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.
General requirements
Starting an RLT program is an exciting step that comes with important considerations. Meeting the necessary licensing and safety requirements is key to ensuring a safe operation for both staff and patients.
Minimum requirements
To establish and operate an RLT program, institutions will need to meet key requirements across several areas1:
Licenses and protocols
- Obtain appropriate RAM licensing
- Develop and follow standard operating procedures for receiving, handling, and decaying RAM and for discharging treated patients
Space and equipment
- Provide a designated hot lab, infusion space, and bathroom that comply with all regulatory standards
- Ensure the availability of proper equipment for measuring, handling, delivering, and storing RAM safely
Staff and training
- Designate an authorized user (AU) who meets the training requirements of the Nuclear Regulatory Commission to safely manage RAM specific to intravenous administration of RLT (eg, nuclear medicine physician, radiologist, or radiation oncologist)
- Ensure infusion support from a nuclear medicine technologist, radiation therapist, or nurse trained to set up and manage RLT intravenous infusions under AU supervision
- Qualify a radiation safety officer to oversee safety protocols
- Provide patient navigation support to guide patients through the treatment process
The information herein is intended to assist practitioners in providing appropriate care for patients when using radiopharmaceuticals. This information is not intended to establish, nor should it be used to establish, a legal standard of care. It is important to adhere to all applicable standards when handling and administering radiopharmaceuticals. Institutions are responsible for ensuring their compliance with all laws and regulations by establishing their own policies, procedures, and guidance. Novartis Pharmaceuticals Corporation does not endorse or recommend any specific course of action, or any third-party organization referenced herein.
Reference: 1. Mittra ES, Wong RKS, Winters C, et al. Cancer Med. 2024;13(3):e6780. doi:10.1002/cam4.6780.