Current through Register 1537, December 20, 2024
Section 120.535 - Authorization for Calibration, Transmission and Reference Sources(A) Any person authorized by 105 CMR 120.506 for medical use of byproduct material may receive, possess, and use any of the following byproduct material for check, calibration, transmission, and reference use: (1) Sealed sources, not exceeding 1.11 GBq (30 mCi) each, manufactured and distributed by a person licensed under 105 CMR 120.128(L) or equivalent Nuclear Regulatory Commission or Agreement State regulations;(2) Sealed sources, not exceeding 1.11 Gbq (30 mCi) each, redistributed by a licensee authorized to redistribute the sealed sources manufactured and distributed by a person licensed under 105 CMR 120.128(L) or equivalent Nuclear Regulatory Commission or Agreement State regulations, providing the redistributed sealed sources are in the original packaging and shielding and are accompanied by the manufacturer's approved instructions;(3) Any byproduct material with a half-life not longer than 120 days in individual amounts not to exceed 0.56 GBq (15 mCi);(4) Any byproduct material with a half-life longer than 120 days in individual amounts not to exceed the smaller of 7.4 MBq (200 µCi) or 1000 times the quantities in 105 CMR 120.297: Appendix C; or(5) Technetium-99m in amounts as needed.(B) Byproduct material in sealed sources authorized by 105 CMR 120.535 shall not be: (1) Used for medical use as defined in 105 CMR 120.502 except in accordance with the requirements in 105 CMR 120.568; or(2) Combined (i.e., bundled or aggregated) to create an activity greater than the maximum activity of any single sealed source authorized under 105 CMR 120.535.(C) A licensee using calibration, transmission, and reference sources in accordance with the requirements in 105 CMR 120.535(A) and (B) need not list these sources on a specific medical use license.Amended by Mass Register Issue 1480, eff. 10/14/2022.