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