USP Compounded Preparation Monographs contain formulations used in human and animal patients. These monographs provide quality standards for specific preparations to assist practitioners in compounding formulations for which there is no suitable commercially available product.
USP Compounded Preparation Monographs include the following:
- Formulas (ingredients and quantities)
- Directions to correctly compound the preparation
- Beyond-use dates based on stability studies
- Packaging and storage information
- Acceptable pH ranges
- Stability-indicating assays
These monographs appear in the USP–NF and in the USP Compounding Compendium. The monographs may be used by compounders to prepare specific formulations for patients for whom there are no suitable commercially available products. The monographs also contain important beyond-use date information on the formulation, which is the date after which the preparation must not be used.
A list of all the currently official compounded preparation monographs can be accessed below.
- Submit public comments on the new monograph proposals via the Pharmacopeial Forum.
- Participate in the compounded preparation monograph development process by donating materials to USP through the USP Compounded Preparation Monograph Donation Program.
The USP Compounding Expert Committee is responsible for developing and revising compounded preparation monographs. Review their work plan and past meeting summaries.