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.
Standards for comment
The USP has included the following standards in the MC for public comment: acyclovir; acyclovir topical cream; amlexanox; chloroquine phosphate; chloroquine sulphate; chloroquine oral solution; etoricoxib; nelfinavir mesylate; ormeloxifene hydrochloride; and stibogluconate sodium.
Comments for the initial 10 standards can be submitted until September 30 2011. The USP has also selected 11 standards that it proposes developing and opening up for public comment.
Standards proposed for development include: artesunate; clarithromycin; diphenhydramine hydrochloride; efavirenz; eflornithine hydrochloride; eflornithine for injection; eflornithine topical cream; mefloquine hydrochloride; nelfinavir for oral suspension; and nelfinavir tablets.
Final authorised standards are expected to be added in December 2011. Modifications may be made based on public comment before the final standards are approved by the USP Council of Experts.