Podcast: DSCSA or Track & Trace

- [Becky] All right hello there Pharmacy Podcast Network. Thank you so much for tuning in today to another installment of the Pharmacy Compliance Guide. I'm Becky and I'll be your host today as we navigate another fun area of the world of complexities with compliance in the realm of pharmacy. Today I'm actually joined by Greg Wozniak. And Greg I'm so glad that you were able to tune in today.

- [Greg] Thanks Becky, I look forward to sharing with you and the audience more about the Drug Supply Chain Security Act or well often known as Track and Trace especially for retail pharmacies and health care organizations.

- [Becky] Wonderful, Now Greg, you are joining us today. You're also here in this fabulous commonwealth of Pennsylvania and you're company is Excellis Health Solutions. Can you give us a little bit of background on who you are and what your company does for independent pharmacies?

- [Greg] Sure, so Excellis Health Solutions or Excellis as we refer to ourselves was founded in 2010. We are in the commonwealth of Pennsylvania based in New Hope, Pennsylvania right south side of Philadelphia. We're the leading organization in the pharmaceutic supply chain which specifically focusing on the Drug Supply Chain Security Act regulations. So how independent pharmacies can ensure compliance with the regulations as well as derive business value. We believe this is an exciting opportunity to not only improve patient safety but also improve business value to independent pharmacies and their patients specifically as well. So we are an advisory firm and we help independent pharmacies and other organizations literally around the world. Although we're based in Pennsylvania. These type of regulations are spanning the globe to protect people from fraudulent illegitimate products that often show up in our supply chain and so really it's a patient safety initiative. So that's why we like it, we truly believe with our independent pharmacy partners that we are making a difference in the lives of our patients and like to collaborate with them as well.

- [Becky] Now today as you mentioned we're gonna be discussing the Drug Supply Chain Security Act also known as DSCSA and you mentioned Track and Trace. So, it's gone by a couple of different names. Can you tell us why this specific item DSCSA is what I'm gonna abbreviate it as on this podcast why it's so important to retail pharmacies and their customers?

- [Greg] It really started in the early 2000's. What really this was about is that is was broomwide problem over in the United States where there has been fraudulent illegitimate product, particularly prescription products introduced into the pharmacy supply chain and dispensed to patients. And it's an opportunity to protect the patients from these illegitimate products that could cause harm to them. Back in 2013 President Obama signed the Drug Quality and Security Act, DQSA that's why your gonna learn why many people call this Track and Trace and DSCSA is a sub of that regulation which focused on prescription drugs. And he signed that on November 27th of 2013. And so all the regulation compliance dates usually revolve around November. They gave the United States 10 years to become fully compliant with the regulations. And so that's the whole idea behind it. For the independent pharmacy in particular which shortages. Often times they have a primary wholesaler that's providing them the drug but then during shortages they may go to a secondary wholesaler. And often times it's that secondary supplier of drugs is where, if you will black market or illegitimate drugs get introduced in the supply chain and that's what creates the safety concerns. So often times when we speak to independent pharmacists that often becomes one of their areas of concern at the same time they're striving to meet the needs of their patients and so they're working hard to find those shortage products and often times that where it gets introduced into the supply chain. So it's really a patient safety initiative. It was made a national standard because in the early 2000's, several states, most notably California so some of your listeners may know the Pedigree Law was gonna be introduced there and then there was a national understanding that really if we are gonna do this it's best to do this as a national standard versus a state by state standard And that's what was the impetus behind the law itself.

- [Becky] You already mentioned back in 2013 was really when this started to come into everybody's wheelhouse of knowing that this is gonna happen because of that piece of legislation. But they gave us 10 years to take care of that. So from 2013 all the way up to 2023. Hopefully our listeners have already been exposed to this and are aware of those dates. Can you share some of the key dates that pharmacies already had to have in place? You've mentioned November is always the key month every year. Can you mention some of the key dates that have happened in the past? And some more of these key dates that will even be happening in the future that we should be preparing for?

