Licensing and safety

Application type

• New, renewal, amendment¹
• Diagnostic, unsealed therapy, etc¹

Applicant details, including center address¹

Requested radioactive materials (specifying the element and mass number and its chemical and/or physical form), the maximum activity that will be possessed at any one time, and the purpose for use¹

Individuals responsible for the radiation safety program and their training and experience

Radiation safety officer (RSO)⁶

§ 35.50 Training for a radiation safety officer 

See more about the RSO

Authorized users (AUs)^3,7

§ 35.390 Training for use of unsealed byproduct material for which a written directive is required , specifically for parenteral administration § 35.396 

See more about AUs

Additional authorized individuals may include:

Authorized nuclear pharmacist⁸: § 35.55 Training for an authorized nuclear pharmacist 

Authorized medical physicist⁹: § 35.51 Training for an authorized medical physicist 

Expert insight

Training for individuals working in or frequenting restricted areas

• Before using licensed materials, AUs and radiation workers must have successfully completed training as described in NUREG-1556, Vol 9, Rev 3¹ 
• The person conducting the training should be a qualified individual (eg, a person who meets the qualifications for RSO or AU on the license and is familiar with the licensee's program)⁶
• Be prepared to provide a description of the radiation safety training program, including topics covered, groups of workers, assessment of training, qualifications of instructors, and the method and frequency of refresher training¹
• Keep all training records on file¹

Facilities and equipment

• An RLT facility must include a hot lab, treatment room, designated bathroom, and decay space, be prepared to provide a facility diagram as described in NUREG-1556, Vol 9, Rev 3^1,12
• Visit the facilities and equipment section of the Novartis RLT Institute for detailed considerations

Radiation protection program

Radiation safety manual

• All licensees will be required to have a radiation safety manual onsite. The manual will usually be made up of the processes, policies, and procedures submitted to and requested by the NRC or Agreement State as part of the initial application process as described in NUREG-1556, Vol 9, Rev 3¹ 

Waste management and waste disposal procedures

• Documentation of the waste management plan, as described in NUREG-1556, Vol 9, Rev 3 , is required¹
• Visit the waste management page of the Novartis RLT Institute for detailed considerations

Financial qualification and financial assurance

• The NRC and Agreement States will often require proof that a potential licensee is financially stable prior to issuing a license. This stability shows that the licensee can procure, store, and handle radioactive materials, implement a radiation safety program with adequate training and equipment, and manage operational costs effectively.¹⁴
• Documentation of financial assurance is required for licensees possessing radioactive materials with physical half-lifes greater than 120 days, provided the quantities exceed the thresholds specified by the NRC in § 30.35¹⁵ 
• If the NRC or Agreement State determines a licensee meets these requirements, they will require a decommissioning funding plan and financial assurance prior to issuing a license.¹⁵
• The decommissioning funding plan is a cost estimate, based on actual vendor quotes, approved by the licensee management that allocates funds to support decommissioning activities such as labor cost, planning and preparation, decontamination, and waste disposal.¹⁵
• Financial assurance resources must cover appropriate waste disposal, decommissioning, and emergency costs if needed.¹⁵