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Electronic Code of Federal Regulations

e-CFR data is current as of February 13, 2020

Title 21Chapter ISubchapter EPart 516Subpart C → §516.155


Title 21: Food and Drugs
PART 516—NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES
Subpart C—Index of Legally Marketed Unapproved New Animal Drugs for Minor Species


§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.

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