21 CFR § 99.405 - Applicability of labeling, adulteration, and misbranding authority.

---
identifier: "/us/cfr/t21/s99.405"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 99.405 - Applicability of labeling, adulteration, and misbranding authority."
title_number: 21
title_name: "Food and Drugs"
section_number: "99.405"
section_name: "Applicability of labeling, adulteration, and misbranding authority."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "A"
subchapter_name: "GENERAL"
part_number: "99"
part_name: "DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331, 351, 352, 355, 360, 360c, 360e, 360aa-360aaa-6, 371, and 374; 42 U.S.C. 262."
regulatory_source: "63 FR 64581, Nov. 20, 1998, unless otherwise noted."
cfr_part: "99"
---


# 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 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360aaa) 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 of the act and the requirements of this part.