On Jul. 1, 1972, the Regulation of Biologics–including serums, vaccines, and blood products–was transferred from the NIH to the FDA.

Today, biologics are also defined as drugs. Therefore, when the biological authorities joined FDA , all of the provisions of the federal Food, Drug and Cosmetic Act (FD&C Act) became operative. Having the authority to administer both the FD&C Act and the Public Health Service Act (PHS Act) now gives FDA great flexibility and scope.

The Division of Biologic Standards, the DBS as it was known, became the Bureau of Biologics. It has remained in FDA ever since, with occasional variations in its size, structure, and affiliations. 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.