USP Monograph Modernization Initiative

Type of Posting: 
General Announcement

As part of USP's initiative to update and improve its monographs for drug substances, drug products and excipients in the United States Pharmacopeia and the National Formulary (USP–NF) compendia, USP is focusing on monographs identified as a priority by the Food and Drug Administration (FDA). A recent letter to USP from FDA listed acetaminophen and diphenhydramine and several related dosage forms, most of which are over-the-counter (OTC) medications, as high priority monographs for updating. The letter also identified as priorities the inactive ingredients or excipients copovidone, crospovidone, povidone and talc. FDA cited potential health issues as the basis for these requests.

To view the FDA letter and USP's response along with a complete listing of the affected monographs, please visit the Monograph Modernization Hot Topics Page.