For substances that cannot be completely characterized by chemical and physical means, it may be necessary to express quantities of activity in biological units of potency, each defined by an authoritative, designated reference standard.

Units of biological potency defined by the World Health Organization (WHO) for International Biological Standards and International Biological Reference Preparations are termed International Units (IU). Units defined by USP Reference Standards are USP Units, and the individual monographs refer to these. Unless otherwise indicated, USP Units are equivalent to the corresponding International Units, where such exist. Such equivalence is usually established on the basis solely of the compendial assay for the substance.

For biological products, whether or not International Units or USP Units do exist (see Biologics 1041), units of potency are defined by the corresponding U.S. Standard established by the FDA.