Preparing for DSCSA – What Actions Do I Need to Take

Hello and welcome. My name is Scott Mooney with McKesson Corporation and I'm about to talk to you about the Drug Supply Chain Security Act and the changes that come in November of 2023. This particular video is around what things must I as a practitioner or pharmacy, be able to do for myself under the DSCSA that I can't rely on others such as my sole seller to do for me. This video is part of a series of five videos that talk about a variety of DSCSA topics such as what are the changes that are coming in November of 2023. What is the global location number? And why do I need one for DSCSA purposes? Where do I find my transaction information and my transaction statements under the November 2023 DSCSA requirements. What things must I as a dispenser or practitioner do on my own or for myself under the DSCSA that I cannot delegate or ask others to do for me. And finally, the last one in the video series is what changes the DSCSA impose on saleable returns as it changes the requirements for wholesalers in November of 2023. These videos are all designed around the core concept of making them easily digestible by you or by members of your organization by putting them into short 10 to 15 minute formats that can be reviewed during a break or during a lunch or when you happen to have time to sneak away from the busy things that you do day to day in your practices. We recognize that you're very busy and that the regulatory topic is sometimes challenging when you're doing the other things to keep your practice moving. So we try to make this as simple and easy for you as possible. So let's move on to today's topic and that topic being what things must I as a dispenser or practitioner have to do for myself under the DSCSA that I cannot rely upon others. When we talk about what changes in November of 2023 there's a couple of things that are all kind of ingrained together around the use of the new barcode and the new serialized information that's included in the product. One of the first was that discussion that we had in the other video about being able to receive transaction information from a purchaser perceived from a seller. Whenever a change of ownership occurred, that seller is going to identify to you that they're selling you. Case number one as an example, an inside case number one might be bottles one through 48. If it's a case quantity of 48 they're gonna identify for you, the lock number and the expiration date of that product. But also the individual serial numbers of each of the packages included. In that particular case, that information is posted to you either through the portals or is posted to you through the opportunity to use a third party solution provider, whichever you've chosen to use for your DSCSA record keeping. But the point of that is you now have detail about what products that you purchased into your practice. And people will be coming to you asking you about that from time to time. State Boards of Pharmacy and the FDA are both empowered to be able to enforce the DSCSA. And as part of their audits may come in and select an item off of your shelf and say, ok, I picked up bottle number five, show me your DSCSA data for bottle number five and you'll be expected with the inspector there in front of you to go find where you purchased bottle number five in your DSCSA transaction information and show that transaction information to the regulator. It is within their confines to be able to ask for any of that information upon an inspection or more problematically to ask for it during the course of an investigation. They may be investigating for some reason a bottle that they believe has got some issue with it, whether they believe it was diverted or whether they believe it was stolen and maybe asking you to produce your DSCSA records to show whether you did or whether you did not have that particular bottle in your ownership. At any particular point in time. You'll notice, I didn't say necessarily in your possession. The DSCSA is not about chain of custody. It's not about tracking physically where a bottle has moved through the supply chain. It is about tracking ownership who owns the bottle and who's lawfully responsible for the bottle is what the DSCSA requires. So it's about tracking whether or not you purchased that item, not necessarily about whether it was physically in your building. Other things the inspector may ask you to do in the course of that event is, may be able to ask you about lot numbers that you may have purchased if they're checking up on a recall to see if you pulled that product from your shelf or if you properly notified patients who may have been exposed to it. Investigators are empowered by the DSCSA to look at a variety of different things and those can all be accessed or referenced by DSCSA transaction data to support that this bottle was yours or this bottle was not yours that they may come along and seek. You'll also from time to time be expected to do what's called a suspect product investigation. If you happen to come across a product that's coming into your pharmacy, that you have one or more indications may lead you to believe there's something wrong with it. That that's possible that it's an illegitimate product, it becomes what's called a suspect product as soon as you have that indication that there's something up, These indications may be that you received a package that is lacking a US required items such as the NDC number being printed on the package or such as the two D data matrix barcode or the linear barcodes that the US FDA requires as part of the labeling. It may have a foreign language on the package. It may be something that all the other packages you have for that particular product are in a blue box. And for some reason, this one comes in a, in a green box and it's slightly different color. You may have a reason to believe that perhaps it's not authentic, any of those things cause you to believe that there's a suspicion that the product could be illegitimate. And you're required to begin doing a suspect product investigation under the DSCSA. This is nothing new. The DSCSA has required this since 2015 of dispensers, but they're adding to this complement of information, the requirement that when you're doing a suspect product investigation that you look at the barcode, you look at the serial number and you corporate that into your process that you go back and reach out to see? When did I buy that