FDA Updates Staff Manual on Accepting Standards from Foreign Pharmacopoeias

The FDA updated its staff’s Manual of Policies & Procedures covering the acceptance of standards from foreign pharmacopoeias during the review of INDs and NDAs.

The manual spells out to CDER reviewers when it is appropriate to use the quality standards found in the British, European, and Japanese pharmacopoeias, related to chemistry, manufacturing and controls reviews of excipients, drug substances and finished drug products. The policy’s main update from previous versions was to reflect the reorganization of the Office of Pharmaceutical Science under the Office of Pharmaceutical Quality.

The FDA said the applicant is responsible for justifying the use of a standard from a foreign compendium. It’s reasonable to accept a foreign standard as long as it meets or exceeds the corresponding standard in the U.S. Pharmacopoeia or the National Formulary, but the USP/NF monographs remain the official standards when testing for compliance.