[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: 21CFR201.128]

[Page 54-55]
 
                        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. 201.128  Meaning of ``intended uses''.

    The words intended uses or words of similar import in Secs. 201.5, 
201.115, 201.117, 201.119, 201.120, and 201.122 refer to the objective 
intent of the persons legally responsible for the labeling of drugs. The 
intent is determined by

[[Page 55]]

such persons' expressions or may be shown by the circumstances 
surrounding the distribution of the article. This objective intent may, 
for example, be shown by labeling claims, advertising matter, or oral or 
written statements by such persons or their representatives. It may be 
shown by the circumstances that the article is, with the knowledge of 
such persons or their representatives, offered and used for a purpose 
for which it is neither labeled nor advertised. The intended uses of an 
article may change after it has been introduced into interstate commerce 
by its manufacturer. If, for example, a packer, distributor, or seller 
intends an article for different uses than those intended by the person 
from whom he received the drug, such packer, distributor, or seller is 
required to supply adequate labeling in accordance with the new intended 
uses. But if a manufacturer knows, or has knowledge of facts that would 
give him notice, that a drug introduced into interstate commerce by him 
is to be used for conditions, purposes, or uses other than the ones for 
which he offers it, he is required to provide adequate labeling for such 
a drug which accords with such other uses to which the article is to be 
put.

[41 FR 6911, Feb. 13, 1976]