[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.129]

[Page 55]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 201--LABELING--Table of Contents
 
         Subpart D--Exemptions From Adequate Directions for Use
 
Sec. 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 Sec. 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 Sec. 361.1(f) of this chapter.

[41 FR 6911, Feb. 13, 1976]