Pub. L. 115-234, tit. III, sec. 302 (as amended)
INDEX OF LEGALLY MARKETED UNAPPROVED NEW ANIMAL DRUGS FOR MINOR SPECIES.
SEC. 302. [21 U.S.C. 360ccc-1 note] 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”.
- Cross-references to the US Code
- 21 U.S.C. 360ccc-1 note