21 C.F.R. § 558.58 Amprolium and ethopabate.
Title 21 - Food and Drugs
(a) Specifications. Type A medicated articles containing: (1) 25 percent amprolium and 8 percent ethopabate or 5 percent amprolium and 1.6 percent ethopabate; (2) 25 percent amprolium and 0.8 percent ethopabate or 5 percent amprolium and 0.16 percent ethopabate. (b) Approvals. See No. 050604 in §510.600(c) of this chapter. (c) Special considerations. Do not use in Type B or Type C medicated feeds containing bentonite. (d) Related tolerances. See §§556.50 and 556.260 of this chapter. (e) Conditions of use. (1) It is used for chickens as follows: (2) [Reserved] [41 FR 10990, Mar. 15, 1976] Editorial Note: For
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
§ 558.58 Amprolium and ethopabate.
---------------------------------------------------------------------------------------------------------------- Amprolium and ethopabate in Combination in grams grams per ton per ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) Amprolium 113.5 (0.0125 ....................... Broiler chickens as an Not for laying hens; pct) and ethopabate 3.6 aid in the prevention as sole source of (0.0004 pct). of coccidiosis. amprolium. Bambermycins, 1 to 3; Broiler chickens: As Feed continuously as 016592 plus roxarsone, 22.8 an aid in the the sole ration; as to 34.1. prevention of sole source of coccidiosis; and for amprolium and organic increased rate of arsenic; withdraw 5 d weight gain, improved before slaughter; feed efficiency, and roxarsone provided by improved No. 046573, pigmentation.. bambermycins by No. 016592 in § 510.600(c) of this chapter..(ii) Amprolium 113.5 Bambermycins 2 to 3 Broiler chickens; as Feed continuously as 016592 (0.0125%) and ethopabate plus roxarsone 22.8 to an aid in the the sole ration; as 3.6 (0.0004%). 34.1 (0.0025% to prevention of sole source of 0.00375%). coccidiosis; for amprolium and organic increased rate of arsenic; amprolium weight gain, improved and ethopabate as feed efficiency, and provided by No. pigmentation. 050604 in § 510.600(c) of this chapter, roxarsone by No. 046573, bambermycins by No. 016592; withdraw 5 d before slaughter. Lincomycin 2 to 4...... Broiler chickens; for Not for laying increase in rate of chickens; as weight gain; improved lincomycin feed efficiency; as hydrochloride an aid in the monohydrate; as sole prevention of source of amprolium. coccidiosis. Lincomycin 2 to 4 plus Broiler chickens; for Not for laying roxarsone 45.4 increase in rate of chickens; as (0.005%). weight gain; improved lincomycin feed efficiency and hydrochloride pigmentation; as an monohydrate; withdraw aid in the prevention 5 d before slaughter; of coccidiosis. as sole source of amprolium and organic arsenic. Roxarsone 45.4 (0.005 Broiler chickens; to Do not feed to laying pct). aid in prevention of chickens; withdraw 5 coccidiosis where d before slaughter; severe exposure to as sole source of coccidiosis from amprolium; do not use Eimeria acervulina, as a treatment for E. maxima, and E. outbreaks of brunetti is likely to coccidiosis; feed as occur; for increased sole ration from time rate of weight gain chickens are placed in broiler chickens on litter until the raised in floor pens. past the time when coccidiosis is ordinarily a hazard; roxarsone as provided by No. 046573 in § 510.600(c) of this chapter; combinations as provided by No. 050604.(iii) Amprolium 113.5 ....................... Broiler chickens and Not for chickens over (0.0125%) and ethopabate replacement chickens 16 weeks of age. 36.3 (0.004%). where immunity to coccidiosis is not desired; as an aid in the prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur. Arsanilic acid 90 (0.01 Broiler chickens and Not for laying hens; 061133 pct) plus erythromycin replacement chickens withdraw 5 d before 4.6 to 18.5. where immunity to slaughter; as sole coccidiosis is not source of organic desired; prevention arsenic; as of coccidiosis; erythromycin growth promotion and thiocyanate. feed efficiency; improve pigmentation. Bacitracin 4 to 50..... 1. Broiler chickens Not for chickens over and replacement 16 weeks of age; do chickens where not feed to laying immunity to chickens; as sole coccidiosis is not source of amprolium; desired; to aid in not for use as a prevention of treatment for coccidiosis where outbreaks of severe exposure to coccidiosis; as coccidiosis from bacitracin methylene Eimeria acervulina, disalicylate as E. maxima, and E. provided by No. brunetti is likely to 046573 or bacitracin occur; for increased zinc as provided by rate of weight gain No. 046573 in § in broiler chickens 510.600(c) of this raised in floor pens. chapter; feed as the sole ration from the time chickens are placed on litter until past the time when coccidiosis is ordinarily a hazard; combination as provided by No. 050604 in § 510.600(c) of this chapter. ....................... 2. Broiler chickens; Not for chickens over 046573 as an aid in 16 weeks of age; do prevention of not feed to laying coccidiosis where chickens; as sole severe exposure to source of amprolium; coccidiosis from not for use as a Eimeria acervulina, treatment for E. maxima, and E. coccidiosis; brunetti is likely to bacitracin zinc as occur; improved feed provided by No. efficiency. 