This webpage provides the background information for compliance with FDA requirements for a Circular of Information, including purchase, implementation, and updates.
UPDATED INFORMATION FROM FDA (12-22-17)
Please contact Regulatory Affairs with your questions at
Frequently Asked Questions:
How can we order the Circular of Information for the Use of Human Blood and Blood Components?
Please visit the
AABB Marketplace to order the new Circular of Information for the Use of Human Blood and Blood Components (the
Circular), dated October 2017.
Is there a PDF document available?
The October 2017
Circular can be
viewed as a pdf document but
not copied or printed.
Does FDA require a circular of information? And if so, why?
Yes – In addition to the labeling regulations at
21 CFR 606.121, Container label, the Food and Drug Administration (FDA) requires an extension of container labeling for blood and blood components. This extension of container labeling is necessary because the blood container label has limited space, and is similar to the use of a package insert provided for a drug product. In
§606.122, Circular of information, the FDA states that:
- “A circular of information must be available for distribution if the product is intended for transfusion.”
- “The circular of information must provide adequate directions for use, including” the information listed in §606.122(a) through (n).
As clarified by FDA representatives during the
2016 Ask the FDA session at AABB’s Annual Meeting, it is “FDA's expectation is that consignees will be provided with a hard copy of the
Circular”. Electronic distribution of the
Circular is not acceptable at this time.
Who is responsible for making the
Each blood collection establishment is responsible for compliance with the requirements to make a hard copy of the
Circular available at distribution, as described in
§606.122, Circular of information.
Is each blood collection establishment required to develop a circular?
A blood collection establishment can use the
available here, and are not required to develop their own circular. AABB’s Circular of Information Task Force (the AABB Task Force) is tasked with preparing the
Circular to assist you in meeting the requirements of
§606.122. The AABB Task Force is comprised of AABB member experts, including representatives from the American Red Cross, America's Blood Centers, the Armed Services Blood Program, and liaisons from the FDA. Once finalized by the AABB Task Force, AABB’s Regulatory Affairs Staff submits the
Circular for formal FDA review and acceptance.
How does FDA formally accept the AABB
FDA representatives serve on the AABB’s Circular of Information Task Force. Following submission by AABB for formal FDA review, the agency issues a guidance recognizing the
Circular as acceptable to meet existing regulations in
§606.122. AABB is permitted to make the
Circular available only after the FDA guidance is posted. You should review the
December 2017 guidance because FDA provides recommendations and detailed instructions for use of the
What is the current version of the
The current version is dated October 2017. FDA issued the
December 2017 Level II guidance for immediate implementation to formally recognize the October 2017
Circular as acceptable to meet the requirements of
§606.122. The FDA’s December 2017 guidance supersedes the previous guidance issued for the November 2013
Circular and, following a brief period of time for implementation, FDA will no longer recognize the November 2013
Circular as acceptable for use.
What are the changes to the
AABB developed the
Table of Changes for the October 2017 Circular to assist members in identifying changes in the current
Circular as compared to the November 2013
What are the implementation requirements?
In the December 2017 guidance, FDA describes options for compliance with the requirements in
§606.122 and provides instructions to licensed manufacturers for reporting requirements for this labeling change under
§601.12, Changes to an approved application:
- Implementing without modifications - You have the option to use the October 2017
Circular, as prepared by the AABB Task Force and formally recognized by FDA as acceptable for use. If you implement the October 2017
Circular without modifications and in its entirety, FDA considers this a minor change that must be reported in your annual report, noting the date of implementation, consistent with the reporting requirements of §601.12(f)(3).
- Implementing with modifications - Historically, if you implement with modifications, the FDA considers that a major change reported as a Prior Approval Supplement consistent with 601.12(f)(1). We encourage you to review the FDA’s December 2017 guidance for specific instructions or contact your FDA Consumer Safety Officer.
Will FDA require updated language that must be added to the new
Yes—Some updates were available at the time of printing and others were not. Please review the following and the section, REQUIRED UPDATES:
Language for testing using the FDA licensed ZIKV NAT: The October 2017
Circular was printed before the FDA licensed a ZIKV NAT making it necessary to update the language for those using the newly licensed test. Refer to the
November 02, 2017 News Flash (sent to all AABB members and accreditation contacts) for more information. Refer to the next section.
Language for use with an investigational test for ZIKV (under IND): The required update for facilities that continue to test for ZIKV under IND remains unchanged. Refer to the next section.
Language for Pathogen Reduction: The required language that was previously posted on the AABB website regarding pathogen reduction and FDA contact information/address for fatality reporting was incorporated in the October 2017 version.
REQUIRED UPDATES to the
Concerning ZIKV Testing Language in the
The October 2017 Circular was printed before a licensed ZIKV NAT test system was approved by FDA. Therefore, the Circular does not address ZIKV testing. As of the date FDA posted the December 2017 guidance, testing for ZIKV is performed using an investigational test or a licensed test and both require the addition of language to update the Circular.
The following recommendations are consistent with historic practice and address the necessary changes to the October 2017
Circular based on your current ZIKV testing:
- AABB suggests using an adhesive label or an ink stamp to insert additional language into the
- The version date of October 2017 for the
Circular should not be changed.
- Contact your Consumer Safety Officer if you are planning to add additional language.
- You must select the appropriate option for ZIKV NAT testing language based on testing for ZIKV performed under IND
or performed using an FDA licensed test.
- For the period of time your inventory includes components tested by a licensed ZIKV test and others tested using an investigational test for ZIKV, you should add language for both to ensure the
Circular, as extension of labeling, accurately reflects your practice and operations. This also applies to imported components that you distribute.
1. Testing for ZIKV using an investigational test:
The required additional language remains unchanged. The additional language for testing under IND
will continue as provided by the IND sponsor. As clarified by FDA representatives during the
2016 Ask the FDA session at AABB’s Annual Meeting, blood collectors must update their
Circular regarding testing for ZIKV using the language provided by their IND sponsor. This change to the
Circular is reported as a minor change in your annual report because the language in the IND has already been reviewed and approved by FDA. This information continues to apply to ZIKV testing under IND.
2. Testing for ZIKV using an FDA licensed test:
The following language, developed by the Task Force and accepted by FDA, is similar to that used for other licensed NAT tests that are required: “A licensed nucleic acid test (NAT) for Zika Virus RNA has been performed and found to be nonreactive.” This language must be added to the
Circular until it can be incorporated in a future version.
The Circular of Information Task Force will continue to provide updates to this webpage as changes in testing and product approvals require corresponding changes in labeling.