DCL Learning Series

Christopher Hill:

Hello everyone. I'm Chris Hill with DCL and welcome to our DCL learning series. Today's topic is "SPL is Here to Stay in the USA." And shortly we'll be hearing from Howard Shatz. I'll introduce him in a moment, but before I do that I want to just give you a brief introduction to who Data Conversion Laboratory is. Data Conversion Laboratory provides data and content transformation services and solutions. And since the 1980s, we've really been focused on the tasks of bringing data to a level that makes it more consumable. And that's becoming increasingly critical as we find the economy runs more and more on this well curated, structured data. So over the years, we've been through a huge number of changes from SGML to XML. Those terms don't mean anything to you. That's okay. We can cover that later. And lately we've gotten into some of the latest tools like machine learning, artificial intelligence, natural language processing.

Christopher Hill:

These are all things that we bring together into one organization, and it makes us experts on organizing and structuring content data for modern technologies and platforms. To do that we have a number of services that we've developed over our long history. We do the data conversion and transformation tasks, which is oftentimes, as straight forward as I've got a bunch of word documents. I need them in some other format for some other purpose. We also can help design architectures around that, that hopefully minimize the amount of future conversions you might have to do. We do enrichment, which is to bring greater metadata and other information to improve the utility discovery and interoperability of your content. We can do decomposition and entity extraction tasks where we go to freeform text and we pull information out using a number of techniques.

Christopher Hill:

And again, that's where a lot of our AI and machine learning work is emerging. Data harvesting, sometimes you need to get data from websites or applications that traditionally maybe don't have an API or an easy way to collect it. We've become experts on a number of tools that lets you go out and find that information and pull it in from wherever it might be and then put it together in an organized way. All of this leads to a QA expertise, so quality assurance. We have many approaches that we can go and make sure that not only are these tasks being done, but they're being done to the level of quality that you need to make it usable in your organizations.

Christopher Hill (3:15):

Content reuse is a big area that I'm involved in. I happen to be the product manager of one of the tools in this area. I won't go into that, but basically it's trying to identify where are all these duplicates happening and how do I build an architecture that can let me avoid having many, many, many copies of things and having to maintain all those copies. And then we also get into structured content delivery, and this is working with a number of our partners and other vendors who have platforms to deliver content to a large base of customers through the web or other technologies. And we work with a lot of those companies. We've probably worked with them all over the years because again, when you want to distribute that content, you have to get it into a form where these platforms can efficiently deliver them. So that's a little bit about what we do at DCL.

Christopher Hill:

We're also very active throughout the industry. We have memberships and most of the major industry memberships. Some of them are listed here. And as I mentioned, we've been around and doing this since the '80s. So we certainly have had plenty of opportunity to meet a lot of people out there. Here is just a small sampling of some of the verticals and some of those people that we've met over those years. You'll see that we work across many different verticals. This isn't even a comprehensive list when you've been working as long as we have in the business. We've worked with most major organizations that have content requirements. So we certainly talk to them all. So that just gives you an idea of all that.

Christopher Hill:

But enough about DCL let's get into the subject and today's presenter. So I'm really pleased to present today one of our experts, Howard Shatz. He's been active in the SPL world since its inception in 2003. So he's an active member of the SPL working group, composed of pharmaceutical companies and conversion vendors like ourselves. And that activity gives him a lot of knowledge as well as the networking and the connections to really know this business well. Howard serves on the establishment registration, drug listing, and OTC sub-teams of the SPL group, as well as on the leadership team. So pleased to present Howard Shatz, our product manager and SPL specialist at Data Conversion Laboratory. Howard, take it away.

Howard Shatz (6:06):

Okay. Thank you. So just to cover briefly that we're Life Sciences Offerings in general. Of course, SPL is Structured Product Labeling. We do conversions, we do FDA submissions. Those submissions are restricted to the listing submission. We'll talk about listing submissions versus approval submissions. But even if you're not using us for the conversions, you can use us for SPL consulting and training. We can do one on one. We can do it in a group setting. Those are options. Some of you may be aware of the ACA 6004 regulation to report drug samples. That's the Affordable Healthcare Act among, everybody knows that in terms of the insurance coverage and whatnot, but also in there is the requirement that drug companies report the free drug samples that they distributed to healthcare providers, is not the sample size that you might ... well, this is the sample size you'll get from your doctor or so on.

