§ 516.155. Labeling of indexed drugs.
214 words·~1 min read·
/us/cfr/t21/s§ 516.155·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]
Connections2 cite this
Cited by 2 sections
Citation graph
cites case law
§ 516.155
Labeling of indexed drugs.
Fed. Reg.×2
Cites 0Cited by 2 across 1 source