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USP <797>

Sterility.  Compliance.  Assured safetly.

Cardinal Health provides unit-dose radiopharmaceutical service to help nuclear medicine departments comply more easily with USP <797> standards. 

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.

Test your USP <797> IQ

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.

Did you know?

The handling of immediate-use CSPs must meet all of the following criteria:

  • Used when there is a need for emergency or immediate patient administration
  • Not intended for storage for anticipated needs or batch compounding is not a medium-risk level (lengthy or complex) or high-risk level (prepared from non-sterile ingredients) CSP
  • Compounding involves simple transfer or not more than 3 commercially manufactured package of sterile nonhazardous products or diagnostic radiopharmaceuticals from the manufacturer’s original containers and not more than 2 entries into any one container (i.e. bag or vial) of sterile infusion solution or administration container or device
  • Aseptic tchnique is followed, and if not immediately administered, the finished CSP is under continuous supervision to minimize the potential for contact with sterile surfaces, introduction of particulate matter or biological fluids, mix-up with other CSPs and direct contact of outside surfaces
  • Administration begins no later than 1 hour following start of preparing CSP
  • Unless immediately and completely administered by the person who prepared it, the CSP shall bear a label listing patient ID information, the names and amounts of all ingredients, the name or initials of the person who prepared the CSP and the exact one hour beyond-use-date (BUD)
  • If administration has not begun within one hour following the start of preparing the CSP, the CSP shall promptly, properly and safely be discarded

Do you have additional questions about USP <797>?

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