Circular of Information for the Use of Cellular Therapy Products

The Circular of Information for the Use of Cellular Therapy Products (Circular) is intended to be an extension of the cellular product label. It has been prepared and endorsed by ASFA, AABB, American Association of Tissue Banks, American Red Cross, America’s 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.