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NCI: A compound or product that was available prior to the passage of the 1938 Federal Food, Drug and Cosmetic Act.,NCI: A drug product that was on the market prior to the passage of the 1938 Federal Food, Drug, and Cosmetic Act (the FD&C Act) and which contained in its labeling the same representations concerning the conditions of use as it did prior to passage of that act, was not considered a new drug and therefore was exempt from the requirement of having an approved new drug application. (ICSR)
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