21 C.F.R. § 558.55 Amprolium.
Title 21 - Food and Drugs
(a) Approvals. Type A medicated articles: 25 percent to 050604 in §510.600(c) of this chapter for use as in paragraph (d) of this section. (b) Special considerations. Do not use in Type B or Type C medicated feeds containing bentonite. (c) Related tolerances. See §556.50 of this chapter. (d) Conditions of use—(1) Calves. It is top-dressed on or thoroughly mixed in the daily feed ration as follows: (i) Amount. 227 milligrams per 100 pounds (5 milligrams per kilogram) body weight per day. (a) Indications for use. As an aid in the prevention of coccidiosis caused by Eimeria bovis and E. zurnii. (b) Limitations. Administer from a Type B feed containing from 0.05 to 1.25 percent amprolium with the usual amount of feed consumed in 1 day; feed for 21 days during periods of exposure or when experience indicates that coccidiosis is likely to be a hazard; withdraw 24 hours before slaughter; as sole source of amprolium. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. (ii) Amount. 454 milligrams per 100 pounds (10 milligrams per kilogram) body weight per day. (a) Indications for use. As an aid in the treatment of coccidiosis caused by Eimeria bovis and E. zurnii. (b) Limitations. Administer from a Type B feed containing from 0.05 to 1.25 percent amprolium with the usual amount of feed consumed in 1 day; feed for 5 days; for a satisfactory diagnosis, a microscopic examination of the feces should be done by a veterinarian or diagnostic laboratory before treatment; when treating outbreaks, the drug should be administered promptly after diagnosis is determined; withdraw 24 hours before slaughter; as sole source of amprolium. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. (2) Chickens and turkeys. It is used as follows: (3) Pheasants. It is used as follows: (i) Amount. 0.0175 percent (159 grams per ton). (ii) Indications for use. For the prevention of coccidiosis in growing pheasants caused by Eimeria colchici, E. duodenalis, and E. phasiani. (iii) Limitations. Feed continuously as sole ration. Use as sole source of amprolium. Fertility, hatchability, and other reproductive data are not available on amprolium in breeding pheasants. Do not use in feeds containing bentonite. [41 FR 10985, 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
§ 558.55 Amprolium.
---------------------------------------------------------------------------------------------------------------- Combination in grams per Amprolium in grams per ton ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 36.3 to 113.5 (0.004% ........................... Replacement chickens; Feed as follows_ to 0.0125%). development of active immunity to coccidiosis.----------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------------------- Up to 5 weeks of From 5 to 8 weeks Growing conditions age of age Over 8 weeks of age---------------------------------------------------------------------------------------------------------------- Amprolium Amprolium Amprolium grams per ton grams per ton grams per tonSevere exposure to coccidiosis 113.5 (0.0125%) 72.6-113.5 36.3-113.5 (0.008%-0.0125%) (0.004%-0.0125%)Moderate exposure to coccidiosis 72.6-113.5 54.5-113.5 36.3-113.5 (0.008%-0.0125%) (0.006%-0.0125%) (0.004%-0.0125%)Slight exposure to coccidiosis 36.3-113.5 36.3-113.5 36.3-113.5 (0.004%-0.0125%) (0.004%-0.0125%) (0.004%-0.0125%) ----------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------------------- Combination in grams Amprolium in grams per ton per ton Indications for use Limitations Sponsor---------------------------------------------------------------------------------------------------------------- Arsanilate sodium 90 Replacement chickens; Withdraw 5 d before (0.01%). development of active slaughter; as sole immunity to source of organic coccidiosis; growth arsenic; feed promotion and feed according to subtable efficiency; improving in item (i). pigmentation. Arsanilic acid 90 Replacement chickens; Withdraw 5 d before (0.01%). development of active slaughter; as sole immunity to source of organic coccidiosis; growth arsenic; feed promotion and feed according to subtable efficiency; improving in item (i). pigmentation. Arsanilic acid 90 Replacement chickens; Withdraw 5 d before (0.01%) plus development of active slaughter; as sole erythromycin 4.6 to immunity to source of organic 18.5. coccidiosis; growth arsenic. Feed promotion and feed according to subtable efficiency; improving in item (i). pigmentation. Arsanilic acid 90 1. Replacement Feed for 2 d before (0.01%) plus chickens; development stress and 3 to 6 d erythromycin 92.5. of active immunity to after stress; coccidiosis; growth withdraw 5 d before promotion and feed slaughter; as sole efficiency; improving source of organic pigmentation; as an arsenic. Feed aid in the prevention according to subtable of chronic in item (i). respiratory disease during periods of stress. 