In late November, USP published the first ten standards to be included in its Medicines Compendium (MC). The new standards cover medicines used as anti-HIV agents, antivirals, analgesics, oral contraceptives and antiparasitic treatments.
The recently authorized standards cover: acyclovir, acyclovir topical cream, amlexanox, chloroquine oral solution, chloroquine phosphate, chloroquine sulfate, etoricoxib, nelfinavir mesylate, ormeloxifene hydrochloride and stibogluconate sodium. Among the ten, the MC standard for the antiparasitic agent stibogluconate sodium is the first public quality standard published for that drug anywhere in the world. Approval of five more authorized standards is anticipated before the end of the year.
Created by USP in June, the MC is a free, online source of public standards aimed at helping ensure the quality of drugs and biotech products.
In a press release, USP CEO Roger Williams commented that “approval of these initial MC standards is an example of USP’s steadfast commitment to the improvement of global public health through quality standards for medicines. Intended for use by manufacturers, regulators, pharmacopeias and others worldwide, the MC provides rigorous quality assurance measures for medicines where they otherwise might not exist. It’s through the availability of public standards such as those developed for the MC that manufacturers of a given medicine or ingredient can meet the same fundamental requirements, allowing practitioners to have confidence in the medicines they prescribe and patients in the medicines they take.”
The Medicines Compendium includes monographs, general chapters, and reference materials for medicines and their ingredients. Its approach to creating public monographs with reference materials starts with a Performance Based Monograph (PBM) that gives tests for critical quality attributes and acceptance criteria, but does not give specific step-by-step procedures.
“By providing criteria for acceptable procedures,” the USP press release explained, “the information in a PBM allows USP to proceed with the development of a public monograph for inclusion in the MC, and for manufacturers to consider how they wish to develop their own acceptable procedures for either a private regulatory filing or the public monograph.”
Following completion of the criteria in the Performance Based Monograph, USP develops reference procedures that can be used to test any article under a monograph’s title and thus are source-independent (i.e., not exclusively developed from a single manufacturer’s procedures). Reference materials for these procedures are also provided to enhance testing capabilities. Once a source-independent reference procedure and any related reference materials are completed, a monograph standard is eligible for inclusion in the Medicines Compendium.
MC standards are created in an “open, transparent process similar to that utilized for USP’s other compendia.” After a 90-day comment period during which a proposed standard is open to public review by any interested party, the standard is authorized by a vote of an MC Expert Committee.
The first of USP’s Expert Committees focused on the MC was established in India, reflecting its status as a major drug exporter. USP’s Board of Trustees recently approved the formation of additional MC Expert Committees.
The newest Expert Committee, to be composed of “distinguished scientists” from the Chinese community, is now forming in East Asia. Its initial focus will be on quality standards for excipients. Additional Expert Committees also may be formed in other regions for the development of standards for articles approved by regulatory authorities in those regions.