1. 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.
2. 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).
3. Monographs refer to the units defined by USP Reference Standards as “USP Units.” For biological products, units of potency are defined by the corresponding U.S.
4. Standard established by FDA, whether or not International Units or USP Units have been defined (see Biologics <1041>).
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