Regulation Text
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 .
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.