[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: 21CFR201.128]
[Page 72]
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 Sec. Sec.
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]
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