Licensing and safety

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.

Authorized user(s)

AUs are prescribing physicians who are approved to use RAM under a RAM license, ensuring their safe and compliant use.¹ To administer RLTs like PLUVICTO® (lutetium Lu 177 vipivotide tetraxetan) and LUTATHERA® (lutetium Lu 177 dotatate), the AUs need to be authorized specifically for the parenteral (ie, non-oral) administration of RAM.^2-4

The key responsibilities, qualifications needed, and certification methods for AUs are outlined below.

Responsibilities

For the medical use of RAM, some key responsibilities of AUs include:

• Safe handling and use: Ensuring RAM is handled and used safely in accordance with federal and state requirements as well as the facility's RAM license¹
• Training: Completing radiation safety training commensurate with authorizations for use¹
• Radioligand imaging (RLI)/RLT dosage: Prescribing and administering RLIs and RLTs, including preparing and signing written directives for patients receiving RLTs^1,5
• Staff supervision: Directing individuals preparing and administering RLT/RLI, ensuring staff is adequately trained and follows proper procedures¹

AU certification

For an RLT program, the AU is typically a nuclear medicine physician, radiation oncologist, or radiologist.¹

Training and experience

For the authorization needed to administer PLUVICTO and LUTATHERA, physicians must complete 700 hours of training, including 200 hours of classroom and laboratory instruction in areas such as radiation physics, protection, chemistry, and biology, plus supervised work experience in handling radioactive materials, including 3 cases of parenteral (ie, non-oral) administration of a radioactive drug for which a written directive is required, as described by the Nuclear Regulatory Commission (NRC) in § 35.390⁶ .

For nuclear medicine physicians and radiation oncologists who completed residency programs in the US or Canada, the training and experience required for authorization were likely met by the residency program; however, documentation is required.⁶

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.⁷ See board certifications that meet training requirements relevant to administration of PLUVICTO and LUTATHERA (ie, use of unsealed byproduct material for which a written directive is required).

Certification methods

In reference to NRC Form 313A (AUT) , certification methods include:

Recentness of training

Training and experience, including board certification, must have been obtained within the 7 years preceding the date of AU application. If the physician pursuing authorization is applying >7 years since board certification and is not already an AU for other radiation therapy, they will need to work with their state regulator to identify the type and extent of continuing education needed, which may include repeating the full training.⁸

Special consideration for radiation oncologists

For radiation oncologists board certified after January 1, 2024, the “alternate pathway” must be utilized to demonstrate compliance with the training and experience requirements without using board certification.¹²

To apply to the NRC to become an AU for RLT infusion, see NRC Form 313A (AUT) .

The NRC provides a NRC Medical Uses Licensee Toolkit designed to help licensees find key information easily.