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

Interim Language on Chagas’ for Circular of Information
The AABB Circular of Information Task Force has developed new language on Chagas’ that it is recommending for interim use in the Circular of Information for the Use of Human and Blood Components. The 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 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."  Until the Circular is updated, 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.


Interim Language on WNV for Circular of Information 
The AABB Circular of Information Task Force has developed new language on West Nile virus (WNV) that it is recommending for interim use in the Circular of Information for the Use of Human and Blood Components. The language, which was reviewed by FDA, is intended for use by facilities using a licensed WNV test system. A system is not licensed until the test reagents and the testing platform receive FDA approval.  

The language developed by the AABB task force is as follows: "A licensed nucleic acid test (NAT) for West Nile virus (WNV) RNA has been performed and found to be nonreactive." Until the Circular is updated, 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.

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

Circular of Information for the Use of Human Blood and Blood Components (WNV Language Inserted, April 2006) (PDF)

Circular of Information for the Use of Cellular Therapy Products
(June 2007 Reposting) - The contact information was updated on the last page of the document (previous version July 2005, which was posted October 2005).  The rest of the document content remain the same.

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, Foundation for the Accreditation of Cellular Therapy, ICCBBA, International Society for Cellular Therapy, and National Marrow Donor Program. The US Food and Drug Administration provided a liaison 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 printed version of 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 and contains a brief statement about the use of more than minimally manipulated products.

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. This Circular is supplied to conform to applicable federal statutes and regulations of the US Food and Drug Administration, US Department of Health and Human Services.


Interim Language on Chagas’ for Circular of Information
The AABB Circular of Information Task Force has developed new language on Chagas’ that it is recommending for interim use in the Circular of Information for the Use of Cellular Therapy Products. The language, which was reviewed by FDA, is intended for use by facilities using a Chagas’ test licensed for use with donor samples.  In addition to screening people who donate whole blood, this test in intended for use in screening plasma and serum samples from organ, cell and tissue donors.

The language developed by the AABB 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."  Until the Circular is updated, 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.

Interim Language on WNV
WNV testing is not included in Table 1. Testing of Cellular Therapy Product Donors as it has not yet been required by FDA to be performed on cellular therapy (or blood) donors.  However FDA has reviewed language that can be used by facilities using a licensed WNV test system to indicate that WNV testing has been performed. A system is not licensed until the test reagents and the testing platform receive FDA approval. 

The language reviewed by FDA is as follows: "A licensed nucleic acid test (NAT) for West Nile virus (WNV) RNA has been performed and found to be nonreactive." Until such time as WNV is a required test for cellular therapy donors the language could be included in the summary of records that accompanies the HCT/P product.  When WNV is required by FDA to be performed on cellular therapy donors Table 1 will be updated to include WNV testing. 


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