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

This webpage provides the background information for compliance with FDA requirements under 21 CFR 606.122 for a Circular of Information (the Circular), including information on purchase options, implementation, and updated language. AABB encourages you to review the information for important changes.This webpage provides the background information for compliance with FDA requirements under 21 CFR 606.122 for a Circular of Information (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.

Proper Use of the Circular

The Circular was designed as an extension of container labeling to provide specific instructions for the administration and use of blood and blood components intended for transfusion (as required in §606.122). 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.

The User Guide for the Circular provides blood collection establishments, transfusion services and clinical staff with information to supplement their understanding of the regulatory responsibilities for implementation and use of the Circular. The User Guide also provides information about the electronic version of the Circular (eCircular provided in USB format to blood manufacturers).

Purchase

Please visit the AABB Marketplace to order the current Circular of Information for the Use of Human Blood and Blood Components, dated October 2017, as a brochure or brochure/electronic bundle.

View Posted Version

AABB has made the Circular publicly available for review (as a pdf document) to ensure access to the content. This posted watermarked version may not be copied, printed or used as the extension of labeling.

Formal FDA Acceptance

The AABB Circular of Information Task Force (the AABB Task Force) developed the Circular to assist all blood manufacturers with the extension of container labeling required under 21 CFR 606.122. In a December 2017 guidance, FDA formally recognized the Circular as acceptable for use.

FDA Required Updates to the Circular

Under 21 CFR 606.122(h), FDA states “the circular of information must include the names and results of all tests performed when necessary for safe and effective use.” As new testing requirements are implemented or new information becomes available, the November 2017 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 3 blank pages prior to the Table of Contents of the hard copy version of the Circular.
  • Updates to the eCircular be added to the 3 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 your FDA Consumer Safety Officer before making any other changes to the content of the Circular.

NOTE: The version date of October 2017 for the Circular must not be changed.

Babesia Testing Language Update

In the May 2019 FDA guidance, Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis, FDA recommends implementation of testing where applicable, within 12 months following the guidance issuance date.

In the May 2019 Guidance, FDA states:

  1. When testing is performed, you must update your circular of information (21 CFR 606.122(h)). We recommend the following statement:

    A licensed NAT for Babesia has been performed and found to be nonreactive.

  2. If a blood system distributes components from both tested and untested donations, we recommend the following statement:

    A licensed NAT for Babesia has been performed and found to be nonreactive for blood collected in states where testing is required by FDA.

Note: FDA has clarified that statement #2 applies for blood establishments with a “mixed inventory” that includes both tested and untested units.

ZIKV Testing Language Update

In FDA’s July 2018 Guidance, Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components, FDA states:

  • You must update your circular of information to include the non-reactive test result using an FDA-licensed test for ZIKV (21 CFR 606.122(h)).

The following language, developed by the AABB Task Force and accepted by FDA in 2017, is similar to that used for other licensed NAT tests that are required. This language should be added to the Circular until it can be incorporated in a future version:

  • A licensed nucleic acid test (NAT) for Zika Virus RNA has been performed and found to be nonreactive.