---
kind: "section"
citation: "21 C.F.R. § 99.405"
title: "21"
number: "99.405"
heading: "Applicability of labeling, adulteration, and misbranding authority."
url: "https://uscodex.org/cfr/21/99.405"
---

# §99.405. Applicability of labeling, adulteration, and misbranding authority.


The dissemination of information relating to a new use for a drug or device may constitute labeling, evidence of a new intended use, adulteration, or misbranding of the drug or device if such dissemination fails to comply with [section 551](/cfr/21/551.md) of the Federal Food, Drug, and Cosmetic Act (the act) ([21 U.S.C. 360aaa](/usc/21/360aaa.md)) and the requirements of this part. A manufacturer's failure to exercise due diligence in submitting the clinical studies that are necessary for the approval of a new use that is the subject of information disseminated under this part or in beginning or completing such clinical studies shall be deemed a failure to comply with [section 551](/cfr/21/551.md) of the act and the requirements of this part.


## Notes

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 360c, 360e, 360aa-360aaa-6, 371, and 374; 42 U.S.C. 262.

### Source

Source: 63 FR 64581, Nov. 20, 1998, unless otherwise noted.