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—will become official on May 1, 2017.

Stakeholder Engagement

  • Submit public comments on the new and revised monograph proposals in the Pharmacopeial Forum.
  • Participate in the monograph development and revision process by submitting materials to USP.