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Supply Chain Logistics

1rem

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

Despite challenges surrounding communication overload, drug shortages, and cybersecurity risks, this term is revolutionizing medication management and patient care through the use artificial intelligence and predictive forecasting. 

The Digital Transformation Reshaping Hospitals and Medication Management

The license agreement will feature an upcoming Phase III trial and—depending on results—the development, manufacturing, and commercialization of evenamide as a potential treatment option.

Newron, Myung In Pharm Form Partnership Centered Around Treating Schizophrenia in South Korea

The program intends to address supply chain challenges surrounding product safety, traceability, and counterfeiting. 

Merck KGaA Unveils Cyber-Physical Trust Platform

The Drug Supply Chain Security Act was a major coverage area for Pharma Commerce in 2024. 

Popular DSCSA Pieces Throughout the Year

How will supply chains in the space continue to develop?

Forecasting the 2025 Healthcare Logistics Space

Focusing on the Patient

, Donald Prentiss, founder and CEO of Qualthera, describes how compounding pharmacies play a critical role in addressing unique and unmet medication needs that cannot be met by commercially available drugs. Their role in the pharmaceutical supply chain varies depending on the type of compounding facility: 503A or 503B.

A 503B facility, also known as an outsourcing facility, primarily supplies office-use medications to healthcare providers, who then administer them to patients. These facilities must adhere to current Good Manufacturing Practice (cGMP) standards, as they are FDA-registered and subject to inspections. In contrast, a 503A facility focuses on compounding medications based on individual prescriptions, typically in smaller, patient-specific batches. This allows for customization, such as removing allergens or adjusting dosage forms to better suit a patient's needs.

Both types of compounding pharmacies are particularly useful in cases of drug shortages or when commercially available drugs are insufficient. For example, if a patient requires a medication that is in short supply, a compounding pharmacy can step in to provide a tailored solution. This flexibility makes compounding pharmacies essential for meeting the unique needs of patients, whether by modifying an existing medication or creating entirely new formulations to address specific medical conditions.

Ultimately, the primary function of compounding pharmacies is to bridge gaps in the pharmaceutical market by providing personalized, alternative treatments that meet the diverse needs of patients.

Prentiss also comments on the tirzepatide shortage, the notion that commercialized and compounded drugs are competing with one another, what needs to be done amid the various legal battles pertaining to GLP-1s that are currently taking place, and much more.

Could you describe the importance of the patient within the pharma supply chain?

We're here to serve the patient. They are our primary stakeholder. Whether there's physicians involved, nurse practitioners, vendors, 503A’s, 503B’s. I just encourage everyone to remember that and bring it back home. At the end of the line, there's going to be your family member, my family member, who will be affected by these medications, and we definitely do not want to have a repeat of what happened with the New England Compounding Center, which is widely known in industry. That is actually what gave birth to section 503B, which created outsourcing facilities just over 10 years ago. We don't want more tragedy like that. Let's just keep it focused on the patient, keep it focused on quality, and I think we'll end up just fine.

In the final part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Donald Prentiss, founder and CEO, Qualthera, describes the importance of the patient within the pharma supply chain.

A Qualthera Deep Dive 

What was the inspiration behind Qualthera, and what are its objectives?

Our tagline is “quality therapy for life.” It has a double meaning. Life meaning lifespan from newborn to hospice, as well as situational—whatever life throws at you in between. Again, that key focus on quality [is essential]. As the name suggests, we compounded quality and therapy to come up with a name, Qualthera. Looking at the pharmacy landscape, you see the CVS, Walgreens on every single corner, and really focused on the retail, one-size-fits-all drugs, and then you look at the compounding space a little bit more fragmented. You have the mom and pops, or the independents across the country really serving their local areas. In my personal opinion, the personal touch, the community integration, the level of accountability associated with the independent compounding pharmacy world is just really appealing. I think that's what a lot of people appreciate and love, and that's why they stick to those types of pharmacies if they can get their drugs there.

As I looked around, I said, there's really nothing at scale. Meaning, a compounding pharmacy, same brand across every country. You're going to have networks. I think there's one or two large compounding networks out there, but a lot of them have the same, original name. They're not consistently branded. You have to look at the locations on the site and things like that, and there's not another network that has a store in every single state and territory, and that's my goal. I want to have Qualthera compounding pharmacies across the country, in every state, which gives you a lot of benefits.

