The USFDA's Center for Biologics Evaluation and Research (CBER) has released the final guidance document, titled “An Acceptable Circular of Information for the Use of Human Blood and Blood Components,” to assist healthcare providers in complying with labeling requirements for the distribution of blood and its components. This updated version, released in June 2024, supersedes the March 2022 guidance. It outlines crucial standards for safe handling, administration, and use of human blood and blood components.
Circular of Information: A standardized label for blood and its components, similar to a package insert for drugs, outlining instructions for use, risks, and storage. The Circular is periodically updated to address changes in regulations, technology, testing, and product indications.
Human Blood and Blood Components: Products derived from blood, such as Red Blood Cells, plasma, and platelets, used for therapeutic purposes like transfusions.
The guidance is designed to ensure compliance with 21 CFR 606.122, which mandates that a Circular of Information must accompany all blood and blood components intended for transfusion. This circular acts as a standardized product label that healthcare professionals refer to for instructions on handling, storage, and risks associated with transfusions. Section 606.122 further specifies the details that must be included in this circular to safeguard public health.
Licensed manufacturers must report the implementation of the June 2024 Circular to FDA under 21 CFR 601.12 as follows:
If the June 2024 Circular is implemented without modification and in its entirety, the change is considered to be minor. You must report such changes to FDA in your annual report, consistent with 21 CFR 601.12(f)(3) and noting the date the process was implemented.
If the December June 2024 Circular is implemented with modification, the change is considered to be major. You must report such changes as a Prior Approval Supplement, consistent with 21 CFR 601.12(f)(1), unless a lower reporting category is recommended by FDA in guidance. Unlicensed blood establishments are not required to report this change to FDA.
For more details
USFDA, "An Acceptable Circular of Information for the Use of Human Blood and Blood Components" – Link to guidance.
USFDA, Full Guidance Document PDF – Downloadable PDF.
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