What USP <797> requirements apply to the handling of each of the following radiopharmaceuticals?
- Unit doses of radiopharmaceuticals (e.g., 99mTc-sestamibi).
- If only unit doses are administered, USP <797> does not apply. However, if the unit dose is manipulated (e.g., normal saline is added to the syringe to dilute the contents), then USP <797> standards do apply. Nearly all such manipulations can likely fall under the immediate-use exemption. Remember that the key components of the immediate-use provisions are the avoidance of touch contamination and administration within 1 hour. Dilution with normal saline, whether in a vial or in the syringe, is considered compounding under USP <797>.
- Dilution of Persantine® (dipyridamole) for pharmacological stress testing.
- Addition of normal saline to a container (vial or syringe) for dilution of its contents is considered compounding under USP <797> . However, this can generally be performed under the immediate-use exemption. Remember that the key components of the immediate-use provisions are the avoidance of touch contamination and administration within 1 hour. Dilution with normal saline, whether in a vial or in the syringe, is considered compounding under USP <797>.
- Tagging RBCs for MUGAs.
- 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, 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.
USP <797> defines categories of compounding based on risk of microbial contamination. However, USP <797> states “the licensed healthcare professionals who supervise compounding are responsible for determining the procedural and environmental quality and attributes that are necessary for the risk level they assign to specific CSPs.” Hence, there may be some differences in interpretation among health-care practitioners in specific circumstances. Nonetheless, there is general agreement in most situations.
It appears that radiolabeling of RBCs using the UltraTag™ method can be performed “on the open bench” if the Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standards (29 CFR 1910.1030) are followed. An important aspect of these standards is the use of personal protective equipment. Handling blood in a biological safety cabinet is desirable, but it appears that someone who is compounding could handle blood “on the bench-top” if they are supplied with and use “…appropriate personal protective equipment such as, but not limited to, gloves, gowns, laboratory coats, face shields or masks and eye protection, and mouthpieces, resuscitation bags, pocket masks, or other ventilation devices.”
