21 C.F.R. § 516.155

Current through May 31, 2024
Section 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.

21 C.F.R. §516.155

72 FR 69121, Dec. 6, 2007, as amended at 89 FR 42362, May 15, 2024
72 FR 69121,2/19/2008, as amended at 89 FR 42362, 5/15/2024