Regulations last checked for updates: Feb 06, 2026

Title 21 - Food and Drugs last revised: Dec 18, 2026
§ 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 of this chapter, shall be exempt from section 502(f)(1) of the act if the packaging, label, and labeling are in compliance with § 361.1(f) of this chapter.

[41 FR 6911, Feb. 13, 1976]
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: 40 FR 13998, Mar. 27, 1975, unless otherwise noted.
cite as: 21 CFR 201.129