The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new standards and guidelines were adopted and recommended for use: the current list of available International Chemical Reference Substances and International Infrared Reference Spectra; guidelines on the active pharmaceutical ingredient master file procedure; the procedure for assessing the acceptability of male latex condoms and that of intrauterine devices for purchase by United Nations and other agencies; and a review of International Nonproprietary Names for biological and biotechnological substances.