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thank you thanks very much my name is Don Duggan I work on the help desk I just want to thank everybody for coming out today and the weather wasn't the best into traffic and for you all tuning in late at night I appreciate you taking the time so I just hope that today is all your questions get answered and if not I just want to say there's email Edie RLS at FDA HHS gov that's where when you come and you leave here and then you go oh man I really wanted to ask that question just email us and I will say this I just want to say this we do our best to try to get to every question as quickly as we can and and sometimes we will answer questions very quickly other times we seem to get inundated you know so sometimes it takes a little bit longer I would say that you know usually we ask for about 10 business days it normally doesn't take that much okay but if something's urgent always let us know okay and hopefully after today there will be anything urgent because you'll know what to do you'll be taking action earlier rather than later so all that said there we go so we have some learning objectives I won't go into the why because Paul Paul did a pretty good job of that but we want to know that who when what and how of establishment registration we'd like you to understand the different types of establishment registration SPLs and then also be able to discuss how to avoid the most common errors I will tell you this will not work at a party though nobody wants to discuss this at a party so it hasn't worked for me so I'll say so that's that's something that we're going to go over right now so the first thing is who must register and generally with the exceptions few exceptions things like some pharmacies and hospitals that don't perform any manufacturing processes any establishment that engages in any manufacturing process so that's obviously manufacturing but it's also things like repacking relabeling salvaging and analysis analysis if you are doing analysis on a drug that will be sold us let's see and then I I have a link there on this to our website our instruction page very good page so when do you register well if your domestic establishment no later than five days after you begin manufacturer processes however we would like you to do it before but up to five days after as far as a foreign establishment you must be registered to get your your drug into the country okay so and and I'll go over this again but if the registration isn't correct with the manufacturer that drug product is gonna have problems getting it into the country are you're going to have problems certifying it so when do you update obviously October to December 31st so now and I'll get into all of that but just when you whenever you close or sell an establishment change a name or a physical address whenever you change the mailing address the telephone number or the email or any kind of contact information we would like that to happen within 30 days okay because we send out lots of emails you know we'll send out reminder emails and all of this kind of thing and if it's going to the wrong person doesn't do any good and then and then people are surprised so we want to avoid that by keeping that information updated now the way it works if you send in a registration SPL between October 1st and December 31st that's good until the end of the following year so if it gets sent in in 2019 it means your read your registration is good all the way till December 31st of 2020 okay so that's every time you send it in in the renewal period if you send it from January 1st to September 30th it's good until the end of the year that it's received so you send it in on the 30th we've had this before if someone has sent it in their little you know they're all anxious they want to do the right thing that comes in on the 30th and then they go it didn't change it didn't change because it's supposed to ask to come in on the 1st of October and that's the way the system works we don't have to worry about that now we only have to worry about December 31st now and then another area where people are somewhat confused private label distributors they don't manufacture anything they don't need to register ok so privately label distributors and that is the that is somebody who has a label errcode and has their name on the outside of the product or firm name they do not register ok only people to register are people who are performing manufacturing processes relabeling repackaging salvage manufacturing of course and analysis so with paul talked about the registration data is used for inspections and imports and and again i just want to say again product listing SPL will fail validation and therefore certification if the establishment is not registered so if your drug product has a bad you know establishment on there you're not going to be able to certify that listing and you're going to have to go back to the manufacturer let them know what to do now if they have any questions by all means give them our email address and we will help them another thing the is not when I'm what we're talking about today is not good oofah a generic drug act right it's not that so there are no fees for this okay we don't charge fees so that's that's something that you want to keep in mind and then the other thing is that first time you register you're not going to have an FBI number so what you're going to need to do is well in general domestic organizations and go ahead and get an FBI by contacting their local district Oh RA office that's available on our website and then domestic I'm sorry foreign manufacturers if you haven't gotten an FBI FBI number there is an email and we'll have that for you I don't want to spell out an email but there's an email for that and we'll get that out to you the information so but generally it should be sixty days or less if not you can let us know okay and okay so the types there's different types of SPL and I apologize for slides but there's there's three different types and let me just get all right so there's very types there's your regular establishment registration where that's just used for okay so you've got the register one you have the D registration establishment D registration you have the no change notification and finally the out of business okay so there's four different types the regular one you would use the first time or renewal the second one