Howard Shatz:

So we can handle those. Also, as part of our general offering, not confined to life scientists, but technical and compliance document management. We can do document management consulting and data conversion services. I don't think Chris mentioned it, but we've been in business for almost 40 years. It's over 39 years, a couple of months over 39 years. And so we're well on it. So next year we'll be able to say 40 years of doing this type of work. Okay. So if we can move on to the next slide.

Howard Shatz:

Okay. So just for orientation purposes, we've picked a label that's in the DailyMed archives, not a label we did, but we wanted to make sure what the focus of this webinar is that you get to do these listings correctly. The listings that you see on the DailyMed, which this comes from, are what we call the final listings, the ones done by the distributors of the drug, in this case by Bryant Ranch Prepack. So what you don't see on the screen in this screenshot is all the texts that have preceded it. In other words, you have for a prescription drug product, you have the package insert, those little tiny pieces of paper that come with the prescription drugs. For OTC, you have to have the drug facts as content of labeling.

Howard Shatz:

So that's all preceding this. And then what you're looking at here is what we call the drug product information table, which has the scientific information about the drugs, what the dosage form is, what the route of administration is. So this is subject to all sorts of FDA validation rules. So it was the text that proceeded it, the content of labeling, and the package insert, the drug facts. But we're not going to go into that really today, but we will be talking about the drug products formation. Again, this is the heart of it.

Howard Shatz:

Now I should also mention by way of orientation, we're going to be talking about the drug listing submissions that you do to the FDA. That's for in the case of prescription drugs, it's been approved by the FDA, and now you want to market it. If it's an OTC drug and you're subject to a monograph, you just want to start distributing it, those are called the final listings. But in addition to that, the FDA regulations require that the manufacturer of the drug, even if they're not the distributor, they have to list the drug as well, not just the private label distributor but the manufacturer. There have to be two drug listings, but the manufacturer listing is a much simpler one. It does not need the content of labeling I was talking about before. It's just basically giving you the drug product information, this table that you see here, and it's not put on the DailyMed.

Howard Shatz (11:12):

So it's not to scare you. We're going to put up the next slide, but I don't want anybody to be scared. But we're going to show you an excerpt of what the SPL looks like. We speak about Structured Product Labeling. Structured Product Labeling is based on this format that Chris referred to earlier, that would then explain XML. It's a readable format. Human beings can actually read it, whether they can understand it is another question. You need training to understand it, but we bring it up here just to show you what it looks like. And also we highlighted a couple of pieces of information.

Howard Shatz:

The first one you see is the set ID and version number. Now that is a critical piece of information. When you drug list something, every version of that drug list, as you modify the drug listings, you must have that same set ID that you use the first time. And every time you submitted, you have to increase the version number. So that's a critical piece of information, and that's highlighted as set ID, and it has something called a root attribute. And that has some globally unique identifier, a series of letters and numbers. And that'll identify the drug and all the variations of this listing as it goes through time by cycle. And the version number, so I'd say, "Okay, this is version number four of this particular drug listing."

Howard Shatz:

We also highlight the DUNS number. We're going to talk about that a little bit more, but I imagine many of you are already familiar with it. But that's a critical to every type of SPL file. Every company, the FDA uses the DUNS number as the unique identifier for a company. And we're going to talk about that in a couple of slides. And also to show you that there is some method to this madness, we highlighted the product code, right? The NDC consists of three parts, the labeler code, the product code, and then the package code.

Howard Shatz:

So in this SPL file the product code is used for two different purposes. One is when you have an establishment, it shows you when you list the establishment. In this case, the establishment is Bryant Ranch Prepack and Distributor is the manufacturer. And they're involved with manufacturing the product code, that particular product code. You may have multiple product codes in a listing, and the FDA wants to differentiate if you have several different product codes and you have a bunch of establishment, which establishment is involved with which product code. And even if you only have one establishment in the listing, you have to specify each of the product codes that are in that listing for that establishment.

