• Our brand would like to create a sticker with an LU code listed and they are willing to put the code criteria also on the sticker. The sticker will then be placed on various branded, PAAB approved leave behinds. So a) can this be done? And b) if the criteria is broader than the indication, is that an issue?


  • @kiki

    I'm sure that @Jennifer-Carroll will provide a more complete/corrected answer, but in the spirit of getting the conversation going I thought I'd provide a few initial resources/thoughts:

    • Our brand would like to create a sticker with an LU code listed and they are willing to put the code criteria also on the sticker.
    • The sticker will then be placed on various branded, PAAB approved leave behinds. So a) can this be done?
      • Yes, but sticker placement will have to be assessed for all tools; see PAAB Q&A #516.
    • And b) if the criteria is broader than the indication, is that an issue?
      • This will be an issue in the scenario you described, given the criteria would be considered off label. See this post.

  • @Kiki

    Thanks @palanski for the thorough answer. Your response is accurate and complete.