---
kind: "section"
citation: "21 C.F.R. § 201.129"
title: "21"
number: "201.129"
heading: "Drugs; exemption for radioactive drugs for research use."
url: "https://uscodex.org/cfr/21/201.129"
---

# §201.129. Drugs; exemption for radioactive drugs for research use.


A radioactive drug intended for administration to human research subjects during the course of a research project intended to obtain basic research information regarding metabolism (including kinetics, distribution, and localization) of a radioactively labeled drug or regarding human physiology, pathophysiology, or biochemistry (but not intended for immediate therapeutic, diagnostic, or similar purposes), under the conditions set forth in [§ 361.1](/cfr/21/361.1.md) of this chapter, shall be exempt from [section 502(f)(1)](/cfr/21/502.md?p=f-1) of the act if the packaging, label, and labeling are in compliance with [§ 361.1(f)](/cfr/21/361.1.md?p=f) of this chapter.


## Notes

### Amendments

[41 FR 6911, Feb. 13, 1976]

### Authority

Authority: 21 U.S.C. 321, 331, 343, 351, 352, 353, 355, 358, 360, 360b, 360ccc, 360ccc-1, 360ddd, 360ddd-1, 360ee, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.

### Source

Source: 40 FR 13998, Mar. 27, 1975, unless otherwise noted.

### Amendments

[41 FR 6911, Feb. 13, 1976]