Howard Shatz:

Okay, so we're ready to ... and if we have no questions at this point, I will go on to the next slide. And these are the key considerations. With the new drug ... well, it's no longer new. It was in 2017 that the FDA issued what was called then the final rule. Now it's just the regulation. But they require that drug listings need to be certified every year. We want to ensure that the information is the file, is the most current version. And the purpose of the regulation was that the FDA was finding that people would list the drug when they first started marketing it, and then forgot about it. They never updated the information that the FDA had in this database. The FDA is charged with maintaining the safety of all the drug products.

Howard Shatz:

I'm not paid to be a spokesman for the FDA, but I respect them for what they're doing with this. And they're saying, "Well, it's our responsibility to maintain the safety of the drug supply. We have to know all these different things about the drugs." So they want to make sure that the drug things that they have in their databases is the most current version. So each year, a company needs to go through all of the products that it has listed with the FDA and make sure that the listings that are there, which in the case of final drug listings, they're on the DailyMed, but even for the intermediate drug listings, they want to make sure everything is current. So they put the responsibility on the manufacturer to make sure that the listing is the most current version. And if it's not, if they've changed establishments, for example. If they were a private label distributor and they used to get it from company X and now they're getting it made by company Y, they've got to revise their drug listing to have that.

Howard Shatz:

The FDA reviewed the drug listings are verified, and they verify that some or all are completely up-to-date. They don't have to do anything. Then they submit what's called a Blanket No Change Certification. When they submit the Blanket No Change Certification, they're certifying that the drug listing that is already on file is the most current version. And they can have multiple product codes labeled or best product code combinations in that Blanket No Change Certification. And they can say for each one of these, these are all up-to-date and they can do that once. If all of their drugs need absolutely no revisions, they can just submit the Blanket No Change Certification. And even if they have a hundred drugs, they can [inaudible 00:17:34] one Blanket No Change Certification, and all those 100 drugs will be certified. If any of those 100 needs revisions, they need to resubmit the entire label.

Howard Shatz:

Two key differences is that if they need to submit a revised version, they can do it at any time during the year. And the way the regulations are written, they are supposed to resubmit the file either this June or December after the revision, whichever comes first. So if they change the listing in April, by June they should be submitting a revised version. If they change it in July, they should be submitting a revised version by December. But if they have no changes to make, they can only state that in the last quarter of the year. And from October 1st through December 31st, they can do this Blanket No Change Certification.

Howard Shatz:

Now, besides making sure that nothing needs to be changed, they also have to make sure that the current listing meets current validation rules. As you know, when you submit a file to the FDA for a drug listing, it has to pass validation. Validation rules do change over time. Now, it could be something that is out of your control. They have for every active ingredient, or every ingredient I should say, they have a preferred substance name and a uni. The FDA can change that preferred substance name and/or the uni if they so choose. So you have to make sure that whatever your listing has, that has the current preferred substance name and uni. It could be something that's in your control. You just didn't pay that much attention, because if you're in regulatory operations, how did you know that they're getting the drug manufactured by a different establishment?

Howard Shatz:

So if the establishment is no longer registered, if the old establishment that you were using is not currently registered ... When your listing is no longer valid, according to FDA validation rules, every establishment in your drug listing has to be currently registered. So therefore you would date to update your listing to reflect that. To make sure it passes validation we have, later we'll be showing a link to the ... we have various resources available to you through our website, but there's a pragmatic data site for those who are not familiar with it. It's a publicly available site that allows you to validate SPL files and also to view SPL files. When you try to open up an SPL file in internet explorer, depending on your internet explorer's security settings, your company's security settings, it may come out like just the bunch of texts without looking nice and pretty. If you do it through the pragmatic viewer, it will look okay, you'll be able to read it.

Howard Shatz:

But they also offer a validator. Now, the validator was developed to catch 90 to 95% of the validation rules that the FDA has. So if you pass pragmatic validated, you're in pretty good shape. When it goes through the FDA validator, the FDA validator is adding validation rules to check against the data that they have in their own databases. But you can use the pragmatic validator to see if you meet most of the validation rules. Okay. I think we've beaten this one to death and we're ready to move on to the next slide.

