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USP <797>

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.

Nuclear medicine departments should be “exempted” from complying with most USP <797> standards if they solely use unit doses as supplied by commercial nuclear pharmacies.

If unit doses are administered without manipulation, USP <797> does not apply.

Dilution of a dose with normal saline, whether in a vial or syringe, is considered compounding under USP <797>.

However, this should generally be able to be performed under the immediate-use exemption if certain other requirements are met.

The immediate-use provision allows for the preparation and dispensing of compounded sterile products (CSPs) without the need to be in compliance with USP <797> requirements such as ISO Class 5 hood or isolator, facility design, environmental controls, personnel cleansing and garbing.

These are the requirements stipulated in USP <797> for low-risk CSPs. The key criteria for immediate-use exemption are avoidance of touch contamination and administration within one hour of preparation.

The Society of Nuclear Medicine and Molecular Imaging answers frequently asked questions.