[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.128]

[Page 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 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]