21 C.F.R. § 558.500 Ractopamine.
Title 21 - Food and Drugs
(a) Specifications. Type A medicated articles containing 9 or 45 grams of ractopamine hydrochloride per pound. (b) Approvals. See No. 000986 in §510.600(c) of this chapter. (c) Related tolerances. See §556.570 of this chapter. (d) Special considerations. (1) Labeling of Type B and Type C swine feeds shall bear the following: (i) “Caution: Pigs fed PAYLEAN are at an increased risk for exhibiting the downer pig syndrome (also referred to as “slows,” “subs,” or “suspects”). Pig handling methods to reduce the incidence of downer pigs should be thoroughly evaluated prior to initiating use of PAYLEAN.” (ii) “Not for use in breeding swine.” (2) Tylosin in combinations as tylosin phosphate. (3) 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. (e) Conditions of use. (1) Swine— (2) Cattle— [67 FR 71820, Dec. 3, 2002, as amended at 68 FR 54659, Sept. 18, 2003; 69 FR 12068, Mar. 15, 2004; 69 FR 51174, Aug. 18, 2004; 71 FR 31074, June 1, 2006]
Title 21: Food and Drugs
PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
Subpart B—Specific New Animal Drugs for Use in Animal Feeds
§ 558.500 Ractopamine.
---------------------------------------------------------------------------------------------------------------- Combination in grams/ Ractopamine in grams/ton ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 4.5.......................... .................... For increased rate of Feed continuously 000986 weight gain, improved as sole ration.. feed efficiency, and increased carcass leanness in finishing swine fed a complete ration containing at least 16 percent crude protein from 150 lb (68 kg) to 240 lb (109 kg) body weight..(ii) 4.5......................... Tylosin 40.......... Finishing swine: As in Feed continuously 000986 paragraph (e)(1)(i) of as sole ration this section; and for until market prevention of swine weight following dysentery (vibrionic).. the use of tylosin at 100 grams per ton (g/t) for at least 3 weeks..(iii) 4.5........................ Tylosin 100......... 1. Finishing swine: As Feed continuously 000986 in paragraph (e)(1)(i) as sole ration for 000986 of this section; and 21 days.. for prevention and/or Feed continuously control of porcine as sole ration for proliferative at least 3 weeks enteropathies followed by (ileitis) associated tylosin at 40 g/t with Lawsonia until market intracellularis.. weight.. 2. Finishing swine: As in paragraph (e)(1)(i) of this section; and for prevention of swine dysentery (vibrionic)..(iv) 4.5 to 18................... .................... For improved feed Feed continuously 000986 efficiency and as sole ration.. increased carcass leanness in finishing swine fed a complete ration containing at least 16 percent crude protein from 150 lb (68 kg) to 240 lb (109 kg) body weight..(v) 4.5 to 18.................... Tylosin 40.......... Finishing swine: As in Feed continuously 000986 paragraph (e)(1)(iv) as sole ration of this section; and until market for prevention of weight following swine dysentery the use of tylosin (vibrionic).. at 100 g/t for at least 3 weeks..(vi) 4.5 to 18................... Tylosin 100......... 1. Finishing swine: As Feed continuously 000986 in paragraph as sole ration for 000986 (e)(1)(iv) of this 21 days.. section; and for Feed continuously prevention and/or as sole ration for control of porcine at least 3 weeks proliferative followed by enteropathies tylosin at 40 g/t (ileitis) associated until market with Lawsonia weight.. intracellularis.. 2. Finishing swine: As in paragraph (e)(1)(iv) of this section; and for prevention of swine dysentery (vibrionic)..----------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------------------- Combination in grams/ Ractopame in grams/ton ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 8.2 to 24.6.................. .................... Cattle fed in Feed continuously 000986 confinement for as sole ration slaughter: For during the last 28 increased rate of to 42 days on weight gain and feed. Not for improved feed animals intended efficiency during the for breeding. last 28 to 42 days on feed.(ii) 8.2 to 24.6................. Monensin 10 to 30... Cattle fed in As in paragraph 000986 confinement for (e)(2)(i) of this slaughter: As in section; see paragraph (e)(2)(i) of § 558.355(d) this section; and for of this chapter. prevention and control of coccidiosis due to Eimeria bovis and E. zuernii.(iii) [Reserved].................(iv) 8.2 to 24.6................. Monensin 10 to 30, Cattle fed in As in paragraph 000986 plus tylosin 8 to confinement for (e)(2)(i) of this 10. slaughter: As in section; see paragraph (e)(2)(i) of §§ this section; for 558.355(d) and prevention and control 558.625(c) of this of coccidiosis due to chapter. E. bovis and E. zuernii; and for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Actinomyces (Corynebacterium) pyogenes.(v) [Reserved]...................(vi) 9.8 to 24.6................. .................... Cattle fed in Feed continuously 000986 confinement for as sole ration slaughter: For during the last 28 increased rate of to 42 days on weight gain, improved feed. Not for feed efficiency, and animals intended increased carcass for breeding. leanness during the last 28 to 42 days on feed.(vii) 9.8 to 24.6................ Monensin 10 to 30... Cattle fed in As in paragraph 000986 confinement for (e)(2)(vi) of this slaughter: As in section; see paragraph (e)(2)(vi) § 558.355(d) of this section; and of this chapter. for prevention and control of coccidiosis due to E. bovis and E. zuernii.(viii) 9.8 to 24.6............... Monensin 10 to 30, Heifers fed in As in paragraph 000986 plus melengestrol confinement for (e)(2)(vi) of this acetate to provide slaughter: As in section; see 0.25 to 0.5 mg/head/ paragraph (e)(2)(vi) §§ day. of this section; for 558.342(d) and prevention and control 558.355(d) of this of coccidiosis due to chapter. Eimeria bovis and E. Melengestrol zuernii; and for acetate as suppression of estrus provided by No. (heat).. 000009 in § 510.600(c) of this chapter..(ix) 9.8 to 24.6................. Monensin 10 to 30, Cattle fed in As in paragraph 000986 plus tylosin 8 to confinement for (e)(2)(vi) of this 10. slaughter: As in section; see paragraph (e)(2)(vi) §§ of this section; for 558.355(d) and prevention and control 558.625(c) of this of coccidiosis due to chapter. E. bovis and E. zuernii; and for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Actinomyces (Corynebacterium) pyogenes.(x) 9.8 to 24.6.................. Monensin 10 to 30, Heifers fed in As in paragraph 000986 plus tylosin 8 to confinement for (e)(2)(vi) of this 021641 10, plus slaughter: As in section; see melengestrol paragraph (e)(2)(vi) §§ acetate to provide of this section; for 558.342(d), 0.25 to 0.5 mg/head/ prevention and control 558.355(d), and day. of coccidiosis due to 558.625(c) of this Eimeria bovis and E. chapter. zuernii; for reduction Melengestrol of incidence of liver acetate as abscesses caused by provided by Nos. Fusobacterium 000009 and 021641 necrophorum and in § Actinomyces 510.600(c) of this (Corynebacterium) chapter.. pyogenes; and for suppression of estrus (heat)..----------------------------------------------------------------------------------------------------------------
