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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, Rob Sobie, chief product officer of Intelliguard, a provider of hospital medication management and data intelligence solutions, discusses:

The key challenges that hospitals are currently facing

Why he believes that the drug supply chain is failing

Successes surrounding the implementation of RFID technology

A high-level overview of the Drug Supply Chain Security Act, along with his thoughts on the latest exemptions that were recently announced by the FDA

Rob Sobie outlines the importance of supply chain transparency for the benefit of patients.  

The Impact of RFID: Enhancing Medication Management

 interview, Chris Williams, International Managing Director of Alloga Europe and ICS, discusses:

What’s needed to support advanced therapy medicinal products from a temperature standpoint

The current state of third-party logistics (3PLs) in Europe and what areas need to improve

How expectations of pharma companies have changed in terms of what they expect a 3PL partner to provide

How Alloga’s new facilities in Spain and the Netherlands fit within the company’s strategy

What he believes 3PLs can do to support supply chains more efficiently

Chris Williams expands on the services that a third-party logistics (3PL) partner should offer, while sharing ways to alleviate standard supply chain issues.

The Capabilities of a 3PL Provider

 interview, Peter Ax, founder and CEO of UpScriptHealth, a direct-to-consumer telehealth company, describes:

Why he believes ongoing and active drug shortages are the highest they’ve been since ASHP began tracking this in 2001

The current landscape of shortages in general

How drug shortages directly affect patients

What is needed to alleviate these issues surrounding the supply chain

Peter Ax provides insight as to industry’s lack of supply, along with how to mitigate these issues. 

Addressing the Drug Shortage Crisis

 interview, Chip Davis, president and CEO of the Healthcare Distribution Alliance (HDA), a national organization that represents primary pharmaceutical distributors, discusses:

The benefits of the Distribution Management Conference, and the value it provides for the industry

, including a look at how the challenges presented to distributors now differ, and how they are being addressed

Progress that has been made toward full connectivity since the FDA announced a “stabilization period” to finalize implementation of the DSCSA before November 2024, along with some of the most significant issues for trading partners

Some of the root causes of drug shortages, and how distributors are work to mitigate them

Key initiatives and plans that the HDA is focused on for the second half of 2024, and how these will shape the future of the pharmaceutical supply chain.

Chip Davis recaps the organization’s Distribution Management Conference and addresses distributors’ preparedness for DSCSA implementation. 

Overcoming Supply Chain Challenges

 interview, Allen Jacques, a life sciences industry thought leader at Kinaxis, dives into:

What he sees as limitations of current government efforts when it comes to boosting domestic production of essential medicines, and why they aren’t sufficient

The challenges that generic drug manufacturers are facing today

Why more resilient and transparent supply chains are necessary in the pharmaceutical industry, and how these can help mitigate shortage issues

Allen Jacques explains the history behind medications’ lack of supply, while offering ways to help alleviate their impact. 

Mitigating Drug Shortages

 interview, Brandon Newman, Xevant’s CEO and founder, explores:

The implications of the Inflation Reduction Act’s price negotiation provisions, and how these could result in ripple effects across the healthcare system

The role that pharmacy benefit managers (PBMs) and other intermediaries' play when it comes to determining drug costs, and how spread pricing is involved

How Xevant helps improve drug cost transparency efforts

Strategies for affordability Newman would offer the pharma industry that can be implemented immediately

Brandon Newman joins The Pharmaceutical Commerce Podcast to discuss the evolving role of PBMs, including the importance of drug price transparency. 

A Further Examination of Pharmacy Benefit Managers

 interview, Rob Besse, Archbow Consulting’s VP of distribution services, shares:

A general overview of how the 3PL process works, using his 20-plus of pharma supply chain experience as added insight

The factors that manufacturers should consider when selecting a 3PL, along with the array of services that a quality 3PL should provide

Valuable lessons he believes 3PLs learned during the COVID-19 pandemic that have helped improve efficiencies

Trends affecting the pharma industry that 3PLs be on the lookout for the rest of the year

Podcast is available directly on SoundCloud.

Rob Besse offers a breakdown of the third-party logistics (3PL) process, including lessons that these providers have learned coming out of the pandemic.  