would be if you're going out of business third one or rather your discontinuing manufacturing sorry and then the the no chant no change notification is another way to renew and then out of business is you know you're going out of business so basically the updates that's what we're going to talk about a lot this is the main form that you would fill out and you see the contact information that's the that's what's really important to us okay so we go through that and there we go okay there's that and this is the part where you've got the the main form and then if you look to the lower right and you'll go into the seedier direct and you and you'll uh you know just go to the establishment registration okay and there's a lot of information that comes here and then when you go ahead and add your establishment there's more information and there's an in place for the imports at the bottom so you need to have your importers listed as well no change notification this is really nice if you don't have any changes to your establishment this year right everything's the same and all you want to do is is check that box you want to do a no change notification s SPL okay and it's only though for ten one to twelve thirty one so if you try to do this in January not going to work okay this is what it looks like and this is why I like it because it's not hard to do what it is is you're going to have your set ID let me just quickly go over what we're talking about here as far as a little bit of vocabulary the core idea I'm going to be talking about the core ID either comes in its the ID that you get when you send something to us you get a core ID it's going to either be CI and that means that you went through the Gateway or CD which meant you use seed or direct just so you know leaderless cannot work on anything that's been created by pragmatics we're gone through the ESG we have no access to the ESG can't look at anything they're the types of submissions we can help with are the ones that are done with cedar direct because we do have access to those submissions okay so if you ever send in a question about something that's gone through and it's the core idea because we always have to have the core ID it'll say CI we're going to have to refer you to the SPL coordinator there's also the the darker route ID that's that's like in that's given it's a unique ID that's given to every single submission so we owe every time you send in a new submission it has to be a new doc or route ID then there's the set ID set ID is kind of like the address it's always going to be the same for a type of submission so your establishment registration submission you'll always use the same set ID to update it okay the version number you always want to put one higher version number on your submission so in this situation if I'm doing no change notification I'm gonna need to know my set ID I'm gonna need to know what version I should be at okay and if I know those two things I can put my set ID in I can put my my version number in and my route ID okay and I will just generate a new route ID here okay so where it says generate you can just generate that okay and then you would go ahead and save it and then submit it okay so that that's and then deregistration you're no longer it's very similar at least as far as doing it you would not you would deregister because you no longer manufacturing drug products and again it looks very similar except for the document type this deregistration it's got the same thing though set ID you need to have that new route ID and the version number that's correct now you're still awesome but you're doing something else now so you would do an out of business as we go and it's exactly the same so some tips please ensure that your establishment information that you enter is exactly exactly what is in Dunn and Bradstreet it is that's the way it matches up it's not a fuzzy match and so it's not going to work so if it's Road you know exactly just that the key is this go to dun and bradstreet know what it says and that makes sure that that's accurate and then put that in your establishment registration obviously you want to update your your contact addresses because that's very critical we want to let you know when your we want we want you to do everything right but if you're not we want to let you know so we can get it done and taken care of before it becomes a real problem multiple establishments can be registered using one establishment SPL so if you wanted to do all your establishments on one SPL you can do that okay because you can just keep adding establishments and then today will come around we'll show you how to do that and we've had people who are trying to work on an establishment SPL and things are grayed out if it's grayed out you're not going to be able to use it you're going to have to create a new version and then quick word we get a lot of questions about mergers and acquisitions and and please going to go into that a little bit later but you need to change everything with us and that that includes the labeler name so if you change your legal name you want to change your label or name and then you're going to have to go ahead and update all the drug listing STL's as well reflect that new name okay so avoid errors okay not to be used as small talk cocktail parties but how to avoid errors same set ID a different route ID and one higher version make sure you put in a qualifier okay so it's great that your manufacturer tell us what your manufacturing human OTC animal drugs what is it phone format because that we know we get a lot of we get a lot of phone numbers and they all have different formats we're looking for things to be formatted in our version ok the US version you can just click on the format in Cedar directing and look at see the example it's it's a standard us example generally we just got this you can now validate you can validate before you send it in so we would encourage you to save your submission and then click on validate to see if there's any errors before you send it in faster than waiting and finally yeah you do have to click that submit SPL button to get it here sometimes I mean you know not everybody's always familiar with types of software that they use because they don't use it every day and we understand that so you get people that you know just have to remember to click the submit yeah let's just say the odd thing occurred and you actually got