Harsh Thakkar (00:10)
Okay, I know it's on, but I'm doing one more thing before.

All right, we're on. What if I told you that the pharma industry is, especially the supply chain side of the industry is racing against the clock? What I'm talking about is the DSCSA regulations and lot of the updates that have come around with the timelines being extended for many of the partners in the industry. So what I'm, the guest I have today on the podcast is

somebody who is extremely an expert in this area. I have worked with him in the past on a couple of projects and I wanted to bring him on this show because if you've never heard about DSCSA, think of it as a GPS of your pharmaceutical supply chain. And what DSCSA essentially is pushing for is a approach to embrace transparency.

throughout the pharmaceutical logistics and the supply chain workflows. So with that said, let's dive in and talk to Michael Rowe. He is the Senior Director of DSCSA and Serialization Services at TwoLabs. He has worked with nearly 55 pharmaceutical companies to help them on their supply chain, serialization, and all types of projects.

We'll go into this episode. We'll talk to him about the drug supply chain security act and what it means for the industry in the coming months and in the future. Welcome, Michael. Great to have you on the show.

Michael.rowe@twolabs.com (02:15)
Hi, Harsh. Yeah, thank you so much for the opportunity. Happy to chat today with you.

Harsh Thakkar (02:20)
Yeah, before we get into the weeds of DSCSA and all, where are you calling from?

Michael.rowe@twolabs.com (02:26)
I'm actually in Ohio, just outside of Columbus.

Harsh Thakkar (02:29)
Okay, are you an Ohio State fan?

Michael.rowe@twolabs.com (02:33)
You know, yes I am. think

it's an obligation when you live here that you've got to root for the Buckeyes. So my wife went there, a lot of family and friends. So, yep, I'm cheering them on in the National Championship Monday. So don't call me Tuesday morning.

Harsh Thakkar (02:37)
Yeah.

Yeah, so I can relate to that because my wife went to Penn State. So I have a lot of Penn State gear that I get from my in-laws during Christmas time because they also live in Pennsylvania. I was I was I know this is a this is a Life Sciences podcast, but I was really disappointed the way the Penn State game ended. But, you know, maybe next year. Yeah.

Michael.rowe@twolabs.com (03:07)
Thank

I know. Maybe next year. There's always next

year, I guess.

Harsh Thakkar (03:16)
Yeah. So before we get into the DSCSA, I can imagine that there are a lot of people, listeners, viewers of this podcast that may have never heard about that term, don't know what it means. Can you give them a 30,000 foot overview of when did that act come into place in the first time? And then what is all the buzz right now going around it?

Michael.rowe@twolabs.com (03:29)
Mm-hmm.

Sure. Yeah, Harsin. So you even mentioned it briefly, I think in your intro, the DSCSA, Stantial Drug Supply Chain Security Act. It's actually a federal law passed by Congress in 2013 with really the aims of standardizing a couple different things across the country. So if you look prior to that timeframe, different states were starting to initiate a patchwork of different regulations to try and curb counterfeit drugs.

and also to license how different pharmaceutical supply chain partners were licensed. And so that was creating a lot of angst within the industry because 50 different types of ways to comply with it would have been really cumbersome. the government responded with a national response to really put together a series of milestones over a 10 year period.

Harsh Thakkar (04:17)
Mm-hmm.

Michael.rowe@twolabs.com (04:39)
which we'll talk about later where it's more than 10 years. To really get to a point where there was more traceability of pharmaceutical products in the supply chain, standardizing licensure standards in many cases for different companies. Really the aim and the idea was how do you keep counterfeit drugs from entering the legitimate supply chain, your local homes, know, hometown pharmacy.

Harsh Thakkar (04:42)
Mm-hmm.

Michael.rowe@twolabs.com (05:05)
to even the big pharmaceutical manufacturers. How do you get that traceability that that way we can authenticate products more quickly and easily?

Harsh Thakkar (05:16)
Okay, great. And so from my knowledge, I think this came out first in 2013, correct? Yeah.

Michael.rowe@twolabs.com (05:25)
Correct. Yep. So

November 2013 was when the law was signed into effect by President Obama. And really the FDA has the enforcement responsibilities for this law, but also it gives state boards of pharmacies the ability to enforce it as well. So it's multifaceted in terms of its requirements. And it was meant to be a series of milestones over 10 years with creating

Harsh Thakkar (05:43)
Mm.