046573 in § 510.600(c) of this chapter; feed as the sole ration from the time chickens are placed on litter until market weight; combination as provided by No. 046573.. Bacitracin 5 to 35 plus Broiler chickens; for Do not feed to laying roxarsone 34 increased rate of chickens; withdraw 5 (0.00375%). weight gain and as an d before slaughter; aid in the prevention as sole source of of coccidiosis where amprolium and organic severe exposure to arsenic; do not use coccidiosis from as a treatment for Eimeria acervulina, outbreaks of E. maxima, and E. coccidiosis; feed as brunetti is likely to the sole ration from occur in broiler time chickens are chickens raised in placed on litter floor pens. until past the time when coccidiosis is ordinarily a hazard; amprolium and ethopabate as provided by No. 050604 in § 510.600(c) of this chapter; bacitracin methylene disalicylate as provided by No. 046573 or bacitracin zinc as provided by No. 046573 in § 510.600(c) of this chapter; roxarsone as provided by No. 046573 in § 510.600(c) of this chapter; combination as provided by No. 050604 in § 510.600(c) of this chapter. Bacitracin 20 to 35 Broiler chickens; for Do not feed to laying plus roxarsone 34 increased rate of chickens; withdraw 5 (0.00375%). weight gain, improved d before slaughter; feed efficiency, and as sole source of as an aid in the amprolium and organic prevention of arsenic; do not use coccidiosis where as a treatment for severe exposure to outbreaks of coccidiosis from coccidiosis; feed as Eimeria acervulina, the sole ration from E. maxima, and E. time chickens are brunetti is likely to placed on litter occur in broiler until past the time chickens raised in when coccidiosis is floor pens. ordinarily a hazard; amprolium and ethopabate as provided by No. 050604 in § 510.600(c) of this chapter; bacitracin methylene disalicylate as provided by No. 046573 in § 510.600(c) of this chapter; roxarsone as provided by No. 046573 in § 510.600(c) of this chapter; combination as provided by No. 050604 in § 510.600(c) of this chapter. Bacitracin 10 to 50 Broiler chickens; as Do not feed to laying 046573 plus roxarsone 15.4 to an aid in prevention chickens; withdraw 5 45.4 (0.0017% to of coccidiosis where d before slaughter; 0.005%). severe exposure to as sole source of coccidiosis from amprolium and organic Eimeria acervulina, arsenic; do not use E. maxima, and E. as a treatment for brunetti is likely to outbreaks of occur; improved feed coccidiosis; feed as efficiency. the sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard; amprolium and ethopabate as provided by No. 050604 in § 510.600(c) of this chapter; bacitracin zinc as provided by No. 046573 roxarsone as provided by No. 046573 combination as provided by No. 046573. Bacitracin 10 plus Broiler chickens; as ......do.............. 063238 roxarsone 30 to 45.4 an aid in prevention (0.0033% to 0.005%). of coccidiosis where severe exposure to coccidiosis from E. acervulina, E. maxima, and E. brunetti is likely to occur; improved feed efficiency and improved pigmentation. Bambermycins 1 to 3.... Broiler chickens; as Feed continuously as an aid in the the sole ration; as prevention of sole source of coccidiosis where amprolium; amprolium, severe exposure to ethopabate as coccidiosis from provided by No. Eimeria acervulina, 050604 in § E. maxima, and E. 510.600(c) of this brunetti is likely to chapter, bambermycins occur; for increased as provided by No. rate of weight gain, 057926 in § and improved feed 510.600(c) of this efficiency. chapter. Bambermycins 1 to 3 Broiler chickens; as Feed continuously as 016592 plus roxarsone 22.8 to an aid in the the sole ration; as 34.1 (0.0025% to prevention of sole source of 0.00375%). coccidiosis where amprolium and organic severe exposure to arsenic; amprolium coccidiosis from and ethopabate as Eimeria acervulina, provided by No. E. maxima, and E. 050604 in § brunetti is likely to 510.600(c) of this occur; for increased chapter, roxarsone by rate of weight gain; No. 046573 improved feed bambermycins by No. efficiency, and 016592. Withdraw 5 improved pigmentation. days before slaughter. Erythromycin 4.6 to Broiler chickens and Not for laying hens; 18.5. replacement chickens withdraw 24 hours where immunity to before slaughter; coccidiosis is not erythromycin desired; prevention thiocyanate. of coccidiosis; growth promotion and feed efficiency. Virginiamycin, 15...... Broiler chickens, as Feed continuously as 000069 an aid in the sole ration, do not prevention of feed to laying hens, coccidiosis where not for chickens over severe exposure to 16 weeks of age, as Eimeria acervulina, sole source of E. brunetti, and E. amprolium, amprolium maxima is likely to and ethopabate as occur, for increased provided by 050604 in rate of weight gain § 510.600(c), and improved feed virginiamycin as efficiency. provided by 066104. Virginiamycin, 5 to 15. Broiler chickens, as ......do.............. an aid in the prevention of coccidiosis where severe exposure to Eimeria acervulina, E. brunetti, and E. maxima is likely to occur, for increased rate of weight gain.