Food and Drug Administration

This agency is better known as the “FDA”. The FDA is an incredibly large and complex United States Government agency (a division of the US Department of Health and Human Services) charged with ensuring safety of a wide variety of products, including blood and pharmaceuticals. One portion of FDA known as the “Center for Biologics Evaluation and Research” (CBER) is specifically responsible for blood safety, and establishes standards for blood product collection and processing, publishing them in the U.S. Code of Federal Regulations (CFR). Essentially, the FDA’s goal is to have blood products collected and processed under standards very similar to those expected of the pharmaceutical industry. U.S. blood facilities are inspected by FDA personnel at least once very two years to ensure compliance. FDA also publishes guidelines of current FDA thought on various topics as “guidances,” available on the FDA web site. U.S. blood collection and transfusion services are required to report suspected collection and transfusion-related fatalities to the FDA promptly.

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