USP Monographs for Bulk Drug Substances and Other Ingredients

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. These monographs appear in the USPNF.

The 2016 edition—USP 40NF 35—became official on May 1, 2017.

Stakeholder Engagement