A monograph starts with the name of the ingredient or preparation; includes a definition with clear indications as to what is in that name; packaging, storage, and labeling requirements; and the specifications for identity, strength, performance attributes, and limits for contaminants or unwanted substances. The specifications consist of series of tests, analytical procedures for those tests, and their acceptance criteria. These tests and analytical procedures have been validated following the directions of the General Chapter <1225> Validation of Pharmacopeial Procedures. The use of official USP Reference Standards is encouraged for verification purposes. Dietary ingredients and dietary supplements will have the stipulated strength, quality, and purity if they conform to the specifications and other requirements of the relevant monograph and general chapters.
Find definitions of other USP Dietary Supplements-specific terminology in the Guide to USP-Speak.
Monograph development
Monograph development is a multi-step process. Data are carefully reviewed and serve as the foundation for a draft proposal that is reviewed by an Expert Committee that is ultimately responsible for its approval.
Find out how you can be part of the standards development process
For details about the criteria used to determine whether a dietary ingredient qualifies for admission to the USP–NF monograph development process, refer to Admission of Dietary Supplement Ingredients to the USP–NF Monograph Development Process.
Information about the monograph naming process can be found in Guideline for Assigning Titles to USP Dietary Supplement Monographs.
Find more information about submitting monographs or contact the USP Dietary Supplements Science team.