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In 1962, the DBS brought suit against John P. Calise and the Westchester Blood Bank for intentionally altering the expiration dates on whole blood so that the product dating would exceed the 21-day requirement. He pleaded guilty and was convicted in 1964 on three counts of misbranding, three counts of false labeling, two counts of shipping an unlicensed biological product, and one count of conspiracy. Calise was placed on probation for five years and forbidden to engage in the manufacture, distribution, or sale of any biological, plasma, or blood products. The case marked the first court confirmation that blood is a drug under the definition of the Food, Drug, and Cosmetic Act. The case also marked the first litigation brought against a biologics manufacturer.

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Blood banks and blood products were regulated through the NIH DBS Laboratory of Blood and Blood Products. In the 1950s, the NIH Blood Bank was part of the Laboratory of Blood and Blood Products. Much of the important research completed by the Laboratory was done hand in hand with the NIH Blood Bank. At some point in the late 1950s or early 1960s, the blood bank (which was located in the basement of the NIH Clinical Center) was administratively separated out from the Laboratory of Blood and Blood Products and became part of the Clinical Center (Department of Transfusion Medicine). When the DBS transitioned administratively from the NIH to the Food and Drug Administration (FDA), the Laboratory of Blood and Blood Products’ regulatory role continued in the Division of Blood and Blood Products.

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