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
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 (eCircularprovided in USB format to blood manufacturers).
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.
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.
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 October 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:
NOTE: The version date of October 2017 for the Circular must not be changed.
Consistent with the December 2020 FDA recommendations to control the risk of bacterial contamination in platelets stored at room temperature, at the time you implement these recommendation, you may choose one of two statement options that must be added to your Circular.
“Apheresis and pre-storage platelet pool components stored at room temperature have been:
(1) tested and found negative for bacterial contamination using FDA recommended bacterial risk control strategies and FDA-cleared or approved devices*, or
(2) treated using FDA approved pathogen reduction technology.
* Note: Certain bacterial testing strategies include secondary culture or rapid testing that must be performed prior to distribution or issue.
Single unit whole blood derived platelets and post storage pooled platelets stored at room temperature have been found negative for bacterial contamination using FDA recommended bacterial risk control strategies that include rapid testing or culture using FDA cleared or approved devices prior to distribution or issue unless otherwise labeled. Refer to the ICCBBA Technical Bulletin-015 Bacterial testing strategies for Platelets-US Guidance for example labels.”
“To control the risk of bacterial contamination in platelets, [insert blood center name] uses either 1) pathogen reduction technology or 2) single-step, large volume, delayed sampling (LVDS) no sooner than 36-hour strategy for 5-day platelets and single-step LVDS no sooner than 48-hour strategy for 7-day platelets using the [insert name of microbial detection device] system with both aerobic and anaerobic cultures.
https://www.INSERT BLOOD CENTER WEBSITE”
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:
Note: FDA has clarified that statement #2 applies for blood establishments with a “mixed inventory” that includes both tested and untested units.
On May 12, 2021, the FDA’s July 2018 Zika virus (ZIKV) Testing Guidance was withdrawn because the agency has determined that testing for ZIKV, or pathogen reduction as an alternative to testing for ZIKV, is not necessary to comply with the requirements of 21 CFR 610.40(a)(3) because ZIKV is no longer a Relevant Transfusion-Transmitted Infection (RTTI). FDA requires establishments to update the Circular at the time testing is discontinued and report the changes to your Circular “in the annual report under 21 CFR 601.12(d).”
Accordingly, after consulting with FDA regarding the least burdensome approach to satisfy FDA’s expectations, AABB recommends adding this statement to your Circular at the time testing is discontinued:
“Blood components collected between [insert date-date] were tested with a licensed nucleic acid test (NAT) for Zika Virus RNA and found to be nonreactive.”
At the time your blood center no longer has ZIKV-tested units in your distributed inventory, you can opt to delete this statement from your Circular of Information.