an error you know so read the error messages because they're very useful and telling you what needs to be done they'll tell you if your Unni is not correct they'll tell you all kinds of things we also understand it not everybody is you know a computer whiz and so sometimes these things can look pretty scary ugly so what we tell you to do is to take a screenshot of the error message itself and also the go to when you could click on a go to and I'm talking about cedar director you can go to the error so we can see the data that you entered because sometimes might have done something with the data maybe you have a comma maybe you have a - maybe you don't and we can see that but we can't tell you just just by an error message all the time okay and then also provide the core ID so screenshots and a core ID and that's what we need now if you use pragmatic then your or if you send it through the ESG and that's the CI core ID it starts with C I if it's that you need to contact the SPL coordinator at SPL at FDA hhs.gov okay because again we don't have access to those finally to see if you did this right to see if it's correct you can go to the deckers or the drug establishments current registration site and it will have a list and everything there that you can see your your company there so you can rest assured I will I will say this if you send in your submission and it doesn't happen immediately do not be surprised give it 24 48 hours okay because it takes time for they run things in batch process and if you hit just over yours you know if you just missed it then it's going to take another 24 so we're not sure when you're going to send it in so we say 24 to 48 if it's beyond that contact us okay providing you know and if there's any error you know contact us it's helpful to give us all the information about the submission so the core ID and you know and you know your knowledge that it was accepted and that kind of thing and you give that to us because there have been occasionally issues getting our data to the web display the data is actually in our database and we have it and it's right but sometimes there's a problem getting it on to the web there's all kinds of things going on and when that happens you'll see a delay so just let us know because III really appreciate it myself because I then you know we can fix the problem because if you're having a problem other people might be having it too and the database doesn't have the 503 B registrants for that you need to go to the outsourcing facilities you will see a compounder on this list if they are a regular manufacturer and they need to do that also but if there are solely a compounder it will be on the outsourcing facilities only and wholesale distributors third party logistics providers they are not included as well so we got some challenge questions here and I'm not sure how these go so just ask this first one should private label distributors register before listing their product Oh be sure to hate them oh yeah sure right they should never register okay let me ask you that or false will the product listing SPL fail validation or certification if the establishment is not registered that's right so now that doesn't mean they have to register for this year it means in the past so if I look at today at their registrations got to be current and you will find that out if if anything does come back you should should follow up with us regarding an establishment registration the rule is only one establishment per SPL you could do many as many as you want okay I guess I passed so finally for any questions leaderless at FDA dot HHS gov again it's our busy season please be patient we will do everything we can to get it done and there's uh just talking about pragmatic and in the SPL coordinator our instruction page and if you haven't seen your listing instruction page it's a real good page to go to and point some contacts thank you and I guess we'll take questions after a police presentation okay hello everyone my name is Polly Heber and this morning I'm going over Labor Code request here's an overview of what we will be getting into we will get started with what a Labor Code is who should apply for labor code when and how to apply for labor code and and then we'll go over some reasons why a Labor Code is rejected and what you can do to avoid those rejections and then we'll move on to some common errors and and with mergers and acquisition with the labor code and what to do with it so this slide is a is probably a review for most of you but for those of you in attendance that are not familiar with NDC structure I will quickly go over it the first so the NDC the national drug code is divided into three segments the first one that's highlighted here is the Labor Code this the labor code is assigned by the FDA and it identifies the company the second set that was just highlighted in blue is the product code and this identifies the dosage and strength of a product and the package code identifies the package type or size so the product code and package code numbers are both are proposed by the firm but the labor code is assigned by the FDA labor code requests must be submitted when first introducing a product into commercial distribution and as you can see here drug listing must be submitted within five days so it is important that you submit request and complete your labor code process prior to drug listing if you do not have products to list you should not apply for a labor code one question that we get is for drug sponsors and application holders if you are not involved in any manufacturing or processing or marketing of the drug you are not required to register or list so you should not apply for a labor code and any labor code that is not used for purpose of drug listing will automatically be inactivated within 24 months so if a company has multiple establishments multiple sites so for example if you have a site in New Jersey and you have another side in Delaware you don't need to labor codes you only need one labor code as I mentioned earlier it's each site the New Jersey side and the Delaware side will have its own Duns or FBI number but labor codes are assigned to the company not to the site so this is one of common questions we get about labor code so how to request for a labor code the first step would be to go in to see the direct and click on the NBC labor code request document and since you are requesting a new