USP Publishes Results of National Formulary Recall Evaluation

October 28, 2010 8:42 am

The United States Pharmacopeial Convention (USP) has published a statement summarizing its evaluation of the factors contributing to the recall of USP 33-NF 28 in January 2010. Three evaluations were performed to determine why errors occurred during the monograph redesign of the publication. The evaluations revealed that underestimating the scope and complexity of the project was the most significant factor contributing to the need for recall. Issues related to staffing, deadlines, and accountability, among other areas, were also identified as causes. Based on the evaluation, USP has implemented corrective and preventative actions to guide the redesign project. The changes include plans to redesign the monographs on a prioritized basis gradually over several years, with a 2015 target completion date.