Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 6 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / 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 / § 558.500 Ractopamine.
§ 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 9.0 | For 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 slaughter | Feed continuously as sole ration | 058198, 054771 | |
| (ii)-(iv) [Reserved] |
(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 feed | Feed continuously as sole ration during the last 28 to 42 days on feed. | 058198, 054771 | |
| (ii) 8.2 to 24.6 | Monensin 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 | Cattle fed in confinement for slaughter: As in paragraph (e)(2)(i) of this section; for prevention and control of coccidiosis due to | As 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 chapter | 058198, 054771 |
| (iii)-(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 feed | Feed continuously as sole ration during the last 28 to 42 days on feed. Not for animals intended for breeding | 058198, 054771 | |
| (vii) 9.8 to 24.6 | Monensin 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 | Cattle fed in confinement for slaughter: As in paragraph (e)(2)(vi) of this section; for prevention and control of coccidiosis due to | As 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 chapter | 058198, 054771 |
| (viii) 9.8 to 24.6 | Monensin 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/day | Heifers fed in confinement for slaughter: As in paragraph (e)(2)(vi) of this section; for prevention and control of coccidiosis due to | 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)-(x) [Reserved] | ||||
| (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/day | Monensin 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 | Cattle fed in confinement for slaughter: As in paragraph (e)(2)(i) of this section; for prevention and control of coccidiosis due to | 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 chapter | 058198, 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 90 | Finishing hen turkeys: As in paragraph (e)(3)(i) of this section; and for the prevention of coccidiosis in growing turkeys caused by | 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 90 | Finishing tom turkeys: As in paragraph (e)(3)(ii) of this section; and for the prevention of coccidiosis in growing turkeys caused by | 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 |
(4) Ractopamine may also be used in combination with tylosin in as in § 558.625.