The U.S. Pharmacopeia (USP) has announced that it will begin publishing the U.S. Pharmacopeia – National Formulary (USP – NF), in Spanish beginning in November 2005.
The USP – NF provides standards of identity, strength, quality, and purity for prescription and non – prescription drug ingredients and dosage forms, dietary supplements, medical devices, and other health care products. The compendium includes tests, analytical procedures, and acceptance criteria. As with the English version, the Spanish publication will include a certificate of authenticity. The Spanish version will enable Spanish-speaking customers to use the USP – NF in their own language.
The Spanish version (Farmacopea de los Estados Unidos de America – Formulario National) will be a scientifically exact translation of the English version and will be published in November 2005, and become official on January 1, 2006. The main book will be accompanied by two supplements, to be released in February (official on April 1) and June (official on August 1). The USP 29 – NF 24 Spanish version will be available for sale in late summer 2005.
“As Chair of the Council of Experts, I am honored to be able to present the work of this distinguished body to practitioners and patients, manufacturers and compounding professionals in Spanish-speaking countries who care about the quality of medicines and good pharmaceutical care,” said Roger L. Williams, M.D., executive vice president and chief executive officer of USP. “The USP – NF Spanish version makes it easier for non-English speakers to understand and meet USP standards while also helping to fulfill our mission of providing standards for quality medicines worldwide. USP looks forward to publishing translations in official text in other major languages of the world.”
The Spanish translation of USP – NF is possible through the involvement of the Implementation Group, which consists of volunteers representing various public health organizations, pharmaceutical industry and pharmacy schools in Spanish-speaking countries. Members of the Implementation Group were appointed by USP based on their scientific expertise, understanding of the standards, and fluency in Spanish. The Implementation Group was responsible for translating the initial glossary of commonly used terms in the USP – NF into universal Spanish.
“The Implementation Group served a vital role in producing an exact translation of the English version,” said Enrique Fefer, Ph.D., chair of the Implementation Group and honorary member of the U.S. Pharmacopeial Convention. “By working together, this group ensured that the USP – NF Spanish version was a mirror image of the English version and retained the stringent scientific standards established by USP.”
Linguistic Systems, Inc. (LSI) was selected by USP to translate the USP 29 – NF 24 into Spanish, with the help of Spanish-speaking staff from USP and numerous translators from Spanish-speaking countries. Translators used a technological tool to translate the text using the glossary developed by the USP Implementation Group. Editors from LSI then implemented the first level of a quality control process to ensure the accuracy of the Spanish translation of USP 29 – NF 24. A second stage of Quality Control, consisting of several feedback loops, was performed by the bilingual staff of USP’s Department of Standards Development, with input from the Implementation Group, thus assuring an accurate translation of the technical content.