Circular of Information for the Use of Human Blood and Blood Components

The Circular of Information (the Circular) is made available through the important work of the AABB's Circular of Information Task Force. This webpage provides the background information for compliance with FDA requirements under 21 CFR 606.122 for use of the Circular, including information on purchase options, implementation, and updated language. AABB encourages you to review the information for important changes.

Please contact Regulatory Affairs with your questions at regulatory@aabb.org.

FDA's Formal Acceptance and Expectation for Proper Use of the June 2024 Circular

• On September 25, 2024, FDA issued guidance formally recognizing the June 2024 Circular as an “extension of labeling” which provides specific instructions for the administration and use of blood and blood components intended for transfusion as required in 21 CFR 606.122.
• The Circular is a controlled document and must not be revised. Once revised by a facility, the document is no longer recognized by FDA and must be resubmitted to FDA for review.
• The designated pages at the front of the Circular permit the addition of facility specific information and FDA required updates in these defined areas only. Additions in these defined areas only are not revisions to the Circular.
• The Circular must be available for review by Transfusion Services, prescribing physicians, and staff anywhere blood is issued or transfused. If the environment includes blood transfusion, the Circular should be available.
• During the 2017 Ask the FDA session and again in 2021, FDA stated, “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.”
• As provided above, FDA has clarified their expectations for use of a hard copy with no expressed prohibition on the addition of an electronic version. An electronic version of the Circular has been developed and approved by the Circular Task Force to supplement distribution of the hard copy.

FDA Required Updates to the Circular

According to 21 CFR 606.122, a Circular of Information must be available for distribution if a blood product is intended for transfusion. As new products for transfusion become available, new testing requirements are implemented or new information becomes available, the June 2024 Circular must be updated to accurately reflect the changes. Until the new language is incorporated into the next version of the Circular and consistent with historic practices, AABB recommends:

• Using an adhesive label or an ink stamp to insert additional language into the 2 blank pages prior to the Table of Contents of the hard copy version of the Circular.
• Updates to the eCircular be added to the 2 blank pages prior to the Table of Contents of the eCircular, similar to the hard copy version. The FDA required updates and approved language may be added to the large, editable text boxes on the designated pages.
• Contacting FDA at CBEROBRRBPBInquiries@fda.hhs.gov before making any other changes to the content of Circular.

NOTE: The version date of June 2024 for the Circular must not be changed.

Licensed COVID-19 Convalescent Plasma (CCP)

CCP manufacturing processes, including the criteria used to qualify the donor and product, may differ among blood establishments and include unique manufacturing considerations. Therefore, FDA will work individually with each manufacturer during the Blood License Application process to review and approve appropriate language to be added to the facility Circular.

Alternative Procedures for the Manufacture of Cold-Stored Platelets

On June 23, 2023, FDA issued a guidance, for immediate implementation, Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding when Conventional Platelets Are Not Available or Their Use Is Not Practical that permits blood establishments to adopt exceptions and alternatives to certain requirements to support the manufacture of cold-stored platelets (CSP) without submitting a variance request to the agency under 21 CFR 640.120. FDA noted that maintaining platelet availability in the face of logistical challenges (e.g., in military, prehospital or austere settings) or other threats to blood availability (e.g., mass casualty events or public health emergencies) is critical to assure that platelets are available to patients with active bleeding.

Until CSP collection devices are approved, variances are no longer needed, and such information has been included in the next version of the Circular, blood establishments that manufacture CSP must update their June 2024 Circular to provide adequate directions for the use of CSP. FDA recommends including the following statements and information:

1. “CSP are intended for the treatment of active bleeding when conventional platelets are not available, or their use is not practical.”
2. “CSP must be stored continuously at 1-6°C to control the risk of bacterial contamination for up to 14 days.”
3. “Transfusion services should establish procedures for examining CSP for visible aggregates before transfusion.”