NABP Launches Compounding Pharmacy Information-Sharing Project With FDA

In June 2020, the National Association of Boards of Pharmacy (NABP) began to further develop a system to gather and share compounding pharmacy information as part of a three-year pilot project with Food and Drug Administration (FDA). Funded by FDA, this project builds upon the existing NABP e-Profile system with the addition of data fields and functionality specific to compounding activities. This new network will increase the amount of compounding data available to member state boards of pharmacy and, upon approval by a board of pharmacy, FDA. With more compounding data available, regulators are better positioned to help reduce the risk of injury to patients from improperly compounded drug products.

The NABP Information-Sharing Network created by this project will collect data specific to compounding activities including, for example, the number of compounded medications dispensed to patients located in and outside of the pharmacy’s home state, regardless of whether the pharmacy’s home state joins the project via the FDA Memorandum of Understanding (MOU). Collected data will be available to all states. Additionally, states that sign the FDA MOU are required to investigate complaints and report them to FDA, as well as review and report certain compounding data, in accordance with the MOU requirements.   

For details regarding this project, including data collection and regulator access, review the following resources:

• “Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products” (MOU)”
• NABP FDA Compounding MOU Project