I think number one for me personally, as an operator on both the 503A and the 503B side, you reduce a lot of regulatory pressure. Right now, there's a race in the compounding world to say, who has the biggest pharmacy? I landed a 45,000 square-foot facility here, and 50,000 here. For me, although you get that economies of scale there, you can ship across all 50 states. If you get an issue in Florida and Texas finds out about it, Texas is going to want their pound of flesh too, right? If you get a fine there, you're going to get a fine there, and that goes into a database, and all the other states find out about it, and they want to get their pound of flesh too.

There's a lot of regulatory pressure. You put a lot on these pharmacists that have to maintain all these licenses in different states for you to ship there. [Regarding] environmental risk—if you saw what happened to Baxter, a hurricane happens, or some facility gets damaged, you're down. I want to diversify that risk. I want to have all these pharmacies across each state, also have the ability to serve the contiguous states as well, to have that redundancy. But we're not going to load these stores down with 50 licenses and just carry that kind of risk, but you still get the economies of scale and the group purchasing power, because you're all under common ownership. You can transfer prescriptions because you're on the same software. We have some pretty unique models behind the scenes that will help us scale faster, and we're really excited about that.

In the fourth part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Donald Prentiss, founder and CEO, Qualthera, discusses the origins of the compounding pharmacy, including what it seeks to accomplish.  

Clearing Up the Competition Myth 

The tirzepatide shortage officially ended October of last year. Up to that point, what role did compounding pharmacies play in bridging that gap for patients in need of their medication? Could you dispel the notion that commercialized and compounded drugs are competing with one another?

I think these are two great questions. To start off with the with the shortage piece—like I said, when there's limited or no supply, the FDA has what's called a drug shortage list. I encourage your viewers and listeners to look at that list to get an example of what's on there. Whether it be tirzepatide or semaglutide, you can go to that database and see whether or not that particular drug is on shortage. If it is on shortage, then compounders have the ability to make a one-to-one copy of that.

What happened in this case is that these blockbuster drugs, [they’ve got] all these wonderful indications, and everything's going really well. Obviously, that ate up all the supply, and so that opened the door—by way of the shortage list—for compounders to again step in and fill that gap. That's what you've seen them do. As you mentioned, back in October is when the FDA indicated that it was now off of shortage. There was some litigation out there from the Outsourcing Facilities Association and others that argue that it was not actually off of shortage in the market, because a lot of pharmacies were getting feedback that patients were still having trouble getting that, since they couldn't get it from their wholesalers to give it to their patients. You saw some back and forth there.

Since that time—I believe sometime in December—the FDA came back and said, “okay, we're going to provide 60 days for compounding pharmacies to essentially continue to service patients as the supply kind of ramps back up from the drug manufacturer. For outsourcing facilities, I think it's 90 days to do that. When you think about shortages, such as from the perspective of an outsourcing facility, I'm making the large batches. Again, they follow cGMP, so they have to put their stuff through studies. These are called stability studies. They have to prove the long-term, the potency, the sterility profile, and impurities across the shelf life of that BUD [beyond use data] that they're putting on the label. That can cost hundreds of thousands of dollars.

If I'm only allowed to make something when it's on shortage, I have to be fairly certain that it's going to be on shortage a good while, so I can recoup my cost, while also making some money, because they are a business, they have to make good business decisions. That's a little bit of the rub between compounding pharmacies and the FDA and drug manufacturers—compounding pharmacies can step in to fill these gaps, only when on shortage, but guess what? This is off shortage now. You stop making it, and now you're stuck, holding back with your cost.

I saw it firsthand during COVID. When a lot of supply chain disruption happened, there were shortages of all kinds of critical drugs, using hospitals, for example. There was actually a really neat situation where there was collaboration with the FDA and with industry stakeholders to help create a website, a list of all these 503Bs that could make all these medications to help bridge that gap. It was a perfect situation to show what compounding was all about. Even with hand sanitizer—FDA came out with a formula, with a set BUD. So it says, “hey, if you make this compounders, then you can sell hand sanitizer,” because we were short.

