Compounding Pharmacy Information Sharing Project
The Compounding Pharmacy Information Sharing Project was created in partnership with Food and Drug Administration (FDA) to improve data sharing related to compounding pharmacies. Originally, the project was intended to facilitate the information sharing outlined in the FDA Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products (MOU).
As part of this project, NABP developed the Information Sharing Network to help state boards of pharmacy collect, manage, and share data related to compounding pharmacies with FDA and meet the obligations of the MOU. NABP has put on hold on the ability of this system to provide FDA with information required by the MOU due to the FDA’s decision in February 2022 to suspend the MOU.
The Information Sharing Network still remains accessible to boards of pharmacy via e-Profile Connect and continues to provide a valuable resource to help monitor compounding activities in their state.
FDA worked with NABP to develop a standard MOU for use by the state boards of pharmacy to aid with their compliance of section 503A(b)(3)(B)(i) of the Food, Drug and Cosmetic Act. As part of the MOU, boards were required to identify pharmacies that are compounding human drug products and distributing inordinate amounts of such products interstate and report those pharmacies to FDA. The final standard MOU was issued in October 2020.
Shortly thereafter, FDA was sued by several compounding pharmacies in the US District Court for the District of Columbia. In September 2021, the court halted the MOU and required FDA to either certify that the MOU would not have a significant economic effect on small businesses or evaluate alternatives that would accomplish the same objectives without undue burden to small businesses.
FDA announced in February 2022 that the MOU was suspended, and that the agency would publish any proposed revisions in the Federal Register for public comment. Meanwhile, FDA is not accepting additional state signatories, and those states that have signed the MOU do not need to carry out the agreed-upon activities.
- Contact firstname.lastname@example.org if you have any questions about the suspended status of the MOU.
- If you have questions related to data collected as part of the program, contact email@example.com.
- More information on the MOU and the 5% limit on distribution is available on FDA’s website.
Monitor Compounding Activities with the Information Sharing Network
While the MOU is currently suspended, our Information Sharing Network, accessible via e-Profile Connect, still makes it easy to collect and review data about pharmacies compounding sterile or nonsterile human drugs, as well as complaints against a pharmacy or physician. The system will not allow any information to be sent to FDA.
Easy Access to Data
All boards can access data in the Information Sharing Network by logging in to NABP e-Profile Connect.
Reduced Administration Burden
Compounding data is collected in the facility e-Profile, as well as on certain accreditation and the VPP applications, and appears automatically in the system for board review, helping to reduce the amount of data entry required by the boards.
The Information Sharing Network is hosted in NABP e-Profile Connect, which has been expanded to accommodate the collection of compounding pharmacy data. Data in the system is accessible to all boards.*
*Boards can opt not to share information about their licensees.