- [Greg] Sure, so a couple thoughts to think about what this was the United States decided to do and this is different than other countries is to start usually with the regulations with the pharmaceutical manufacturers first. And to think about it logically getting the products where they're made at to comply to the law. And then they moved to the wholesaler distributors re-packagers and then they move to independent retail pharmacies and healthcare organizations. Those independent retail pharmacies and healthcare organizations are often talked to in the law as the term dispensers. So if you hear me talk about manufacturers wholesalers and dispensers the law refers to retail pharmacies and healthcare organizations as dispensers. So the way the law is designed it starts with the manufacturers. They become compliant and then it moves to the wholesalers. And then it moves to dispensers or the retail pharmacies. So one of the challenges for the dispensers and retail pharmacies have been it's only recent years even though this was signed back in 2013. It's only been recent years and I would say literally the last year that most people are becoming aware of the regulations and starting to realize that there were compliance regulations they needed already to be complied with. And there's a big one coming in November of 2020. So let me go through for independent retail pharmacy. Back in 2015, you had to put in regular processes to comply with a regulation called Authorized Trading Partners. And the idea behind that was who you're buying from verifying that they are truly authorized to sell you the product. So the wholesaler needs to verify that the manufacturer selling them the product is truly authorized. Which usually means license in the state. That they're shipping from or making a product and license with the federal government. You have to keep those records and that's intended to block someone from selling product illegitimately. So that was a 2015 regulation. You also back in 2015, if you identified suspect product, so something that didn't seem right you needed to quarantine it. And there's explicit procedures for a retail pharmacy to do is how they investigate that and the reporting requirements. They would need to report to the FDA as well as to the wholesaler or manufacturer they received the drug from. So that was really 2015. Then came 2016 and that's where manufacturer or wholesaler should be shipping your products to you but also sending three pieces of information related to the transaction. The history, where's the product been made at, who was shipped to so say a wholesaler and then it now it's coming to you. A statement that the person selling you the product attest that they received it directly from another wholesaler and didn't go anywhere else. And then the third is what's called the transaction information. All the information about the product. Where it was made, the expiration date, et cetera. The product name, there's 10 elements of that. So those three things are called T3. Transaction history, transaction information and transaction statement. And last report the T3 in the industry. So what needs to happen starting 2016 is that retail pharmacies and other dispensers needed to check that information before they accepted the product. So that way, they're knowing that the product is legitimate. So it's almost like a chain of custody. And that's where the term often comes Track and Trace. We know where the product came from and we're tracking that and retracing it not moving forward. So that's really where the independent pharmacies need to be today. What's coming in 2020 and many of the people on the podcast will started to see these 2D data matrices showing up on your assailable units of prescription drugs. Remember, this isn't related to prescription drugs not over the counter. And a 2D data matrix has four readable lines to it. And that includes the expiration date, the lot number what's called a global trade item number or GTIN as an acronym and better than that GTIN is the NDC, so the National Drug Code for each product is embedded in that and then the last thing which is very unique is a serial number. Every saleable unit very similar to your and my social security number will have a unique serialized number unique to that saleable unit that the manufacture and or re-packager will assign to that number. So you can specifically trace that drug to know it came from a legitimate source. And those four indicators are what they call the product identifier it must be on all packaging. So in November of 2018 any product manufacturer in the United States been packaged needed to have those on them. And then this November every wholesaler that ships those products to you must have those on those as well unless they're because they were made before the date. And then in November of 2020 a independent pharmacy as well as healthcare organizations when they receive the product will have to ensure that that product identifier and the four elements are on the product. And that's why November 2020 becomes really, really important to independent pharmacies.

- [Becky] Thanks so much for sharing that. I was actually taking copious notes as you are going through that. And it definitely seems like there's been a lot of things that have happened in the past. There's a couple of things that are gonna be happening in the future. I think a lot of people would like to know what are the implications of this? And what type of regulatory enforcement measures could a pharmacy in particular see in the future?

