Hyderabad:  To help ensure that medicines and their ingredients used around the world are of good quality, the United States Pharmacopeial Convention (USP) announced today the availability of a free, online collection of voluntary public standards to allow testing of a medicine and its ingredients. These standards appear in the new USP Medicines Compendium (MC).

The MC will support good quality medicines through tests, procedures, and acceptance criteria for critical quality attributes. Published by USP and available at www.usp-mc.org, theMC will include standards for medicines legally marketed in various countries. Initially, theMC will include 10 standards proposed for public comment, and another 11 standards proposed for development.

The first group of standards posted today includes those for anti-malarial, anti-retroviral (HIV), and contraceptive medicines, among others. For some of the medicines to be included in theMC, no other public standard may currently exist in any pharmacopeia. MC is designed to address such public health gaps.

MC standards are voluntary, unless they are adopted by a regulatory authority. They are intended to support the text and work of other pharmacopeias, and not to supplant it. MCstandards may be especially useful for manufacturers who export to countries with scarce regulatory resources and no national pharmacopeia.

“Public standards help ensure that all manufacturers of a given medicine or ingredient meet the same fundamental requirements, providing a ‘common ground’ that allows practitioners to have confidence in the medicines they prescribe, and patients in the medicines they take. These standards are critical-especially where regulatory resources are constrained or absent,” said Roger L. Williams, M.D., chief executive officer of USP. “The USP Medicines Compendium will be offered freely to all, so that it can be used by anyone-not just manufacturers, but purchasers, regulatory agencies and other pharmacopeias as well, as a means of helping to ensure high-quality medicines. As the only nongovernmental pharmacopeia in the world, USP is in a special position to develop this compendium-a manifestation of the organization’s global public health mission.”

Based on public comment, USP expects the standards to become authorized and final later in 2011, following approval by an Expert Committee of the USP Council of Experts. The written standards, or monographs, included in the MC utilize a novel scientific approach that differs from any other pharmacopeia. MC standards are Performance Based Monographs (PBMs). PBMs feature Reference Procedures, which are developed by USP‟s laboratory and are based on International Conference on Harmonization (ICH) approaches. (For example, ICH impurity limits will typically be followed in the MC.) PBMs allow flexibility by permitting a manufacturer to use the Reference Procedure or other Acceptable Procedures in the monograph. MC standards can include a posting of validation data relied upon to set the standards; this type of disclosure is a special feature of the MC. USP will offer reference materials for monograph tests where needed.

MC standards are created in an open, transparent process similar to that utilized for USP‟s other compendia. MC standards will be approved by the Council of Experts-USP‟s volunteer, independent, elected body of experts. The initial Expert Committee focusing on the MC is based in the South Asia region, in India, which is a major exporter of medicines to the world. Additional Expert Committees in other regions may be added over time.

Standards proposed for inclusion in the MC are available for public review by any interested party for a 90-day comment period before becoming authorized by the MC Expert Committee. At that time, regulators, purchasers, manufacturers, pharmacopeial bodies or others will be free to utilize these standards. The MC will be updated monthly at www.usp-mc.org.

The standards proposed today are: acyclovir, acyclovir topical cream, amlexanox, chloroquine oral solution, chloroquine phosphate, chloroquine sulfate, etoricoxib, nelfinavir mesylate, ormeloxifene hydrochloride, and stibogluconate sodium. Standards proposed for future development are: artesunate, artesunate tablets, clarithromycin, diphenhydramine hydrochloride, efavirenz, eflornithine for injection, eflornithine hydrochloride, eflornithine topical cream, mefloquine hydrochloride, nelfinavir tablets, nelifinavir for oral suspension.

Frequently Asked Questions about the MC are available at http://www.usp.org/pdf/EN/MedicinesCompendiumFAQs.pdf.

To learn more about the MC, please visit www.usp-mc.org or email [email protected].