10 CFR § 35.200 - Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required.

---
identifier: "/us/cfr/t10/s35.200"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "10 CFR § 35.200 - Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required."
title_number: 10
title_name: "Energy"
section_number: "35.200"
section_name: "Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required."
chapter_name: "NUCLEAR REGULATORY COMMISSION"
part_number: "35"
part_name: "MEDICAL USE OF BYPRODUCT MATERIAL"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
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."
regulatory_source: "67 FR 20370, Apr. 24, 2002, unless otherwise noted."
cfr_part: "35"
---


# 35.200 Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required.

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 imaging and localization studies 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, or 35.390 and 35.290(c)(1)(ii)(G); 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;

(c) 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

(d) 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.

[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]