Howard Shatz:

Now I mentioned the DUNS numbers as being a common ... In every SPL file companies will be referenced by their DUNS number. Now, depending on what type of SPL file it is, you may have the company name and DUNS number and just that, or you may have the company named DUNS number and its address. A common problem that we have here, and that obviously other people doing SPL filings, is that the DUNS number, that information, that was included in the SPL file that was submitted to the FDA did not match the DUNS number information that is found in the Dun & Bradstreet database. So Dun & Bradstreet partnered with the FDA, I don't know if it's legally a partnership or whatever, but to facilitate SPL submissions and maybe for other FDA related submissions as well. But the Dun & Bradstreet set up the FDA DUNS portal. And you can use that to verify that you both have the correct DUNS number and that you have the correct address and company name for a company.

Howard Shatz:

If you put an SPL file with a company name of, let's say, ABC Inc. And that DUNS number is in Dun & Bradstreet as ABC LLC, you will get a validation error because the names do not match. So through the FDA DUNS portal, you can see what the company name is, and you can also check all the components of the street address if you would need to include the street address in your file. And it's a very nice site. It's free. You need to register when you put in a DUNS number. And that you have to put in the address information, you don't have to put in the DUNS number, but it will validate your information. So if you did not have the DUNS number, if you just entered the company name and street address, it'll come back to you and tell you what the DUNS number is that you can use now.

Howard Shatz:

And also keep in mind that company's DUNS number may change over time. So it's important to keep track of that. And they'll validate it for you right on the screen and they'll also send you an email. So I found it very nice to use. Of course, you can always go to the establishment registration. If you're talking about a company that's registered as an establishment, the FDA has a separate establishment registration site, and there they show you the DUNS number and the address for companies, you can match it up against there. But for distributors in particular who are not registered as establishments, this is a very convenient way, a free method of verifying the DUNS information.

Howard Shatz:

Okay. So we're ready to move on to there. And again, on our SPL resources, we will on the FAQ, we'll give you the URL for that. Okay. So, yeah, they just put up the Dun & Bradstreet email that shows you. Now, what I want to get into is the BNCC details. As I described it before, it's a convenient way. If you've had no changes to your labels, to labels during the year, rather than having to resubmit each and every label that had no changes ... now, by the way, you can't just resubmit a label if it had no changes, you must update. There's a document ID. those who were paying careful to that slide we put up earlier, you'll see there's also a document ID, so you have to change that. You need to change the date. So there are things that you need to change, and of course increase the version number. You don't change the set ID. That's one thing you don't change, but you do have to change the version number, the revision date, and the document ID at a minimum before you resubmit a file that has "no changes".

Howard Shatz:

However, while it's convenient, it will fail validation because of the type of checking that it does. So again, what you're doing essentially in the BNCC is to provide a product code or product codes. And for each of those product codes, you're providing the DUNS number of the establishment. So what the checks that it does are as follows going by this bulleted list. So when you include a product code, the FDA goes out automatically checks the label, the listing that you currently have, and then makes sure that it meets current validation rules. As I said, among other things it will check that the establishment included in there are all currently registered. But if there was a change of preferred substance name or unis, it'll pick that up. And there are a whole host of other changes that don't occur very often, but if they do occur and you don't have it in your current listing, it'll flag it as an error.

Howard Shatz:

Also, the BNCC is limited to products that have a marketing status of active. Active means that you're currently distributing the product, your product is still being manufactured. If you're a private label distributor, and you're working with a contract manufacturer, that contract manufacturer is still producing the drug for you. So that's an active drug. If you have de-listed the drug ... now the de-listed drug means that you're no longer manufacturing it. You may still be distributing. You have inventory that you're sending out, but you're not expecting to start up manufacturing anytime soon. So you tell the FDA, this is completed and you give an end marketing date that says the expiration date of the last lot manufactured. So that effectively de-lists the product. Now that doesn't mean it's not on the market. It just means that your note is no longer being manufactured, but it may still be on the market. It goes off the market when the expiration date of the last slot manufactured is reached, because then it knows that it's no longer available in the marketplace.