A First-Hand Account of 3PLs

A session investigates the drivers of these shortages and ways to mitigate them. 

Trade & Channel Strategies 2024: A Deep Dive into Drug Shortages

The seminar focuses on US supply chain resiliency, while remaining compliant and preserving patient access.

Trade & Channel Strategies 2024: Protecting the Pharma Supply Chain

A case study explores a way to potentially transform commercial organizations, while driving revenue growth.

Trade & Channel Strategies 2024: Navigating Pharma and Its Distribution Models

A panel uncovers how distribution channels are aligning commercialization efforts. 

Trade & Channel Strategies 2024: Evolving with the Times

The value of this sometimes-unheralded technology to the pharma industry—as well as potential use cases—are starting to come to light.

An Appreciation for RFID

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 third 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.

Peer Exchange: RFID Testing and Experimentation (Episode 3)

 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.

Information on the pilot can be accessed 

In the third part of this roundtable discussion, experts discuss the value of Michigan State University’s Axia Institute—including its RFID testing efforts—and dive into the Institute’s end-to-end RFID pilot that it has been conducting. 

Navigating DSCSA Delays

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

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. 

Properly Preparing for Supply Chain Disruptions 

, Gaurav Gupta, managing director and head of R&D at

Kotter, discusses the regulatory pressures and rising R&D costs impacting the pharmaceutical industry as it looks toward 2025. Gupta highlighted that many regulatory challenges, such as drug pricing pressures from the Inflation Reduction Act, will persist in the coming years. Additionally, he pointed out the growing integration of real-world evidence into clinical trials and the need for regulators to keep pace with emerging technologies like AI. Gupta believes that these trends will continue to shape the industry without major new disruptions expected in the short term.

He also comments on the steps pharmaceutical leaders should take to better prepare their teams and organizations for supply chain disruptions; specific technical and "soft" skills that will be critical for pharmaceutical leaders and frontline employees to thrive in the evolving industry landscape, and how this can help when it comes to proactivity in handling talent shortages.

A transcript of Gupta’s conversation with

With increasing uncertainty on the horizon, what steps should pharmaceutical leaders take in order to better prepare their teams and organizations for supply chain disruptions?

Viewing supply chain primarily through the lens of efficiency and cost reduction has shifted, where there’s a recognition that we've got to be more flexible with supply chain, we've got to be more adaptable. How we're setting up our supply chains is very much being felt. I think you're just spot on that that's an area of focus, and there are a few things for leaders to be thinking about.

One is just getting folks to appreciate that. That's the first step. We've got to think about our supply chain with flexibility in mind. How do we create more flexible supply chains? Because we don't know what the next disruption might be. We do know that there probably will be a disruption, we just don't know exactly what it's going to look like. I think getting closer to the frontline and making sure decisions are happening closer to the frontline, so that you can move faster. You can shift faster when you start to see things changing, whether that's on the policy front or regarding logistic disruptions.

I think the other part is just thinking through scenarios, doing a little bit of scenario planning around the fact that we can't identify all of the disruptions, but we can certainly think through what some of them might be. What happens if you know some of the conversation around tariffs come into play? What does that mean for our supply chain? What happens if we have, disruption in shipping lanes? Thinking through what your responses might be ahead of time, so that you can be more flexible and adaptable, and doing a little bit of that scenario planning ahead of time [is essential]. If those disruptions were come to pass, you kind of have a have an idea of where you want to go.

In the second part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Gaurav Gupta, managing director and head of R&D at Kotter, outlines the steps that pharma leaders should keep in mind to when combatting supply chain issues.

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.

Why Blockchain is Key to Enhancing Supply Chain Integrity

managing director, global operations & supply chain practice at UST, discussed how the East and Gulf Coast port strikes highlighted the contrasting dynamics between branded and generic pharmaceuticals. Branded drugs, which offer higher profit margins, are produced at limited manufacturing sites, creating potential vulnerabilities. In contrast, generics have multiple supply sources but operate with tighter margins, leading to less robust business controls and raising concerns about safety. This disparity underscores the complex challenges faced by both sectors in the pharmaceutical industry. Colehower also spoke on the valuable in pharma supply chain transparency and visibility.

A transcript of Colehower’s conversation with

Why is building a chain of custody within the life sciences industry so valuable?

