[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: 21CFR201.117]

[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. 201.117  Inactive ingredients.

    A harmless drug that is ordinarily used as an inactive ingredient, 
such as a coloring, emulsifier, excipient, flavoring, lubricant, 
preservative, or solvent, in the preparation of other drugs shall be 
exempt from section 502(f)(1) of the act. This exemption shall not apply 
to any substance intended for a use which results in the preparation of 
a new drug, unless an approved new-drug application provides for such 
use.