A licensee may use any unsealed byproduct material identified in § 35.390(b)(1)(ii)(G) prepared for medical use and for which a written directive is required that is—
(a) Obtained from:
(1) A manufacturer or preparer licensed under § 32.72 of this chapter or equivalent Agreement State requirements; or
(2) A PET radioactive drug producer licensed under § 30.32(j) of this chapter or equivalent Agreement State requirements; or
(b) Excluding production of PET radionuclides, prepared by:
(1) An authorized nuclear pharmacist;
(2) A physician who is an authorized user and who meets the requirements specified in §§ 35.290, 35.390, or
(3) An individual under the supervision, as specified in § 35.27, of the authorized nuclear pharmacist in paragraph (b)(1) of this section or the physician who is an authorized user in paragraph (b)(2) of this section; or
(c) Obtained from and prepared by an NRC or Agreement State licensee for use in research in accordance with an Investigational New Drug (IND) protocol accepted by FDA; or
(d) Prepared by the licensee for use in research in accordance with an Investigational New Drug (IND) protocol accepted by FDA.
[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19324, Apr. 21, 2003; 71 FR 15009, Mar. 27, 2006; 72 FR 55932, Oct. 1, 2007; 83 FR 33107, July 16, 2018]
authority: Atomic Energy Act of 1954, secs. 81, 161, 181, 182, 183, 223, 234, 274 (
42 U.S.C. 2111,
2201,
2231,
2232,
2233,
2273,
2282,
2021; Energy Reorganization Act of 1974, secs. 201, 206 (
42 U.S.C. 5841,
5846;
44 U.S.C. 3504 note
source: 67 FR 20370, Apr. 24, 2002, unless otherwise noted.
cite as: 10 CFR 35.300