FDA extends grace period for 5 percent limit exemption on compounded drugs

NCPA October 21, 2022

The Food and Drug Administration is extending the period before it begins enforcing the statutory 5-percent limit on distribution of compounded drugs. This applies to human drug products out of the state where they are compounded in states that have not entered into a standard memorandum of understanding with the FDA. It addresses certain distributions of compounded human drug products. FDA is extending the period, which was scheduled to end on Oct. 27, 2022, until the effective date of a final rule regarding certain distributions of compounded human drug products and publication of an updated standard MOU. NCPA will keep members informed of developments.