[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: 21CFR201.117]
[Page 70]
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.
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