(iv) Amprolium 113.5 to 227 ....................... For broiler chickens Not for laying hens... (0.0125% to 0.025%) and and replacement ethopabate 3.6 (0.0004%). chickens where immunity to coccidiosis is not desired; prevention of coccidiosis. Arsanilic acid 90 Broiler chickens and As sole source of (0.01%). replacement chickens organic arsenic; where immunity to withdraw 5 d before coccidiosis is not slaughter; not for desired; prevention laying hens. of coccidiosis; growth promotion and feed efficiency; improving pigmentation. Arsanilic acid 90 1. For broiler Feed for 2 d before (0.01%) plus chickens and stress and 3 to 6 d erythromycin 92.5. replacement chickens after stress; where immunity to withdraw 5 d before coccidiosis is not slaughter; as sole desired; prevention source of organic of coccidiosis; as an arsenic; not for aid in the prevention laying hens. of chronic respiratory disease during periods of stress; growth promotion and feed efficiency; improving pigmentation. 2. For broiler Feed for 7 to 14 d; chickens and withdraw 5 d before replacement chickens slaughter; as sole where immunity to source of organic coccidiosis is not arsenic; not for desired; prevention laying hens. of coccidiosis; as an aid in the prevention of infectious coryza; growth promotion and feed efficiency; improving pigmentation. Arsanilic acid 90 For broiler chickens Feed for 5 to 8 d; do (0.01%) plus and replacement not use in birds erythromycin 185. chickens where producing eggs for immunity to food purposes; coccidiosis is not withdraw 5 d before desired; prevention slaughter; as sole of coccidiosis; as an source of organic aid in the prevention arsenic. and reduction of lesions and in lowering severity of chronic respiratory disease; growth promotion and feed efficiency; improving pigmentation. Bacitracin 4 to 50..... For broiler chickens As bacitracin and replacement methylene chickens where disalicylate; not for immunity to laying hens. coccidiosis is not desired; prevention of coccidiosis; growth promotion and feed efficiency. Bacitracin 100 to 200.. 1. Broiler chickens ......do.............. and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; treatment of chronic respiratory disease (air-sac infection) and blue comb (nonspecific infectious enteritis). 2. For broiler As zinc bacitracin, chickens and not for laying hens. replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; treatment of chronic respiratory disease (air-sac infection), blue comb (nonspecific infectious enteritis). Bacitracin 4 to 50 plus Broiler chickens and As bacitracin roxarsone 22.7 to 45.4 replacement chickens methylene (0.0025% to 0.005%). where immunity to disalicylate; not for coccidiosis is not laying hens; as sole desired; prevention source of organic of coccidiosis; arsenic; withdraw 5 d growth promotion and before slaughter. feed efficiency; improving pigmentation. Chlortetracycline 100 For chickens where Do not feed to to 200. immunity to chickens producing coccidiosis is not eggs for human desired; prevention consumption. Feed for of coccidiosis; 7 to 14 d. control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline. Chlortetracycline 200 For chickens where In low calcium feed to 400. immunity to containing 0.8% coccidiosis is not dietary calcium and desired; prevention 1.5% sodium sulfate; of coccidiosis; feed continuously as control of chronic sole ration for 7 to respiratory disease 14 d; do not feed to (CRD) and air sac chickens producing infection caused by eggs for human M. gallisepticum and consumption. E. coli susceptible to chlortetracycline. Erythromycin 92.5...... 1. For broiler Feed for 2 d before chickens and for stress and 3 to 6 d replacement chickens after stress; where immunity to withdraw 24 h before coccidiosis is not slaughter; not for desired; prevention laying hens. of coccidiosis; as an aid in the prevention of chronic respiratory disease during periods of stress. 2. For broiler Feed for 7 to 14 d; chickens and withdraw 24 h before replacement chickens slaughter; not for where immunity to laying hens. coccidiosis is not desired; prevention of coccidiosis; as an aid in the prevention of infectious coryza. Erythromycin 185....... For broiler chickens Feed for 5 to 8 d; do and replacement not use in birds chickens where producing eggs for immunity to food purposes; coccidiosis is not withdraw 48 h before desired; prevention slaughter. of coccidiosis; as an aid in the prevention and reduction of lesions and in lowering severity of chronic respiratory disease. Penicillin 2.4 to 50... For broiler chickens Not for laying hens; and replacement as procaine chickens where penicillin. immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and feed efficiency; improving pigmentation. Roxarsone 22.7 to 45.4 Broiler chickens and As sole source of ......... (0.0025% to 0.005%). replacement chickens organic arsenic; where immunity to withdraw 5 d before coccidiosis is not slaughter; not for desired; prevention laying hens. of coccidiosis; growth promotion and feed efficiency; improving pigmentation.----------------------------------------------------------------------------------------------------------------
