USP Offers Herbal Medicines Compendium - - BioPharm International

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USP Offers Herbal Medicines Compendium


The U.S. Pharmacopeial Convention (USP) is offering free online access to public standards to help ensure the quality of the herbal ingredients used in medicinal products. USP has proposed the first 23 ingredients to be included in the new Herbal Medicines Compendium (HMC) for comment by interested stakeholders worldwide at hmc.usp.org. HMC will provide standards for herbal articles, but will not include standards for ingredients of animal origin, synthetic chemicals, or biotechnology-derived medicines, according to the press announcement (PDF).

USP is an independent, nonprofit organization that establishes standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements. USP’s standards for pharmaceuticals are contained in the United States Pharmacopeia and the National Formulary
(USP–NF), which are recognized in US law and used throughout the world.

“USP believes that public standards are critically important to help ensure the quality of all medicines, including herbal medicines,” said Roger L. Williams, M.D., chief executive officer of USP. “Given medicines’ key role in maintaining health and treating disease for a majority of the world’s population, the importance of public standards for all medicines, including herbal preparations, cannot be overstated. Through the Herbal Medicines Compendium, we will now have the ability to better meet the needs of our worldwide stakeholders who seek public standards for herbal medicinal ingredients.”

HMC monographs provide quality specifications—tests, procedures and acceptance criteria—with validated analytical procedures and allied reference materials that aid in conformity assessment. HMC monographs and associated general chapters can help ingredient manufacturers, herbal product manufacturers, regulatory agencies, and other stakeholders to assess conformance of herbal medicinal ingredients with independent public standards and control the quality of articles moving in international commerce. When coupled with sound registration processes and adherence to suitable Good Manufacturing Practices, standards in HMC can become an important part of the safety net that helps ensure access to good quality medicines, USP reports.

HMC standards are developed through a public standards-setting process that invites input from interested parties, and with the collaboration and approval of experts from around the world, via the volunteers who serve on the USP Council of Experts. Proposed monographs on the HMC website are initially posted as “For Development,” which indicates more information is needed before they can advance to the next stage. Once all the information is complete, monographs are advanced for public comment as “For Comment” monographs. After addressing public comments, the standards are authorized by the USP Council of Experts and published as “Final Authorized.”

These monographs will be open for a 90-day comment period before they are reviewed and adopted by the USP Council of Experts as authorized monographs. Users will be able to submit comments directly within the website for the USP Council of Experts to consider, and each monograph has an associated discussion forum to allow for real-time exchange among users worldwide. An additional 20 monographs in the For Development category also are available on the HMC website. After monographs become authorized, comments may be submitted for consideration for possible future revisions.

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