“New drug” defined. “New drug” means any drug the composition of which is such that the drug:
1. 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. As a result of investigations to determine its safety and effectiveness for use under those conditions, has become so recognized, but which has not, other than in the investigations, been used to a material extent or for a material time under those conditions.
Last modified: February 26, 2006