Howard Shatz:

So it'll be on the DailyMed, for example, even if it's completed, as long as you haven't reached the end marketing date. Now again, one of the checks, which I've mentioned before, is it specifies a company that is not currently registered as an establishment. Another common mistake is that you're using the private label distributors number. I'll use the example of CVS and National Chain. And they have their own label of code. To the best of my knowledge, they don't manufacture any drugs. They contract that all to the manufacturer. So if you put in a CVS NDC product code, the label look under product code for CVS product, and you associated with the CVS DUNS number, that will be a invalid submission because the DUNS number must be the manufacturer of the drug, not necessarily the distributor.

Howard Shatz:

So when that happens, I gave the example before of you've included a hundred product codes in there and two of them failed validation, well, guess what? Your entire BNCC is rejected. You then have to go and either fix the DUNS number. If your error was that you used the private label distributors DUNS number, not the manufacturers. You can fix that DUNS number. But if the label is not currently valid, it has an unregistered establishment in there, or any other validation issues, then you must resubmit the entire label. And once you submit the entire label that you've certified the product, and after you've taken out those DUNS numbers of those product codes that did not pass validation. If you typically take out those ones that did not pass validation, you resubmitted without those, and then you fixed the ones that ... and you resubmit the individual ones that had validation errors.

Howard Shatz (32:24):

Okay, so we're ready for the next slide. Now, an important thing is maintaining the drug listing. We've been talking about these BNCCs and resubmitting the labels. The FDA has lately been notifying and last year, they slotted the new policy, they notified companies if their drugs were going to be declared inactive. Inactive means that the drugs were not certified in the prior year and/or if there are products that have deficiency levels associated with them, the FDA had done a manual review and identified problems with the listing and had notified the company with a deficiency letter that says, "You better fix this before you relist it." So in any of those cases, they're going to be inactive.

Howard Shatz:

So the NDC directory provides you with a way of checking the current status of just about all the labels. I'd say just about all there is an exception, but the point is that you can go into the NDC directory and if you are talking about what I was referring to as a final drug listing, you want to go into finished products. You'll see that there's a box there for finished products, and there's a second box of, I should say, button for unfinished products.

Howard Shatz:

So finished products means that this was done under an NDA or it's subject to a LTC monograph. There are a number of different categories that fall into finished product. But then you can search the NDC database for the finished drug products and for either finished or unfinished, you can do it by specifying the label or code, you can do it by the proprietary name and so on and so forth. There's a pull down list that makes it very easy. My personal preference is you either put in the label or code in which case you'll get all the products that are for that label of code or you can put in a labeler code, the actual product code, and you'll get just those product codes. That's my preference for those. But you'll get a list and the list will show you whether it's active or inactive.

Howard Shatz:

So when it's active, you'll get all sorts of information about the drug that'll be displayed and it'll be in black font. If it's inactive, it'll just have minimal information on it and it will be in a red flag. So it makes it very simple. Now that's for the finished products. For the human API or intermedia drugs, you can use the unfinished products. Those are the ones that are drugs for ... as long as they're drugs for further processing or an API. An API means all you're making is a active pharmaceutical ingredient and that's being used to create drugs. That's been used as the active ingredient in other drugs. That's an API, that's a bulk ingredient.

Howard Shatz:

A drug for further processing is you've manufactured, let's say, a thousand tablets, you've packaged them in a drum and you've shipped them to somebody else to be packaged and labeled. So that's a drug for further processing. It's not ready to be distributed in the marketplace. It's not ready for commercial distribution. It's at an intermediate stage of being manufactured. And so you listed as a drug for further processing. So those two APIs and drug for further processing are listed under unfinished products.

Howard Shatz:

A drug that's manufactured under contract of the example I gave of CVS, so they use company X to manufacture the drug. Company X is supposed to have listed the drug using their label of code and under the marketing category of manufactured under contract approved drug product, or LTC monograph drug product manufactured under contract. So those listings are not made publicly available at this time by the FDA. So if you want to check on the status of any drug that was manufactured on a contract, you have to contact the electronic drug registration listing system group, EDRLS, at an easy-to-remember email, edrls@fda.hhs.gov and say, "Are these currently listed or what's the status of them?" And they do get back to you. Maybe not right away, but they will get back to you.