Michael.rowe@twolabs.com (05:54)
different requirements to get to unit level traceability. not just, it really doesn't talk about ingredient traceability or upstream manufacturing traceability. It's once products are first introduced into commerce, into the supply chain, is when that traceability starts. And so a lot of people called it the serialization law because one of the major milestones that ended up four years after the law, 2017,

Harsh Thakkar (06:11)
Mm-hmm.

Michael.rowe@twolabs.com (06:23)
was when manufacturers had to change all of their packaging and labeling to apply a specific serial number to every unit that they package. Think of it as like a VIN number on your car, right? You have a VIN number and you can track, who owned it? Oh, there's a recall on it. You know, all the parts that went into that car, you can do a recall on. It was the same sort of concept with these pharmaceuticals is that a serial number would be physically encoded in that what's called a 2D data matrix barcode on all of the packages.

Harsh Thakkar (06:31)
Mm-hmm. Yep.

That's a great analogy of the VIN number. I wasn't thinking about that. That really puts it into perspective. Yeah, go ahead.

Michael.rowe@twolabs.com (06:54)
So it kind of, yeah, go ahead.

Yep.

And so the industry has kind of moved from this traceability requirements in 2013 to moving to lot level tracing. In 2017, serial numbers started being physically applied to products and then marching towards what was supposed to be the full deadline in November of 2023 was what the FDA is called kind of enhanced drug traceability where those serial numbers on the products

Harsh Thakkar (07:10)
Mm-hmm.

Mmm.

Michael.rowe@twolabs.com (07:29)
think of it as like a digital ledger that had to move with the product. So as the product moved and changed hands, a digital ledger would have to follow along with the product, building basically the ability for data to be retrieved in the event that there's a counterfeit drug investigation. Other parts of the world have different types of these laws. And what makes the US DSCSA so specific is that there is no national hub

Harsh Thakkar (07:38)
Mmm.

I see.

Michael.rowe@twolabs.com (07:58)
where all this data lives. It's basically become a series of distributed databases. Every company has to hold and maintain all of their own data and also connect with all of their partners. So it's created a lot of complexity in terms of how do you pass data efficiently? Because, you know, when I worked in the industry at a major wholesaler, you're getting orders at seven o'clock at night from a hospital that need to be there next morning.

Harsh Thakkar (07:59)
Mm.

Michael.rowe@twolabs.com (08:28)
at 7 a.m. for a procedure. And so it's how do you do at that level of scale, moving that amount of data with the amount of precision that the law requires.

Harsh Thakkar (08:39)
Okay, so it's having those labels with these unique serial numbers and then having softwares and systems in place to monitor these. So in case there's a recall or there's a counterfeit drug, can be easily, you go back to the raw data and pinpoint to exactly which vial or which bottle it was coming from. Okay.

Michael.rowe@twolabs.com (09:04)
Exactly. And

so it also impacts operations, right? If you think about a physical warehouse that's packing orders, shipping orders, it totally changed the game in terms of as long as I got the lot number correct and the delivery, or even just the right product. It's now, it's not just the right product, the right lot. The exact serial number that I put in that box has to match what's in that data file that moves with the product. And so the level of precision operationally

Harsh Thakkar (09:09)
Hmm.

Hmm.

Michael.rowe@twolabs.com (09:34)
It's really up the ante.

Harsh Thakkar (09:36)
Yeah, and from what I understand, like it applies, like the DSCSA has different requirements that may apply to, you know, like manufacturers, you mentioned that you were working at a wholesale distribution type companies, or there are repackagers. So I know we don't want to go too much into this, but at a high level, what is the impact of DSCSA on all these different players? Like who has the most impact versus who has the least?

Michael.rowe@twolabs.com (09:55)
Yeah.

Right.

Yeah, that's a great question. one of the things that the DSCSA also, I think, has radically changed is that it's created these different classifications of trading partners. Different states were calling different people different things. So for example, if you were a manufacturer, a drug manufacturer, like let's just take a brand name that you would, know, imagine a brand name pharmaceutical manufacturer name in your head right now.

Harsh Thakkar (10:16)
Mm-mm.

