[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: 21CFR201.115]

[Page 53]
 
                        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. 201.115  New drugs or new animal drugs.

    A new drug shall be exempt from section 502(f)(1) of the act:
    (a) To the extent to which such exemption is claimed in an approved 
application with respect to such drug under section 505 or 512 of the 
act; or
    (b) If no application under section 505 of the act is approved with 
respect to such drug but it complies with section 505(i) or 512 of the 
act and regulations thereunder.

No exemption shall apply to any other drug which would be a new drug if 
its labeling bore representations for its intended uses.