Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 4 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER C - DRUGS: GENERAL
/ PART 201 - LABELING
/ Subpart D - Exemptions From Adequate Directions for Use / § 201.129 Drugs; exemption for radioactive drugs for research use.
§ 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.