Michael.rowe@twolabs.com (10:31)
Some states were calling them wholesale distributors, but they were manufacturers distributing their own product. Are they really a wholesale distributor that's aggregating products from multiple manufacturers? No. So the DSCSA defined these different trading partners and what their roles are and gave them specific requirements. So that's a key part of the law is understanding where you fit in the whole ecosystem and what are you really from a DSCSA perspective. So

Harsh Thakkar (10:38)
Hmm.

Michael.rowe@twolabs.com (10:59)
I think the manufacturers, be quite honest, and the wholesalers probably have the biggest lion's share of changes in operational things that they had to do. From a pharmacy perspective, it really changed how you receive product, but it really doesn't change a whole lot how you dispense product and handle patient care. The assumption is that if the supply chain is more tightly controlled upstream with the manufacturers and the wholesalers,

Harsh Thakkar (11:22)
Hmm.

Michael.rowe@twolabs.com (11:29)
that by the time it gets to a pharmacy, things should have been flushed out. And so it really puts a big onus on pharmacies on their receiving practices. That's what I tell a lot of companies are, hey, I'm a pharmacy. This doesn't impact me. You've got to make sure that the product coming in and who you're sourcing from are really reliable. And if you think about the weaknesses in our supply chain,

Harsh Thakkar (11:49)
Correct.

Michael.rowe@twolabs.com (11:54)
There's a lot more pharmacies than there are wholesalers and manufacturers. And so I think that's the biggest gap I'm seeing right now is that pharmacies really need to understand what DSCSA is and what the changes are that they have to do. They've kind of thought there's nothing they had to do for quite some time. They're at the point now where they have to get on board and think about how they're changing, how they receive product in and how they source product.

Harsh Thakkar (12:05)
Hmm.

Right.

Michael.rowe@twolabs.com (12:20)
Manufacturers had the biggest lift, I think, because they had to change a lot of the packaging and the, kind of start the chain of data. So if you think about it, they're the first ones introducing the product to commerce. And so if they start with bad data, it's going to cause a ripple effect through the whole industry. As well as the FDA kind of has envisioned in their guidance documents that manufacturers

Harsh Thakkar (12:30)
Yes.

Michael.rowe@twolabs.com (12:47)
If there is one of these suspect drug investigations, they're kind of almost on the hook of playing quarterback in driving those investigations because again, they started the chain of data. The challenging part is, that because the U S law protects everyone's information, manufacturers don't have all the data to do the investigation. They have to go to their wholesale. They have to go to the pharmacies and say, Hey, what do you have? What do I have? And so that to me, I think is still where.

Harsh Thakkar (12:52)
Hmm

Mmm.

Michael.rowe@twolabs.com (13:15)
And we'll talk about this probably later, like the current state of the industry. Those are types of things that kind of keep me up at night. From a wholesaler perspective, the biggest thing is operational precision and efficiency. You now have to operate at a higher level of precision than you've ever had to.

Harsh Thakkar (13:23)
Yeah, so.

Hmm.

Yeah, and you mentioned, you know, like the example of the pharmacy and, you know, the misconception that DSCSA doesn't apply to them. But like you said, it's still important because they have to make sure they're receiving the right product from the right source. And yes, once they put it on their shelf, once it's in there, logged into their system,

maybe they're at the lowest end where they can't really be non-compliant even if they wanted to because it's like they're at the end of the spectrum there. yeah, that's the really fascinating part about this because typically when there's a guidance, sometimes it's very obvious who it applies to and then you can easily pinpoint. But especially now with the industry going to virtual manufacturing and

Literally like every month or every every year there is tons of CDMOs coming up Nobody is doing in-house manufacturing or building sites. They're they're going virtual from day one now You're adding another player into the into the you know, this whole puzzle So yeah, it's really important to understand the misconceptions and also understand like what you really need to do as a wholesaler as a manufacturer as

Because it's not like one person that says, I'll do everything and we're fine. Everybody has to play their part in the process.

Michael.rowe@twolabs.com (15:01)
Mm-hmm.

It's such a collaborative effort and that's been one of the reasons honestly, I keep staying in the sectors because the amount of industry collaboration it takes to pull this off is pretty paramount. mean, pretty big paramount in that you're getting a lot of companies that normally view each other as fierce competitors getting in the room saying, how do we do this together? Cause if not, if one of us fails, we all fail.

Harsh Thakkar (15:10)
Yeah.

