USP Issues Explanatory Statement Regarding Recall of USP 33–NF 28

The US Pharmacopeia released a statement this week that explains in more detail last January’s recall of the United States Pharmacopeia 33–National Formulary 28 (USP 33–NF 28). The statement also discusses steps to ensure the quality of future USP–NF volumes.

The recall of the USP 33–NF 28 volume was made after errors were discovered in the publication (See back story, “USP Recalls Latest Monographs”. “These errors occurred as a result of an initiative known as the Monograph Redesign Project, in which all of the monographs in the compendia were redesigned to streamline presentation, improve the ease of use, and update and harmonize terminology,” according to the USP statement on the subject.

Since the recall, USP’s management, a Board-appointed task force (consisting of Board, USP Convention, and USP Council of Experts volunteers), and an independent law firm have performed three separate evaluations to examine factors that led to the errors, including the role of the Monograph Redesign Project. The three teams reached similar conclusions, some of which are highlighted below.

• -“The Monograph Redesign Project proved to be far more complicated than originally thought…. At the outset, a decision not to include experienced scientific liaisons in the redesign project for USP–NF, as was done with the redesign of USP's Food Chemicals Codex (FCC) standards, precluded a full understanding of the magnitude of the task.”        

• “The Project was not handled through USP's normal systems and management processes. As a result, typical quality assurance protections and controls were not utilized.”   

• “USP senior management was not adequately involved in supervising the Project and there was a lack of clear accountability and responsibility. The Project lacked a strong, cross-functional management team to ensure organization-wide oversight.”

The evaluation teams proposed several corrective and preventative actions to ensure the future success of the Monograph Redesign Project, which will continue. Among the recommendations are: to include scientific liaisons who have intimate knowledge of the monographs in the redesign work (USP plans to add new staff to ensure adequate resources); to make division chiefs ultimately responsible and accountable for the redesign work; to implement a new automated workflow system that will track the monographs; to make the staff aware of the project’s importance; and to establish a quality assurance group that will perform regular process audits to the project before republication of the USP–NF volumes. In addition, rather than redesigning all of the monographs at once, they will be redesigned based on priority over several years. The overall project completion target is 2015.

The full conclusions and recommendations can be reviewed on the USP website. In the USP statement, Board Chair Duane Kirking, PhD, said he is “convinced that the redesign project remains vital to improved usability of these important compendia-and that USP management and staff are ready, willing, and able to move this project forward with assurance of accuracy.”