ABSTRACT
The modern blood industry dates back more than 50 years. Establishments known as blood banks began to appear in the 1930s, and widespread use of blood and its derivatives began during World War II. Federal regulatory control was exerted over blood and blood products almost from their inception based on the preexisting Biologics Control Act of 1902 (also known as the Virus-Toxin Act). This law requiring licensing of biologics was consolidated with other public health laws in 1944 to become the Public Health Service (PHS) Act. The first blood product, Normal Human Plasma, was licensed for medical use in 1940. The first blood bank was licensed for the manufacture of whole blood in 1946. The first blood grouping reagent for serological testing of red blood cells was licensed in 1949. The PHS Act was implemented by the National Institutes of Health (NIH) during the time the first blood licenses were issued. Blood was also considered to be a drug subject to the Federal Food, Drug and Cosmetic (FDC) Act; however, the full scope of regulatory controls available under the FDC Act was not implemented until regulatory control for biologics was transferred from the NIH to the U.S. Food and Drug Administration (FDA) in 1972 (1). Today, blood, blood components, blood-derived and analogous products, and in vitro diagnostic blood screening tests and other medical devices used in the manufacture of blood and blood components are regulated under federal statutes implemented by FDA.
