
Licensing and safety
This section of the Novartis RLT Institute reviews important aspects for obtaining or amending a radioactive materials (RAM) license for medical use, including types of licenses, components of the application, and key individuals, focusing on the key considerations for a radioligand therapy (RLT) program.
Key individuals
This section provides an overview of the key individuals involved in a RAM license, specifically the authorized users (AUs) and radiation safety officer (RSO), detailing their responsibilities and requirements for certification.

Radiation safety officer
An RSO is responsible for overseeing the safe use of radioactive materials in an RLT facility, ensuring compliance with regulations and maintaining radiation safety programs.1
The key responsibilities, qualifications needed, and certification methods for the RSO are outlined below.
Responsibilities
The responsibilities of the RSO include1:
- Safe handling and use: Ensuring that RAM is handled and used safely in accordance with federal and state requirements and the facility's RAM license
- Radiation safety program: Overseeing and holding primary responsibility for the facility's radiation protection program
- Training: Completing radiation safety training to understand the hazards associated with all RAMs listed on license
- Authority: Holding independent authority to stop operations deemed unsafe
- Incident reporting: Reporting incidents and medical events to regulatory authorities as part of the licensee's radiation protection program
RSO certification
For an RLT program, the RSO is often an authorized individual or an AU.2 The RSO may be on-site or remote.1
Training and experience
See training and experience requirements from the Nuclear Regulatory Commission (NRC) in § 35.50
Recognized board certificates
The NRC maintains a list of medical specialty boards whose certification process have been recognized by the NRC or an Agreement State.3 See board certifications that meet training requirements for an RSO for the medical use of RAM.
Certification methods
There are various methods that can result in an RSO certification, depending on the candidates' qualifications, experience, and role4:
- Board certification: Providing a certification from an approved board
- Authorization expansion: Requesting authorization for additional medical uses as a currently authorized RSO
- Existing AU authorization: Requesting RSO authorization as an existing AU
- Simultaneous application: Applying to become both an RSO and AU at the same time
- Structured educational program: Completing a structured educational program, supported by preceptor attestation to demonstrate competence
Recentness of training
Training and experience, including board certification, must have been obtained within the 7 years preceding the date of RSO application.4
To apply to the NRC to become the RSO for an RLT program, see NRC Form 313A (RSO)