The Circular of Information for the Use of Human Blood and Blood Components (Circular) is considered an extension of labeling for blood and blood components since the space on the product labels is limited.  The Circular is supplied to conform with applicable federal statues and regulations of the Food and Drug Administration (FDA), US Department of Health and Human Services and the contents provided have been reviewed and are recognized as acceptable by the FDA. 

The Circular includes:

• General information concerning donors and testing of donor blood, blood and component labeling and instructions for use of Whole Blood and components. 
• The side effects and hazards of transfusion including immediate and delayed immunologic complications, non-immunologic complications and transfusion reactions. 
• The description, actions, indications, contraindications, dosage and administration, product-specific side effects and hazards, and specific components available for Whole Blood and Red Blood Cells containing components, Plasma, Cryoprecipitate, Platelets and Granulocytes products. 
• The description and indications of further processing activities such as Leukoreduction, the identification of Cytomegalovirus (CMV)-seronegative blood and Irradiation. 
• A chart by product category summarizing the major indications, action/recipient benefit, contraindications, special precautions and hazards, and rate of infusion for each product.
• A list of associated references.

Click here to view the Circular of Information.

A Circular of Information for the Use of Cellular Therapy Products (Cellular Therapy Circular) is available and is likewise considered an extension of labeling since the space on the cellular therapy product labels is also limited.  The scope of the Cellular Therapy Circular is restricted to cellular therapy products such as hematopoietic progenitor cells (HPCs) and other leukocytes that are minimally manipulated.  The Cellular Therapy Circular is supplied to conform with applicable federal statues and regulations of the Food and Drug Administration (FDA), US Department of Health and Human Services.   

The Cellular Therapy Circular includes:

• General information concerning autologous and allogeneic cellular therapy product donors, product labeling (including biohazard and warnings), instructions for storage and administration of cellular therapy products and reporting of deviations and adverse reactions.   
• The side effects and hazards including immediate and delayed immunologic complications and non-immunologic complications. 
• The sources of HPCs including Marrow, Apheresis and Cord.
• The description, actions, indications, contraindications, dosage and administration, and storage conditions for HPCs products.  
• The descriptions, indications and administration of minimally manipulated cellular therapy products including Plasma Reduced-, Red Cell Reduced-, Buffy Coat Enriched-, Density Enriched-, Cryopreserved- and CD34 Enriched-HPCs and Lymphocytes.   
• The use of an FDA-approved Investigational New Drug (IND) protocol for more than minimally manipulated cellular therapy products.  
• A list of associated references.