---
kind: "section"
citation: "10 C.F.R. § 35.100"
title: "10"
number: "35.100"
heading: "Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not required."
url: "https://uscodex.org/cfr/10/35.100"
---

# §35.100. Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not required.


Except for quantities that require a written directive under [§ 35.40(b)](/cfr/10/35.40.md?p=b), a licensee may use any unsealed byproduct material prepared for medical use for uptake, dilution, or excretion studies that is—

- (a) **Obtained from—**
  - (1) A manufacturer or preparer licensed under [§ 32.72](/cfr/10/32.72.md) of this chapter or equivalent Agreement State requirements; or
  - (2) A PET radioactive drug producer licensed under [§ 30.32(j)](/cfr/10/30.32.md?p=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](/cfr/10/35.290.md), or [35.390](/cfr/10/35.390.md) and [35.290(c)(1)(ii)(G)](/cfr/10/35.290.md?p=c-1-ii-G); or
  - (3) An individual under the supervision, as specified in [§ 35.27](/cfr/10/35.27.md), of the authorized nuclear pharmacist in [paragraph (b)(1)](#b-1) of this section or the physician who is an authorized user in [paragraph (b)(2)](#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 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.

## Notes

### 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]