21 CFR §558.330

1. (a)Specifications. Each pound of Type A medicated article contains 4.54 grams (10 grams per kilogram) or 22.7 grams (50 grams per kilogram) of lubabegron as lubabegron fumarate.
2. (b)Sponsor. See No. 058198 in § 510.600(c) of this chapter.
3. (c)Related tolerances. See § 556.370 of this chapter.
4. (d)Special considerations. Labeling shall bear the following caution statements:
   1. (1)Lubabegron has not been approved for use in breeding animals because safety and effectiveness have not been evaluated in these animals.
   2. (2)Do not allow horses or other equines access to feed containing lubabegron.
   3. (3)A decrease in dry matter intake may be noticed in some animals receiving lubabegron.
5. (e)Conditions of use.
   1. (1)It is used in cattle feed as follows:
   2. (2)Lubabegron may also be used in combination with:
      1. (i)[Reserved]
      2. (ii)Tylosin as in § 558.625.