REGULATORY UPDATE: New FDA Guidance Accepts June 2024 Circular of Information for the Use of Human Blood and Blood Components

The Food and Drug Administration issued a Level II guidance Wednesday recognizing the June 2024 Circular of Information for the Use of Human Blood and Blood Components (Circular) as an acceptable extension of container labeling, as required by 21 CFR 606.122. This guidance supersedes the December 2021 guidance of the same name and allows for the immediate implementation of the June 2024 Circular, replacing the December 2021 edition.

The updated Circular, developed by the AABB Circular of Information Task Force, reflects significant developments in transfusion medicine, including guidance on identifying the signs and symptoms of transfusion-associated circulatory overload (TACO), new information on the collection of leukocyte-reduced red blood cells in a carbon dioxide-reduced environment and reflects the availability of an FDA-licensed test for malaria. It also addresses drug interactions that affect platelet function in whole blood and provides updated levels of key proteins in cryoprecipitate-reduced plasma.

For additional information, visit AABB’s updated Circular of Information web page. The page includes an AABB-developed user guide with instructions for compliance with FDA regulations, implementation options, details on the appropriate use of the electronic version of the Circular and purchasing information. The user guide also contains a comprehensive table (AABB member-protected) outlining the key changes and new information in the June 2024 edition.

AABB offers the Circular in hard copy (available in bundles of 50) and as a brochure/USB drive bundle in the AABB Store. Members with questions may contact regulatory@aabb.org.