I think those are very specific instances where compounders responded, but there were still questions of, if we jump in and make these medications, how long and what kind of tail can we expect when they come off as shortage to again, recoup our costs? There were was a lot of back-and-forth discussion on that, in order to help protect everyone's interests.

Looking at your second question when it comes to competition, the straightforward answer is that they’re not competitors. They serve two different needs—two different levels of the supply chain—but you're certainly right. That is the perception out there, and unfortunately, it's propagated by both sides. In any industry, you're going to have good actors and bad actors. Some see, on the compounding side, the opportunity to make a lot of money during this remarkable point in time, and not necessarily respect the boundaries around compounding. Again, unique unmet needs or shortage. I think it's just really a call to action or collaboration with compounders, with the FDA, with drug manufacturers, I think this is a unique point in time that we could really do a lot of good for the key stakeholder, the patient.

In the second part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Donald Prentiss, founder and CEO, Qualthera, describes compounding pharmacies’ efforts in tackling the tirzepatide shortage, and dispels the notion that commercialized and compounded drugs are competing with one another.

Clearing Up the Competition Myth

The Role of Compounding Pharmacies in Meeting Patient Needs

Generally speaking, what role do compounding pharmacies play in the pharmaceutical supply chain?

I think the primary role for compounding pharmacies is to fulfill unique unmet needs when it comes to the medication needs of patients across the country. How those needs are met are dependent on the dosage form. Who is administering the medication will then decide whether or not it's coming from what's called a 503B, an outsourcing facility, or a 503A, which is a your traditional compounding pharmacy. Typically, on the 503B side, you're going to have them primarily focused on supplying office-use medications to doctors, who then administer to patients in the office. You're going to have some of them that do have the ability to dispense pursuant to prescription.

But the tricky part there is, on the 503 B side, they have to follow what's called current Good Manufacturing Practice, or cGMP, because they are registered with the FDA, and succumb to those inspections. On the 503A side, you're going to have them focused on the just for Nico, or just for Don; your prescription only. They're not making these large batches of medication, and that's going to be a certain adjustment, just like on the B side, to what's commercially available. Whether Nico is allergic to something in a medication, we can make it without that excipient. For example, we can put in a different dosage form that's more amenable to his specific needs, unique unmet needs, either through the 503B or through the 503A, and then also what's called just in general shortages, which we'll get into a little bit later, when there's just limited or no supply of these commercially available drugs. That's where both of these types of compounding facilities can step in and help fill that gap, which is very important.

In the first part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Donald Prentiss, founder and CEO, Qualthera, comments on the role that compounding pharmacies play in the pharmaceutical supply chain from a macro perspective.

The Future of eSampling Portals

, Mark Jara, founder and CTO of RxS, dives into how the sample distribution process in the pharmaceutical industry has evolved significantly over the years. A major change has been the reduction in the size of sales teams. In the past, organizations had large sales forces with 5,000-10,000 representatives, but that is no longer the case. Technological advancements and changes in product types have contributed to this shift. While products were once ambient (requiring less complex distribution), they are now more biologic and often require cold chain logistics, catering to a smaller, more specific patient population.

This shift in product types means that the traditional push model of distribution—where samples and literature were sent out to healthcare providers (HCPs) by sales reps—is no longer the primary approach. Instead, pharmaceutical companies have moved toward a “right-sizing” of their organizations, streamlining operations and using alternative communication methods. The new model is more focused on the needs of HCPs, who now drive the communication process. HCPs are the ones requesting access to samples at their convenience, based on patient needs.

This shift from a push to a pull model reflects broader changes in the industry, where technology, product specialization, and the role of HCPs in decision-making have reshaped the way samples and information are distributed.

Jara also discusses the value in an online portal that offers logistics flexibility, the inspiration behind developing SampleHub, the future of eSampling platforms, and more.

How do you envision eSampling platforms developing over the next decade?

 The post-COVID world just expanded from a reach perspective, as well as from a technology perspective, where AI is getting into the middle of all this. Data analytics is getting to be part of this, because once you have a platform—or more so a consolidated platform—it gives everybody the ability to do that analytics. Personalization is going to play a big factor so when these healthcare providers do log into these portals, there's going to be a lot more personalization of that, driven by the remote aspects of HCP telehealth these days. 

