The USP is a compendium of drugs, active substances and testing standards (covering areas like chemical and microbiological analysis), with a focus on demonstrating the efficacy and safety of medicines.
The USP has extended its remit to include a global health standard, and it is likely to be the first of several such standards. The aim of the standards will be to examine high-burden health challenges outside of the U.S.
The first standard addresses a drug used to save millions of new-borns at high-risk of infection and death: chlorhexidine gluconate topical gel. Chlorhexidine is an antibacterial used as an antiseptic and for other applications. Chlorhexidine gluconate, at 2 to 4 percent, acts as a skin cleanser solution with persistent anti-infective activity. It is used for surgical site preventive cleaning and as a hand disinfectant (as would be used by health care professionals). Chlorhexidine is also used as an active ingredient in mouthwash designed to reduce dental plaque and oral bacteria.
The standard has been developed to assist with the development, manufacture and distribution of the gel, in order to increase access to the product in countries where there is a need due a high level of infant death rates. These countries include Nigeria and Pakistan.
In these regions the primary use of: chlorhexidine gluconate topical gel is to prevent umbilical cord infections (omphalitis) in new-born infants in developing countries. Infection is a major cause of new-born mortality, and this can be caused by bacteria entering the body of the baby through a newly-cut umbilical cord.
Because people in many cultures apply substances to the freshly cut cord stump, including ash, oil, butter, spice pastes, or mud, this unhygienic practice exposures to the fresh wound to pathogens and this can lead to new-born sepsis.
To be included in the new part of the USP, a product need not be approved by the U.S. Food and Drug Administration but it must have been approved by a recognized regulatory body within the scope of the International Conference on Harmonization (which seeks to align the safety and regulation of medicinal products).
The new standard appears in the 40th edition of the USP (in conjunction with the 35th edition of the U.S. National Formulary.) It appears in a new Global Health Monographs section.
