Section 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.
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Last accessed
Dec. 5, 2016