As proposed by the National Association of Boards of Pharmacy (NABP), the current project will establish a novel information-sharing system capable of collecting, managing, and exchanging data pertaining to state-licensed pharmacies engaged in human drug compounding. Such a system will improve upon the information available to the state boards of pharmacy and the Food and Drug Administration (FDA) about compounding pharmacies that distribute interstate. This project addresses the significant risk of injury to patients resulting from human drug products that have been improperly compounded and distributed interstate. To date, there is no unified system in place to collect, manage, and share information about entities engaged in human drug compounding, let alone one that monitors compounded drugs being distributed interstate. As such, no mechanism exists that would identify compounders exposing patients to the greatest risk of harm. As a result of this project, the boards of pharmacy and FDA will gain a better understanding of the interstate distribution of compounded drugs, including significant compliance issues, enabling them to advance public health protections associated with compounded drugs. The proposed system will provide the boards of pharmacy with an ongoing means of reporting information relating to compounding pharmacies to FDA, giving FDA an improved visibility to determine whether additional federal oversight is warranted. It will also enable the boards of pharmacy to better prioritize their limited resources to address those compounding pharmacies in their jurisdictions that pose the highest risk to patients. Upon completion, the proposed project will foster better and more targeted regulation and oversight of compounding pharmacies for the purpose of reducing risk to patients.
Despite the recent implementation of new rules pertaining to compounding pharmacies, current policies and existing data remain insufficient to substantially reduce the risk of poor-quality compounded drug products reaching patients. The proposal of the National Association of Boards of pharmacy addresses this weakness by developing and implementing a data system to collect, manage, and share information on compounding entities distributing compounded drugs interstate. By arming the Food and Drug Administration and the state boards of pharmacy with much needed information on such compounders, the proposed project would support better and more targeted regulation and oversight of compounding activities to reduce risk to patients and to further public health protections associated with compounded drugs.
