316 - What are the limitations in terms of advertising for OTC pharmaceutical brands with a DIN?

  • I'll assume the question relates to HCP advertising. For any healthcare product (as defined in section 11 of the PAAB code), regardless of its federal schedule, advertising must be contistent with the Terms of Marketing Authorization (TMA). Where the reference for a particular claim is something other than the TMA, the reference must meet all rigors required in the PAAB code (which from an evidentiary perspective are identical for Rx products versus non Rx products). For fair balance requirements relating to OTC products, refer to PAAB code section 2.4.3.