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    PAAB exemption for a pharmacy communication?

    FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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    • S
      Stanley last edited by

      I'm looking into the PAAB code regarding what is/isn't PAAB exempt (s1.5), and I would just like to ask for some more clarification.

      s1.5.d states that contextual use of a healthcare product name can only be used in a context wherein it is not connected to therapeutic or promotional claims. s1.5.d then also gives examples of where this is permitted. However, is that an exhaustive list of examples?

      E.g., if I wanted to create a short piece just announcing the availability of a specific drug and nothing else, something like "X is back in stock", would that be PAAB exempt per s1.5.d? It seems similar to s1.5.d.iii, but it isn't the same.

      As a follow-up question, would the indication statement count as attaching the drug name to a therapeutic claim, thereby requiring PAAB approval?

      Jennifer Carroll 1 Reply Last reply Reply Quote 0
      • Jennifer Carroll
        Jennifer Carroll @Stanley last edited by

        Hey @stanley, sorry for the late response, this one must have slipped through the cracks.

        S.1.5 is not considered to be an exhaustive list. The copy “X is back in stock” would be viewed as a commercial availability message. If it was not linked to any other messaging, it could be considered exempt.

        You are correct, the addition of the indication statement would create a link to the therapeutic use and prompt at least lowest level fair balance and PAAB review.

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