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AABB > Resource Center > Regulatory/Government Affairs > Blood and Blood Components

Blood and Blood Components 

Overview

Blood, a living tissue circulating throughout the human body, is comprised of red blood cells, white blood cells, platelets and plasma. Although often collected as whole blood and separated into major components prior to transfusion, automated collections have become common practice whereby the components that are needed for transfusion are the only ones collected.

In the U.S., the collection, testing, preparation, storage and transport of blood and blood components is governed by FDA regulations and guidance documents. 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 is an important part of the labeling for a blood component, similar to the package insert provided for a drug. The Code of Federal Regulations, Title 21, requires that it be available for distribution with blood and blood components intended for transfusion. 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).

On behalf of the transfusion medicine community and as part of ongoing collaborative efforts, AABB works directly with FDA and through government advisory committees to ensure the safe and effective collection and transfusion of blood products. In addition, AABB works with other federal agencies, including the Center for Medicare and Medicaid Services, to achieve adequate reimbursement for blood and blood products.

Recent Actions

04/07/14
FDA issued a guidance for industry titled “An Acceptable Circular of Information for the Use of Human Blood and Blood Components” accepting the November 2013 Circular of Information  that revises language relevant to storage for Plasma Frozen Within 24 Hours after Phlebotomy (collected by manual methods) and for Apheresis Plasma Frozen Within 24 Hours After Phlebotomy.

02/28/14
The AABB Circular of Information Task Force responded to questions concerning alternatives to the use of 0.9% Sodium Chloride Injection (USP) for blood or blood component transfusions due to the ongoing shortage of 0.9% sodium chloride.  Read more

01/03/14
AABB submitted comments to the FDA on the proposed rule “Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products.”  The principle recommendation is that whole blood, blood components, and cellular and gene therapy products be exempt from the proposed regulations as they do not have a history of shortages as described for other drugs and biologicals affected by the requirements of the proposed rule.

11/01/13
CareFusion provides a letter announcing FDA approval to update the ChloraPrep arm prep label to a thirty second dry time.

8/28/13
The AABB Interorganizational Task Force on Quarantine Release Errors released a white paper that addresses the issues of common terminology for discussing QREs, including a consensus definition for a QRE.  The paper also explores work environment issues and human factors contributing to QREs.

8/12/13
FDA published the guidance for industry titled “An Acceptable Circular of Information for the Use of Human Blood and Blood Components.”  The guidance recognizes the April 2013 Circular of Information as acceptable for use by manufacturers of blood and blood components intended for transfusion.  

5/31/13
FDA announced a draft guidance for industry titled "Changes to an Approved Application: Biological Products — Human Blood and Blood Components Intended for Transfusion or for Further Manufacture." The guidance is issued to manufacturers of licensed whole blood and blood components intended for transfusion or further manufacture as well as source plasma. It provides recommendations to assist with determining the most appropriate reporting mechanism through which changes may be submitted to an approved biologics license application. The document also addresses applicability and content of comparability protocols as well as labeling changes. Once the guidance has been finalized, it will replace the document of the same title dated July 2001.

4/29/13
FDA announced its approval of the Hemerus Leukosep HWB-600-XL Leukocyte Reduction Filtration System for Whole Blood with CPD Anticoagulant and Solx Additive Solution.

9/25/12
FDA finalizes recommendations in a guidance document for pre-storage leukocyte reduction of Whole Blood and blood components intended for transfusion, including recommendations for validation and quality control monitoring of the leukocyte-reduction process.

9/13/11
The Quarantine Release Errors in Blood Establishments Workshop provided a forum for discussion on quarantine release errors (QREs) and provided FDA and industry with information that indicated QREs are most frequently the result of human error and defects in process control.

1/31/11
FDA issues draft guidance on pre-storage leukocyte reduction of whole blood and blood components intended for transfusion.

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