CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR516.155]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 516 -- NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES

Subpart C - Index of Legally Marketed Unapproved New Animal Drugs for Minor Species

Sec. 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: "NOT APPROVED BY FDA. - Legally marketed as an FDA indexed product. Extra-label use is prohibited." "This product is not to be used in animals intended for use as food for humans or other animals."

(b) The labeling of an indexed drug that was 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: "NOT APPROVED BY FDA. - Legally marketed as an FDA indexed product. 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.