§35.100. Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not required.
10 C.F.R. § 35.100
Except for quantities that require a written directive under § 35.40(b), a licensee may use any unsealed byproduct material prepared for medical use for uptake, dilution, or excretion studies that is—
Obtained from—
A manufacturer or preparer licensed under § 32.72 of this chapter or equivalent Agreement State requirements; or
A PET radioactive drug producer licensed under § 30.32(j) of this chapter or equivalent Agreement State requirements; or
Excluding production of PET radionuclides, prepared by—
An authorized nuclear pharmacist;
A physician who is an authorized user and who meets the requirements specified in §§ 35.290, or 35.390 and 35.290(c)(1)(ii)(G); or
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
Obtained from and prepared by an NRC or Agreement State licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by FDA; or
Prepared by the licensee for use in research in accordance with a Radioactive Drug Research Committee-approved application or an Investigational New Drug (IND) protocol accepted by FDA.
Notes, amendments, and revision history
Amendments
[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19324, Apr. 21, 2003; 71 FR 15009, Mar. 27, 2006; 72 FR 55931, Oct. 1, 2007]
Authority
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
Source: 67 FR 20370, Apr. 24, 2002, unless otherwise noted.
Amendments
[67 FR 20370, Apr. 24, 2002, as amended at 68 FR 19324, Apr. 21, 2003; 71 FR 15009, Mar. 27, 2006; 72 FR 55931, Oct. 1, 2007]