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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2016.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2016]
[CITE: 21CFR558.500]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E--ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 558 -- NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

Subpart B--Specific New Animal Drugs for Use in Animal Feeds

Sec. 558.500 Ractopamine.

(a) Specifications. Type A medicated articles containing 9 or 45.4 grams of ractopamine hydrochloride per pound.

(b) Approvals. See Nos. 054771 and 058198 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 feeds shall bear the following: "Not for animals intended for breeding."

(2) Labeling of Type B and Type C swine feeds shall bear the following:

(i) "No increased benefit has been shown when ractopamine concentrations in the diet are greater than 4.5 g/ton."

(ii) "Ractopamine may increase the number of injured and/or fatigued pigs during marketing."

(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) Tylosin in combinations as tylosin phosphate.

(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.

(e) Conditions of use --(1) Swine --

Ractopamine in grams/ton Combination in grams/ton Indications for use Limitations Sponsor
(i) 4.5 to 9.0For increased rate of weight gain, improved feed efficiency, and increased carcass leanness in finishing swine, weighing not less than 150 lbs, fed a complete ration containing at least 16% crude protein for the last 45 to 90 lbs of gain prior to slaughterFeed continuously as sole ration058198, 054771
(ii) 4.5 to 9.0Tylosin
40 or 100
Finishing swine: As in paragraph (e)(1)(i) of this section; and for control of swine dysentery associated with Brachyspira hyodysenteriae and porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis.Feed 100 grams per tons (g/ton) continuously as sole ration for at least 3 weeks followed by 40 g/ton until market weight. Ractopamine as provided by Nos. 058198 or 054771; tylosin as provided by Nos. 058198 or 016592 in 510.600(c) of this chapter.058198, 016592, 054771
(iii) 4.5 to 9.0Tylosin
100
Finishing swine: As in paragraph (e)(1)(i) of this section; and for control of porcine proliferative enteropathies (PPE, ileitis) associated with L. intracellularis.Feed continuously as sole ration for 21 days. Ractopamine as provided by Nos. 058198 or 054771; tylosin as provided by Nos. 058198 or 016592 in 510.600(c) of this chapter.058198, 016592, 054771
(iv) 4.5 to 9.0Tylosin
40 to 100
Finishing swine: As in paragraph (e)(1)(i) of this section; for treatment and control of swine dysentery associated with B. hyodysenteriae and for control of porcine proliferative enteropathies (PPE, ileitis) associated with L. intracellularis.Feed continuously as sole ration for 2 to 6 weeks, immediately after treatment with tylosin tartrate in drinking water as in 520.2640(d)(3) of this chapter. Ractopamine as provided by Nos. 058198 or 054771; tylosin as provided by Nos. 058198 or 016592 in 510.600(c) of this chapter.058198, 016592, 054771

