USP Compounded Preparation Monographs contain formulations and procedures for practitioners who are compounding specific preparations for which an FDA-approved dosage form is not available to meet the individual health needs of a patient. Following the procedures and formulations in the monograph will help the compounder produce a preparation of consistent identity, strength and potency.
USP Compounded Preparation Monographs provide standard instructions for 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
Donate Compounded Preparation Monographs Today
USP is collaborating with stakeholders to identify unmet public health needs for which compounded preparation monographs will help establish quality standards. As we identify those needs, we will reach out to parties to submit information necessary for developing monographs. USP encourages you to submit your compounded formulations and supporting stability information.
The donated information will be used to establish formulas, preparation procedures, assays, testing methods and stability criteria required to develop compounding preparation monographs. The USP Compounding Expert Committee is responsible for developing and revising compounded preparation monographs based on the data submitted.
Benefits of Participating in the Compounded Preparation Monograph Donation Program
Promote Public Health
By participating in this program, you will promote public health by contributing to the creation of a comprehensive repository of compounding monographs in the USP–NF.
USP values its donors and volunteers in the monograph development process, and recognizes these contributions with a certificate of appreciation. USP also acknowledges significant scientific contributions and participation in the process in a variety of ways, including the following:
- Recognition in USP publications
- Recognition on USP’s annual donor list
- Personalized engraved crystal globe recognition statue
- Complimentary workshop registrations or Global Education and Training courses
- Complimentary print subscription to one of USP’s publications
- Complimentary USP Reference Standards
To donate today, please contact the Program Manager, at CPMDonate@usp.org.
- Download the Compounded Preparation Monograph Donation Program Fact Sheet
- For additional information about the benefits of donating to USP, read the Donor Recognition Fact Sheet.
- Sign up for the Healthcare Quality Standards Newsletter to receive updates on USP Compounding Standards.