Statement on Modernization*
USP engages in a continuous process of assessing and updating its standards to ensure that they are based on current scientific knowledge. USP prioritizes standards for modernization based on factors such as prevalence of use, toxicological data, evolving scientific techniques and technologies, requests from FDA or other stakeholders, and emergent public health issues.
- USP intends to maintain all its monographs in the most modern, relevant condition.
- USP is also working to ensure that general chapters, which are referenced in multiple monographs, reflect current industry practice and provide effective technology for assessing the quality of drugs, excipients, and packaging materials.
- Recently, USP, in partnership with the Food and Drug Administration and related industry groups, has modernized high profile medicines and ingredients, such as heparin and glycerin and related sugar alcohols, to ensure a safer supply of important medicines and ingredients.
*USP General Chapter Project Team, Prescription–Nonprescription Stakeholder Forum, de Mars S, et al. General chapter management in the 2010–2015 cycle. Pharmacopeial Forum. 2009;35(5):1372–1379.
Standards-setting practices of the United States Pharmacopeial Convention (USP) are articulated in statements that reflect the science-based understanding of USP volunteers and staff. These practices and principles undergird all of USP’s public standards, which result in the continuous revision of USP’s compendia for medicines and foods.