21 C.F.R. § 558.195 Decoquinate.
Title 21 - Food and Drugs
(a) Specifications. Type A medicated article containing 6 percent decoquinate. (b) Approvals. See No. 046573 in §510.600(c) of this chapter. (c) Related tolerances. See §556.170 of this chapter. (d) Special considerations. (1) Bentonite should not be used in decoquinate feeds. (2) Type A medicated articles may be used to manufacture dry or liquid Type B cattle (including veal calf), sheep, and goat feeds as in paragraphs (e)(2) and (e)(3) of this section. (3) Type C cattle feeds may be manufactured from decoquinate liquid Type B feeds having a pH between 5.0 to 6.5 and containing a suspending agent to maintain a viscosity of not less than 500 centipoises. (e) Conditions of use. It is used as follows: (1) Chickens. (2) Cattle. (3) Minor species. [67 FR 72370, Dec. 5, 2002; 68 FR 15372, Mar. 31, 2003; 69 FR 26499, May 13, 2004; 69 FR 52816, Aug. 30, 2004; 69 FR 62407, Oct. 26, 2004; 69 FR 67264, Nov. 17, 2004; 70 FR 2567, Jan. 14, 2005]
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
§ 558.195 Decoquinate.
---------------------------------------------------------------------------------------------------------------- Combination in grams/ Decoquinate in grams/ton ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 27.2......................... .................... Broiler chickens: For Do not feed to 046573 prevention of laying chickens.. coccidiosis caused by Eimeria tenella, E. necatrix, E. mivati,E. acervulina, E. maxima, and E. brunetti..(ii) 27.2........................ Bacitracin methylene Broiler chickens: As in Feed continuously 046573 disalicylate 4 to paragraph (e)(1)(i) of as sole ration; do 50. this section; and for not feed to laying increased rate of chickens. weight gain and Bacitracin improved feed methylene efficiency.. disalicylate as provided by No. 046573 in § 510.600(c) of this chapter..(iii) 27.2....................... Bacitracin zinc 10 Broiler chickens: As in Feed continuously 046573 to 50. paragraph (e)(1)(ii) as sole ration; do of this section.. not feed to laying chickens. Bacitracin zinc as provided by No. 046573 in § 510.600(c) of this chapter..(iv) 27.2........................ Bacitracin zinc 12 Broiler chickens: As in Do not feed to 046573 to 50 plus paragraph (e)(1)(ii) laying chickens; roxarsone 11 to 45. of this section.. withdraw 5 days before slaughter; as sole source of organic arsenic.. .................... ....................... Bacitracin zinc and ......... roxarsone as provided by No. 046573 in § 510.600(c) of this chapter..(v) 27.2......................... Bacitracin methylene Broiler chickens: As in Feed continuously 046573 disalicylate 50 and paragraph (e)(1)(ii) as sole ration; do roxarsone 22.7 to of this section; as an not feed to laying 45.4. aid in the prevention chickens; withdraw of necrotic enteritis 5 days before caused or complicated slaughter. Not for by Clostridium spp. or use in breeder other organisms chickens. Use as susceptible to sole source of bacitracin; and for organic arsenic. improved pigmentation.. Poultry should have access to drinking water at all times. Drug overdosage or lack of drinking water may result in leg weakness or paralysis.. Bacitracin methylene disalicylate and roxarsone as provided by No. 046573 in § 510.600(c) of this chapter..(vi) 27.2........................ Chlortetracycline Chickens: As in Feed continuously 046573 100 to 200. paragraph (e)(1)(i) of for 7 to 14 days; this section; control do not feed to of infectious chickens producing synovitis caused by eggs for human Mycoplasma synoviae consumption.. susceptible to chlortetracycline..(vii) 27.2....................... Chlortetracycline Chickens: As in As in paragraph 046573 200 to 400. paragraph (e)(1)(i) of (e)(1)(vi) of this this section; and for section.. control of chronic respiratory disease (CRD) and air sac infection caused by M. gallisepticum and Escherichia coli susceptible to chlortetracycline..(viii) 27.2...................... Lincomycin 2........ Broiler chickens: As in Feed as sole 000009 paragraph (e)(1)(ii) ration; do not 046573 of this section.. feed to laying chickens; lincomycin provided by No. 000009 in § 510.600(c) of this chapter..(ix) 27.2........................ Roxarsone 45.4...... Broiler chickens: As in Do not feed to 046573 paragraph (e)(1)(ii) laying chickens; of this section; and withdraw 5 days for improving before slaughter; pigmentation.. as sole source of organic arsenic..----------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------------------- Combination in grams/ Decoquinate in grams/ton ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 12.9 to 90.8................. .................... Cattle (including Feed Type C feed or 046573 ruminating and milk replacer to nonruminating calves provide 22.7 and veal calves): For milligrams (mg) prevention of per 100 pounds coccidiosis caused by (lb) of body Eimeria bovis and E. weight (0.5 mg/kg) zuernii. per day. Feed at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to cows producing milk for food. See paragraph (d)(3) of this section..(ii) 12.9 to 90.8................ Chlortetracycline Calves, beef, and Feed Type C feed to 046573 500 to 4,000.. nonlactating dairy provide 22.7 mg cattle: As in decoquinate and 1 paragraph (e)(2)(i) of gram this section; for chlortetracycline treatment of bacterial per 100 lb body enteritis caused by weight per day for Escherichia coli; and not more than 5 for treatment of days. When bacterial pneumonia consumed, feed caused by Pasteurella 22.7 mg multocida organisms decoquinate per susceptible to 100 lb body weight/ chlortetracycline.. day for a total of 28 days to prevent coccidiosis. Withdraw 24 hours prior to slaughter when manufactured from CTC (chlortetracycline ) Type A medicated articles under NADA 141-147. Zero withdrawal time when manufactured from AUREOMYCIN (chlortetracycline ) Type A medicated articles under NADA 141-185. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Do not feed to animals producing milk for food. Chlortetracycline as provided by No. 046573 in § 510.600(c) of this chapter..(iii) 12.9 to 90.8............... Monensin 5 to 30.... Cattle fed in Feed only to cattle 046573 confinement for fed in confinement slaughter: As in for slaughter. paragraph (e)(2)(i) of Feed continuously this section; and for as the sole ration improved feed to provide 22.7 mg efficiency.. of decoquinate per 100 lb body weight per day and 50 to 360 mg of monensin per head per day. Feed at least 28 days during period of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to animals producing milk for food. Do not feed to lactating dairy cattle. Also see paragraph (d)(1) of this section and § 558.355(d)(8). Monensin as provided by No. 000986 in § 510.600(c) of this chapter..(iv) 13.6 to 27.2................ Chlortetracycline Calves, beef and Feed Type C feed to 046573 approximately 400 nonlactating dairy provide 22.7 mg 048164 (varying with body cattle: As in decoquinate and 1 weight and feed paragraph (e)(2)(i) of gram (g) consumption to this section; for chlortetracycline provide 10 mg/lb of treatment of bacterial per 100 lb body body weight per enteritis caused by E. weight (0.5 mg/kg) day). coli; and for per day for not treatment of bacterial more than 5 days. pneumonia caused by Type C feed may be Pasteurella multocida prepared from Type organisms susceptible B feed containing to chlortetracycline.. 535.8 to 5,440 g/ ton decoquinate and 6,700 to 80,000 g/ton chlortetracycline. When consumed, feed 22.7 mg decoquinate per 100 lb body weight/ day for a total of 28 days to prevent coccidiosis. Withdraw 24 hours prior to slaughter when manufactured from chlortetracycline Type A medicated articles under NADA 141-147 and ANADA 200-359. Zero withdrawal time when manufactured from AUREOMYCIN (chlortetracycline ) Type A medicated articles under NADA 141-185. Do not feed to calves to be processed for veal. Do not feed to animals producing milk for food. Chlortetracycline as provided by Nos. 046573 and 048164 in § 510.600(c) of this chapter..