2. Replacement Feed for 7 to 14 d; chickens; development withdraw 5 d before of active immunity to slaughter; as sole coccidiosis; growth source of organic promotion and feed arsenic. Feed efficiency; improving according to subtable pigmentation; as an in item (i). aid in the prevention of infectious coryza.(i) 36.3 to 113.5 (0.004% to Arsanilic acid 90 Replacement chickens; Feed for 5 to 8 d; do ......... 0.0125%). (0.01%) plus development of active not use in birds erythromycin 185. immunity to producing eggs for coccidiosis; growth food purposes; promotion and feed withdraw 5 d before efficiency; improving slaughter; as sole pigmentation; as an source of organic aid in the prevention arsenic. Feed and reduction of according to subtable lesions and in in item (i). lowering severity of chronic respiratory disease. Bacitracin 100 to 200.. Replacement chickens; As bacitracin ......... development of active methylene immunity to disalicylate or coccidiosis; bacitracin zinc. Feed treatment of chronic according to subtable respiratory disease in item (i). (air-sac infection) and blue comb (nonspecific infectious enteritis). Bacitracin methylene Replacement chickens; Feed according to 046573 disalicylate 4 to 50. development of active subtable in item (i); immunity to bacitracin methylene coccidiosis, disalicylate as increased rate of provided by 046573 in weight gain, and § 510.600(c) of improved feed this chapter.. efficiency.. Bacitracin methylene Replacement chickens; Feed according to 046573 disalicylate 50 plus development of active subtable in entry roxarsone 22.7 to 45.4. immunity to (i); bacitracin coccidiosis; as an methylene aid in the control of disalicylate and necrotic enteritis roxarsone as provided caused or complicated by 046573 in § by Clostridium spp. 510.600(c) of this or other organisms chapter.. susceptible to bacitracin; increased rate of weight gain, improved feed efficiency, and improved pigmentation.. Chlortetracycline 100 Chickens; development Do not feed to ......... to 200. of active immunity to chickens producing coccidiosis; control eggs for human of infectious consumption. Feed for synovitis caused by 7 to 14 d. Mycoplasma synoviae susceptible to chlortetracycline. Chlortetracycline 200 Chickens; development Do not feed to ......... to 400. of active immunity to chickens producing coccidiosis; control eggs for human of chronic consumption. Feed for respiratory disease 7 to 14 d. (CRD) and air sac infection caused by M. gallisepticum and E. coli susceptible to chlortetracycline. Erythromycin 4.6 to Replacement chickens; As erythromycin ......... 18.5. development of active thiocyanate. Feed immunity to according to subtable coccidiosis; growth in item (i). promotion and feed efficiency. Erythromycin 92.5...... 1. Replacement Feed for 7 to 14 d; ......... chickens; development withdraw 24 h before of active immunity to slaughter. Feed coccidiosis; as an according to subtable aid in the prevention in item (i). of infectious coryza. 2. Replacement Feed for 2 d before ......... chickens; development stress and 3 to 6 d of active immunity to after stress; coccidiosis; as an withdraw 24 h before aid in the prevention slaughter. Feed of chronic according to subtable respiratory disease in item (i). during periods of stress. Erythromycin 185....... Replacement chickens; Feed for 5 to 8 d; do ......... development of active not use in birds immunity to producing eggs for coccidiosis; as an food purposes; aid in the prevention withdraw 48 h before and reduction of slaughter. Feed lesions and in according to subtable lowering severity of in item (i). chronic respiratory disease. Hygromycin B 8 to 12... Replacement chickens; Feed according to ......... development of active subtable in item (i). immunity to coccidiosis; control of infestation of large round worms (Ascaris galli), cecal worms (Heterakis gallinae), and capillary worms (Capillaria obsignata). Penicillin 2.4 to 50... Replacement chickens; As procaine ......... development of active penicillin. Feed immunity to according to subtable coccidiosis; growth in item (i). promotion and feed efficiency. Roxarsone 22.7 to 45.4 Replacement chickens; Withdraw 5 d before ......... (0.0025% to 0.005%). development of active slaughter; as sole immunity to source of organic coccidiosis; growth arsenic. Feed promotion, and feed according to subtable efficiency; improving in item (i). pigmentation.