Yeah.

Mmm.

Right, right. So based on your work that you're doing at two labs, I imagine you're working day in and day out with clients and companies who are either building systems or workflows or taking your team's help in complying with these regulatory requirements. What are some of the common challenges you've seen that stop people from getting all the checks and balances in place?

Michael.rowe@twolabs.com (15:55)
Yeah.

Yeah, no, I think a lot of the challenges even for a lot of companies is just getting the right sponsorship. A lot of people view it as well. This isn't my group. So someone else should handle it or this person should handle it. Here's the thing I tell people. This law impacts almost every aspect of your business. So if you're going to pigeonhole this to this is just a quality function or is it just an IT function? You're going to be set up for failure that way.

Harsh Thakkar (16:07)
Hmm.

Okay.

Hmm.

Michael.rowe@twolabs.com (16:30)
because if you don't think about it comprehensively and everything that will, it will impact. We've talked about some of that already, your operational processes, your IT systems, your quality systems. It touches so much of your business. And so I think that's fundamentally not having the right sponsorship and cross-functional kind of leadership to say, how are we going to tackle this as a team?

Obviously at the end of the day you have to assign certain people to certain accountabilities.

However, if you don't have that leadership at the top, it makes it difficult to get things done. That's kind of a basic challenge. think anytime you deal with a regulation, people view it as a tax. And how do I get away with doing the least amount possible? When, if you kind of take shortcuts, I'm trying to launch this new drug and wait, what do you mean we can't ship it?

Harsh Thakkar (17:13)
Right, right.

Mmm.

Michael.rowe@twolabs.com (17:34)
well, we didn't test all the data properly ahead of time. just thought it would work. Not, not, not something you want to sell to your CEO that we're launching the delay of the drug another couple weeks or months.

Harsh Thakkar (17:39)
Mm.

Hahaha

Right, right. You mentioned about earlier in our conversation, you gave the example of thinking of the unique numbers, the serial numbers as a VIN number for a car. And I feel like anytime there is a new compliance requirement or industry guidance or a new best practice to do something differently than how it's been done before,

people look at technology to be the solution, right? And in many cases, they look at technology to be the magic wand. Like, can I just put my data in a system and the system helps me become DSCSA compliant? Like, I don't know the answer to that question, right? But that's how I've seen a lot of people think where, you know, even in quality where I work, people are like, okay, I just put my documents in a QMS and I'm good. Like, I don't need to do anything.

No, that's not how it works, right? So my question to you is, from what I've seen, if we look at all the emerging technologies like automation, robotics, AI, blockchain, I feel like blockchain is probably the best that is designed for this kind of a problem. What are your thoughts? Have you worked on any interesting case studies or project where companies have either used blockchain or

maybe done some analysis with you to explore the possibility of using it.

Michael.rowe@twolabs.com (19:22)
Sure. Yeah. No, I totally agree with that. It's the DSCSA is actually more about developing trusted partnerships and collaboration, which technology helps with. Certainly. But DSCSA, it's you're right. Just putting the data in a repository isn't going to work. So it requires a lot of communication and collaboration because

Harsh Thakkar (19:35)
Yep.

Michael.rowe@twolabs.com (19:52)
You might, Hey, I put the data in my system and it loaded, but if your customer can't load it, then it doesn't matter. So I think the technology in DSCSA, it has to be built on standards and the actual law itself says that you must use an internationally recognized standard for communicating this data. And so, I view kind of the technology of how do we standardize the data?

Harsh Thakkar (19:57)
Hmm.

Michael.rowe@twolabs.com (20:21)
it and harmonize, I think is really where, where, where the industry needs to go. Now there are certain technologies. blockchain has been brought up and I've been in several conversations around blockchain and DSCSA. I think the challenge we've seen with it gaining mass adoption is the cost, the speed, and the fact that in order for it to work, you kind of have to get everyone on a similar blockchain platform.

Otherwise then you're building different. And again, I'm by no means a blockchain expert, but the challenges we encountered was, well, you kind of almost have to have everybody on the same platform. And that gets into sometimes antitrust issues and there's no government mandate that everyone's on the same system. And so then what we started doing was building blockchains with different connectors. it, it kind of really did you, you lost them the intrinsic value that that blockchain itself felt now.

