USP <797>

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Compliant with USP <797>?

USP <797> is a comprehensive set of standards designed to improve patient safety by reducing the number of transmitted infections due to improperly compounded pharmaceuticals. As with all medications, the compounding of radiopharmaceuticals must comply with these standards whether in a hospital nuclear medicine department or by an outsourced licensed nuclear pharmacy.

Cardinal Health, a leader in nuclear pharmacy services, provides unit-dose radiopharmaceutical service to help nuclear medicine departments comply more easily with USP <797> standards with limited incremental cost to the department and minimal impact on day-to-day operations.

Resources on USP <797>:

Cardinal Health Compliance Statement
Cardinal Health is committed to ensuring our nuclear pharmacies provide safe, accurate, and effective unit dose radiopharmaceuticals. We comply with USP chapters <797> and <795> as enforced by state boards of pharmacy for the practice of nuclear pharmacy.

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Can nuclear medicine departments be “exempt” from USP <797> provisions? Answer
What if a unit-dose needs to be manipulated (e.g. to dilute activity with saline)? Answer
What is the immediate-use provision for USP <797>? Answer
The handling of immediate-use compounded sterile products must meet which criteria? Answer