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good morning my name is don duggan and iamp;#39;m with the help desk operations team and with durless and cedar iamp;#39;m going to be talking about labeler code requests today so we have some learning objectives weamp;#39;re going to talk about who needs a labeler code and when should a firm apply for a labeler code weamp;#39;re going to talk about the steps required to obtain a labeler code and also why itamp;#39;s important to confirm the labeler code so what is the labeler code process well a manufacturer or private label distributor requests a labeler code from the fda using cedar direct the fda will go ahead and receive that submission we will process it manually and then weamp;#39;ll send an email with the assigned labeler code number and confirmation instructions back to the firm then the firm will go ahead and send back a confirmation labeler code which is really just a a labeler code request with the same set id a different root id the version number is one higher than
