ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Any chemical compound that may be used on or administered to humans as an aid in the diagnosis, treatment, cure, mitigation, or prevention of disease or other abnormal conditions.

See also: API

Publication Source: Committees on Human Research


1. Articles recognized in the official United States Pharmacopeia (USP), official Homoeopathic Pharmacopeia of the United States, or official National Formulary (NF), or any supplement to any of them.

2. Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.

3. Articles (other than food) intended to affect the structure or any function of the body of man or other animals.

4. Articles intended for use as a component of any article specified in definitions 1 and 2.

5. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 403(r) of the Federal Food, Drug, and Cosmetic Act is not a drug solely because the label or the labeling contains such a statement.

See also: Generic Drug

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