- [Greg] Sure, great question. So I would say three points. These applications are very important to a retail pharmacy because what you're gonna have to do is start to change your processes. And if you think about it, when you receive a product even before you do that, when you order a product you have to authorize make sure that trading partner's in good standing at the time. And there's been cases where even some of the big names have shipped something and then the FDA or another governmental body has said that they fell out of compliance and they no longer allow that site to be compliant until they view it as being in good standing until they fix it. So oftentimes, when I talk to people, they'll say, "Well, that's just for the gray market." And I'll say, "That is intended for the gray market. "But it also is intended in case "there's been a problem somewhere else." And that has happened. So the first thing they have to do is before they order product know who they're ordering from and checking those state licenses and the FDA to ensure they're in good standing. The second thing is when you receive your T3 information it should be electronic although many of the wholesalers are not there yet manufacturers particularly for direct and drop shipments you have to review that T3 information before you accept the product. So that changes your receiving process. So your order is changing and your receiving processes. And if that information is not there you have to set it aside and investigate it the product itself. And then the next step is then when serialization comes. So when serialization comes in your receiving process so by November of 2020 and those 2D data matrix sees that you're starting to see on product if you have those four product identifiers the expiration date, the lot number, the global trade item number or GTIN which includes the NDC that we're all used to today. And then that unique serial number your gonna have to ensure that that product has all four elements on that. Which means you're gonna have to scan that product. And a lot of independent pharmacies don't scan upon receipt. So they're gonna have to scan that product and then put suspect product processes in place in case those indicators are not there. At the same time, you have to make sure the T3 information's there as well. So your receiving processes will have to change dramatically as well. And then your return processes have to change as well. So one of the biggest changes coming and the wholesalers are working on right now any saleable returns that you make you'll have to provide information back to the wholesaler to show that you bought it from them. So they can issue that saleable return credit to the pharmacy. So that's really starts to get the business aspects of the pharmacy as well. So that's why everyone says November of 2020 is gonna be the big biggest change for retail pharmacies moving forward. Your second question was, who has enforcement responsibility? The FDA has enforcement responsibility. Usually and there's been a couple of cases already where there's been a illegitimate drug identified they'll look at and trace that drug throughout the pharmaceutical supply chain and check to see how people were following the drug did they authorize the trading partner? Did that they verify the T3 that was all there. And now when sterilization come did they confirm that as well? So the FDA has the enforcement authority.

- [Becky] Now, has there been any enforcement actions today?

- [Greg] That's a great question. The first one occurred last year around July with one of the big three wholesalers. And it was very interesting it reginated with a few retail pharmacies. Those pharmacies had put processes in quite similar drugs from the same wholesaler that had been tampered with. With that tampering, the retail pharmacies did a great job. They notified the FDA so they're following the requirements. They notified the wholesaler. They also quarantined the suspect product and started to investigate it and then determined that it was illegitimate and then they notified the FDA and the wholesaler so they did a great job. What the FDA then did is investigated the origins of that and track and traced it all the way through to the retail pharmacies. And unfortunately, the wholesaler which is one of the big three could not show that they had completed all the requirements of DSCSA. And then this February of 2019 so this occurred back in early 2018. In 2019 the FDA issued a letter of warning to that wholesaler that they needed to fix the issues. And if they didn't fix the issues there was a potential they could shut them down until those issues were fixed. So that became the first and candidly like any law I think people say, was this really gonna be enforced? And that was the first one. So this year has been I think for dispensers or retail pharmacies and healthcare organizations recognizing that they will start to do that and really focus on this. The other big event that occurred is the Office of Inspector General. We hear a lot about the OIG these days. And they did two reports on the law and issued those reports in 2018. Basically focused on retail pharmacies compliance and healthcare organizations. So that really got everybody's attention in the retail pharmacy world because the Office of Inspector General was looking at that and identified issues and primarily that the retail pharmacies and healthcare organizations were very under informed about the regulations. Had not started to make the changes. And also clarified some confusion about the regulations and how it should be implemented. They gave their findings to the FDA the FDA concurred on those. And then two reports are published with the OIG. Those OIG reports also started to get everybody's attention as well. That the government was very interested in this. Felt it was a necessary regulations to protect patients and also to take care of some fraudulent players in the market that we're trying to help their costs as well. So those two actions the enforcement of one of the big three as well as the OIG reports really have led to the industry to take more notice of the regulations and has really caused the independent pharmacies to start to implement the regulations.

