In 1955, the Division of Biologics Control (DBS) became an independent entity within the National Institutes of Health (NIH). The DBS was responsible for establishing and maintaining standards of quality and safety of all biological products. The safety, purity, and potency of all biologics had to be established before the product was licensed by DBS. 

The DBS was formed in the wake of the “Cutter Incident.” In 1955, the year following a field trial that showed the Salk inactivated (killed) polio vaccine to be safe and effective, the DBS licensed several firms to produce the vaccine.

One firm, Cutter Laboratories, accidentally released vaccine that retained live polio virus, resulting in 260 paralytic cases of the disease in children, a disaster that caused panic among parents and scientists alike. The vaccine from Cutter Laboratories was pulled from the market on April 27, 1955, but the damage had already been done. The Cutter Incident became a defining moment in the history of vaccine manufacture and government oversight of vaccines.