21 CFR § 516.155 - Labeling of indexed drugs.

---
identifier: "/us/cfr/t21/s516.155"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 516.155 - Labeling of indexed drugs."
title_number: 21
title_name: "Food and Drugs"
section_number: "516.155"
section_name: "Labeling of indexed drugs."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "516"
part_name: "NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES"
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. 360ccc-1, 360ccc-2, 371."
regulatory_source: "72 FR 41017, July 26, 2007, unless otherwise noted."
cfr_part: "516"
---


# 516.155 Labeling of indexed drugs.

(a) The labeling of an indexed drug that is found to be eligible for indexing under § 516.129(c)(7)(i) shall state, prominently and conspicuously: “LEGAL STATUS—In order to be legally marketed, a new animal drug intended for a minor species must be Approved, Conditionally Approved, or Indexed by the Food and Drug Administration. THIS PRODUCT IS INDEXED—MIF # (followed by the applicable minor species index file number and a period).” “Extra-label use is prohibited.” “This product is not to be used in animals intended for use as food for humans or food-producing animals.”

(b) The labeling of an indexed drug that is found to be eligible for indexing for use in an early, non-food life stage of a food-producing minor species animal, under § 516.129(c)(7)(ii), shall state, prominently and conspicuously: “LEGAL STATUS—In order to be legally marketed, a new animal drug intended for a minor species must be Approved, Conditionally Approved, or Indexed by the Food and Drug Administration. THIS PRODUCT IS INDEXED—MIF # (followed by the applicable minor species index file number and a period).” “Extra-label use is prohibited.”

(c) The labeling of an indexed drug shall contain such other information as may be prescribed in the index listing.

[72 FR 69121, Dec. 6, 2007, as amended at 89 FR 42362, May 15, 2024]