§ 201.128 - Meaning of “intended uses”.

§ 201.128 Meaning of “intended uses”.

Cross Reference

Link to an amendment published at 82 FR 2217, January 9, 2017.

Cross Reference

This amendment was delayed until Mar. 21, 2017, at 82 FR 9501, Feb. 7, 2017.

Cross Reference

This amendment was further delayed until Mar. 18, 2018, at 82 FR 1439501, Mar. 20, 2017.

Cross Reference

This amendment was delayed indefinitely at 83 FR 11639, Mar. 16, 2018.

Cross Reference

Link to an amendment published at 86 FR 41401, Aug. 2, 2021.

The words intended uses or words of similar import in §§ 201.5, 201.115, 201.117, 201.119, 201.120, and 201.122, and 1100.5 of this chapter refer to the objective intent of the persons legally responsible for the labeling of drugsan article (or their representatives). The intent is determined may be shown by such persons' expressions or may be shown , the design or composition of the article, or 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 Objective intent may be shown, for example, by the circumstances that in which the article is, with the knowledge of such persons or their representatives, offered and or used for a purpose for which it is neither labeled nor advertised; provided, however, that a firm would not be regarded as intending an unapproved new use for an approved drug based solely on that firm's knowledge that such drug was being prescribed or used by health care providers for such use. 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 or she received the drugarticle, 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[86 FR 41401, Aug. 2, 2021]