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

(November 2013)

The Circular of Information for the Use of Human Blood and Blood Components provides an extensive review of licensed and some unlicensed blood and blood components, their indications for use, special precautions, instructions for administration, and adverse effects of transfusion. It also includes a broad and up-to-date list of references. The Circular is an important part of the labeling for a blood component, similar to the package insert provided for a drug. The Code of Federal Regulations, Title 21, requires that it be available for distribution with blood and blood components intended for transfusion and that it provide adequate directions for use. The information contained in the Circular is intended to be widely available and easily accessed by health care providers as it is recognized by the FDA as an extension of the blood component label.

The Circular is prepared by the Circular of Information Task Force comprised of representation from AABB, the American Red Cross, America's Blood Centers, the Armed Services Blood Program and a liaison from the Food and Drug Administration (FDA).

The November 2013 Circular revised storage conditions for the “Plasma Frozen Within 24 Hours After Phlebotomy” components listed in the April 2013 Circular. The previous sentence on storage conditions was deleted from the “Description” section, and a “Components Available” section was added that includes information on storage conditions for Plasma Frozen Within 24 hours After Phlebotomy (collected by manual methods) and for Apheresis Plasma Frozen Within 24 hours After Phlebotomy.

Implementation Instructions for the November 2013 Circular

When a facility implements the use of a different Circular it is considered a labeling change. The guidance document issued by the FDA on April 7, 2014 recognized the November 2013 Circular as an acceptable extension of container labels and provided instructions to licensed manufacturers for reporting implementation to FDA under 21 CFR 601.12.

  • If the November 2013 Circular is implemented without modifications and in its entirety, the change is considered to be minor.  The change should be reported in the establishment's annual report consistent with 601.12(f)(3), noting the date the process was implemented.
  • If the November 2013 Circular is implemented with modifications, the change is considered to be major. The change should be reported as a Prior Approval Supplement consistent with 601.12(f)(1).

November 2013 Circular of Information for the Use of Human Blood and Blood Components (PDF)

Concerning ZIKV testing language in the Circular

During the October 2016 AABB Annual Meeting, Food and Drug Administration officials were questioned about new ZIKV screening requirements during the Ask the FDA & CMS/CLIA session. Since they began screening donors for ZIKV using an approved IND nucleic acid test, many blood establishments have wanted clarity about FDA requirements for the language to be used in their Circular of Information. FDA representatives clarified that blood collectors must update their Circular regarding testing for ZIKV using the language provided by their IND sponsor. In addition, since the language in the IND has been reviewed and approved by FDA, blood collectors can report this change to the Circular in the establishment’s Annual report. The clarification was provided in response to the following question: “Following FDA’s August 2016 ZIKV guidance, does FDA continue to require that establishments use language provided in their approved IND for Zika virus testing to update their Circular, or does FDA expect AABB’s Circular of Information Task Force to develop language for the Circular?”

Interim Language for Further Processing Section – Pathogen Reduction

Suggested methods for inserting language into the Circular include use of an adhesive label or an ink stamp. The version date of the Circular should not be changed. The interim language, accepted by the FDA, will be incorporated at a later date into the Further Processing section of the Circular. It describes further processing of blood components using pathogen reduction technology. This Table of blood components approved by the Food and Drug Administration for further processing using pathogen reduction technology updates the interim language accessible at the links below.

Manual Collections Automated Collections (collected on approved platforms)
Whole blood-derived plasmaApheresis Platelets Leukocytes Reduced
 Apheresis Platelets Platelet Additive Solution (PAS-C) Added Leukocytes Reduced
 Apheresis Plasma

Interim Language (MS Word)
Interim Language Formatted for Adhesive Labels (MS Word)

Reporting Fatal Transfusion Reactions to FDA – Updated Mailing Address

FDA relocated the offices and laboratories of the Center for Biologics Evaluation and Research (CBER) from locations in Bethesda and Rockville, Maryland to the FDA White Oak campus in Silver Spring, Maryland. Effective May 12, 2014 the phone number and mailing address referenced in the Circular under “Fatal Transfusion Reactions” are updated to:

Director, Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research
Attn: Fatality Program Manager
Document Control Center
10903 New Hampshire Avenue
WO71, G112
Silver Spring, MD 20993-0002