October 21, 2022

FDA extends period before enforcing out-of-state distribution limits

Yesterday, FDA announced it is extending the period before it intends to begin enforcing the statutory five percent limit on distribution of compounded human drug products out of the state in which they are compounded for those states that have not already entered into a standard memorandum of understanding (MOU) with the agency addressing certain distributions of compounded human drug products.

The pre-enforcement period was originally scheduled to end on October 27, 2022.

FDA published a standard MOU in October 2020 but has suspended it pending rulemaking and publication of a new standard MOU.