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
(August 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.
Implementation Instructions
When a facility implements the use of a different Circular it is considered a labeling change. The guidance document issued by the Food and Drug Administration on October 21, 2009 recognizing the August 2009 Circular as an acceptable extension of container labels provides instructions to facilities for reporting the labeling change to FDA.
Language on Chagas’ for Circular of Information
The Chagas’ language was not incorporated in the August 2009 Circular of Information for the Use of Human Blood and Blood Components. This language, which was reviewed by FDA, is intended for use by facilities using a Chagas’ test licensed for use with donor samples.
The language developed by the AABB Circular of Information Task Force is as follows: "A licensed test for antibodies to Trypanosoma cruzi (the agent of Chagas' disease) has been performed and found to be nonreactive." The suggested methods for inserting this language into the publication include use of an adhesive label or an ink stamp. The version date of the Circular should not be changed.
Implementation of Chagas’ language – FDA regulations do not require testing language to be included in the Circular when a test is not required. However, FDA has indicated that if an establishment wants to include Chagas’ language it should submit to the agency a “Change Being Effected” supplement along with the SOP that clarifies how the facility will distinguish if a shipment includes products that are both tested and untested.
Circular of Information for the Use of Human Blood and Blood Components (PDF)
This version incorporates the technical correction issued in December 2009. Anyone who accessed the electronic file of the circular before Dec. 12, 2009, is asked to replace that file by downloading this version.
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)