Ann Marie Alessi, BS, CNMT, NCT, RT(N), Product Sales Manager, Nuclear Medicine, Biodex Medical Systems, Inc.
The section in USP <797> addressing the requirements for radiopharmaceuticals as Compounded Sterile Preparations (CSPs) is based on specific and detailed recommendations from an advisory panel of nuclear pharmacists. This section clarifies details and exemptions for radiopharmaceutical compounding, especially in regards to microbial contamination risk levels.
Determining the risk level of CSPs prepared in a nuclear pharmacy is one of the most important aspects of the section. Keep in mind that both radionuclides and non-radioactive medications are handled, prepared, and stored in nuclear pharmacies. Table 1 provides a list of common radionuclides and traditional drugs that are prepared and dispensed with their corresponding risk levels.>>