The USP has published a free, online collection of standards to support drug quality, particularly where regulatory resources are limited.
Publication of the US Pharmacopeia (USP) Medicines Compendium (MC) gives manufacturers, purchasers and regulators access to standards for testing the quality of ingredients and finished products.
Roger Williams, CEO of the USP, said: “Public standards help ensure that all manufacturers of a given medicine or ingredient meet the same fundamental requirements, providing a ‘common ground’.”
The USP anticipates the standards may be useful to manufacturers exporting drugs and ingredients to countries with limited regulatory resources and no national pharmacopeia. As such, the initial batch of standards includes anti-malarials, anti-retrovirals and contraceptives.
Publication of standards for these drugs is intended to fill public health gaps, for instance where no other standard is available for any pharmacopeia. All the standards are voluntary and designed to support, as opposed to replace, work done by other pharmacopeias, said the USP.