(ii) 72.6 to 113.5 (0.008% ....................... Broiler chickens; Feed according to ......... to 0.0125%). prevention of subtable in item (i). coccidiosis caused by Eimeria tenella only. Arsanilate sodium 90 Broiler chickens; Withdraw 5 d before (0.01%). prevention of slaughter; as sole coccidiosis caused by source of organic E. tenella only; arsenic. growth promotion and feed efficiency; improving pigmentation. Arsanilic acid 90 ......do.............. ......do.............. (0.01%). Bacitracin 100 to 200.. Broiler chickens; As bacitracin prevention of methylene coccidiosis caused by disalicylate, or zinc E. tenella only; bacitracin. treatment of chronic respiratory disease (air-sac infection) and blue comb (nonspecific infectious enteritis). Chlortetracycline 100 Chickens; prevention Do not feed to to 200. of coccidiosis caused chickens producing by E. tenella only; eggs for human control of infectious consumption. Feed for synovitis caused by 7 to 14 d. M. synoviae susceptible to chlortetracycline. Chlortetracycline 200 Chickens; prevention Do not feed to to 400. of coccidiosis caused chickens producing by E. tenella only; eggs for human control of chronic consumption. Feed for respiratory disease 7 to 14 d. (CRD) and air sac infection caused by M. gallisepticum and E. coli susceptible to chlortetracycline. Hygromycin B 8 to 12... Broiler chickens; Feed according to prevention of subtable in item (i). coccidiosis caused by Eimeria tenella only; control of infestation of large round worms (Heterakis gallinae), and capillary worms (Capillaria obsignata). Penicillin 2.4 to 50... Broiler chickens; As procaine penicillin prevention of coccidiosis caused by E. tenella only; growth promotion and feed efficiency. Roxarsone 22.7 to 45.4 Broiler chickens; Withdraw 5 d before (0.0025% to 0.005%). prevention of slaughter; as sole coccidiosis caused by source of organic E. tenella only; arsenic. growth promotion and feed efficiency; improving pigmentation.(iii) 113.5 (0.0125%)....... ....................... 1. Laying chickens; ...................... prevention of coccidiosis. 2. Laying chickens; For moderate outbreaks treatment of of coccidiosis; coccidiosis. administer for 2 weeks. 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; for amprolium and organic increased rate of arsenic; roxarsone as weight gain, improved provided by No. feed efficiency, and 053501 in § improved pigmentation. 510.600(c) of this chapter, bambermycins by No. 016592; withdraw 5 d before slaughter. Bambermycins 1 to 4.... Growing turkeys; Feed continuously as 016592 prevention of the sole source of coccidiosis; amprolium; increased rate of bambermycins as weight gain and provided by No. improved feed 016592 in § efficiency. 510.600(c) of this chapter.(iv) 113.5 to 227 (0.0125% ....................... 1. Broiler chickens to 0.025%). and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis. 2. Turkeys; prevention of coccidiosis. Arsanilate sodium 90 1. Broiler chickens Withdraw 5 d before (0.01%). and replacement slaughter; as sole chickens where source of organic immunity to arsenic. coccidiosis is not desired; prevention of coccidiosis; growth promotion and feed efficiency; improving pigmentation. 2. Turkeys; prevention ......do.............. of coccidiosis; growth promotion and feed efficiency; improving pigmentation. Arsanilic acid 90 1. Broiler chickens ......do.............. (0.01%). and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and feed efficiency; improving pigmentation. 2. Turkeys; prevention ......do.............. of coccidiosis; growth promotion and feed efficiency; improving pigmentation. Arsanilic acid 90 1. Broiler chickens Feed for 2 d before (0.01%) plus and replacement stress and 3 to 6 d erythromycin 92.5. chickens where after stress; immunity to withdraw 5 d before coccidiosis is not slaughter; as sole desired; prevention source of organic of coccidiosis; arsenic. growth promotion and feed efficiency; improving pigmentation; as an aid in the prevention of chronic respiratory disease during periods of stress. 2. Broiler chickens Feed for 7 to 14 d; and replacement withdraw 5 d before chickens where slaughter; as sole immunity to source of organic coccidiosis is not arsenic. desired; prevention of coccidiosis; growth promotion and feed efficiency; improving pigmentation; as an aid in the prevention of infectious coryza. Arsanilic acid 90 Broiler chickens and Feed for 5 to 8 d; do (0.01%) plus replacement chickens not use in birds erythromycin 185. where immunity to producing eggs for coccidiosis is not food purposes; desired; prevention withdraw 5 d before of coccidiosis; slaughter; as sole growth promotion and source of organic feed efficiency; arsenic. improving pigmentation; as an aid in the prevention and reduction of lesions and in lowering severity of chronic respiratory disease. Arsanilic acid 90 Broiler chickens and Withdraw 5 d before (0.01%) plus replacement chickens slaughter; as sole erythromycin 4.6 to where immunity to source of organic 18.5. coccidiosis is not arsenic. desired; prevention of coccidiosis; growth promotion and feed efficiency; improved pigmentation. Bacitracin 4 to 50..... 