There are some really unique value beyond compliance things that a lot of groups are doing in blockchain space, where can you leverage the serialization data to help in areas around financial transaction reconciliation. So the DSCSA has nothing to do with how the drugs are priced. The price isn't even included in any of the records. But if you're tying a serial number to a

Harsh Thakkar (21:32)
Mm-hmm.

Michael.rowe@twolabs.com (21:49)
purchase order or to an invoice, inherently people know what the price they paid for a particular serial number is. Whether it's not implicitly in the data, but you can do a lookup, right? So there's a lot of interesting groups that are saying, hey, I'm willing to participate in a single blockchain with different partners. And how can we use it to do different financial reconciliations? Because

Harsh Thakkar (21:52)
Hmm.

Interesting,

Mm-hmm.

Michael.rowe@twolabs.com (22:17)
There's billions of dollars changing hands around what price did you pay versus what price that I, you know, invoice. And we see drugs taking price decreases, price increases. And so there's a lot of interesting use cases, I think, for blockchain outside of compliance reasons, but for more value beyond compliance, because you've got to get people to participate in the same network. Yeah.

Harsh Thakkar (22:44)
Yeah.

Michael.rowe@twolabs.com (22:47)
So I think the technology area that I'm really interested in is AI and how it can help in what I call kind of day-to-day exception handling. So the law requires a hundred percent precision. The serial numbers that I got have to be the serial numbers in my database. How can a technology solution predict issues

Harsh Thakkar (22:55)
Mm-hmm.

Michael.rowe@twolabs.com (23:16)
find the issues more quickly than a human can, right? And get more proactive and automate some of those day to day like, hey, I have the wrong serial number. Can you correct it for me? Today, exception handling is the, if you ask me what keeps me up at night, that's it with the SCSA. Fixing these data errors that the FDA has called a clerical data error. It sounds easy in theory. Yep, just reverse a serial number. Well,

Harsh Thakkar (23:44)
Hmm.

Michael.rowe@twolabs.com (23:46)
I could have a coral. I'm not smart enough. didn't come up with this term, but people come up with this term called a corollary exception where if I scan serial number one, but I actually gave the customer serial number two, that means somebody else's serial number one when I thought they got serial number two. So now I've got two different customers that are impacted by one shipping error. And how do you fix that? And so to me,

Harsh Thakkar (24:06)
Hmm.

I see, yep.

Michael.rowe@twolabs.com (24:16)
That's the biggest challenge we face right now that we need technology to try and help us. Right now people are throwing bodies at it, which again, I think that's a short-term solution. think long-term it's how do you get data AI, honestly, to find these issues, predict these issues, communicate the issues, fix the issues. Like how do you use data and information to make that job faster?

Harsh Thakkar (24:43)
Yeah, yeah. No, you brought up a really good point about, you know, not the adoption of blockchain and why having, understanding the building a right platform so that it can be used end to end because if, and that's something I've also talked to a lot of other people in the industry and clients, like take for example, digital health, where there is lot of these apps.

that come with different medical device or medical products or equipment. And if all of that data is just in some app, and if you're a pharmaceutical company, now you are getting data from all these apps. But if you don't have one single analytics platform or a data lake or a data warehouse where you set the requirements that, hey, here...

I should get the data in this file format and it should go here, then people are just going to keep sending you all these data files and packages. And at the end of the day, you're to have to manually pay someone to go through all of that, or it's just going to create more work. And that defeats the purpose of doing it. So it sounds like for the blockchain building that platform and understanding end to end, how can every stakeholder or player

keep that integrity maintained right from start to finish.

Michael.rowe@twolabs.com (26:16)
Yeah, yeah. And I think for me, my perspective is that I think the blockchain technology will be used for outside of compliance reasons. I don't foresee all of the transactional data running through a blockchain. And that's my perspective. I think things could change, but I would say it's been a conversation going on.

Harsh Thakkar (26:25)
Hmm.

Michael.rowe@twolabs.com (26:41)
really since 2018, 2019, know, like, hey, we think blockchain can solve all these problems. And, you know, it really hasn't yielded that. But some of the work that groups are doing again in these, hey, how can we do it for things outside of compliance reasons? Hey, I want to engage in this type of, like you said, this data sharing model. It does have some value add.

