Authorization for calibration, transmission, and reference sources.

§ 35.65 Authorization for calibration, transmission, and reference sources. (a) Any person authorized by § 35.11 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 § 32.74 of this chapter or equivalent 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 § 32.74 of this chapter or equivalent 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 appendix B of part 30 of this chapter; or (5) Technetium-99m in amounts as needed. (b) Byproduct material in sealed sources authorized by this provision shall not be: (1) Used for medical use as defined in § 35.2 except in accordance with the requirements in § 35.500; or (2) Combined ( i.e., bundled or aggregated) to create an activity greater than the maximum activity of any single sealed source authorized under this section. (c) A licensee using calibration, transmission, and reference sources in accordance with the requirements in paragraph (a) or (b) of this section need not list these sources on a specific medical use license. [83 FR 33106, July 16, 2018]