Pub. L. 115-234, tit. III, sec. 302
INDEX OF LEGALLY MARKETED UNAPPROVED NEW ANIMAL DRUGS FOR MINOR SPECIES.
SEC. 302. INDEX OF LEGALLY MARKETED UNAPPROVED NEW ANIMAL DRUGS FOR MINOR SPECIES. 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”.