(v) 13.6 to 27.2................. Monensin 5 to 30 Cattle fed in Feed only to cattle 046573 plus tylosin 8 to confinement for fed in confinement 10. slaughter: As in for slaughter. paragraph (e)(2)(i) of Feed continuously this section; for as the sole ration improved feed to provide 22.7 mg efficiency; and for of decoquinate per reduction of incidence 100 lb body weight of liver abscesses per day, 50 to 360 caused by mg of monensin per Fusobacterium head per day, and necrophorum and 60 to 90 mg of Actinomyces tylosin per head (Corynebacterium) per day. Feed at pyogenes.. least 28 days during period of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to animals producing milk for food. Also see paragraph (d)(1) of this section and § 558.355(d)(8). Monensin and tylosin as provided by No. 000986 in § 510.600(c) of this chapter..(vi) 90.9 to 535.7............... .................... Cattle (including Feed Type C 046573 ruminating and medicated feed nonruminating calves supplements as a and veal calves): As top dress or mix in paragraph (e)(2)(i) into the daily of this section.. ration to provide 22.7 mg per 100 lb of body weight (0.5 mg/kg) per day. Feed at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to cows producing milk for food. See paragraph (d)(3) of this section..(vii) 90.9 to 535.7.............. Chlortetracycline Calves, beef, and Feed Type C 046573 4,000 to 20,000.. nonlactating dairy medicated feed cattle: As in supplements as a paragraph (e)(2)(i) of top dress or mix this section; for into the daily treatment of bacterial ration to provide enteritis caused by 22.7 mg Escherichia coli; and decoquinate and 1 for treatment of gram bacterial pneumonia chlortetracycline caused by Pasteurella per 100 lb body multocida organisms weight per day for susceptible to not more than 5 chlortetracycline.. days. When consumed, feed 22.7 mg decoquinate per 100 lb body weight per day for a total of 28 days to prevent coccidiosis. Withdraw 24 hours prior to slaughter when manufactured from CTC (chlortetracycline ) Type A medicated articles under NADA 141-147. Zero withdrawal time when manufactured from AUREOMYCIN (chlortetracycline ) Type A medicated articles under NADA 141-185. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Do not feed to animals producing milk for food. Chlortetracycline as provided by No. 046573 in § 510.600(c) of this chapter..----------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------------------- Combination in grams/ Decoquinate in grams/ton ton Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 12.9 to 90.8................. .................... 1. Young sheep: For the Feed Type C feed or 046573 prevention of milk replacer at a coccidiosis caused by rate to provide Eimeria ovinoidalis, 22.7 mg per 100 lb E. crandallis, E. of body weight parva, and E. (0.5 mg per kg) bakuensis.. per day; feed for at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to sheep producing milk for food.. .................... 2. Young goats: For the Feed Type C feed or prevention of milk replacer at a coccidiosis caused by rate to provide E. christenseni and E. 22.7 mg per 100 lb ninakohlyakimovae.. of body weight (0.5 mg per kg) per day; feed for at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to goats producing milk for food..(ii) 90.9 to 535.7............... .................... 1. Young sheep: As in Feed Type C 046573 item 1 of paragraph medicated feed (e)(3)(i) of this supplements as a section.. top dress or mix into the daily ration to provide 22.7 mg per 100 lbs of body weight (0.5 mg per kg) per day; feed for at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to sheep producing milk for food.. .................... 2. Young goats: As in Feed Type C ......... item 2 of paragraph medicated feed (e)(3)(i) of this supplements as a section.. top dress or mix into the daily ration to provide 22.7 mg per 100 lbs of body weight (0.5 mg per kg) per day; feed for at least 28 days during periods of exposure to coccidiosis or when it is likely to be a hazard. Do not feed to goats producing milk for food..----------------------------------------------------------------------------------------------------------------
