Non-U.S. Monographs

USP has provided standards for articles intended to treat neglected diseases legally marketed outside the United States since 2007. The purpose of these monographs is to support testing by first (e.g., manufacturer), second (e.g., payors), and third (e.g., government control laboratories) parties. Details of the approach are described in the Non-U.S. Guideline.

USP now publishes the Medicines Compendium (MC)—a free, online collection of standards to help assure that medicines and their ingredients are of good quality. The MC includes monographs and reference materials for suitable chemical and biological medicines and their ingredients if approved by national regulatory authorities or otherwise legally marketed. To view MC monographs and other information about MC, visit www.usp-mc.org.

All Non-U.S. Mongraphs will migrate to the MC once USP has developed a Reference Procedure for each monograph. This transition will take up to a year or more to complete. USP will maintain this Non-U.S. Monographs page until all Non-U.S. Monographs have transitioned to the MC.

For additional information, contact Todd L. Cecil, Ph.D., (tlc@usp.org)

Authorized Monographs