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  2. PAAB Q&A
  3. FYI post-approval change/preclearance exemption/what requires review/PAAB scope
  4. 159 - If we were to have a backorder situation for one of our products and we wanted to inform pharmacies of this fact by way of a letter or fax to help prevent a backorder, would this letter/fax need to be PAAB approved? I was reviewing section 6.2 for clarification, and believe that it does not need submission to PAAB (I believe it's an institutional message), however I'm not entirely sure?
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159 - If we were to have a backorder situation for one of our products and we wanted to inform pharmacies of this fact by way of a letter or fax to help prevent a backorder, would this letter/fax need to be PAAB approved? I was reviewing section 6.2 for clarification, and believe that it does not need submission to PAAB (I believe it's an institutional message), however I'm not entirely sure?

Scheduled Pinned Locked Moved FYI post-approval change/preclearance exemption/what requires review/PAAB scope
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  • Jennifer CarrollJ Offline
    Jennifer CarrollJ Offline
    Jennifer Carroll
    wrote on last edited by
    #1

    Actually, you would want to refer to PAAB code section 1.5. The intent of section 6.6(d) is to allow for the expedient communication of non-comparative, commercial messages. These include changes in availability, price and formulary coverage. If the only message in the letter/fax is that the product is backordered, than the ad is exempt from PAAB review. Clients often elect to also include messaging regarding alternative therapeutic options for consideration during the back order. This would be an example of something which would disqualify the ad from being exempt. Please call the PAAB office if you have any questions. Also refer to Q&A # 155.

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