Pub. L. 107-296, tit. XVII, sec. 1716
CLARIFICATION OF DEFINITION OF VACCINE.
SEC. 1716. CLARIFICATION OF DEFINITION OF VACCINE. Section 2133 of the Public Health Service Act (42 U.S.C. 300aa-33) is amended by adding at the end the following: “(7) The term ‘vaccine’ means any preparation or suspension, including but not limited to a preparation or suspension containing an attenuated or inactive microorganism or subunit thereof or toxin, developed or administered to produce or enhance the body’s immune response to a disease or diseases and includes all components and ingredients listed in the vaccines’s product license application and product label.”.