The FDA is responsible for ensuring the safety of our nation's blood supply. The Center for Biologics Evaluation and Research (CBER) regulates the collection of blood and blood components used for transfusion or for the manufacture of pharmaceuticals derived from blood and blood components, such as clotting factors, and establishes standards for the products themselves. CBER also regulates related products such as cell separation devices, blood collection containers and HIV screening tests that are used to prepare blood products or to ensure the safety of the blood supply. CBER develops and enforces quality standards, inspects blood establishments and monitors reports of errors, accidents and adverse clinical events. CBER works closely with other parts of the Public Health Service (PHS) to identify and respond to potential threats to blood safety, to develop safety and technical standards, to monitor blood supplies and to help industry promote an adequate supply of blood and blood products. While a blood supply with zero risk of transmitting infectious disease may not be possible, the blood supply is safer than it has ever been.

Over a period of years, FDA has progressively strengthened the overlapping safeguards that protect patients from unsuitable blood and blood products. Blood donors are now asked specific and very direct questions about risk factors that could indicate possible infection with a transmissible disease. This "up-front" screening eliminates approximately 90 percent of unsuitable donors. FDA also requires blood centers to maintain lists of unsuitable donors to prevent the use of collections from them. Also, blood donations are now tested for seven different infectious agents. In addition to strengthening these safeguards, FDA has significantly increased its oversight of the blood industry. The agency inspects all blood facilities at least every two years, and "problem" facilities are inspected more often. Blood establishments are now held to quality standards comparable to those expected of pharmaceutical manufacturers.

In 1997, the FDA initiated the Blood Action Plan to increase the effectiveness of its scientific and regulatory actions, and to ensure greater coordination with our PHS partners. The plan was adopted by DHHS and is revised as new concerns emerge. As biological products, blood and blood products are likely always to carry an inherent risk of infectious agents. Therefore, zero risk may be unattainable. The role of FDA is to drive that risk to the lowest level reasonably achievable without unduly decreasing the availability of this life saving resource.

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Blood Product Availability

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Updated: May 28, 2008