Compounded Drug MOU Out for Viewing

FDA has released for public viewing a standard memorandum of understanding (MOU) between the agency and states as part of the regulatory process addressing compounded drug distribution while preserving access. An agency notice says the compounding program is an FDA priority that develops policies that ensure appropriate access to lawfully-marketed compounded drugs for patients who have a medical need for them while also protecting public health.

One of the most crucial aspects of its work, the notice says, has been to identify opportunities to partner with states to address the important public health goals.

The release of the MOU marks a significant milestone in the agency’s regulation of human drug compounding and reflects years of collaborative dialog and stakeholder input, FDA says. The MOU was developed in close consultation with the National Association of Boards of Pharmacy.