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AABB > Resource Center > Blood and Cellular Therapies Information

Circulars of Information 

Circular of Information for the Use of Human Blood and Blood Components
Circular of Information for the Use of Cellular Therapy Products

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).

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)

Purchase printed copies of the Circular of Information for the Use of Human Blood and Blood Components

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.


Circular of Information for the Use of Cellular Therapy Products

(September 2013)

The Circular of Information (Circular) for the Use of Cellular Therapy Products is intended to be an extension of the cellular product label. It has been prepared and endorsed by AABB, American Association of Tissue Banks, American Red Cross, American Society for Blood and Marrow Transplantation, American Society for Apheresis, Americas Blood Centers, College of American Pathologists, Foundation for the Accreditation of Cellular Therapy, ICCBBA, International Society for Cellular Therapy, National Marrow Donor Program, Joint Accreditation Committee of ISCT and EBMT, and NETCORD. The US Food and Drug Administration and Health Resource and Services Administration provided liaisons to this group. As an extension of container labels, each processing/issuing facility has the option and is encouraged to provide more facility or product specific information in the space provided in the Circular.

The organizations involved in writing the Circular limited the scope to minimally manipulated cellular products such as peripheral blood progenitor cells, bone marrow, cord blood and leukocytes. The group recognizes the fact that there are other cellular products which could not be adequately covered in the Circular. The electronic version of the Circular has been enhanced to allow for addition of facility specific information at the end of the document.

Cellular products are biologic products and, in the form of cellular products, living human tissue intended for use in patient treatment. Professional judgment based on clinical evaluation determines the selection of products, dosage, rate of administration, and decisions in situations not covered in this general statement.

Circular of Information for the Use of Cellular Therapy Products (PDF)

Download a digital copy the Circular of Information for the Use of Cellular Therapy Products

Purchase printed copies of the Circular of Information for the Use of Cellular Therapy Products

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