Howard Shatz:

Okay. So we'll move on these ... So finally we summarize the general tips for successful drug listings. You use the proper document type, bulk ingredient for APIs, drug for further processing, for drugs that intermediates stage, except manufactured of the contract. And again, the manufacturer under contract is really ready for distribution. At that point, it's been packaged, it's been labeled, but it's just being distributed by somebody, not by the manufacturer and when you have a final drug listing use the appropriate type. Typically, it's either human prescription drug label or human OTC drug label. Okay. Now, the DUNS number and company name validate the number, verify the legal entity name [inaudible 00:38:50]. So I've said legal entity name and address. For those SPL filing, such as establishment registration, where you have to specify the address for the entity, you need to make sure it matches the Dun & Bradstreet information. And then for drug product information, their FDA validation resources, we'll be distributing that after the meeting I believe. And then we're ready to go onto the next slide.

Howard Shatz:

Okay. So I've been giving you a general overall tips for doing these things, whether you use DCL or anybody else, but for those of you on the call who are ... that's the middle of the DCL process, we'll have a word from the sponsor of this webinar. And we'll go through how we handle these processes. So the client notifies us of the conversion requirement, and then we get the materials for the conversion. So if it's an initial conversion, we need the content of labeling. That's the drug facts or the package insert typically. We also provide an Excel workbook that will be shown in a couple of slides where you enter the drug product information, that same drug product information table that you saw at the beginning of this presentation, that information is provided to us as an Excel workbook including the establishment information and the drug product listing data.

Howard Shatz:

And if you want the product image file, that's a special category that the FDA provides, but not many people are using it where if you have a solid dosage form product, that tablet or a capsule, and you take pictures of it subject to searches specifications you can use that image as a product image file. If you have a revision process, if you have revisions to make to an SPL file. Ideally we get the word document, we track changes. We are flexible. We can get the revisions in other ways. We need the previous version of the SPL. If we're only going to be revising the SPL we want to have the SPL, so we don't have to recreate it from scratch and also if needed the DCL workbook for changes to SPL or establishment registrations. Okay. All right. And so next slide.

Howard Shatz:

Okay. Now what we do is we then process the materials that we received. And the initial conversion, we converted to SPL. And in the revision process obviously, we revise it to SPL. We deliver to you the SPL, and we have reports and forms. We have a feedback form where you can give us requests the changes. We will evaluate them. 

Sometimes their wording changes that you recognize. Sometimes there are issues you have with how it displayed, but there's nothing we can do about it because this is SPL. It's subject to an FDA style sheet. We have limits as to what we can control in the appearance. And occasionally, admittedly, maybe we made an error somehow to fight all of our checking, our QC software that does the text checking and whatnot. Maybe something needed to be changed, but we'll change it. You review the SPL and if necessary, provide the DCL with the feedback using the GCL form. And upon client approval, we can submit the SPL to FDA for a drug listing. Again, we don't do submissions for an ECTD for an approval submission, but we can certainly do the listing submissions.

Howard Shatz:

Okay, moving along. When you become a DCL client, we provide a number of resources to make your FDA submissions accurate, fast and easy. We send out an SPL welcome kit. Net welcome kit has instruction fusing the DCL workbook, establishment registration, labeler code requests, new SPL label requests, and revised SPL label requests. And you have a snapshot of the workbook, which has a tab for most of the SPL files that you will be submitting, whether it's generic, self identification, establishment registration, NDC labeler code support, single component drug listing, or multi component drug listing. And so you just basically fill out the entries, and we provide instructions next to the cell so what you need to do.

Howard Shatz:

Okay. And file, we talk about our turnaround times. So again, for those of you not familiar with our service, if it's NDC labeler code or establishment registration, we'll turn it around in two business days, including the date of the request. So if we get it before 5:00 PM Eastern time on a business day, let's say on a Monday, we'll turn it around and get it to you on Tuesday. If it's an initial conversion of an SPL file, the state of turnaround time, there's three business days, which means if we get it by 5:00 PM Eastern time on Monday, we'll get it out to you by 5:00 PM, Wednesday. But we can do it less than that. We also have revision service, which we'll revise the SPL. If we received the request before 1:00 PM, we'll revise it the same day. Otherwise, we'll ship the revised SPL the next day.