We're certainly going to see where there's no longer brick and mortar. How does a representative go to a non-brick-and-mortar location and have a discussion—a fluid discussion—with an HCP? They're ultimately going to be within these portals, where it's personalized to the HCP and their habits of what kind of products they like. Coupled with telehealth, it's ultimately going to be direct-to-patient as well, because being not brick and mortar also, how do you then provide, or handoff by a healthcare professional, potential sample products to see if they'll be useful for the patient? Try Drug A, and get back to me in two weeks, see what that experience looks like. 

It's going to go from the hands of the HCP directly to the hands of the patient at this point, which now minimizes that supply chain. Ultimately, where it used to go from manufacturer, logistics, to healthcare professional to the patient, now, all of a sudden, it's in the hands of the HCP. They're logging in when they need to, when they want to, for a specific patient in mind. You don't see that push-versus-pull mentality. It's all about the patient in this whole process.

In the final part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Mark Jara, founder and CTO, RxS, comments on how personalization could play a role in the future development of eSampling platforms.

Designing a One-Stop-Shop Sampling Platform

What was the inspiration behind developing SampleHub?

 We have the platforms available for that branded experience, and there are organizations who will want that, such as the top 10 pharma companies. More and more, we're seeing those smaller pharmaceuticals, those biologic organizations coming out, where they have a finite patient base, but from a financing perspective, they don't have the ability to create their own environment from a branded solution, or they want to be co-mingled with other industry leaders in that same therapeutic class. 

We saw the value of creating this one-stop-shop platform called SampleHub, allowing them to be able to log in and do what they need to do. On our end, technically, each one of these pharmaceutical organizations or manufacturers have relationships with their own logistics organizations. We're partnered with many of the leading logistics organizations. The backend process made it very simple for us to be able to integrate, where a doctor may place an order for different products from different manufacturers, and we—behind the scenes—place those orders, make sure that they're compliant, and track those orders, making sure that they are getting to the HCP, who ultimately gets it to the patient's hands as well.

In the third part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Mark Jara, founder and CTO, RxS, shares his inspiration behind designing SampleHub. 

Making Sample Ordering Simpler for HCPs

Why is an online portal that offers logistics flexibility so valuable?

 Take it from a personal perspective. I'm sure that as an HCP, the consumer goes on to multiple portals, logging in with their own access credentials to different shopping environments. The same thing is currently happening right now for HCPs. They're logging into individual portals to get their samples, specific from a brand. That may work for some companies, but ultimately, for the HCP experience, they're logging into very unique and different portals. 

What we've seen is a push to consolidate that information—consolidate the ability to order literature material with regards to specific products or therapeutic classes—and being able to go into that one portal. As you can imagine, HCPs don't have time, so you're trying to minimize that impactful time that they have to be able to drive patient needs instead of being able to navigate administratively. They really don't have that administrative time.

In the second part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Mark Jara, founder and CTO, RxS, explains the value of an online portal that offers logistics flexibility.

The Evolution of Pharmaceutical Sample Distribution: From Push to Pull

How was the sample distribution process evolved over the years?

I’d like to take a step back with all of this, just with regards to evolution of sampling. Years ago, if you've been in industry, these organizations had 5,000-10,000 sales representatives. That's no longer the case these days. Certainly, technology has played a big role. But also, when you look at the product base itself, years ago, we used to be ambient products. These days, they're more biologic, cold chain. It's more specific for a finite patient base.

That doesn't apply to 5,000 sales rep teams. You can certainly see where pharma now is going into what we would say is “right sizing” of an organization. They're using other means of communication with the HCPs. So it's no longer a push model, where you're pushing samples, you're pushing literature to organizations. It's really now a pull method by HCPs. They actually are the drivers of communication. They want the access and they want the samples at their point of time when they need it for the patients.

In the first part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Mark Jara, founder and CTO, RxS, describes the progression of the sample distribution process. 

The Impact of RAIN RFID 

 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 fifth part of this roundtable discussion, subject matter experts discuss the role that various GS1 initiatives have played, and provide a breakdown of stakeholders who have benefitted greatly from RFID.

Peer Exchange: The Impact of RAIN RFID (Episode 5)

Learning from Other Industries 

In the fourth part of this roundtable discussion, key opinion leaders discuss how successful RFID use cases in the food sector can translate well to pharma, including what needs to be implemented in order to see success. 

Supply Chain

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