FDA Compounding MOU Project
Compounding Pharmacy Information Sharing Project
The Compounding Pharmacy Information Sharing Project was created in partnership with FDA to improve data sharing related to compounding pharmacies as outlined in the 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 Food and Drug Administration (FDA) and meet the obligations of the MOU.
Understanding the MOU
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 must identify pharmacies that are compounding human drug products and distributing inordinate amounts of such products interstate and report those pharmacies to FDA. Boards can use the Information Sharing Network, accessible via e-Profile Connect, to meet the obligations outlined in the FDA MOU on compounded human drug products.
Learn more about the MOU and data collection for the project:
- Read the Compounding Pharmacy Information Sharing FAQs.
- Read FDA’s answers to common questions about the MOU.
- Download our slide deck for details on preparing for the FDA MOU.
- Download the information sheet for a breakdown of the process for data entry and data flow through the Information Sharing Network.
- Contact email@example.com if you have any additional questions about the data collected and reporting obligations.
For more information about how the MOU can better position your board to address patient safety and improve communication between FDA and all boards of pharmacy, watch the recent webinar, Preparing for FDA’s Compounding MOU.
See the signed MOUs on FDA’s website.
Meet MOU Obligations with the Information Sharing Network
Our Information Sharing Network makes it easy to report and review data about pharmacies compounding sterile or nonsterile human drugs, as well as complaints against a pharmacy or physician.
While signing the MOU does not require boards to enter data into the network, boards are encouraged to use the Information Sharing Network to create a uniform and streamlined reporting process with FDA. Boards can rely exclusively on the data reported through the network and easily transmit data to FDA electronically.
|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, and will soon be collected on certain accreditation and the VPP application and appears automatically in the system for board review, helping to reduce the amount of data entry required by the boards.
|Simple Submission Process|
Boards can review and submit data to FDA with the click of a button.
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, even if they have not signed the MOU.