Licensing and safety

Overview

Guidance for obtaining a RAM license for medical use from the Nuclear Regulatory Commission (NRC) is covered in their Program-Specific Guidance About Medical Use Licenses Final Report NUREG-1556, Vol 9, Rev 3¹.

The NRC RAM license (RAML) application is NRC Form 313¹. The application can vary by state, as the NRC directly regulates only select states in the US. For the other states, known as “Agreement States” due to their agreement with the NRC to regulate their own RAM use while still adhering to its rules, there may be a state-specific application, while some states accept the NRC application. See the NRC Agreement States website for state-specific applications.²

Administration of ¹⁷⁷Lu-based RLTs, like PLUVICTO® (lutetium Lu 177 vipivotide tetraxetan) and LUTATHERA® (lutetium Lu 177 dotatate), follows the NRC Regulations Title 10, Code of Federal Regulations, Part 35 , specifically Subpart E, as RLT administration requires the use of unsealed byproduct (ie, RAM) for which a written directive is required.^3-5 Agreement States may have their own regulations, but must align with guidelines from the NRC, as states are not permitted to be less restrictive than the NRC.⁶

Requirements and responses to the application will vary for limited scope and broad scope licenses.¹ As reviewed in the previous section, each license type has different benefits and considerations, and the type of license will be driven by the types and quantities of requested radionuclides.¹ Questions about which license type is most appropriate for the practice needs should be directed to the NRC or applicable Agreement State program.