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Code · STATUTE-COMPILATIONS · Animal Drug and Animal Generic Drug User Fee Amendments of 2018 · Sec. 302

Sec. 302. INDEX OF LEGALLY MARKETED UNAPPROVED NEW ANIMAL DRUGS FOR MINOR SPECIES

112 words·~1 min read·/statute-compilations/comps-15549/sec-302

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## SEC. 302 INDEX OF LEGALLY MARKETED UNAPPROVED NEW ANIMAL DRUGS FOR MINOR SPECIES **[**[21 U.S.C. 360ccc-1 note](/us/usc/t21/s360ccc-1)**]** Effective on October 1, 2018, section 572(h) (21 U.S.C. 360ccc-1(h)) is amended— ####
(1)by amending paragraph
(1)to read as follows: > > #### “(1) > > ‘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.’;” > ; and ####
(2)in paragraph (2), by striking “other animals” and inserting “food-producing animals”.
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Sec. 302
INDEX OF LEGALLY MARKETED UNAPPROVED NEW ANIMAL DRUGS FOR MINOR SPECIES
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