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
(December 2009)
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, and the Code of Federal Regulations, Title 21, requires that it be available to all medical personnel involved in transfusion processes. The information contained in the Circular is intended to be widely available and easily accessed by health care providers as it is 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 FDA recognizes the Circular of Information as an acceptable extension of container labels.
Implementation Instructions
When a facility implements the use of a different Circular it is considered a labeling change. The guidance document issued by the FDA on October 21, 2009 (updated December 2009) recognizing the revised Circular as an acceptable extension of container labels provides instructions to facilities for reporting the labeling change to FDA. Any facility that continues to update printed copies of the August 2009 brochure per the December 2009 Memorandum should indicate that the update has occurred by adding "revised December 2009, see pages 40-41" to the back cover of the brochure.
Circular of Information for the Use of Human Blood and Blood Components (PDF)
The PDF educational version of the Circular of Information for the Use of Human Blood and Blood Components was reposted May 12, 2011 to correct four spacing and other typographic errors. One correction to note is that the low birth weight, in gram weight, listed in the CMV paragraph (page 8 of the printed brochure, page 6 in the PDF) is corrected to ≤1200. Anyone who accessed the electronic file of the circular before May 12, 2011 is asked to replace that file by downloading this version.
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Testing Language Not Incorporated in the December 2009 Version
Suggested methods for inserting language into the Circular on testing for antibodies to T. cruzi or HBV DNA by NAT include use of an adhesive label or an ink stamp. The version date of the Circular should not be changed.
Language for Antibodies to T. cruzi - The following language is recommended by FDA in the December 2010 guidance document: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion. "All blood has been collected from donors who have tested negative by a licensed test for antibodies to T. cruzi either on the current donation or at least one previous donation."
Licensed blood establishments that use the recommended language can submit the revised labeling in a Special Labeling Supplement – Changes Being Effected, in accordance with 21 CFR 601.12(f)(2). Licensed blood establishments that use different language in their statement must submit the labeling change prior to distribution of the product, in accordance with 21 CFR 601.12(f)(1)
Language for HBV NAT – The following language, developed by the task force, is similar to that used for other licensed NAT tests that are required to be performed: "A licensed nucleic acid test (NAT) for HBV DNA has been performed and found to be nonreactive."
FDA has indicated that if an establishment wants to include language for testing not recommended by FDA, it should contact the establishment's Consumer Safety Officer.
Product Language Not Incorporated in the December 2009 Version
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 language accessible at the following link has been accepted by FDA to describe the PF24RT24 plasma component. An amendment to the PF24 plasma component is available to describe changes relevant to collection by apheresis.
The following language, accepted by FDA, describes the PAS platelet component:
"APHERESIS PLATELETS PLATELET ADDITIVE SOLUTION ADDED LEUKOCYTES REDUCED (Platelets Pheresis Platelet Additive Solution Added Leukocytes Reduced) are platelets collected by apheresis and suspended in variable amounts of plasma and an approved platelet additive solution (PAS), for example, approximately one third plasma and two thirds PAS containing sodium chloride, sodium acetate, sodium citrate, and pH buffered sodium phosphate. The volume and number of platelets in this component are comparable to APHERESIS PLATELETS. Plasma proteins including coagulation factors present in the plasma are diluted in proportion to the PAS added. The component must meet the leukocyte reduction requirements for APHERESIS PLATELETS LEUKOCYTES REDUCED. This product may be further processed (e.g., irradiated, divided)."
Circular of Information for the Use of Cellular Therapy Products
(November 2009)
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 Society for Apheresis, American Red Cross, Americas Blood Centers, American Society for Blood and Marrow Transplantation, College of American Pathologists, Foundation for the Accreditation of Cellular Therapy, ICCBBA, International Society for Cellular Therapy, and 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. Federal law prohibits dispensing the cellular therapy products described in this circular without a prescription.
Circular of Information for the Use of Cellular Therapy Products (PDF)
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