Las Vegas, Nevada ( Mr. Gleason gave a talk on the licensing and regulatory requirements for targeted alpha therapies. He began with a brief history of the atomic energy commission (AEC)/Nuclear Regulatory Commission (NRC).  

The Atomic energy act of 1946 established the nuclear responsibility of the AEC. In 1954 the atomic energy act made commercial nuclear power development possible.

In 1974 the Energy reorganization act created the NRC in its current form. As of today, the NRC is headed by 5 commissioners appointed by the President and confirmed by the senate. 

According to the atomic energy act of 1954, the NRC relinquishes to the states portions of its regulatory authority to license and regulate byproduct materials (radioisotopes) source materials (uranium and thorium); and certain quantities of special nuclear materials. There are currently 11 NRC states and numerous territories, and 39 agreement states (Figure 1). 

Figure 1 – Agreement states:

SNMMI 2019 Figure 1 Agreement states
In the year 2000, the NRC medical policy statement replaced the older 1979 policy. According to the updated medical policy statement, the NRC will continue to regulate the medical use of isotopes as required for the safety of workers and the general public. The NRC will not intrude into medical judgment affecting patients except as necessary to provide for the radiation safety of workers and the general public. NRC will regulate the radiation safety of patients when justified by the risk to patients. Lastly, the NRC will consider industry and professional standards that define acceptable approached to achieving radiation safety.
The 10 CFR § 35: Medical use of the byproduct material chapter contains the requirements and provisions for the medical use of byproduct material. It also provides for the radiation safety of workers, the general public, patients, and human research subjects. The requirements and provision of parts 19, 20, 21, 30, 37, 71, 170, and 171 of this chapter apply to applicants and licensees subject to this part unless specifically exempted.  
The 10 CFR § 35.390 states the training that is required for the use of unsealed byproduct material for which a written directive is required. The licensee shall require an authorized user of unsealed byproduct material for the uses authorized under § 35.300 to be a physician who: 
  1. Is certified by a medical specialty board whose certification process has been recognized by the Commission or an Agreement State
  2. Successfully completed residency training in radiation therapy or nuclear medicine training program or a program in a related medical specialty 
  3. Pass an examination, administered by diplomates of the specialty board, which tests knowledge and competence in radiation safety, radionuclide handling, quality assurance, and clinical use of unsealed byproduct material for which a written directive is required 
  1. Has completed 700 hours of training and experience, including a minimum of 200 hours of classroom and laboratory training, in basic radionuclide handling techniques applicable to the medical use of unsealed byproduct material requiring a written directive 
Mr. Gleason moved on to discuss the licensing and administration of radium-223. A radiopharmaceutical license is required to administer radium-223 (Xofigo) injection, as outlined in Figure 2. In accordance with 10 CFR § 35.75, treatment with the radium-223 injection can be done on an outpatient basis. The average patient (70 kg) receiving 105 µCi would have a dose rate 1 m<0.016 mrem/hr. This is translated to a dose associated with a radium-223 patient to members of the public to be less than 2% of the NRC limit for which instructions are required. For scale, this is roughly equivalent to the radiation dose experienced on a two-hour plane flight. Therefore, there are no restrictions regarding contact with other people after receiving radium 223.

Figure 2 – License to use radium-223: 

SNMMI 2019 Figure 2 License to use radium 223
Lastly, there has been a growing interest in the radionuclide Thorium-227. Thorium-227 is an investigational agent and is currently not approved by the FDA or any other health authorities. The safety and efficacy of this agent have not been established. In the near future, hopefully, this radionuclide will be approved by the FDA and its safety and efficacy will be established.

Presented by: Shaemus Gleason, Bsc, Global Radiopharmaceutical Strategic Operations Leader at Bayer, Denver, Colorado

Written by: Hanan Goldberg, MD, Urology Department, SUNY Upstate Medical University, Syracuse, New York, USA, Twitter: @GoldbergHanan at the 2019 SNMMI Therapeutics Conference: Therapies, Theranostics, and Building Your Radionuclide Clinical Practice, October 25-27, 2019 in Las Vegas, Nevada