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Rockville, MD – April 2, 2018 - USP is currently reviewing stakeholder comments to our proposed change to USP-NF Section 2.20 Official Articles of the General Notices and Requirements to add the following language at the end of the second paragraph: “For a biologic product licensed under the Public Health Service Act, the official title shall be the title specified in the relevant monograph plus any suffix designated by FDA unless otherwise specified in the applicable monograph.”
USP has stated that it will not develop a new monograph for a biologic unless there is stakeholder consensus supporting its creation, including the support of FDA. USP’s proposed revision is intended to align compendial names with FDA’s biologics naming approach and avoid potential issues for manufacturers and other stakeholders.
The proposed change has been open for comment in the USP Pharmacopeial Forum which enables the organization to incorporate feedback from the Food and Drug Administration (FDA), as well as a wide variety of stakeholders, including industry, researchers, health providers and others. The comment period ended March 30, 2018.
USP is an independent non-profit organization that collaborates with the world’s top health and science experts to develop high-quality standards that set the bar for manufacturing and distributing safe and effective medicines, supplements and food around the globe. Two billion people world-wide have access to quality medicines, dietary supplements and food as a result of USP’s standards, advocacy and education.
Through initiatives like the Promoting the Quality of Medicines Program, funded by the US Agency for International Development and implemented by USP, and the USP-APEC Center of Excellence in Securing Medicines Quality in the Supply Chain, the organization strengthens medicines quality assurance systems, increases the supply of quality-assured medicines, and develops capacity to detect and remove poor-quality medicines from the market. By sharing scientific expertise and providing technical support and leadership, USP helps local regulators improve and sustain local health systems, and enables manufacturers to supply quality-assured essential medicines for years to come. Through these efforts, USP is able to help prevent and treat diseases like HIV/AIDS, tuberculosis, malaria, and neglected tropical diseases, and improve maternal, newborn and child health.