21 C.F.R. § 201.129 Drugs; exemption for radioactive drugs for research use.
Title 21 - Food and Drugs
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]
Title 21: Food and Drugs
PART 201—LABELING
Subpart D—Exemptions From Adequate Directions for Use
§ 201.129 Drugs; exemption for radioactive drugs for research use.
