PDA is developing a comment to USP on its proposal to revise its General Chapter on reference standards. This volunteer team will draft PDA’s comment. This team’s work will be complete by May 10, 2019.
USP has proposed to rewrite its General Chapter <11> Reference Standards. Among the changes, USP proposes to include language describing when a USP reference standard is considered a primary standard, and when it is considered a secondary standard, based on metrological principles.