How does USP prioritize which herbal articles are developed into standards?
While any herbal article eligible for inclusion in HMC can be developed into a monograph, USP may give priority to articles based on factors including (1) extent of use by the public; (2) interest to multiple countries or regions; (3) interest by a regulatory agency; (4) well-established chemical characteristics through modern separation, spectroscopic, and other analytical techniques; (5) established pharmacologically active component(s) or marker compounds for establishing identity, composition, quality, and purity, and for stability studies; and (6) extent of recognition by multiple national compendia through monographs. These factors take into account public health considerations (e.g., potential patient exposure) as well as practical considerations (e.g., feasibility of monograph development based on available information).