Title 21

SECTION 201.128

201.128 Meaning of “intended uses”.

§ 201.128 Meaning of “intended uses”. Link to an amendment published at 82 FR 2217, January 9, 2017. This amendment was delayed until Mar. 21, 2017, at 82 FR 9501, Feb. 7, 2017. This amendment was further delayed until Mar. 18, 2018, at 82 FR 1439501, Mar. 20, 2017. This amendment was delayed indefinitely at 83 FR 11639, Mar. 16, 2018.

The words intended uses or words of similar import in §§ 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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