APC Advocacy

Compounding with Dietary Supplements

The issue

FDA takes the position that bulk ingredients that are the subject of a USP Dietary Supplement Monograph are not allowed to be used in compounding unless they are on the 503A positive ingredient list. In other words, FDA states that the Dietary Supplement Compendium is not an “applicable” USP monograph of the FDCA.

The USP Dietary Supplements Compendium currently lists 260 dietary supplement monographs. By excluding those monographs from Section 503A, the FDA has effectively stripped dietary supplements from use within compounding practice, thereby constraining physician practices heretofore regulated by the states and in ways contrary to state regulation. APC is contemplating strategies, including the possibility of legislation, to address this issue.

Resources and information

APC briefing paper