labor code it is very important that you leave this labor code field blank once you enter your labeler details contact address make sure if you're requesting a new labor code this is blank this is not blank na is not black we've had issues in the past on occasion about this field so I just wanted to emphasize that if you enter any value like zero for example this is the error message you will receive so remember to leave it blank in in the step 4 we'll find out what we use this field for but like I said since we're requesting it it should be black and so if you scroll down the seeder direct page once you enter the labor contact details and on their country if you click on a country outside of the United States it is highly suggested that you enter the US agent information now you will notice there is an optional anything that's additional littler details is optional if this is optional but if you do enter this information it will expedite your labor code process if you enter all the information if you opt not to enter this information this is step two if you opt not to enter this information you will receive an email that looks like this asking the point of contact for the laborer with information about company the name of the company the address Don's the type of business the type of drugs that will be listed under the labor code and any u.s. agent information now it's important while you enter this information in the encino direct or in the email that the physical address should not be APO box and this is very important - this is the number one reason a labor code is rejected physical address of the firm must match the information in D and B so before you request for a labor code should probably look in dun and Bradstreet and make sure that the address that you have matches okay so once empty evaluates this information and it all looks good this is a letter of the inner label er code assignment letter you will receive something that looks like this but please make sure that you know you allow seven to ten business days for your labor code to be process if you email us the next day or two days later you might you're from telling you that it takes seven to ten business days if you're wondering why it takes seven to ten business days it's because we're answering all the Status requests for your labor code okay so your labor code is assigned and you get the assignment right the step four this is very important most of you um you know would think okay I have my labor code assignment letter I'm good to go I can list my product but you're wrong this is a step forward this is very important unless you complete this process you will not be able to list your drugs so you go back into your labor code request and now you're going to use that field that was supposed to be blank you're going to put in your labor code and then we revise it and resubmit it unless you do this you will not be able to list your drugs if you attempt to list your drugs without completing the step four process this is the error message you will get in Cedar direct for your product listing okay I've gone through some of this already but here are some of the reasons why a labor code is rejected number one as I mentioned earlier if you are not required to list a drug if you're a drug application holder or sponsor if you already have a labor code assigned for one site like I mentioned earlier if you were assigned a labor code in the paper system your labor code will be rejected because you there's a way to reactivate that old labor code or if it was you know we will let you know but that's one of the reason and then if your labor code was automatically inactivated do not apply for another labor code you can email us and it will reactivate then this is important if your information as I mentioned does not match what's in VN B it will be rejected so make sure you check the dun & bradstreet the address you have with them and then what you enter should match and then if you're a veterinary drug manufacturer or distributor our wonderful colleagues over in CBM will be able to help you if you submit using the NDC labeler code request that's his animal drug Hey any labor information including the physical address email and other information must be updated within 30 calendar days donald already mentioned as well with establishment this is important this is not an annual requirement but I suggest that you treat this as an annual requirement because FDA uses this information for any communication regarding your listing so if you do not receive an MTA communication due to an outdated contact information it does not relieve you from requirements subjected in that communication communication so for example if you receive the deficiency letter a person does not work there anymore he will still move forward with the next steps so this is very important please review your labor contact information especially in the past couple of weeks if you have not received an email from a journalist probably have a bad email address so it is a business decision at the time of a merger or acquisition the transfer or keep your labor code or any NDC's acquired so for example company and B are merging and they're changing their name to company C in addition they have decided to keep company as labor code here's what company a should do they must update their labor code information to include the new name and other any other updates contact any other information that needs to be updated next the drug listing must be updated even though there's using the same label code the labeler name has changed so all the drug listing associated must be updated and now here's what company B would have to do it would have to discuss this continue all the drug listings associated to their old labor code it would have to realize the listing under company C's Labor Code and at the end the labor code must be inactivated so to recap what we've learned we're going to go through some challenge questions the first one is if a company has three establishments how many labor codes do they need one two or three second question they record information including the name physical address email address any and any other information must be updated within 60-90 thirty days or every June and December application holders this is true or false but that performed no manufacturing process are required to obtain a label code correct that is all I have [Applause]