21 CFR §558.500

1. (a)Specifications. Type A medicated articles containing 9 or 45.4 grams of ractopamine hydrochloride per pound.
2. (b)Sponsors. See sponsor numbers in § 510.600(c) of this chapter.
   1. (1)Nos. 016592 and 058198: Type A medicated articles containing 9 or 45.4 grams per pound (g/lb) ractopamine hydrochloride.
   2. (2)Nos. 051311 and 054771: Type A medicated articles containing 45.4 g/lb ractopamine hydrochloride.
3. (c)Related tolerances. See § 556.570 of this chapter.
4. (d)Special considerations.
   1. (1)Labeling of Type B and Type C feeds shall bear the following: “Not for animals intended for breeding.”
   2. (2)Labeling of Type B and Type C swine feeds shall bear the following:
      1. (i)“No increased benefit has been shown when ractopamine concentrations in the diet are greater than 4.5 g/ton.”
      2. (ii)“Ractopamine may increase the number of injured and/or fatigued pigs during marketing.”
   3. (3)Labeling of Type B and Type C tom turkey feeds shall bear the following: “No increased benefit has been shown when ractopamine concentrations in the diet are greater than 4.6 g/ton.”
   4. (4)Tylosin in combinations as tylosin phosphate.
   5. (5)Ractopamine liquid Type B cattle feeds may be manufactured from dry ractopamine Type A articles. The liquid Type B feeds must be maintained at a pH of 4.5 to 7.5 or, if in combination with monensin and/or tylosin, at a pH of 4.5 to 6.0. Mixing directions for liquid Type B feeds requiring recirculation or agitation: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.
5. (e)Conditions of use—(1) Swine—
   1. (2)Cattle.
   2. (3)Turkeys—
   3. (4)Ractopamine may also be used in combination with tylosin in as in § 558.625.