410 ILCS 620/2.14

"New drug" means (1) any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that the drug is not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof; or (2) any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that the drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.