1. Broiler chickens As bacitracin \1\ and replacement methylene 012769 chickens where disalicylate or immunity to bacitracin zinc. coccidiosis is not desired; prevention of coccidiosis; growth promotion and feed efficiency. 2. Turkeys; prevention ......do.............. 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), blue comb (nonspecific infectious enteritis). 2. Broiler chickens As bacitracin zinc.... and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; treatment of chronic ry disease (air-sac infection), blue comb (nonspecific infectious enteritis). Bacitracin 100 to 500.. Turkeys; prevention of As bacitracin zinc.... coccidiosis; treatment of infectious sinusitis, blue comb (mud fever). Bacitracin plus ......do.............. Feed contains 50% to penicillin 100 to 500 75% of bacitracin but (of combination). not more than 125 g penicillin; as procaine penicillin; as bacitracin zinc. Carbarsone 227 to 340.5 Turkeys; aid in Feed continuously 2 000006 prevention of weeks before coccidiosis (Eimeria coccidiosis and adenoeides, E. blackhead are meleagrimitis, and E. expected and continue gallopavonis) and as long as prevention blackhead. is needed; withdraw 5 days before slaughter; use as sole source of amprolium and organic arsenic; do not use as a treatment for outbreaks of coccidiosis; carbarsone by 046573 in § 510.600(c) of this chapter. Chlortetracycline 100 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 M. synoviae susceptible to chlortetracycline. Chlortetracycline 200 Chickens where Do not feed to to 400. immunity to chickens producing coccidiosis is not eggs for human desired; control of consumption. Feed for chronic respiratory 7 to 14 d. disease (CRD) and air sac infection caused by M. gallisepticum and E. coli susceptible to chlortetracycline. Erythromycin 4.6 to Broiler chickens and As erythromycin 18.5. replacement chickens thiocyanate. where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and feed efficiency. Erythromycin 92.5...... 1. Broiler chickens Feed for 2 d before and replacement stress and 3 to 6 d chickens where after stress; immunity to withdraw 24 h before coccidiosis is not slaughter. desired; prevention of coccidiosis; as an aid in the prevention of chronic respiratory disease during periods of stress. 2. Broiler chickens Feed for 7 to 14 d; and replacement withdraw 24 h before chickens where slaughter. immunity to coccidiosis is not desired; prevention of coccidiosis; as an aid in the prevention of infectious coryza. Erythromycin 185....... Broiler chickens and Feed for 5 to 8 d, do replacement chickens not use in birds where immunity to producing eggs for coccidiosis is not food purposes; desired; prevention withdraw 48 h before of coccidiosis; as an slaughter. aid in the prevention and reduction of lesions and in lowering severity of chronic respiratory disease. Hygromycin B 8 to 12... Broiler chickens and Feed according to replacement chickens subtable in item (i). where immunity to coccidiosis is not desired; prevention of coccidiosis; control of infestation of large round worms (Heterakis gallinae) and capillary worms (Capillaria obsignata). Penicillin 2.4 to 50... 1. Broiler chickens As procaine penicillin and replacement chickens where immunity to coccidiosis is not desired; prevention of coccidiosis; growth promotion and feed efficiency. 2. Turkeys; prevention ......do.............. of coccidiosis; growth promotion and feed efficiency. Roxarsone 22.7 to 45.4 1. Broiler chickens Withdraw 5 d before (0.0025% to 0.005%). and replacement slaughter; as sole chickens where source of organic immunity to arsenic. coccidiosis is not desired; prevention of coccidiosis; growth promotion and feed efficiency; improving pigmentation. 2. Turkeys; prevention ......do.............. of coccidiosis; growth promotion and feed efficiency; improving pigmentation.(v) 227 (0.025%)............ ....................... Laying chickens; For severe outbreaks ......... treatment of of coccidiosis; coccidiosis. administer for 2 weeks.----------------------------------------------------------------------------------------------------------------