particular serial number? And what transaction information do I have to support that? You share that serial number with your upstream trading partners as you do the investigation, so they can incorporate that into their research to see. Did they believe that they sold bottle number five. Does the manufacturer have a record they ever made? Bottle number five as an example. So you're expected to use that serial number in your suspect product investigation for the purposes of looking at your, your tracing history of that particular item. But also to validate or verify is the term that the DSCSA uses that that serial number was created by the manufacturer. These are things that can't be done for you by a third party or by an outside party. It's something that's required to be done by you as a practitioner or a dispenser. And it can't be something that the trading partner who sold you the product can do on your behalf. Now, they'll certainly participate in your suspect product investigation because they have to look at their own records as well. They have to also look at their own inventory in case there's any more product that may look like the product that's under suspicion, but they can't, can review your product for you. They can't document your suspected product investigation for you. And, and that kind of brings me to the next point. Each of you should have somewhere in your pharmacy an SOP that describes what steps and processes you'll follow. If you find a suspect product, the suspect product investigation SOP, should be something that you can pull out again to show that inspector or regulator who may come in because they may ask you about, what do you do if you see a suspect product and if you can pull down the SOP from a binder on the shelf and say, here's, here's my operating plan for what I'm going to do, show that to them. And if you document in here that I'm going to take and quarantine the product and I'm gonna put it over on the left shelf, be sure that you can show them anytime you've had a suspect product. That that's exactly what you did that you documented that I found a suspect product and on this date and time I put it on the left shelf, that suspect product, investigation packet is required to be retained by the DSCSA for a period of six years. So we strongly encourage you to have an SOP for that purpose. We strongly encourage you to follow what you write in that sop that you're going to do because the expectation of the regulator is going to be more focused on. Did you follow the SOP and any cases? So we talked about what you do for an investigation. We talked about the records, you should keep about an investigation. The last step in the process that we can't do for you as your wholesale distributor and as you can't delegate to another party is reporting to the FDA. If you truly at the end of your suspect product investigation, determine that an item is still legitimate. The DSCSA requires anyone holding an illegitimate product report to the FDA on what's called a form 3911. The information about the illegitimate product, this form is going to ask you who you are. It's going to ask you about how did you get the product? It's going to ask if you know that it's going to ask you about what is the product and in the, what is the product? It's going to ask you for the information about the NDC number that's involved a lot, the expiration and the serial number of the packages that you have. This form 3911 also has been around for a couple of years, but the change for November of 2023 is that the serial number now needs to be incorporated into that particular document. So be sure to be aware of that, be sure to be able to retain that. These are all things that these records, whether it's the filing of the 3911 with the FDA or your suspect product investigation are covered by a six year record retention requirement in the DSCSA. And it's not six years from the date that you purchased the product, it's six years from the end of your investigation of the suspect product. So if you're looking at a product, you may have purchased last year and you're looking at it now and you're investigating it. Now, the calendar starts six years from when you finish the investigation. Now, not from a year ago when you purchased the particular product. So that kind of walks you through some of the things that we can't do for you as your wholesale distributor. We apologize, we can't do it for you, but please understand we can't stand in your shoes and make statements to regulators on your behalf. That's something that you have to do on your own. I think you understand that and it's not too much of a problem. Hopefully they don't have a lot of these incidents where you're having to deal with the regulators, but be prepared for when the regulator comes in. No, how to access your transaction information. If they're asking you to trace an item, know how to show them your transaction information. If they want to see. Where did you acquire a particular item? Don't let it be the first time that you're trying to figure out how to get into that data when the regulator is standing there at your counter, drumming their fingers waiting for you to figure out how to log in and look the data up. Be sure that you've done that ahead of time and that the staff in the pharmacy should do not be there, knows how to do that and can answer those questions. You have 24 hours in the law to respond to a regulator's request for tracing information. It's a fair amount of time. If you know what you're doing, it's not a lot of time if you're trying to figure it out for the first time, so be sure that you're prepared ahead of time how to answer that particular question. If you have other questions about what you have to do for yourself or what we can't do for you under the DSCSA, please feel free to reach out to your customer support representative or team. They're prepared to take those questions and channel them into the appropriate people at McKesson to get you as best of an answer as we possibly can. Please look at the N CPA website if you're looking for that model suspect product SOP that you want to have available in your pharmacy. And as always, thank you for joining us in this small short 10 to 15 minute video. Feel free to share this video with others in the organizations who may have interest in this particular topic or any of the other topics covered in the five videos in this particular series. Thank you very much for joining me today.