Howard Shatz:

The upgrade of SPL the R3 SPL to R4, actually, we should be taking that out. That's become outdated. I think everything that's listed with the FDA is now in what's called R4 or later, actually. That was a special upgrade that was needed in 2012 or 2010. The normal hours expedite will be same day if request is received before 1:00 PM. After 1:00 PM we'll ship the next day. Before or after hours expediting or holiday weekend expediting is either one day or two days. But it's too big, the typical conversion time is so we need one day or two day turnaround notification before we can do it. And the TBD is because we have to make sure we have the resources in place to accommodate the expedited service outside of business hours. That pretty much wraps it up.

Christopher Hill:

All right. Well, thank you, Howard. That was very interesting. We can take some questions. If you have some questions, you can go to the questions box and feel free to type some in. I already have a few of them. One of them is a pretty straightforward one, is the webinar recorded for later viewing? So if you want to review this or, or maybe you missed the beginning or whatever, we certainly are recording it and you will receive a follow-up email with some of the links mentioned in this presentation, as well as a link to a recording of this. We'll also be including a link to our website. We have an SPL frequently asked questions page, and we'll be sending that along as part of that follow-up email. We have a few questions here, Howard, for you. Where can I find the rules for over-the-counter drugs? I guess, is that it's something different or what can you tell us about that?

Howard Shatz:

Okay. So they have a status of SPL rulemaking and we'll send that out with that ... That's in the FAQ. You need to be familiar, it'll give you all the regulations concerning that and what the status is to verify whether it's OTC monograph or not monograph.

Christopher Hill:

Okay. Another question comes in from one of our participants. What is the marketing date that should appear on the SPL? Is this the first date the product is on the market or is it the date it's approved?

Howard Shatz:

Okay. So there, the FDA is flexible. It should be the date it goes on the market. Let me just give you a little bit of background of how that date is. There are two marketing dates. There's one for the product and there's one for the package. So the one for the package is used actually by the Center for Medicare and Medicaid Services. If this is a drug that's reimbursable by them, they will use the start marketing date as being the earliest state that they will reimburse for you. So if somebody submits a submission for reimbursement for an NDC, and they say, "We used it on January 1st, 2020." And the SPL listing says they started marketing it on February 1st, 2020, then the reimbursement request will be rejected.

Howard Shatz:

But the general rule is that there is no set rule, but so you can use the date of approval, you can use the date that it actually gets distributed. I was advised by clients in the pharmaceutical industry that actually that date ... their CMS has these cutoff dates in order for the product to even appear in the CMS database. So you may want to do it a little bit earlier than the marketing date. Now, the other significant, practical factor to the start marketing day is that that is the date when you drug list. Again, this is final drug listing. That will be the date that the listing goes on the DailyMed.

Howard Shatz:

If you submit something today and it has a start marketing date of June 30th, it will not go on the DailyMed, it will not be publicly available sites like DailyMed until June 30th. So we should be aware of that, and it will not be publicly available until that start marketing date. We have one of my war stories is the company that listed the drug, they had the start marketing date, they had the plan launch date was whatever it was, and the day that it was supposed to launch, they made the decision to delay the launch by a month or two months, whatever it was. And they were very upset because it had gone on to the DailyMed, which meant that their competitors knew that they were coming out with this product. So they said, "What do we do?"

Howard Shatz:

Well, the only thing you can do in that situation if it goes public before you want it to is to de-list it that same day. So if you put a June 1st as the marketing date on, on June 1st, you would have to submit it again with an end marketing date of June 1st. And on June 2nd, it would come off and then you would revise the listing to have the correct revised marketing date of June 30th. So those are the ground rules. Again, don't pull your hair out over what start marketing day to use, but those are examples of how the start marketing date is used. And the FDA says, "Okay, you can use the approval date." You can use the date that it's actually distributed if they wanted to do it a little bit earlier than this date it's distributed so that you get into the CMS in a timely fashion. I hope that answers the question.

Christopher Hill:

Okay, great. Are there any exceptions for manufacturers of an over-the-counter drug product from drug listing?