- [Becky] This is a little bit of an odd question for you. Now, if you had a crystal ball and could look into the future and being able to speculate or forecast what type of cautionary tales could you tell them as far as enforcement? Obviously we know they're already starting to look at it. We've got these dates in place, it's gonna be happening. Do you think this is gonna be something more like a fine? Do you think they're going to start with that written warning like they did for that wholesaler? How severe do you think the enforcement measures are going to be when it comes to a retail pharmacy?

- [Greg] Great question and I wish I had a more direct answer for you. I think the way the law is written it doesn't specifically state what's gonna happen but we do see it expect fines and or warning letters as well as basically shutting somebody down. We also recognize that many of the state boards of pharmacies are starting to take a look at this as well. And so they have duplications at the state level. We believe based on the magnitude of the issues. So for example, if that occurred because of something like this obviously, that's gonna have the highest concern. And then also, where an organization's at and responsible for that that we think the commencement penalties will be associated with that as well. We do not see the FDA just doing random on it just because of staffing concerns and that's been discussed publicly. But we do see other accrediting organizations starting to put this in their accreditation standards particularly for specialty pharmacies as well as the State Board of Pharmacies. We just gave a presentation to one of the state's boards about this to educate them as well. So I think you'll see more and more. Like anything in life, it's usually when an event occurs that gets everybody's attention and focus. So the key thing I think that while we work independent pharmacies this is a good thing, this is something about patient care and protecting your patients. Which again, pharmacists are the top if not number one, number two, trusted profession. And specially community pharmacies really want to be as attached to their community. So this is a patient safety initiative. But there's also business value for that as well.

- [Becky] Earlier in our conversation you mentioned a couple of phrases that I'd like to revisit to just help clarify a few items. So you mentioned authorized trading partner. Can you recap again, what an authorized trading partner is?

- [Greg] Sure and again, I always encourage people to think about how you order and receive products and dispense them is the key with the law. So when you are purchasing from a wholesaler or purchasing from another manufacturer or distributor before you purchase that drug you should have checked to make sure they're in good standing with the state that you're in and the state that they're shipping to you from. So you could have a big wholesaler that might have different distribution centers you need to understand which distribution center is shipping the drugs to you. And have a method in your pharmacy to check that. A lot of organizations have started to do that manually and found that time consuming and so technology companies have started to help mine the data for them and alert them when something changes. Or if you're in short supply, there are technology groups that we work with that allow you to google it and give you the information that you need. Not through Google but through their websites. But you have to check that. And usually you're checking it with the states and you're also checking it with the federal government levels. So if they're in compliance then you know it's a first screening mechanism that you're buying from a reputable supplier of drugs to you.

- [Becky] We do have quite a few pharmacies who are acquiring other locations right now. Whenever a owner is retiring or maybe they're passing their pharmacy from one generation of pharmacists to another generation of pharmacists. Can you share with us how transferring inventory from one owner to another in regards to this regulation is gonna change moving forward?

- [Greg] That's a great question Becky. And I think especially there's so much movement today in the marketplace, right? So that's very common. So one of the things we recommend is that as part of their due diligence in purchasing that pharmacy that there's a quick assessment that gets done assess other processes for compliance with the DSCSA and we often go in and help look at that for them because what you don't wanna do is inherit risk. And that is what you're trying to avoid in that due diligence process. So oftentimes, you can look at part with their authorized trading partner verification processes, you can look at their suspect product, their quarantine, their investigation processes and how they handle recalls. Also look at how they handle the T3 information we talked about. Their transaction history, information and statements. And then lastly, you're really look at how they're verifying the T3 information. So that will help you understand how tight their policies are, how their processes are put in place and aligns with this which give you a good measure of what your inventory looks like. The second way, if you start to identify issues that you start to dig a little bit deeper into those issues that to check the inventory and in some cases you may not purchase the inventory because you're just not comfortable with that and exclude that from the transaction.

- [Becky] That's very good information to know. And I know that's something we help a lot of our clients with on a regular basis is changing around inventories whenever new owners are coming in. So that's definitely great to be able to work into brokerage conversations. Now I wanna loop over to the 2D data matrix that you had mentioned earlier that's gonna be on the prescription products. Now is that sterilization?

