Under Title 21 CFR 610.41, persons with a history of a positive (confirmed) test for hepatitis B virus surface antigen (HBsAg), regardless of age at the time of the positive test, may not serve as a donor of human blood, plasma, or serum. Donor suitability in regard to a history of viral hepatitis at the age of 11 years or later should be assessed by asking the donor for recollections of experiencing physical signs or symptoms of clinical hepatitis (e.g., "yellow jaundice," or other pertinent physical evidence of clinical hepatitis), or having received a diagnosis of viral hepatitis from a physician. Records of laboratory data (e.g., serology, ALT, AST, bilirubin, prothrombin time), if available, may assist the medical director in making the donor suitability determination in the face of an inconclusive history. However, certain isolated laboratory test results should not be considered equivalent to a history of viral hepatitis. In particular, a history of an elevated alanine aminotransferase (ALT) or a reactive test for antibodies to Hepatitis A Virus (anti-HAV) or Antibodies to Hepatitis B surface antigen (anti-HBs) need not be a cause to defer a donor. If a clinical history or diagnosis of viral hepatitis occurring at age 11 years or later is established, the donor will should be permanently deferred, and blood and blood components collected from the donor should not be used in the manufacture of products intended for transfusion. If viral hepatitis infection before the age of 11 is suspected to have occurred, the donor should be temporarily deferred and blood and blood components collected from the donor should not be used in the manufacture of products intended for transfusion until the circumstances are investigated and a medical opinion rendered on the significance of the history, and the conclusion drawn that there is no history or diagnosis of viral hepatitis after age 11. Please be aware, however, that a blood center may voluntarily elect to adopt more stringent donor deferral criteria in its Standard Operating Procedures (SOPs) than those required or recommended by the FDA. Under these circumstances, FDA does require that the blood center follow its own SOPs. There are two relevant documents available that can further clarify FDA's current donor deferral criteria: | 
