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Specific Questions about USP <797> – CSP Risk Levels
Is red blood cell (RBC) labeling with an Ultra-Tag™ kit considered compounding?
Yes. Transfer of sterile liquids from one container to another container is considered compounding under USP <797>.
What is the SNMMI's official stance on UltraTag® in relation to USP <797> ? Based on the number of times one needs to access the vial, will my institution need a hood? There is mention of using an alternate method to get around this but there are no further details given in the FAQs. Additionally, would using an alternate or modified labeling procedure using the UltraTag® kit be going outside the package insert?
SNM does not take an official stand on the preparation of UltraTag® in relation to USP <797> . To reiterate the disclaimer, "These FAQs reflect the authors' views only. They have not been provided or endorsed by the USP <797> Convention or the USP <797> Expert Committee on Sterile Compounding, nor do they necessarily reflect the views of the authors' institutions, SNM, or any other entities. This document is provided for informational purposes only and is not intended as legal advice. It should not be used to replace the advice of your own legal counsel."
What level of risk assessment do you consider for the tagging of red blood cells with 99mTc?
Radiolabeling of 99mTc RBCs in vitro would normally be considered medium risk level. However, it can fall under the immediate-use exemption if a special standard operating procedure (SOP) is developed and followed whereby the number of needle puncture entries into the reaction vial is limited to two. Also, it is important to remember that USP <797> requires that blood manipulations be clearly separated from routine procedures and that they be controlled by specific SOPs to avoid cross contamination.
What USP <797> requirements apply to the handling of each of the following radiopharmaceuticals?
- Unit doses of radiopharmaceuticals (e.g., 99mTc-sestamibi).
- Dilution of Persantine® (dipyridamole) for pharmacological stress testing.
- Tagging RBCs for MUGAs.
Is the preparation of 99mTc-sulfur colloid low risk or medium risk level?
Low risk level.
If white blood cells (WBCs) are compounded in the nuclear medicine hot lab, does the lab need to meet the criteria of USP <797> and medium-risk standards?
Yes, radiolabeling of WBCs with either 99mTc or 111In is considered a medium-risk-level procedure.
I have heard arguments that the sterility of Tc-99m in vitro RBCs is not a concern due to the fact that you are using the patient’s blood (which isn't sterile). Is this true?
Maintenance of sterility is a foundational feature of USP <797> . For those who claim that blood isn't sterile, one response could be that USP <797> classifies compounding involving the use of a non-sterile ingredient as High-Risk Level, which then requires the most stringent of environment conditions, practices, etc. USP <797> also contains this statement: "the compounding environment maintains the sterility or the pre-sterilization purity, whichever is appropriate…" Hence, the intent of USP <797> is that, for biological products such as red cells, the product's level of 'purity' be maintained and that there be reasonable efforts to prevent contamination with additional bioburden.
Does USP <797> affect drawing multiple doses from a Tc-99m MAA vial prepared by and obtained from an outside nuclear pharmacy?
Yes.
Does USP <797> apply to IND drugs?
Yes, USP <797> applies to all compounded sterile products, including those that are FDA-approved (NDA), investigational (IND), research (e.g., RDRC), and compounded under the state-regulated practices of pharmacy or medicine.
Can the preparation of radiopharmaceuticals be considered under the "Low Risk with less than 12 hour BUD" risk level?
The majority of radiopharmaceuticals can be prepared as Low-Risk Level CSPs with 12-Hour or Less BUD.