The American College of Radiology® (ACR®) filed comments Sept. 1 with the U.S. Nuclear Regulatory Commission (NRC) regarding a request for information on nuclear medicine agent extravasation. The public comments will inform a rulemaking in 2024 to implement the agency’s recent decision to enable Medical Event reporting under 10 CFR 35.3045 of any anomalous radiopharmaceutical extravasation complication that “requires medical attention for a suspected radiation injury.”
The ACR recommended that NRC use existing federal standards on adverse event severity assessment maintained by the National Cancer Institute to guide its future regulations and guidance. Additionally, the College urged NRC to avoid undue impositions on patients and patient care that may result in negative health and safety consequences.
For more information, contact Michael Peters, Senior Government Affairs Director.
NRC Requests Comments to Inform Nuclear Medicine Extravasation Rulemaking
The Nuclear Regulatory Commission (NRC) publicly released a request for information (RFI) and preliminary proposed regulatory language to inform the agency’s rulemaking regarding nuclear medicine agent extravasation. The NRC intends to use responses to inform a proposed rule planned for late 2024. A public meeting is planned for May 24, and public comments will be due by July 18.
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