In 1972, the Food and Drug Administration’s (FDA) new Bureau of Biologics began to regulate all 7000 U.S. blood and plasma centers. Regulation of blood banks.  It has remained in FDA ever since, with occasional variations in its size, structure, and affiliations.

This environment changed dramatically with the first prosecution of an individual in a commercial blood bank in 1962. The responsible head of the blood bank was found guilty of falsification of records, mislabeling, and adulteration and was permanently barred from practicing blood banking in any licensed facility.

The Justice Department at the time elected to prosecute the case under both the drug and the biologies statutes, since prior to that time the courts had held that blood was not a biological product because it was not enumerated specifically in the PHS Act. In 1973 the PHS Act was amended to include blood explicitly.

Today it is an organization with more than 800 scientists, medical officers, and support personnel. Its three offices for product review have full authority to review products, from the investigational stage through marketing.

From a regulatory perspective, strategies must be developed by FDA and industry to provide quality assurance, to prevent errors and accidents, and to ensure conformance with legal requirements without losing the identity of blood banks as both a needed medical service and as manufacturers of biological products. This will require the development of more meaningful partnerships between the federal government and the private sector and between the public and members of the health professions.