Regulations last checked for updates: Oct 17, 2024

Title 21 - Food and Drugs last revised: Oct 15, 2024
§ 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]
source: 40 FR 13998, Mar. 27, 1975, unless otherwise noted.
cite as: 21 CFR 201.129