745 - We have an 8 page print leave-behind detail aid that includes full dosing information. We are thinking of redoing this tool with a half page sized tear off flap that has key reminder information on the dosing. Does this flap have to contain all of the dosing information, or can it just contain e.g., the steps and an example calculation. Thanks.
Jennifer Carroll last edited by
This would require a separate review of the tear off pad to ensure it meets the standards of the code as a stand alone piece. Often information which is required in an APS is based on the specific claims made and whether or not those claims require qualification. That said, in theory it may be possible to create a half page piece with selective dosing information, however this will be highly dependent on the product’s monograph and claims being made. The selective dosing information would generally require a prominent disclaimer “For more information related to dosing and administration please refer to the product monograph” and any dosing related cautionary copy or safety related issues would likely be required in the APS.