Recent Changes

Wednesday, May 10

  1. msg NDC problem the system say i have submitted a similar ndc before message posted NDC problem the system say i have submitted a similar ndc before When you say "family of products" do you mean the same product in different packaging siz…
    NDC problem the system say i have submitted a similar ndc before
    When you say "family of products" do you mean the same product in different packaging sizes?

    If so, these should all be included as different packages in the same drug listing file and should not be submitted separately.
    8:48 am
  2. msg Product Source and the new regulations message posted Product Source and the new regulations Since manufacturers that produce for private label distribution only must now register products usi…
    Product Source and the new regulations
    Since manufacturers that produce for private label distribution only must now register products using their own NDCs, will it now be required that the manufacturer's NDC be included on the PLD's drug listing in the "Product Source" field or is it sufficient that the manufacturer is listed in the establishment/business operation section?

    I haven't asked a question in a while, but as always, I appreciate the assistance!
    6:37 am

Thursday, April 20

  1. msg Revise Newbook link message posted Revise Newbook link Hi, is it possible to update the link for Newbook to just: http://www.newbook.com/ Thanks, Ri…
    Revise Newbook link
    Hi, is it possible to update the link for Newbook to just: http://www.newbook.com/
    Thanks,
    Richard

Wednesday, April 19

  1. page Drug Listing edited ... April 05, 2017 Meeting Minutes {20170405 SPL ERDL minutes final - IDMP_replacement doc types_…
    ...
    April 05, 2017 Meeting Minutes
    {20170405 SPL ERDL minutes final - IDMP_replacement doc types_other.pdf}
    March 22, 2017 Meeting Minutes
    {20170322 SPL ERDL minutes - IDMP Timeline update_ Bayer.pptx}

    January 17, 2017 Meeting Minutes
    {20170111 SPL ERDL minutes - final rule_MEI- w FDA responses.pdf}
    (view changes)
    9:25 am
  2. file 20170322 IDMP Timeline update_ Bayer March17.pptx (deleted) uploaded Deleted File
    9:20 am
  3. file 20170322 IDMP Timeline update_ Bayer March17.pptx (deleted) uploaded
    9:18 am
  4. page Drug Listing edited ... Standing Teleconference: Alternating Wednesdays at 1:00 pm ET, balance of 2016: August 10 and …
    ...
    Standing Teleconference: Alternating Wednesdays at 1:00 pm ET, balance of 2016: August 10 and 24, September 7 and 21, October 5 and 19, November 9 and 23, December 7 and 21
    2017 Meeting minutes
    April 05, 2017 Meeting Minutes
    {20170405 SPL ERDL minutes final - IDMP_replacement doc types_other.pdf}

    January 17, 2017 Meeting Minutes
    {20170111 SPL ERDL minutes - final rule_MEI- w FDA responses.pdf}
    (view changes)
    9:17 am

Thursday, April 6

  1. msg NDC problem the system say i have submitted a similar ndc before message posted NDC problem the system say i have submitted a similar ndc before I have a family of products that de code starts with the same numbers, when i submitt the first one…
    NDC problem the system say i have submitted a similar ndc before
    I have a family of products that de code starts with the same numbers, when i submitt the first one did not get any error, but when submitt the second, i receive and error saying i have submiteds the ndc before. WHAT SHOULD I DO, i have olready printed my package materials, thers a lot of money there.
    example of the ndc 65321-098-40, 65321-098-47, 65321-098-46, the first 2 sections are similar. i dont know what to do.
    10:03 am

More