Howard Shatz:

No. They very effectively enforce the regulation that the manufacturer has to list the drug for foreign manufacturers because customs officers are not supposed to allow the drug into the country if it has not been listed by the foreign manufacturer. Now, on that note, I also want to add a little pet peeve of mine, which is that the FDA draws this distinction between manufacturers and distributors. But I have seen what our "final drug" listings for OTC drugs, that list the foreign manufacturer when actually, when you look at the product, the product was distributed by a domestic company, without naming names, and it's got the trademark product name of the domestic manufacturer. And the domestic distributor apparently denied have a labeler code. I went ahead and checked that. So technically, the domestic distributor of a drug manufactured overseas, or even domestically is not in compliance if the only listing for that drug, if the final drug listing, is under the manufacturers.

Howard Shatz:

The regulations are quite clear that the private label distributor means a person who did not manufacture, or repack, or relabel, or salvage the drug, but under whose label a trade name, the drug is commercially distributed. So companies should be aware that if they own the brand name, then they are the distributor, regardless of who manufacturers it. Again, they can require the manufacturer to do it. I will tell you that we have manufacturers who do their own listings, and tell the distributors that the distributor has to do their listings. We have distributors who do their own listings and for the manufacturers because manufacturers don't want to bother with it. And then we have the companies that are very strict about it. As I said, some private label distributors require that put into the contract that the manufacturer will list it, but there are no exceptions to the regulations. However, as far as I know, the only way they can truly enforce it is on the foreign manufacturers because they have to have a drug listing before it comes into the country.

Christopher Hill:

Okay. And I think you may have just answered this question, but just to make sure. We got a question from Amanda that says if you were the manufacturer and distributing via a distributor who is listing the drug, is there a separate process for the manufacturer to list the drug?

Howard Shatz:

Right. So the manufacturer should list the drug if they are both distributing themselves and manufacturing for somebody else, yeah, they have to list the drug. And again, the key thing is as long as the distributor owns the brand name, they are really the distributor. We had one case where the foreign manufacturer was packaging a product. And the product said distributed by XYZ Corporation here in the United States. But the foreign manufacturer was the one that owned the brand name. It was their product. There was a foreign manufacturer's product. Clearly, the foreign manufactured the product. They just retained a company to distribute for them. But the distributor had no ... it was not their brand name, it was not their product. It was the manufacturer's product. So if a client had back and forth with the FDA, the FDA concluded, "No, you're right. The foreign manufacturer's the only one that does a listing for that drug."

Christopher Hill:

Okay. And I think we have time for just a couple more questions. Here's sort of a current events question. Have you noticed any effects of the current pandemic on the work of the FDA around this? Are there any impacts that I should expect or things you've noticed?

Howard Shatz:

Okay. Yeah. So actually, I've received direct word from the EDRLS that they're handling a lot of questions from these companies that are new to the business. They're trying to manufacture their own hand sanitizers, and they want to make sure they're covered. And so that slowed them down. Also, there's been a significant increase in the number of labeler codes that have recently been assigned. In practical terms, there isn't that much difference. The FDA does have guidance documents that they've issued for those who are manufacturing, but basically if you're manufacturing under a drug facts ... and we've picked up a lot of clients' companies that are buying from drugs that are already being manufactured for as hand sanitizers. And they're just putting it under their own label.

Howard Shatz:

So that goes through the regular channels, establishments that are manufacturing. These things have to be registered with the FDA as drug establishment just as with any other drug. So basically, there has been an impact. Maybe when we have the follow-up email, Chris, I can provide you with the guidances that the FDA has issued if people want to read it, if it impacts them at all. But for the average drug facts, hand sanitizer, it's business as usual.

Christopher Hill:

Okay.

Howard Shatz:

But if they need labeler codes.

Christopher Hill:

Great. All right. Well, I think that just about wraps up our time and if you did have any follow-up questions again, everyone who registered for the webinar will receive a follow-up email, and you're welcome to reply to that if you had any further inquiries. But I really thank you, Howard, for this very informative session today and thank you all for attending. And we'll keep you posted as well on future webinars that might be of interest to you. Have a great afternoon.