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  • 1.  Private Label Drug Listing

    This message was posted by a user wishing to remain anonymous
    Posted 03-Jan-2017 09:45
    This message was posted by a user wishing to remain anonymous

    Hi,

    We manufacture a private label drug and received notification that the FDA published a final rule on August 31, 2016, that requires that manufacturers of private label drugs must now list these drugs twice, generating two NDCs: one with the manufacturer's labeler code and one with the private label distributor's labeler code.

    As the manufacturer of the private label drug, would I be able to create a new private labeler's NDC number?  I was under the impression that an NDC could only be generated by the company who owns the labeler code.  I'ved called up the private label company asking them to generate the NDC and provide to me so that I can also list as part of our drugs per the new FDA rule.  However, the private label company says that we as the manufacturer create the NDC on behalf of them and once it's done, we notify them of the NDC generation.  Is this correct?

    For example, if my labeler code is 11111 and the product we manufacture for the private label company's NDC is 11111-001-01 and the private labeler's code is 22222, could I create a 22222-xxx-xx NDC code myself that references the same product?  Or does this 22222-xxx-xx code need to be generated by the private labeler and provided to me?

    Thanks!



  • 2.  RE: Private Label Drug Listing

    Posted 04-Jan-2017 02:47

    Hi,

    According to the new rule, the manufacturer must propose an NDC to FDA for its own labeler code for each package size and type. In addition, the manufacturer must also propose an NDC must also propose for assignment by FDA an NDC that includes the labeler code of the private label distributor under whose trade name or label the drug is distributed, for each package size and type so distributed. FDA will approve the code if it meets the requirements and is not already assigned to another drug. You can find the details at the following links:

    - 21 CFR 207.33: What is the National Drug Code (NDC), how is it assigned, and what are its requirements?

    - A Rule by the FDA on 08/31/2016: Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs<date datetime="2016-08-31"></date>

    ------------------------------
    Kandarp Shah, PHD, RAC
    Regulatory Affairs Specialist
    California
    United States

    Original Message


  • 3.  RE: Private Label Drug Listing

    Posted 04-Jan-2017 09:01
      |   view attached

    If you haven't already you should read the final rule. The revised CFR is at the end of the final rule. I believe your answer may be in 21 CFR 207.33.

    Cindy

    ------------------------------
    Cynthia Katsempris
    Director, Regulatory Affairs
    Three Bridges NJ
    United States

    Attachment(s)

    pdf
    Final Rule Reg and DL 08-31-16.pdf   565 KB 1 version
    Original Message


  • 4.  RE: Private Label Drug Listing

    Posted 04-Jan-2017 09:10

    Private label distributors (PLD) should be providing you, as the manufacturer, with the NDC to be used for the product.  A manufacturer cannot/should not be responsible for maintaining the data file of NDC numbers for a given PLD.

     

    For example, PLDs often purchase products from several different manufacturers. How would one manufacturer know whether a particular number has been assigned by someone else to another product?  In addition, the package code (last 1 or 2 digits of an NDC) should be consistent across a product range.  So if the PLD is selling a 100-ct bottle of, say, aspirin from one manufacturer but is selling a 100-ct bottle of meclizine from another manufacturer, they should have the same package code (obviously different product code).   I suppose if the same manufacturer was making the entire product line for a given PLD, they could work together to develop a numbering system but the PLD is ultimately responsible for designating the number and the manufacturer for listing it with the FDA.

     

    Based on my experience, this is a common misconception among PLDs. However, they should have a uniform and documented procedure for assigning NDCs so that the numbering system is consistent across their product range.

     

    Susan Crane

     




    Original Message


  • 5.  RE: Private Label Drug Listing

    This message was posted by a user wishing to remain anonymous
    Posted 04-Jan-2017 10:08
    This message was posted by a user wishing to remain anonymous

    Hi!  The new final rule requirement is that the manufacturer perform two drug listings for each product: one as the manufacturer and one for the distributor.  The Drug Listing performed for the distributor will contain the full content of labeling.  The NDC number for this listing is the one provided in the distributor labeling and is the distributor's NDC.  The Drug Listing performed as the manufacturer is an abbreviated listing.  The manufacturer is required to establish an NDC number using the company's labeler code for each product.  This drug listing (manufacturer) will not be viewed by the public.  It will be used internally by the Agency.


    Original Message


  • 6.  RE: Private Label Drug Listing

    Posted 05-Jan-2017 09:53

    It was interesting to read everyone's comment to this question.  Most seemed to suggest (my apologies if I misinterpreted answers incorrectly) that the manufacturer should assign the NDC using the PLD labeler code.

     

    I worked in private label distribution for 20 years prior to consulting.  The company I worked for had hundreds of products in different package size configurations which were obtained from 30 different manufacturers, depending on the product. We also provided the NDC to the manufacturer so that the numbering system was consistent.  NDCs can be in a 4-4-2 format, 5-3-2 format or 5-4-1 format.  The PLD needs to determine what format they are going to use on all their products – they cannot have 5-3-2 for one and a 5-4-1 for another [21 CFR 207.33 (b)((3)].

     

    In addition, as I mentioned in an earlier post, the package code part of the NDC identifies the packaging configuration so that the same size/type of packaging will always have the same package code.  A manufacturer would not necessarily have the information available as to what package code the PLD is using for its products.  So all 100-ct tablets in a bottle should have the same product code, all the 12 oz liquids in a bottle should have the same code, all the 2 oz creams in a tube should have the same code, etc.

     

    I believe there is confusion around the terms "assignment" and "proposing for assignment". In the updated regulations, these relate to the submission process itself, not necessarily the allocation of a particular number to a particular product.  These should communicated to the manufacturer by the PLD. The manufacturer can then "assign" or "propose for assignment" that number in the drug listing submission.

     

    Susan Crane




    Original Message


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