Preparing for DSCSA – Serialized Transaction Data

Hello and welcome. My name is Scott Mooney and I'm with McKesson Corporation. And for the past 10 years, I've been working on the Drug Supply Chain Security Act for all of McKesson's enterprises. We'd like to walk you through today. A short video talking about some of the changes coming up in November of 2023 as it relates to the Drug Supply Chain Security Act and the use of transaction information, transaction statements and what data you can expect to see as we move forward with the next evolution of the DSCSA. This video is part of a series of other videos that talk about a variety of topics of what's changing in November of 2023 which is the last and final evolution of the DSCSA. The other videos cover topics such as what is a global location number or GLN? And why do I need one in order to participate in the DS CS A after November 2023. What things do I have to do for myself as a practitioner or dispenser that I cannot rely on others such as my wholesaler to do for me under the DSCSA another video topic we have is where can I find my transaction information and transaction statements for my purchases from McKesson? And how do I access that data, whether it's in the portal or whether I'm using a third party solution provider to hold that data for me. And another topic we have in this video series is going to talk about what changes can I expect to see happen to sale over returns processes as the DSCSA changes those requirements for my trading partners or distributors come November of 2023. Each of these videos have intended to be a short 10 to 15 minute segment talking about a particular topic so that you don't have to consume them all at once. You can pick and choose which topics interest you, you can consume them in small bites at 10 to 15 minutes perhaps on breaks or lunches if you, you may have time because we recognize that you and your practice are very busy and while this is a regulatory compliance thing that may be a bother or sound like a nuisance to you, it is something that's very important to you as you look to being successful and make sure you're compliant with the laws of forward. So today we're gonna talk about these topics. Uh but we're starting today with uh what is the transaction information, what transaction information changes this November? And I'll start first with a little bit of a history lesson on this. So the DSCSA began in November of 2013 and set up a 10 year evolution for us to move from what at that time was a variety of different state pedigree programs to a single unified national program for traceability under an interoperable electronic system. We began in 2015 with very rudimentary traceability requirements often called lot level traceability, but it's somewhat misnamed because generally lot numbers were not included in the detail that was being provided. But it basically detailed out at that point, who was the buyer, who was the seller of the product? What was the product that was being transacted at a fairly high level N DC number and quantity for the most part? And what was the history of that particular product as we moved from 2015 into 2017 and 2018, the DSCSA began to change how products were marked and how they were identified. The markings changed from being just the linear barcode that had been on his health care packages historically to a two D data matrix barcode that still included the NDC number included in cased inside it global trade number. But it now also includes in that barcode, the lot number of the product and the expiry of the product which had been in human readable format only before, but now is included in the data and it adds 1/4 variable which is the identification of the individual package at a serial number level. Each individual package has a unique serial number on it. So while it may be part of a batch of 10,000, in that batch of 10,000 will be bottles numbered 123, et cetera. All the way up to 10,000. These unique serialization attributes identify that unique package and allow it to be traced all the way through the supply chain from the manufacturer to the distributor, from the distributor to the dispenser. This is really the crux of what 2023 is going to start to change is in November 27th of 2023. As manufacturers sell product to wholesale distributors including McKesson. They're going to be required under the DSCSA to identify the serial numbers of the cases that they're selling to McKesson and the serial numbers of the packages inside the cases for every transaction. If McKesson is acquiring 50 cases from a manufacturer, we are required to receive from that manufacturer details about it's case number one, it's case number two, it's case number three and case number one, it's also required to be more detailed even than that to say case number one is NDC number 1234 from lot ABC D. It all expires in July of 2026 and inside this case are bottles number one bottle, number two, bottle number three et cetera. Every single one of the cases that we receive from the manufacturer is expected to have that level of detail, identifying the cases and the individual packages inside those cases. Similarly, when McKesson goes to sell a new product as an expenses or practitioner purchasing from McKesson, we're expected to detail the product information that we're sending to you in a similar fashion. If we are repacking totes or repacking ups boxes to send to your location, we're expected to detail to you that inside this particular box, there's two pieces of NDC number 1234, they expire on the following dates. They're from the following lot numbers and it's serial number one. It's serial number five, it's serial number 16 and it's serial number seven two. As an example, we're required to get that level of detail for