- [Greg] It is, so the term sterilization really comes from that unique serial number. I was mentioning Becky that every product so just think about it like your social security number. Literally every saleable unit prescription drug saleable unit is gonna have a unique serial number that the manufacturers assigning to that product. So that allows you to track it all the way to through the supply chain up until the point you dispense it. And then you're gonna have a lot number on there. And then you're gonna have an expiration date which is great. And then you have this global trade item number. So let's go into that you have the National Drug Code that we're used to is gonna be embedded in that string of numbers. But you also have information about the product. When was this packaging? Where did it origin from? And the neat thing about all of this it's embedded. All that data is embedded in that square of 2D data matrix that you're starting to see now on products. Cause remember, in November of 2018 any products packaged by manufacturers or repackagers had to have that on it. So really, that's gonna become, if you will, the gold standard to verifying these products. So that provides not only safety issues when in 2020 so November 27 of 2020 which is hard to believe is only about 12 months away. You're gonna have to check that upon receipt to ensure that those products identifiers are on there and they're in good standing. And if they're not, you're gonna have to put that away before you accept that product moving forward. So from a business perspective there's a lot of information here for you. Expirations will be easier to track. So it should help you bring down your core costs. Recalls will be easier because you'll be picking up that lot number. And if you've tied into your retail systems you'll be able to track that information for recall where the product is at. Returns it's gonna be very important to have that information because your wholesaler that you bought it from or other supplier can only take back products that they sold to you. In order to get your credit for saleable returns you're gonna have to look at that as well. Though so we see an opportunity to protect patients safety, ensure your complying it but also use it for business value and hopefully reduce your costs and also notify your patients more specifically when recalls do occur.

- [Becky] Earlier we were talking about some of the enforcement's that have already happened. And you said it was actually at the retail pharmacy level that they found some suspect products and then went into a quarantine process. Can you elaborate a little bit more on I'm a retail pharmacy, I've received my order. I'm in the process of checking it in and now I've got this suspect product. Can you give a little bit more detail what I should be doing?

- [Greg] Sure, so a couple different ways, right? So we've purchased from somebody who's authorized, right? So if they have that authorized trading partner we know they're in good standing. So that makes us feel good. The second part is the T3 information. That should be sent ideally electronically too now cause that's what the law says. And then your receiving team should verify for each of the products that that information is fully completed. If for some reason that information is not fully there that's your first line where you gonna pull that product not accept it and do an investigation. Oftentimes that goes back to the supplier you purchased it from and say, "Hey, I'm missing this information." And they can send it to you and you're good and you can put it back into your supply. Or some reason they can't get that information when we advise clients then is to return that back to the supplier to give that to them. The other issue and this gets specifically to the case we discussed earlier in that case they received product that had been tampered with and the staff was alert, kudos to them. When they were receiving it. They said something didn't look right. So they pulled it aside. And sure enough, it turned out after investigation that somebody had tampered with the product. What they did there is they protected the patient by just pulling it out and quarantined it to make sure until an investigation was done. They have to notify the FDA within a certain time requirement and they also have to notify who they received it from. Once they complete their investigation. If it is confirmed as illegitimate they have to notify the FDA and they also have to notify a wholesaler and then based on the discussions they'll then determine how it gets returned. One thing that your audience needs to remember the FDA is gonna require you at a minimum to store six years of your transaction history information and statements, the T3. And if it is a product that's being investigated in this case, you have to hold it in files up until 12 years. So those investigations may take a long time. So storage of this information having it accessible is very important. And then at the FDA comes to investigate it you have a certain amount of time to turn all the information they asked you for over. It's usually 48 hours to do that. So there's other requirements there as well. And that's where we think the FDA will come in and start to talk to the retail chain talk to the wholesalers, may go back to the manufacturers and really track and trace that all the way back to its origins to find out where the tampering has occurred. Did I answer your question?

- [Becky] Always does, I'm always interested whenever there's record retention that's something we always like to share with our clients. Some items you have to save for three years sometimes it's five, sometimes it's 10. So this is good to know now that we have six years of retention of the T3s but we also have 12 years of retention needed for any of those products investigations. And that's great information to have.

