[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR312.6]

[Page 53]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 312_INVESTIGATIONAL NEW DRUG APPLICATION--Table of Contents
 
                      Subpart A_General Provisions
 
Sec.  312.6  Labeling of an investigational new drug.

    (a) The immediate package of an investigational new drug intended 
for human use shall bear a label with the statement ``Caution: New 
Drug--Limited by Federal (or United States) law to investigational 
use.''
    (b) The label or labeling of an investigational new drug shall not 
bear any statement that is false or misleading in any particular and 
shall not represent that the investigational new drug is safe or 
effective for the purposes for which it is being investigated.