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 .
21 CFR Part 201 · Labeling
§ 201.129 Drugs; exemption for radioactive drugs for research use
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FDA guidance that cites § 201.129
Amendment history
Federal Register documents that created or amended this section.
- 41 FR 6911 13 Feb 1976