 I guess the one thing that I've been advocating for in the pharma supply chain and life sciences altogether is about building that immutable chain of custody using blockchain. I think it's just a matter of time before we see that in more and more supply chains within the life sciences. It goes back to that brand versus generic [scenario]—who's got the money, who's going to pay for this—but it's going to become either a matter of product supply or product safety that's going to mandate that ability to have an immutable chain of custody.

In the final part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Jonathan Colehower, managing director, global operations & supply chain practice at UST, explains how the use of blockchain technology will become more prominent moving forward.

Building Supply Chain Visibility

What have you noticed when it comes to supply chain stakeholders making efforts to build greater visibility?

 We're seeing a lot of efforts to build visibility. The more I can see into my supply chain, the more I should be able to correct and control. We're seeing a lot of efforts for supply chain actors. Whether they're a wholesaler, a distributor, a provider—they want to have that level of visibility, and they're building networks to get that and to see that.

In the second part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Jonathan Colehower, managing director, global operations & supply chain practice at UST, offers his observations as to how stakeholders are building out their networks.  

Analyzing Branded and Generic Pharmaceuticals

How did the East and Gulf Coast port strikes bring to light the differences between branded and generic pharmaceuticals?

I think it’s a fascinating space because of the differences, and when I say the differences, there are a couple things that I'm talking about. One is just the difference between brand and generic pharmaceuticals. It's feast or famine. The brands have lots of margin that they can throw at the problem, but at the same time, they're so proprietary, it's restricted, so you may only have one manufacturing operation that's producing that brand. That's a point of failure that has to be managed.

On the other hand, there’re the generics, where you may have lots of sources of supply, but they don't have the margin. Because they don't have the margin, they don't have some of the same business controls that in other cases might be a luxury, so you then start worrying about things like safety.

In the first part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Jonathan Colehower, managing director, global operations & supply chain practice at UST, describes how events such as the East and Gulf Coast port strikes have brought to light the differences between branded and generic pharmaceuticals. 

The Future of Temperature-Controlled Technology

, Delphine Perridy, chief commercial officer, Envirotainer, noted that the pharmaceutical industry is undergoing significant evolution driven by unmet patient needs, rapid scientific advancements, and the emergence of new technologies. Innovations such as gene therapies, precision medicines, and advancements in obesity treatment with GLP-1s exemplify this shift. Additionally, the integration of artificial intelligence in drug discovery is streamlining research and development processes, lowering costs, and accelerating time to market. As a result, pharmaceutical companies must adapt their business models to ensure that newly approved drugs reach patients worldwide more efficiently. Perridy also shared why ultra-precise temperature control and customized logistics solutions are so critical when it comes to biologics and personalized medicine; why has the demand for sustainable practices has risen exponentially; Where she believes the pharma cold chain is heading in the next few years in terms of technological breakthroughs and market dynamic shifts.

A transcript of Perridy’s conversation with

Where do you believe the pharma cold chain is heading in the next few years in terms of technological breakthroughs and market dynamic shifts?

 We're going to continue to see an increase in personalized medicine, cell & gene therapies, and much more complex treatments that are going to require strict requirements when it comes to cold chain solutions. That's clearly the first shift that I think we're going to continue seeing.

The second one will be the use of AI more and more in the industry. I think that we're going to be able to use artificial intelligence to do much more analysis in terms of trade lane analysis or risk management overall. I think that the second shift that we're going to see coming over the next couple of years is sustainability—it’s going to remain a topic that is not going anywhere. I think it's an important topic for the society. We can expect to get much more pressure when it comes to sustainability—it's going to be very important for us to really design packaging solutions that can be more sustainable moving forward.

The last one is the geopolitics risk; it’s also something that is probably meant to continue. I think it's very important that we work with our partners to come up with very strong logistics strategies so that we can keep pharma moving, regardless of the challenges that we are facing. We need to build resilient networks so that we can adapt quickly and continue shipping medicines wherever they need to be shipped.

In the final part of her video interview with Pharma Commerce Editor Nicholas Saraceno, Delphine Perridy, chief commercial officer, Envirotainer, forecasts the future of the pharma cold chain regarding technological advancements and changes in market dynamics.

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