequent security updates and patching; and ignoring regulatory compliance. Bernstein emphasized that proactive security measures and regulatory compliance are essential for healthcare software management. He also dove into some of the most common cyber threats companies are facing, and how he envisions those threats changing over the next decade.

A transcript of Bernstein’s conversation with

How do you envision these cyber threats evolving over the next decade?

Nico, one of the areas where we may see increased activities over the next 10 years is when it comes to geopolitical tensions. Some of these wars that we're observing on the news every night could spill over into cyber warfare situations where you have a smaller country with less of an arsenal—in order to compete with its adversary—going out and carrying out these asymmetric warfare attacks where they're targeting critical infrastructures. That would include healthcare, government services, transportation, the water and utility systems, and then also things like the power grid and the financial and banking system. This is very concerning because these types of attacks can very quickly lead to cascading consequences, which are very difficult to recover from. I think it's safe to say that we may see bullets and bombs replaced with bits and bytes in the coming years, and it's something you know, that's very scary but also realistic.

In the final part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Jeffrey Bernstein, director of cybersecurity and data privacy for Kaufman Rossin’s risk advisory services, forecasts how cyber threats could potentially evolve over the next decade. 

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