FDA Extends Comment Period for Compounding-Related MOU

In the June 3 Federal Register the Food and Drug Administration (FDA) announced it is extending the deadline to submit comments regarding the compounding memorandum of understanding (MOU) draft that appeared in the Federal Register on February 19, 2015. In the previous notice, FDA requested comments on the MOU, ‘‘Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the State of [insert State] and the U.S. Food and Drug Administration’’. The new deadline date for submitting comments is July 20, 2015.
Extending the deadline from June 19 to July 20 is indicative of the complexity and impact of this proposed MOU for states and other stakeholders. Public comments submitted to date can be viewed on the Regulations.gov website. It is anticipated that there will be thousands of comments submitted by the July 20 deadline. What are your thoughts on the MOU? Share you thoughts by clicking below.