Harsh Thakkar (27:09)
Yeah. And so I want to switch gears and talk about companies that let's say are doing some part of the DSCSA requirements or they're very much familiar with it. They have a strategy in place and maybe they come to you and your team to say, hey, here's what we have that's working really good. And here's like

our pain points, can you help us fix it? Versus you have another, let's say company that comes to you and says, Michael, I have nothing, tell me where to start. How do you approach these two types of clients?

Michael.rowe@twolabs.com (27:54)
Sure, sure. So for those that are feeling more confident where they are, but they still have the sense like, what am I missing? I think how we approach those types of situations, it's really almost looking at it as to how the FDA would. And the FDA has even stated in different public meetings that SOPs,

Harsh Thakkar (28:02)
Hmm.

Michael.rowe@twolabs.com (28:24)
are like the most important thing from their perspective around DSCSA. I think they want to know that companies understand the regulation, that it's written that they understand the duck and that when they interview people, they can intelligently talk about what their process is. I think we're at that level of like, as long as you have good SOPs that are clear that people understand and can, you can demonstrate your following, you're likely going to be okay.

And that the FDA is going to say, you know, maybe tweak this or maybe tweak that, it's not going to turn into this whole like 483, you know, debacle. So I think, I think that's how we kind of approach it with clients that say, Hey, we're good. Okay. Well, show me your SOPs and grill them in a way that's like, well, Hey, can you, what if I called you today and said, I think my product is fake. I'm a patient who's having an adverse event. I'm in the hospital and yeah.

Harsh Thakkar (28:59)
Mm. Yep.

Michael.rowe@twolabs.com (29:21)
I took it, but I bought it here and the packaging looks like this. That's not my packaging. Right. So, you know, those are the types of things that we're doing with a lot of companies right now is to say, Hey, if you think you're good, let's prove it. And we're finding at the SOPs, a lot of the companies have been in a build mode, not a run mode. And so a lot of stuff has been built, but there's a lot of documentation that's been lacking.

Harsh Thakkar (29:42)
Mm-hmm.

Michael.rowe@twolabs.com (29:49)
Yeah, we're sending data to all of our customers. OK, great. Show me all the testing you did to get to that point and that your data is clean. And what did you do to control that environment? And I get a lot of blank stares. I get a lot of blank stares. So for companies that think that they're good, ask yourself, if an FDA auditor came in and said, prove to me that you're doing what you're doing, how would you do it? And if you can't answer that quickly, you know.

Harsh Thakkar (30:01)
Yeah.

Michael.rowe@twolabs.com (30:18)
that afternoon when you get asked the question, then you're not ready. So that's how I kind of approach companies that are at that stage. For companies that are, hey, I don't even know how to spell D-S-C-S-A. A lot of it's doing what we're doing on this podcast here. It's what is the law? What's your role? Hey, explain to me what your model is.

Who are you selling to? Who are your partners? What are their capabilities? And so a lot of it is just level setting on.

really getting a sense of what are your compliant requirements based on where you are. And from there then saying, all right, what either technology or process do you need to build to fill that in? You might need a cloud-based solution that's storing all the serial numbers and it's connecting. And your network might be big enough where you need to maybe take that on internally. Your organization might be small enough where

Harsh Thakkar (31:02)
Yep. Yep.

Hmm.

Michael.rowe@twolabs.com (31:26)
You could potentially outsource a lot of this and so now your role becomes more of a monitoring agent than a facilitating agent so It's it's really sitting down with our clients to say where are you? are your needs and then going to work from there?

Harsh Thakkar (31:29)
Hmm.

And with some of the clients, like you mentioned, some clients that are in this build mode, some are in the run mode, with all the types of projects that you worked on, all the clients that you worked with, have you seen, or do you have any real world example? Maybe you can't share the name of the client or the product, but something that you looked at, how they were achieving compliance or meeting these regulations.

and you maybe learned a lesson or something, you know, a trip or a hack or something like that. You saw them doing it and you're like, okay, this is, I've never seen this done before. This is a very creative way. And then maybe you keep that in your notes and you go and, you know, educate other clients on, hey, XYZ company has done this something really different and,

look what the results are. Do you have any like a client that you feel like you always put up on the pedestal as an example and what are they doing different than the others?

Michael.rowe@twolabs.com (32:53)
Yeah, that's a great question, Harsh. think.

