FDA Extends Period Before it Intends to Enforce Five Percent Limit on Out of State Distribution of Compounded Drugs

If your email program has trouble displaying this email, view as a webpage. FDA Extends Period Before it Intends to Enforce Five Percent Limit on Out of State Distribution of Compounded Drugs FDA is extending until Oct. 27, 2022, the period for states to consider and sign the compounding memorandum of understanding (MOU) before FDA intends to begin enforcing the statutory five percent limit on distribution of compounded human drug products out of state, in states that have not signed the MOU. States may sign the MOU at any time. The MOU addresses the distribution of inordinate amounts (greater than 50 percent) of compounded drug products interstate and provides for appropriate investigation by a state agency of complaints relating to compounded drug products distributed outside such state. FDA published a notice in the Federal Register on the extension. See FDA's webpage on the MOU for more information.

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