[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.129]
[Page 72]
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]
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