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Arm prepped for blood donation

FDA has progressively strengthened the overlapping safeguards that protect patients from unsuitable blood and blood products. Blood donors are asked specific questions about risk factors that could affect the safety of the donation and are deferred from donation if risk factors are acknowledged. FDA also requires blood centers to maintain lists of unsuitable donors to prevent further donations from these individuals. After donation, the blood is tested for several infectious agents. All tests must be negative before the blood is suitable for transfusion. In addition to 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.


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Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3103
Silver Spring, MD 20993-0002

ocod@fda.hhs.gov

(800) 835-4709
(240) 402-8010

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