Government Relations
Frequently Asked Questions (FAQs) about USP <797>
Specific Questions about USP <797> – Compounding Supervision & Responsibility of Compounding Personnel
A question has been raised over a statement that each compounding facility must have direct Physician / Pharmacist supervision at all times. Can that person be in the same building and not have to be present for the compounding? What about off hours / after hours compounding?
USP <797> does not specify whether or not supervision must be 'direct'. "Direct supervision", however, may be required by other regulations such as Conditions of Participation for Medicare.
Disclaimer
These FAQs reflect the authors' views only. They have not been provided or endorsed by the USP Convention or the USP Expert Committee on Sterile Compounding, nor do they necessarily reflect the views of the authors' institutions, SNM, or any other entities. This document is provided for informational purposes only and is not intended as legal advice. It should not be used to replace the advice of your own legal counsel.
