2005N-0403
  

  
 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs that are Regulated Under a Biologics License Application, and Animal Drugs

  


  

  

  


  

  


  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC6
  



  

  
Submitter : 
  

  
Ms. Teresa Tung
  

  
Date & Time: 
  

  
11/27/2006 10:11:26
  



  

  
Organization : 
  

  
Taro Pharmaceuticals USA Inc.
  



  

  
Category : 
  

  
Drug Industry
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Food and Drug Administration, HHS 

Docket No. 2005N-0403 

RIN 0910-AA49 



We believed that the new proposed rule on electronic submission of drug listing and establishment registration is going to improve the efficiency drug listing process and reduce the burden on the paperwork by both the Agency and the Industry.  Here are some questions we need further clarification from the Agency as well as to present the Agency how the proposed rule will affect us tremendously in our operation.  Thank you.





1.        What type of information will be required for requesting NDC preassigned numbers and how long it will take FDA to assign one? Currently we drug list a new product upon the final approval, when we can drug listing a new product under the new rule.  It seems we are doing duplicating work.  Can we have the option to remain assigning our own NDC numbers? 



        Also, changing our current NDC numbers or formats will have tremendous impact on our internal as well as our customers' document control and inventory.   



2.        If the manufacturers are to be responsible drug listing products for private labeler distributors, which labeler code is to be used, private distributor's labeler code, US distributor's labeler code for foreign establishment or manufacturer's labeler code. 



Many private labeler distributors do not have a labeler code, how FDA is going to enforce the rule if all private labeler distributors are required to drug listing the products.  Any exemptions? 



3.        How the electronic drug listing information is to be disseminated and updated to the other Agencies, such as FDA database for Importation and the public.   



4.        Are we going to use the current electronic forms for drug listing, or FDA is planning for a new electronic drug listing system.  How is the electronic drug listing system to be maintained and monitored for the accuracy and confidentiality?