REGULATORY UPDATE: AABB Updates December 2021 Circular with New Language for Pathogen-Reduced Apheresis Platelets “Warnings and Precautions” Section

By Drew Case posted 12-06-2022 02:09 PM


AABB updated the Circular of Information for the Use of Human Blood and Blood Components web page following the Food and Drug Administration’s approval of new language to be inserted in the December 2021 Circular. AABB made the update to provide the approved statement regarding pathogen-reduced apheresis platelets “Warnings and Precautions for Intercept-treated platelets.

The package inserts for the Intercept Blood System for Platelets were revised to remove acute respiratory distress syndrome (ARDS) from the “Warnings and Precautions” section. ARDS remains described in the clinical summary section of the package inserts.

Accordingly, blood centers manufacturing Intercept-treated platelets may update their December 2021 Circular of Information to reflect this change. However, FDA does not require this change until the next revision to the Circular is released.

Until this can be removed in the next version of the Circular, AABB recommends that blood centers add the following statement to update their December 2021 Circular if they manufacture Intercept-treated platelets:

“The package inserts for INTERCEPT Blood System for Platelets no longer include acute respiratory distress syndrome in the “Warnings and Precautions” section. Users should refer to the package inserts for information on adverse events observed in clinical studies of Intercept platelets.”

Licensed establishments that choose to make this change must report it to FDA in their next annual report.

Consistent with historic practices, AABB recommends the use of an adhesive label or an ink stamp to insert the updated language into the Circular using the two blank pages located prior to the Table of Contents. In addition, the version date of December 2021 will not change with this language insertion. Members with additional questions may contact