October 7, 2019
The Nuclear Regulatory Commission (NRC) held the fall meeting of its Advisory Committee on Medical Uses of Isotopes (ACMUI) on September 10-11. The ACMUI discussed several issues of importance to SNMMI, including training and experience (T&E) requirements and USP General Chapter <825> for radiopharmaceuticals.
Training and Experience Requirements
NRC staff summarized the information received from the open comment period, shared options they are planning to present in their paper to the NRC, and outlined the NRC's next steps.
Summary of feedback from open comment period:
- Nuclear medicine and radiation oncology communities oppose any change to T&E and support the status quo.
- Non-traditional physicians wish to treat patients with "patient-ready" radiopharmaceuticals, support tailored T&E, and suggest 80 hours of T&E
- The Organization of Agreement States (OAS) and some states oppose tailoring T&E.
- Some states support the status quo.
- The OAS and some states suggest that the NRC and states should no longer review and approve T&E for physicians but should instead rely on other entities to "credential" Authorized Users (AUs).
Approach 1: Revise the T&E regulatory framework to remove prescriptive requirements, and the NRC and Agreement States would no longer review and approve T&E for AUs.
Approach 2: Maintain or enhance the existing T&E regulatory framework.
More detailed specifics can be found on page 20 of the PDF link here »
- ACMUI T&E Subcommittee and Agreement State review of draft Commission paper options: August–October
- ACMUI T&E Subcommittee comments due: October 7, 2019
- ACMUI Public Teleconference on T&E Subcommittee comments: October 17, 2019
- Agreement State comments due: October 18, 2019
- Staff finalizes Commission paper: November–December 2019
- Deliver paper to Commission: December 20, 2019
SNMMI has provided extensive feedback to NRC and the ACMUI on this topic. Most recently SNMMI-ACNM submitted comments to NRC in July 2019. Our comments highlight several issues outlined below.
- Any reduction in current requirements will compromise the safety of patients, their caregivers, and family members.
- Parenteral radionuclide therapy can be administered safely only by personnel with an extensive understanding of radiation physics, radiopharmacy, pharmacokinetics, dosimetry, and radiation biology, as well as the principles and practices of radiation safety.
- There is no identified shortage of authorized users, so there is no reason for a change in the current requirements.
USP General Chapter <825>
Nuclear pharmacist Richard Green presented on many items included in the new chapter. The public was made aware of the final chapter on June 1, 2019.
- Enforcement of USP standards
- Sterile RP handling environments
- Immediate use of sterile RPs
- Additional sections
- RAM licensees should perform internal assessments of activities performed.
Since the fall ACMUI meeting, the USP announced a postponement of the chapter until further notice.
USP’s bylaws provide that the date by which conformance with a standard is required shall be postponed while an appeal is pending. They further provide that if a standard is upheld, the date by which conformance is required shall be reestablished so that the period allowed for implementation is not less than that provided for upon original publication of the standard.
In practice, the above provisions mean the following with respect to the compounding chapters currently under appeal:
- Chapters <795>, <797>, and <825> will be postponed until further notice.
- None of these chapters will become official on the originally anticipated date of December 1, 2019.
- Regardless of the outcome of the appeals process, USP would not reestablish an official date for chapters <795>, <797>, or <825> without granting another six-month implementation period, at a minimum.
- USP cannot predict or project a future official date for any of these chapters at this time, as the appeals process remains actively in progress.
The next ACMUI public meeting will take place in spring 2020—likely March or April.