AABB Reminds Members About Implementation of the June 2024 Circular of Information
November 26, 2024
In 2017,
FDA clarified that blood suppliers should make the Circular available to their customers as “an extension of the blood bag container label, because the space on these labels is limited.” This is intended to make important information available to transfusion services, prescribing physicians and health care providers “anywhere blood is issued or transfused.”
In response to AABB member questions regarding the intended use of the Circular as an extension of container labeling, FDA clarified the following:
- Health care providers: “If the environment includes blood transfusion, the Circular should be available.”
- Blood suppliers: As clarified in 2021, “…the availability of a hard copy Circular should be part of the overall distribution process, in accordance with §606.122, to include distribution on a yearly basis or whenever a change is made to the Circular, or upon request from your customers.”
Because FDA’s stated expectations for use of a hard copy with no expressed prohibition on the addition of an electronic version, AABB supports blood suppliers interested providing customers electronic access to their Circular along with the required hard copy. The Circular web page provides detailed instructions to blood suppliers on FDA’s requirements and expectations for distribution of the Circular to customers.
