USP Compounding Standards
USP provides three types of public quality standards for compounding:
- General Chapters
- Compounded Preparation Monographs
- Monographs for Bulk Drug Substances and Other Ingredients
- USP Healthcare Quality & Safety Standards-Setting Process
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 six essential compounding General Chapters:
- <795> Pharmaceutical Compounding—Nonsterile Preparations
- <797> Pharmaceutical Compounding—Sterile Preparations
- <800> Hazardous Drugs—Handling in Healthcare Settings
- <1160> Pharmaceutical Calculations in Pharmacy Practice
- <1163> Quality Assurance in Pharmaceutical Compounding
- <1176> Prescription Balances and Volumetric Apparatus Used in Compounding
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.