---
kind: "section"
citation: "21 C.F.R. § 516.155"
title: "21"
number: "516.155"
heading: "Labeling of indexed drugs."
url: "https://uscodex.org/cfr/21/516.155"
---

# §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)](/cfr/21/516.129.md?p=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)](/cfr/21/516.129.md?p=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.

## Notes

### Amendments

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

### Source

Source: 72 FR 69121, Dec. 6, 2007, unless otherwise noted.

### Authority

Authority: 21 U.S.C. 360ccc-1, 360ccc-2, 371.

### Source

Source: 72 FR 41017, July 26, 2007, unless otherwise noted.

### Amendments

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