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Standards of USP General Chapter <825> Radiopharmaceuticals - Preparation, Compounding, Dispensing and Repackaging
USP <825>
From patient safety, to staff satisfaction and everything in between, you have a lot on your plate. Worrying about where to find USP General Chapter <825> resources shouldn't be one. Cardinal Health can help you navigate the radiopharmaceutical standards. Whether your nuclear medicine department uses only unit-dose radiopharmaceuticals, occasionally makes a kit, radiolabels RBCs or handles all of your radiopharmaceutical preparation needs, Cardinal Health can help you stay committed to compliance.
Follow this step-by-step educational guide to prepare for USP <825>
Learn
Partner
Evaluate and Act
Supplies and Solutions
Learn
Familiarize yourself with the information within USP <825> so you understand the standards within the document.
Resources to learn about <825>:
Read the final standards on the USP website.
You can sign up for <825> updates from USP on their website.
Read this short article to learn from two individuals who served on the USP Expert Panel and their perspectives on USP <825> and what you can do now to prepare. ?
Partner
It is imperative that nuclear medicine department (NMD) and hospital pharmacy staff work together to become compliant with <825>.
Resources on partnering with your NMD or hospital pharmacy:
Check out this FAQ that will help you understand your responsibility in overseeing the medications used in the NMD.
Read this FAQ to better understand how the DOP will become more involved with the medications used in the NMD. ?
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Over seventy FAQ’s developed by USP to help you prepare for the new chapter.
Evaluate and Act
To become compliant with <825>, it’s important to understand the practices you are performing today in the NMD. Once you understand what you are doing, you can complete a gap analysis to see what particular areas you need to adjust to adhere to the new standards.
Resources to help you evaluate what you do today:
View this list to help you identify what radiopharmaceuticals are used in your department.
Use this list to understand the contraindications associated with the radiopharmaceuticals you use in your department.
Identify which activities your department performs and review some SOP's you may need to implement.
Supplies and Solutions
Order the supplies you need to prepare your department for USP <825> compliance.
Resources to learn about <825> offerings:
For more information about USP <825>, please reach out to your local nuclear pharmacy.
What is USP<825>?
Due to the uniqueness of radiopharmaceuticals and the need for more specific standards, radiopharmaceuticals are receiving their own USP General Chapter: General Chapter <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging. The chapter, published in June 2019, includes standards tailored to the needs of sterile and non-sterile radiopharmaceuticals.
USP <825> will become official on Dec 1 , 2020.
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Get the whitepaper,?A New Chapter for Nuclear Medicine, that includes perspectives on USP <825> from individuals that belong to organizations like TJC, ASHP, and more:
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