I'm trying to rack my brain on kind of one that I can share that would be, I think, tangible for your audience to appreciate. Where I would go with this is, and I think I hit on it earlier on what makes a company successful or not. We had a client where on day one, we got all together, us included as the consultants, but they got all their stakeholders together.

Harsh Thakkar (33:22)
Mm-hmm.

Michael.rowe@twolabs.com (33:26)
And they said, we're launching this company and DSCSA compliance is going to be our differentiator. And that was the first time I had heard any one of my clients say that it was always like, Hey, we got two labs here and we just got to get this done. you know, you know, but they said from day one, our company, we're going to make DSCSA a differentiator and they're more in the generics space. And they said, there's a lot of companies that are in the generic space that,

Harsh Thakkar (33:37)
Wow.

Hahaha

Hmm.

Michael.rowe@twolabs.com (33:55)
have been laggards in DSCSA. And I go to all these conferences and everyone's complaining about the generic manufacturers because they're always late in getting all the deadlines in. We're launching this company and DSCSA compliance is going to be what we do on day one. And so they launched, and again, this might not be applicable for companies now, but when they launched, they had a choice. And I showed them the choice. said, you can launch without the full scanning.

You can launch just packaging it and serializing it and you get to scanning later. And they made the bold decision to say, no, we're going to scan from day one because I want to be in favor with the wholesalers. and I don't want that to be a reason to not, I don't want, I it to be a frictionless transaction. And, you know, so I think that that's an example where

I've been able to share that with other clients to say like hey, they launched a brand new company and they're growing they're growing new products and it's been there from MO from day one How do you reduce the friction to do business and if you don't do DSCSA right it causes friction?

Harsh Thakkar (35:01)
Mm.

Right, right. Yeah, and we're already in, you know, that's a great example of the client that you mentioned that from day one, almost took it not as a requirement that they have to follow, but almost as a strength or a competitive advantage because they knew that others weren't paying as much attention or doing just the bare minimum. So that's great example.

Michael.rowe@twolabs.com (35:32)
Mm-hmm.

Harsh Thakkar (35:33)
Now I know we're in 2025 already and there are a bunch of dates coming up. I think the manufacturers have to, they have until May, some wholesalers have until August and then the pharmacies and dispensers is November. So what happens if these guys miss the train?

Michael.rowe@twolabs.com (35:53)
Yeah. So I think, like I said, the law was passed in 2013. It originally envisioned a 10 year implementation and through lack of readiness and politicking, we've now come into what's called a phased implementation approach through 2025 and even to 2026. what, you know, like I said before, the manufacturers kind of start the chain of data. And so the, um,

Harsh Thakkar (36:01)
Yep.

Michael.rowe@twolabs.com (36:22)
the industry kind of said, hey, manufacturers should be held accountable first, then wholesalers and pharmacies. And then actually small pharmacies with 25 employees or less have until November of 2026. So effectively, it's a three year delay for the entire industry. But I think for the majority of the industry, it's this year. And so what does it mean if you're not on the bus?

Harsh Thakkar (36:37)
Mm-hmm.

Michael.rowe@twolabs.com (36:52)
is interesting about the DSCSA, it's almost self-policing. The FDA generally has been more focused on upstream manufacturing, inspecting facilities. They've not been very accustomed to inspecting pharmacies and wholesalers. And there's a lot of them and there's only a few amount of FDA people. So interesting about the law is that it's self-enforcing because the pharmacies and the wholesalers

are not going to let product come in if there's a data problem because they could be held liable. So it's almost like your customer, if you're a seller, your buyers enforce it on you because they don't want to get in trouble. So essentially what it's going to mean is if you're not on board and not passing the data and not resolving these exceptions, basically the threat from industry has been the product will get quarantined.

Harsh Thakkar (37:24)
Hmm.

Right, Yep.

Mmm.

Michael.rowe@twolabs.com (37:48)
You're not gonna get paid. And if you don't resolve it quickly, I'm gonna return the product back to you and reorder until you get it right. So what does that mean? A lot of write-offs, a lot of extra work, a lot of waste. And so, some of these therapies are hundreds of thousands of dollars per dose. You're telling me that someone's gonna return it? That could have a major impact to the bottom line.

Harsh Thakkar (37:54)
Hmm.

Yep.