- [Greg] What happens oftentimes is the wholesaler supplier says, "Hey, we'll hold that information for you." Okay, which is they can. Oftentimes we'll advise our clients to keep it themselves because you may change wholesalers. Things may get bought. Somebody may get bought over time by somebody else, a merger, a consolidation and those records may not be there. And it's the independent retail pharmacy as dispenser in the law that has the obligation to produce that information. Now you can use it with your wholesaler but if you're gonna use them, you really should have a guidelines put in place in your contracts for that. Or if you have other suppliers as well. Because if ideally you can hold on to that information now that it's become electronic, it's a little bit easier to manage. And there's different systems out there today that we often advise people on. That way you have it when you need it. And then that reduces some of the burden that you're gonna have to produce when an event occurs.

- [Becky] That's a wonderful suggestion. I very much appreciate that. So we've heard some stories about PBMs out there that are asking for product transaction information before reimbursing pharmacies. Can you explain a little bit about why this is happening?

- [Greg] That's a great question. And it's really an interesting trend. I started first hearing about it myself when I was giving some talks around the country. And this is actually a group of independent pharmacist and before the talk we had presentations for two groups in the conference, two separate groups about 100 each and I asked them even before the conference of my presentation started. I said, "What would be a good topic to you left today "knowing that we covered?" They said, "We'd like to know about why the PBMs "are asking us for the transaction, the T3 information "before they pay us." And it's specifically Becky around it seems to be specialty or those high cost products. And I'll give you an example. One of the independent pharmacies has a large HIV population that they care for. And it was those costly drugs. I think it was a close to a $6,000 drug that they had dispensed appropriately to the patient. But when it came back to reimbursement the PBM asked them to produce the T3 information. And I think it really is just another extension of what a PBM is trying to ensure that legitimate product is administered and dispensed to patients versus illegitimate product. So we think this is another extension of the law that we will see used in other areas. If you look at some of the accreditation organizations for specially again high cost limited supply drugs they're asking questions of how you're verifying. Not specifically about the the DSCSA regulations but inheriting those guidelines or what's your verification processes to ensure the drugs you're purchasing and dispensing are legitimate. So again, we think it's a good thing. It does create some financial challenges to the retail pharmacy and other health systems. In this one case and this is not to be disparaging about the wholesaler but they went back to their wholesaler to ask for the T3 information and the wholesaler could not find it for them. As the lady whose the owner of the pharmacy says, "Thank God, I like to retain everything. "And I went back to my documents paper "and found it and was able to give that information to the PBM." So again, another reason why we encourage people to keep their T3 for themselves because not only is it gonna be compliance reasons we believe this is gonna tie into reimbursement particularly for specialty or shortage type drugs. And we also believe this is gonna grow increasingly at the accreditation level, particularly for specialty but also at the State Board of Pharmacy level as this becomes more widely adopted.

- [Becky] Well, I know our pharmacies have gotten very good at document retention and organization. But this is definitely gonna impact a lot of workflow than our pharmacies that are maybe utilizing some of their staff that aren't pharmacist toward documenting and receiving their shipments. Can you share with us a couple other workflow issues that pharmacy should probably be aware of moving forward?

- [Greg] I would say next to the compliance this is the next question we always get because with any regulation and many believe are overly regulated today and it creates administrative burdens and takes us away from direct patient care. We encourage our clients to adopt this because of that 2D data matrix. And that's why I get so excited about this opportunity. You can start to automate a lot of your information. So if you think about today, I like to use the example if you look say at Amazon or FedEx today we could order something for one of those two get a delivery to our house and check it throughout it's journey to our home and literally almost know when it's gonna arrive say 2 p.m. today and I get home at 1:55 and be there to catch it. That how good track and trace has been for other industries. This is the same opportunity and leveraging the power that 2D data matrix and other technologies. And often cases when we work with our clients they've already purchased a retail pharmacy management system but they may not be using aspects of it. So we work with them to try to change their workflows, plan those out and streamline and automate some of those steps. And again, like the whole world today is changing that 2D data matrix and electronic T3 gives you the opportunity to reduce some of the manual processes, tighten up on your supply chain, identify where there are discrepancies and hopefully save costs, protect your patients and have an opportunity to better exploration management and recall management as well. So it's always about three things. It's about your ordering, about your receiving, your put away process and then your suspect and return processes. Those are the areas that need to change. And we really recommend that you plan that anticipating all the changes and then you build upon each of the compliance states so that you have a more streamlined system that could hopefully be an advantage to your pharmacy business and doesn't create more burden to you and you're protecting your patient.