(2) Cattle --

Ractopamine in grams/ton Combination in grams/ton Indications for use Limitations Sponsor
(i) 8.2 to 24.6 Cattle fed in confinement for slaughter: For increased rate of weight gain and improved feed efficiency during the last 28 to 42 days on feedFeed continuously as sole ration during the last 28 to 42 days on feed.058198, 054771
(ii) 8.2 to 24.6Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/dayCattle fed in confinement for slaughter: As in paragraph (e)(2)(i) of this section; for prevention and control of coccidiosis due to Eimeria bovis and E zuerniiAs in paragraph (e)(2)(i) of this section; see paragraph 558.355(d) of this chapter. Ractopamine as provided by Nos. 058198 or 054771 in 510.600(c) of this chapter; monensin as provided by No. 058198 in 510.600(c) of this chapter058198, 054771
(iii) [Reserved]
(iv) 8.2 to 24.6Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day, plus tylosin 8 to 10Cattle fed in confinement for slaughter: As in paragraph (e)(2)(i) of this section; for prevention and control of coccidiosis due to Eimeria bovis and E zuernii; and for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenesAs in paragraph (e)(2)(i) of this section; see 558.355(d) and 558.625(c) of this chapter. Ractopamine as provided by Nos. 058198 or 054771 with monensin as provided by No. 058198, and tylosin as provided by Nos. 058198 or 016592 in 510.600(c) of this chapter.058198, 016592, 054771
(v) [Reserved]
(vi) 9.8 to 24.6 Cattle fed in confinement for slaughter: For increased rate of weight gain, improved feed efficiency, and increased carcass leanness during the last 28 to 42 days on feedFeed continuously as sole ration during the last 28 to 42 days on feed. Not for animals intended for breeding058198, 054771
(vii) 9.8 to 24.6Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/dayCattle fed in confinement for slaughter: As in paragraph (e)(2)(vi) of this section; for prevention and control of coccidiosis due to Eimeria bovis and E zuerniiAs in paragraph (e)(2)(vi) of this section; see paragraph 558.355(d) of this chapter. Ractopamine as provided by Nos. 058198 or 054771 in 510.600(c) of this chapter; monensin as provided by No. 058198 in 510.600(c) of this chapter058198, 054771
(viii) 9.8 to 24.6Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day, plus melengestrol acetate to provide 0.25 to 0.5 mg/head/dayHeifers fed in confinement for slaughter: As in paragraph (e)(2)(vi) of this section; for prevention and control of coccidiosis due to Eimeria bovis and E. zuernii; and for suppression of estrus (heat).As in paragraph (e)(2)(vi) of this section; see 558.342(d) and 558.355(d) of this chapter. Melengestrol acetate as provided by Nos. 058198 and 054771 or 021641 in 510.600(c) of this chapter.058198, 054771
(ix) 9.8 to 24.6Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day, plus tylosin 8 to 10Cattle fed in confinement for slaughter: As in paragraph (e)(2)(vi) of this section; for prevention and control of coccidiosis due to Eimeria bovis and E zuernii; and for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenesAs in paragraph (e)(2)(vi) of this section; see 558.355(d) and 558.625(c) of this chapter. Ractopamine as provided by Nos. 058198 or 054771 with monensin as provided by No. 058198, and tylosin as provided by Nos. 058198 or 016592 in 510.600(c) of this chapter.058198, 016592, 054771
(x) 9.8 to 24.6Monensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day, plus tylosin 8 to 10, plus melengestrol acetate to provide 0.25 to 0.5 mg/head/dayHeifers fed in confinement for slaughter: As in paragraph (e)(2)(vi) of this section; for prevention and control of coccidiosis due to Eimeria bovis and E zuernii; for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes; and for suppression of estrus (heat)As in paragraph (e)(2)(vi) of this section; see paragraphs 558.342(d), 558.355(d) and 558.625(c) of this chapter. Ractopamine, monensin, and tylosin as provided by No. 058198 with melengestrol acetate as provided by Nos. 058198 or 054771 in 510.600(c) of this chapter; or ractopamine and monensin as provided by No. 058198 with tylosin as provided by Nos. 058198 or 016592 and melengestrol acetate as provided by No. 054771 in 510.600(c) of this chapter; or ractopamine as provided by No. 054771 with monensin and tylosin as provided by No. 058198 and melengestrol acetate provided by No. 054771 in 510.600(c) of this chapter; or ractopamine as provided by No. 054771 with monensin as provided by No. 058198, tylosin provided by No. 016592, and melengestrol acetate provided by No. 054771 in 510.600(c) of this chapter.058198, 016592, 054771
(xi) Not to exceed 800; to provide 70 to 400 mg/head/day. Cattle fed in confinement for slaughter: As in paragraph (e)(2)(i) of this section.Top dress in a minimum of 1.0 lb of medicated feed.058198, 054771
(xii) Not to exceed 800; to provide 70 to 400 mg/head/dayMonensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/dayCattle fed in confinement for slaughter: As in paragraph (e)(2)(i) of this section; for prevention and control of coccidiosis due to Eimeria bovis and E zuernii Top dress ractopamine in a minimum of 1.0 lb of medicated feed during the last 28 to 42 days on feed. Not for animals intended for breeding. See 558.355(d). Ractopamine as provided by Nos. 058198 or 054771 in 510.600(c) of this chapter; monensin as provided by No. 058198 in 510.600(c) of this chapter058198, 054771
(xiii) Not to exceed 800; to provide 70 to 400 mg/head/dayMonensin 10 to 40 to provide 0.14 to 0.42 mg monensin/lb of body weight, depending on severity of coccidiosis challenge, up to 480 mg/head/day, plus tylosin 8 to 10Cattle fed in confinement for slaughter: As in paragraph (e)(2)(i) of this section; for prevention and control of coccidiosis due to Eimeria bovis and E zuernii; and for reduction of incidence of liver abscesses caused by Fusobacterium necrophorum and Arcanobacterium (Actinomyces) pyogenes Top dress ractopamine in a minimum of 1.0 lb of medicated feed during the last 28 to 42 days on feed. Not for animals intended for breeding. See 558.355(d) and 558.625(c). Ractopamine as provided by Nos. 058198 or 054771 with monensin as provided by No. 058198, and tylosin as provided by Nos. 058198 or 016592 in 510.600(c) of this chapter.058198, 016592, 054771

(3) Turkeys --

Ractopamine in grams/ton Combination in grams/ton Indications for use Limitations Sponsor
(i) 4.6 to 11.8 (5 to 13 ppm) Finishing hen turkeys: For increased rate of weight gain and improved feed efficiency when fed for the last 7 to 14 days prior to slaughter.Feed continuously as sole ration during the last 7 to 14 days prior to slaughter.058198
(ii) 4.6 to 11.8 (5 to 13 ppm) Finishing tom turkeys: For increased rate of weight gain and improved feed efficiency when fed for the last 14 days prior to slaughter.Feed continuously as sole ration during the last 14 days prior to slaughter. Feeding ractopamine to tom turkeys during periods of excessive heat can result in increased mortality.058198
(iii) 4.6 to 11.8 (5 to 13 ppm)Monensin 54 to 90Finishing hen turkeys: As in paragraph (e)(3)(i) of this section; and for the prevention of coccidiosis in growing turkeys caused by Eimeria adenoeides, E. meleagrimitis and E. gallopavonis.Feed continuously as sole ration during the last 7 to 14 days prior to slaughter. See 558.355(d).058198
(iv) 4.6 to 11.8 (5 to 13 ppm)Monensin 54 to 90Finishing tom turkeys: As in paragraph (e)(3)(ii) of this section; and for the prevention of coccidiosis in growing turkeys caused by Eimeria adenoeides, E. meleagrimitis and E. gallopavonis.Feed continuously as sole ration during the last 14 days prior to slaughter. Feeding ractopamine to tom turkeys during periods of excessive heat can result in increased mortality. See 558.355(d).058198
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