Michael.rowe@twolabs.com (38:16)
of these companies. And even not just manufacturers, but even wholesalers, right? If they don't operate at the level of precision where they're receiving the product in, inspecting it, and then fully scanning it and catching errors before it leaves, again, the pharmacies that are up to snuff on this are gonna catch it, or it's gonna get caught later when then FDA or state portal pharmacy is gonna get really...

interested in learning about everything that you do and why didn't you catch this?

Harsh Thakkar (38:49)
Yeah, yeah. And it's very interesting you mentioned that this is sort of self-policing in itself because again, if we go back to our car example and VIN number, right? If you have the car maker that makes these cars in Detroit or wherever they make it, South Carolina, Japan, and they ship it to the dealers and the dealers are selling the cars or if it's a big dealer or a used car dealer,

the buyers are going to want to see that VIN number on the car, on their purchase documents. And if they don't get a clear record or history of where this car came from, that's going to not result in a sale. So it's really interesting example that you shared there.

So I know we've been here, I don't know how long we've been on the call here, but I loved everything that you've shared so far. And we've talked a lot about the big picture of DSCSA and the deadlines. You shared some of the challenges that companies are facing. You also talked about how you approach the different types of clients depending on where they are in their journey to be compliant with DSCSA regulations.

So I really appreciate all of this that you've shared, Michael. For our listeners and viewers who are maybe considering working with two labs or picking your brain, or maybe they're just considering to read more on this topic, get some resources, can you share some resources and items with them?

Michael.rowe@twolabs.com (40:28)
I mean obviously the FDA website is a wealth of information There's a whole section on DSCSA on the FDA website and so that is honestly my my source of truth on everything They've done a great job of publishing guidance documents I don't have evidence to back this up, but you know I've heard at different conferences and even from FDA themselves that

Harsh Thakkar (40:32)
Yep.

Michael.rowe@twolabs.com (40:58)
From DSCSA perspective, this is some of the most policy-driven and guidance as they publish for any other regulation that they have. And so the FDA's done an excellent job of engaging with industry and listening to industry and constantly creating new guidances or updating guidance documents. That's a great resource. The other resource I really encourage clients...

Harsh Thakkar (41:08)
Hmm.

Michael.rowe@twolabs.com (41:24)
And even myself, we're a member of this group. called the Partnership for DSCSA Governance. It's actually a public private partnership with FDA and member companies that are looking to build almost like a blueprint of what's the best way to comply with DSCSA that is in a standardized way for all that doesn't exclude anyone. And so it's a cross section of the supply chain from manufacturers.

Harsh Thakkar (41:47)
Hmm.

Michael.rowe@twolabs.com (41:54)
trade relations groups, pharmacies, and even experts and consultants like myself that are part of the PDG. And all the resources are published for free. So I can give you a link to that, and you can include that for your members so that way they can get links to it. Those are two great free resources that I think do a really good job of.

Harsh Thakkar (42:04)
Okay.

Sure. Yep.

Michael.rowe@twolabs.com (42:17)
One is from the FDA, and then the other, that PDG, really respect a lot of the members and the individuals that are part of that group that have a level head that are acting in the best interest of the industry, but not in a self-serving way. So PDG is another resource that I highly trust.

Harsh Thakkar (42:30)
Yeah.

Yeah, and then one quick pro tip for anybody that's, for whoever's listening or viewing this, if you wanna keep tabs on any topics like this, right now we're talking about DSCSA, it could be something else that's going on. The one that I typically like to use is Google Alerts, so I'll go and select some keywords on this topic that I know most articles or regulatory documents or blogs will have.

And then I just set those Google alerts and you know, there's so much of free information literally on every topic like this. So if you want to do that, try it out that way, you know, you can learn. There's others. I'm sure there's a lot of experts like Michael who are doing this day in and day out, working with clients and you know, who are open to sharing everything like whatever Michael's sharing here today is amazing stuff that you're getting to just hear for free if you're if you're tuned in. So.

Thank you, Michael, for coming on.

Michael.rowe@twolabs.com (43:35)
My pleasure, thanks so much, Harsh. It was great. Thank you for the time.

Harsh Thakkar (43:37)
Yep,

thanks and good luck to your Ohio State.

Michael.rowe@twolabs.com (43:42)
Go Bucks! Bye.

Harsh Thakkar (43:44)
All right, yeah, thanks, bye.