Section 109980 Of Chapter 1. General Provisions And Definitions From California Health And Safety Code >> Division 104. >> Part 5. >> Chapter 1.
109980
. "New drug" means either of the following:
(a) Any 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 or advertising thereof.
(b) Any drug the composition of which is such that the drug, as a
result of investigations to determine its safety and effectiveness
for use under these conditions, has become so recognized, but that
has not, otherwise than in the investigations, been used to a
material extent or for a material time under the conditions.