Definition of (2) The term `human drug product

(2) The term `human drug product means the active ingredient of a new drug, antibiotic drug, or human biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Public Health Services Act) including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient." 35 U.S.C. 156(f).