USP Compounding Standards

USP provides three types of public quality standards for compounding:

These standards are developed by the USP Compounding Expert Committee to help ensure the quality of compounded medicines. USP standards—general chapters and monographs—contained in the United States Pharmacopeia and the National Formulary (USP–NF) are recognized in various provisions of the federal Food, Drug and Cosmetic Act. Read USP’s fact sheet on compounding.

USP General Chapters for compounding establish procedures, methods and practices that are utilized by practitioners to help ensure the quality of compounded preparations.

There are several essential compounding General Chapters:

USP Compounded Preparation Monographs contain formulations and quality standards for specific preparations to assist practitioners in compounding preparations for which there is no suitable commercially available product. Read more on the USP Compounded Preparation Monograph Donation Program.

USP Monographs for Bulk Drug Substances and Other Ingredients provide standards for identity, quality, purity, strength, packaging and labeling for bulk substances and other ingredients that may be used in compounded preparations.