Standards-Setting Activities of USP's Council of Experts - Pharmaceutical Technology

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Standards-Setting Activities of USP's Council of Experts
This report provides plans for the USP Council's work in the 2010-2015. This articles contains online bonus material.


Pharmaceutical Technology
Volume 35, Issue 3, pp. 78-88

Nomenclature, Safety, and Labeling Expert Committee

The Nomenclature, Safety, and Labeling Expert Committee has responsibilities that span all Expert Committees. This Expert Committee reviews and approves USP-NF monograph titles for drug products, biologics and biotechnology products, excipients, and dietary supplements. In the 2010-2015 cycle, USP also added the focus on safety and labeling topics, formerly addressed by the Safe Medication Use Expert Committee in previous cycles.

USP has responsibility in law to create established (non-proprietary) names for drug products and to determine proper names for biologics [Section 502(e) of the Food, Drug, & Cosmetic Act (FD&C Act); FDA's policy on established names is set forth in 21 CFR, 299.4]. Along with FDA, the American Medical Association, and the American Pharmacists Association, USP participates in the US Adopted Names Council (USAN) and publishes the USP Dictionary of USAN and International Drug Names (6). USP's monograph naming approaches are outlined in general chapter Nomenclature <1121>. Additionally, a nomenclature guideline is being developed to provide supplemental information to the general approaches outlined in general chapter <1121>. The Nomenclature, Safety, and Labeling Expert Committee plans to revise general chapter <1121> to accommodate the new guideline and to make minor changes to the "Monograph Naming Policy for Salt Drug Substances in Drug Products and Compounded Preparations" (7).

The Nomenclature, Safety, and Labeling Expert Committee also has responsibility for the Medicare Model Guidelines (8) development activities, and to achieve that has appointed the Model Guidelines Expert Panel.

The Work Plan of the Nomenclature, Safety, and Labeling Expert Committee for the 2010-2015 cycle includes the following:

Naming activities. Naming activities include:

  • Approval of 300 monograph titles per year for a total of 1500 monograph titles (approximately 25-30 per month), including

-Standardized monograph titles for biologics and biotechnology drugs (including vaccines and proteins
-Standardized monograph titles for excipients
-Standardized monograph titles for dietary supplements
-Monitoring and addressing new dosage forms and other new delivery systems (e.g., nanotechnology)
-Evolving approaches of monograph naming for food ingredients in FCC
-Evolving approaches to naming non-US monographs.
  • Finalization of the Nomenclature Guideline and establishment of a nomenclature section on the USP website for title approvals, USAN information, and others
  • Updating general chapter <1121>
  • Development, with a USP Expert Panel, of an implementation, education, and communications plan for the "Monograph Naming Policy for Salt Drug Substances in Drug Products and Compounded Preparations"
  • Elaboration of approaches to encourage proper drug name pronunciation.


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