§ 35.65 - Authorization for calibration, transmission, and reference sources.

§ 35.65 Authorization for calibration, transmission, and reference sources.

Cross Reference

Link to an amendment published at 83 FR 33106, July 16, 2018.

(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

.

:

(

a

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

.

;

(

b

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

.

;

(

c

3) Any byproduct material with a half-life not longer than 120 days in individual amounts not to exceed 0.56 GBq (15 mCi)

.

;

(

d

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

µCI) or 1000 times the quantities in

Appendix

appendix B of

Part

part 30 of this chapter

.

; or

(

e

5) Technetium-99m in amounts as needed.

[67 FR 20370, Apr. 24, 2002, as amended at 71 FR 15009, Mar. 27, 2006

(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]