- [Becky] Thank you, now we've gone over quite a bit of information about the regulations when it started, some other dates that need to be aware of, the enforcement actions, things pharmacy should really start looking at and adjusting their workflow. Next up is solutions. You mentioned it's a great idea to start automating your information. But what solutions do you see out there or possibly do you have for our retail pharmacies to help simplify this entire process?

- [Greg] So the first think is understanding the regulations before you start doing anything. Cause I will tell you, what we've learned is like with any laws, it's not clearly defined how it's gonna be implemented. And that's intentional, it gives flexibility but also it also can create some frustration. So the good news has been we're now in our sixth year of the regulations. So a lot has been discussed. The FDA and particularly that OIG report really clarifies some of this particularly for retail pharmacies some of the expectations. So the first thing I would encourage is work with someone that really understands the regulations and what the business applications are there for you. Cause there's examples of people who've bought something and they're still not compliant in it. And they assume were and then they found out that they weren't. The second thing is to really map out your workflows. Look at what you're doing today. What investments have you made already? So it's a retail pharmacy system, it's the scanning solution, evaluate balance. Does the scanning solution to linear or does it do 2D matrix? If it doesn't 2D data matrix you're gonna have to make an adjustment there. Thirdly, then evaluate. Once you know your strategy, what you need and that's where you start to evaluate technologies. So there's a lot of technologies out there based upon what you all have. We work with all the technology companies so we're a good source of understanding which ones will work in your particular situation. And that can range from authorized trading partners to checking the T3 information for you automatically and storing it for you electronically to verifying the serialization when it comes next year in particular with your scanner and capturing that data and storing that data. And then connect that data into your retail systems so that you can leverage the exploration lot number for inventory management as well as recalls and returns. And then the last thing what we've developed is what we file for the independent pharmacist because there's so much time that they wanna focus on their patients, they don't have a lot of time to put this all together. We've come up with a total package that you can have all the technologies that you need plus receive guidance to ensure you are compliant not only today but as the regulations grow. You can do an ad hoc, almost like an A La Carte approach. You can also do a turnkey approach that we offer that includes everything from authorized trading partners tho the scanning, to the technology that you need to store the information T3 and serialization. So really it's the gamut. But the first thing is to assess yourself, understand the regulations, what's gonna impact your operations, develop a strategy to meet not only today's in effect regulations but tomorrow's and 2020 is the next stage. And then there's another regulation in 2023. So that you have a plan and a foundation to build of off.

- [Becky] Wonderful, thank you for that. I always say do what you do best then contract the rest. So it's nice to have those solutions for us. You're allowed to use that if you'd like to but--

- [Greg] And I think that's best. Because the independent pharmacies their focus is on their community and their patients. And that's where they wanna spend their time and more time and effort. And that's really been the hallmark of independent pharmacy is that individual consultation with their patients and taking that away for administrative things are not the best use of their time nor their patients time.

- [Becky] Well, Greg, I wanna say thank you so much for sharing all this great information with us. And all the listeners here at the Pharmacy Podcast Network specifically the Pharmacy Compliance Guide. This information is gonna be super helpful for a lot of our pharmacies as they look back to make sure that they have some of these past regulations in place. And then also when are now looking ahead for 2020 and 2023 regulatory deadlines that they're going to be working towards. So Greg, thank you so very much for joining us today. And folks that are listening I will have a transcript of today's podcast with the Drug Supply Chain Security Act known as DSCSA available so you are more than welcome to hop over to our website rjhedges.com. Go to our blog section if you'd like transcripts of this or you'd like to share it with a friend they'll be some additional information there as well. So from all of us here at the Pharmacy Compliance Guide thank you very much for tuning in today. Safe travels wherever you may be heading. And if ever you need help navigating those waters with regulatory compliance we are here at R.J. Hedges & Associates to help you.