Can USP/NF grade excipients be used in drug applications in other countries?
This depends on the countries in question and whether the excipient has had a previous precedent of use in a drug application in that country. The USP/NF is a recognized compendia in many countries around the world; however, in various regions local or regional pharmacopeias take precedent over USP/NF requirements. For example, in the European Union, an excipient must meet the criteria of the European Pharmacopeia (PhEur) if a monograph for that excipient exists in PhEur. However, if no monograph exists in PhEur, the use of USP/NF grade excipients may be acceptable. A similar situation exists in Japan. If a monograph exists in the Japanese Pharmacopeia (JP) or the Japanese Pharmaceutical Excipients (JPE), the excipient must meet the requirements of the respective monograph. However, if the excipient has previously been used in an approved Japanese drug application and no standard exists in JP or JPE, then USP/NF grade material may be acceptable until such time as a monograph is develop
