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Blood, Vaccines & 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 Email Page
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blood and blood components used for transfusion or for the manufacture of Print Page
pharmaceuticals derived from blood and blood components, such as clotting
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containers and HIV screening tests that are used to prepare blood products or Get email updates
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standards, inspects blood establishments and monitors reports of errors,
accidents and adverse clinical events. CBER works closely with other parts of
Approvals the Public Health Service (PHS) to identify and respond to potential threats to
blood safety, to develop safety and technical standards, to monitor blood
Blood Donor supplies and to help industry promote an adequate supply of blood and blood
Screening Test Kits 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.

Questions About Over a period of years, FDA has progressively strengthened the overlapping
Blood 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.
Resources for You 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
Consumers & Healthcare for seven different infectious agents. In addition to strengthening these
Providers safeguards, FDA has significantly increased its oversight of the blood industry.
The agency inspects all blood facilities at least every two years, and "problem"
Industry 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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