September 27, 2018
The Nuclear Regulatory Commission (NRC) held their fall meeting of its Advisory Committee on Medical Uses of Isotopes (ACMUI) on September 20th and 21st. The ACMUI discussed several topics of importance to SNMMI, including training and experience requirements, nursing mother guidelines, and compounding of sterile and non-sterile radiopharmaceuticals.
Training and Experience Requirements
ACMUI member Darlene Metter, MD, provided an updated on training and experience (T&E) requirements for all modalities. As previously reported, an ACMUI subcommittee was formed to thoroughly review T&E requirements in CFR sub parts D (35.190, 35.290) and E (35.390, 35.392, 35.394, 35.396), and to make recommendations for/against changes in these T&E requirements. During the March 2018 ACMUI meeting, the subcommittee noted two concerns. The first being the approval of Lu-177 DOTATATE for treatment of somatostatin receptor-positive GEP-NETs, including foregut, midgut, and hindgut. The ACMUI believes these broad indications to treat the second most common gastrointestinal tumor could result in potentially high demand for Lu-177 DOTATATE. The second concern noted was the waning number of nuclear medicine physicians in the U.S. As a result, the subcommittee recommended an alternate Authorized User (AU) pathway be considered. In order to explore a limited AU pathway the ACMUI subcommittee reports there are a few specific tasks that need to be accomplished.
Additionally NRC staff reported that after the revision 10 CFR Part 35 (8/2017), the Commission tasked the NRC staff with investigating the feasibility of a limited AU pathway, specifically for radiopharmaceutical therapy. NRC staff conducted limited outreach in April and May, however concluded that additional information gathering is necessary. NRC staff plan to post a Federal Register notice with questions, hold public meetings/webinars, send letter/emails, as well as Newsletter articles. Stakeholders will include licensees, regulators (Agreement States, FDA, CMS, international agencies), medical specialty boards, patient health organizations/advocacy groups, trade organizations/industry groups, medical professional societies, medical specialty training/fellowship organizations, and the medical oncology community. NRC staff also plan to evaluate a possible AU shortage, review medical and radiation safety events, and gather international benchmark information.
Specific questions to be included in the FRN:
NRC staff plan to analyze all public comments and information once obtained, continue to engage the ACMUI, and determine whether changes to current T&E requirements are warranted. The society has submitted comments to NRC on this topic and looks forward to working with the NRC staff and ACMUI as they address this important topic.
Nursing Mother Guidelines
Darlene Metter, MD, also provided an update on the progress of the Nursing Mother Guidelines Subcommittee. The group's charge was to review the radiation exposure from diagnostic and therapeutic radiopharmaceuticals, including brachytherapy, to the nursing mother and child. The subcommittee presented its draft report during the February 1, 2018 public ACMUI teleconference. The report includes recommendations including nursing interruptions for specific radiopharmaceuticals, radiation exposure to the nursing child and nuclear medicine department signage.
Compounding of Sterile and Non-Sterile Radiopharmaceuticals
Mr. Richard Green provided a brief update on the latest activities within the USP. The USP currently has Chapter <797> on Pharmaceutical Compounding - Sterile Preparations, as well as proposed General Chapter <825> Radiopharmaceuticals — Preparation, Compounding, Dispensing, and Repackaging open for public comment. The society has previously reported on these open chapters and will be submitting comments, which are due to USP no later than November 30, 2018.