Use of Other Mo-99/Tc-99m Solutions or Other Generator Systems Sample Clauses

Use of Other Mo-99/Tc-99m Solutions or Other Generator Systems. The licensee’s authorization, under this guidance, will only be for the use of the NorthStar Mo-99/Tc- 99 solution in the RadioGenix® System. Use of any other Mo-99/Tc-99m solution with the RadioGenix® System or any other device with the NorthStar Mo-99/Tc-99m solution will require an amendment to a limited specific medical use or commercial nuclear pharmacy license. A broad scope licensee will have to perform its own engineering and radiation safety evaluation if any other Mo- 99/Tc-99m solution is used with the RadioGenix® System or any other device is used with the NorthStar Mo-99/Tc-99m solution.
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