| U.S. Food & Drug Administration
P.O. Box 25087
Federal Center, Bldg. 20
Denver , CO 80225-0087
| 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. Contact for requirements for testing, storage and inspections of facilities, and Registration requirements. Contact for exceptions.
|FDA requires blood centers to maintain lists of unsuitable donors to prevent the use of collections from them. Blood donations must be tested for seven different infectious agents. The agency inspects all blood facilities at least every two years.