every single bottle that's in every single repack box. If we happen to send you a full tote, that way, all that detail will be aggregated and tied to the label that's on the outside of the tote. So that tote will have a serial number. Also to say that that tote is tote number one and these are the products inside. Should you happen to purchase a multiple that's shipped to you? In the original manufacturer's case, we will send you the manufacturer's case serial number and the detail of the contents of that case as the manufacturer informed us. So we'll rely on the manufacturer's aggregation information to pass that forward to you as part of the transaction information. The transaction information and the transaction statement are required elements of the DSCSA for November of 2023 to include the serial numbers of the product identifiers and must be passed to you at or prior to the change of ownership of the product. We can't do it after the fact, it's required to be fairly contemporaneous, come to you very shortly after the point in time that we finish processing your order and should be there before you actually receive your order each and every morning. Now, your data will be available to you in two different formats. Every customer is going to have their data put into the portal system and can view it through any one of the McKesson portal. Should you choose to do that? Should you choose to have your data sent to either an in house data storage facility or have it sent to a third party DSCSA system? We can facilitate that as well using an industry common practice called A PC is this is the file format that the manufacturers and wholesalers in the industry and the solution providers have agreed upon and the FDA has endorsed as being suitable for transferring data between various different electronic systems. We will have another video talking exclusively about how do I find my D sds, a transaction information and transaction statements from McKesson, how do I access the systems to look at that data? And how can, what can I do with that data once I find it? But we wanted to cover with you today, what changes in terms of the base information that we have to pass along to you for transaction information and transaction statements in November of 2023. Now, along the way, we've been likely sending you since that time, either data in A DSCSA enabled A sn that's being sent to your solution provider. If you're using one for DSCSA purposes, or you've been accessing your data through the McKesson portal that accumulated data in the McKesson portal will continue to reside in the McKesson portal. So you can always look back at it and view it in the future. Uh but very similar to the way you may have been accessing it before you'll be able to access your your new serialized data as well. Both systems will begin to run in parallel here fairly soon. The DSCSA enabled lo level systems with the A SNS or the portals will continue to run all the way through November 27th. As your regulatory source of truth, if you will, you'll begin to see your serialized information also being posted to portals and also soon being transmitted to your solution providers. If you've selected one uh in parallel to the original lot level data that began in 2015 this additional serialized information or serialized transaction information is not a regulatory requirement for you to have it until November 27th. When the law says we switch from the original lot level or rudimentary traceability model to the new model where we are tracing based on the serial numbers through the industry. So you'll have all sets of data between now and November 27th running. The original rudimentary lot level data is your compliance data. Be sure to maintain that. Don't, don't delete that, don't throw it away. Um Your data that you're going to be seeing from the serialized side is there to help you evaluate systems and processes. We get ready for November 27th, but then on November 27th, that data becomes your compliance data and while your lot level data will continue for a period of time after that date, it cannot be used to meet the requirements of the DSCSA. There's no hurry to turn off that lot level data. It doesn't cause us any extra problems with creating it and publishing it. So we're not in any great rush to take and shut that down. But uh we do wanna make sure that we can start testing the new serialized information that you'll see for November of 2023. So as I mentioned, this is short primer on what's going to change from transaction information in a transaction statement perspective as we look at November 2023 a lot of granularity is going to come in here as we have a tremendous amount of visibility required to know exactly which pieces is it that you're purchasing? After November 27th, we have to have that level of detail. But in the other videos, we will talk about how that detail is going to be used, how it's going to affect things like what questions you may have to answer to a regulator if they ask you about a product, what may change as far as a saleable return that may occur after that November 27th date. So be sure to check out the other videos in this series to help yourself get educated. But also if you have somebody else in your organization that may benefit from this video series, be sure to share the with them. Uh You, they could watch all of them, they could watch, whichever topics may be applicable to their particular role or their particular interest. No problem there, but they're all designed similar to this 1, 10 to 15 minutes to give you what you need to know in a short, easily digestible format. And with that, uh if you have any additional questions, I strongly encourage you to submit them to your customer support representative. Thank you for joining me today.