21 C.F.R. § 558.680 Zoalene.
Title 21 - Food and Drugs
(a) Specifications. Type A medicated article containing 25 percent zoalene. (b) Approvals. See No. 046573 in §510.600(c) of this chapter. (c) Related tolerances. See §556.770 of this chapter. (d) Conditions of use—(1) Chickens and turkeys: (2) Zoalene may also be used in combination with roxarsone as in §558.530. [41 FR 11005, Mar. 15, 1976, as amended at 42 FR 18618, Apr. 8, 1977; 42 FR 20817, Apr. 22, 1977; 42 FR 36995, July 19, 1977; 51 FR 7401, Mar. 3, 1986; 52 FR 2686, Jan. 26, 1987; 55 FR 8461, Mar. 8, 1990; 57 FR 8403, Mar. 10, 1992; 57 FR 8578, Mar. 11, 1992; 61 FR 35957, July 9, 1996; 63 FR 38750, July 20, 1998; 67 FR 6868, Feb. 14, 2002; 71 FR 16223, Mar. 31, 2006; 71 FR 27958, May 15, 2006]
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
§ 558.680 Zoalene.
---------------------------------------------------------------------------------------------------------------- Combination in grams/ Zoalene in grams/ton ton Indications for use Limitations----------------------------------------------------------------------------------------------------------------(i) 36.3-113.5 (0.004-0.0125%)....... ....................... Replacement chickens; Grower ration not to be development of active fed to birds over 14 immunity to weeks of age; as coccidiosis.. follows:----------------------------------------------------------------------------------------------------------------
---------------------------------------------------------------------------------------------------------------- Growing conditions Starter ration Grower ration Grams per ton Grams per ton ---------------------------------------------------------------- Severe exposure 113.5 (0.0125%) 75.4-113.5 (0.0083%-0.0125%) Light to moderate 75.4-113.5 36.3-75.4 (0.004%- exposure (0.0083%-0.0125%) 0.0083%) ----------------------------------------------------------------
---------------------------------------------------------------------------------------------------------------- Combination in grams/ Zoalene in grams/ton ton Indications for use Limitations---------------------------------------------------------------------------------------------------------------- Arsanilate sodium 90 Replacement chickens; Grower ration not to be (0.01%).. development of active fed to birds over 14 immunity to weeks of age; withdraw coccidiosis; growth 5 days (d) before promotion and feed slaughter; as sole efficiency; improving source of organic pigmentation.. arsenic; feed as in subtable in item (i). Arsanilic acid 90 Replacement chickens; Grower ration not to be (0.01%).. development of active fed to birds over 14 immunity to weeks of age; withdraw coccidiosis; growth 5 d before slaughter; promotion and feed as sole source of efficiency; improving organic arsenic; feed pigmentation.. as in subtable in item (i). Arsanilic acid 90 Replacement chickens; As erythromycin (0.01%) plus growth promotion and thiocyanate; grower erythromycin 4.6 to feed efficiency; ration not to be fed 18.5.. development of active to birds over 14 weeks immunity to of age; withdraw 5 d coccidiosis; improving before slaughter; as pigmentation.. sole source of organic arsenic; feed as in subtable item (i). Arsanilic acid 90 1. Replacement Feed for 2 d before (0.01%) plus chickens; as an aid in stress and 3 to 6 d erythromycin 92.5.. the prevention of after stress; as chronic respiratory erythromycin disease during periods thiocyanate; grower of stress; development ration not to be fed of active immunity to to birds over 14 weeks coccidiosis; growth of age; withdraw 5 d promotion and feed before slaughter; as efficiency; improving sole source of organic pigmentation.. arsenic arsenic; feed as in subtable in item (i). ....................... 2. Replacement Feed for 7 to 14 d; as chickens; as an aid in erythromycin the prevention of thiocyanate; grower infectious coryza; ration not to be fed development of active to birds over 14 weeks immunity to of age; withdraw 5 d coccidiosis; growth before slaughter; as promotion and feed sole source of organic efficiency; improving arsenic; feed as in pigmentation.. subtable in item (i). Arsanilic acid 90 Replacement chickens; Feed for 5 to 8 d; do (0.01%) plus as an aid in the not use in birds erythromycin 185.. prevention and producing eggs for reduction of lesions food purposes; and in lowering withdraw 5 d before severity of chronic slaughter; as respiratory disease; erythromycin growth promotion and thiocyanate; as sole feed efficiency; source of organic improving pigmentation arsenic; feed as in and development of subtable in item (i). active immunity to coccidiosis.. Arsanilic acid 90 Replacement chickens; As procaine penicillin; (0.01%) plus growth promotion and grower ration not to penicillin 2.4 to 50.. feed efficiency; be fed to birds over development of active 14 weeks of age; immunity to withdraw 5 d before coccidiosis; improving slaughter; as sole pigmentation.. source of organic arsenic; feed as in subtable in item (i). Bacitracin 4 to 50..... Replacement chickens: Feed as in subtable in For development of § active immunity to 558.680(d)(1)(i); coccidiosis; for grower ration not to increased rate of be fed to birds over weight gain, improved 14 weeks of age. As feed efficiency. bacitracin methylene disalicylate provided by No. 046573 in § 510.600(c) of this chapter. Bacitracin methylene Replacement chickens: Feed as in subtable in disalicylate 4 to 50 For development of § plus roxarsone 22.7 to active immunity to 558.680(d)(1)(i); 45.4. coccidiosis; for grower ration not to increased rate of be fed to birds over weight gain, improved 14 weeks of age. feed efficiency, and Discontinue use 5 days improved pigmentation. before slaughter; as sole source of organic arsenic; drug overdose or lack of water may result in leg weakness. As bacitracin methylene disalicylate and roxarsone provided by No. 046573 in § 510.600(c) of this chapter. Bacitracin methylene... Replacement chickens; Feed continuously as disalicylate 50....... development of active sole ration as in immunity to subtable in this item coccidiosis; as an aid (i); grower ration not in the prevention of to be fed to birds necrotic enteritis over 14 weeks of age. caused or complicated Bacitracin methylene by Clostridium spp. or disalicylate as other organisms provided by 046573 in susceptible to § 510.600(c) of bacitracin.. this chapter. Bacitracin methylene Replacement chickens; Feed continuously as disalicylate 100 to development of active sole ration as in 200. immunity to subtable in this item coccidiosis; as an aid (i). To control in the control of necrotic enteritis, necrotic enteritis start medication at caused or complicated first clinical signs by Clostridium spp. or of disease; vary other organisms bacitracin dosage susceptible to based on the severity bacitracin.. of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 grams/ton). Bacitracin methylene disalicylate as provided by 046573 in § 510.600(c) of this chapter. Bacitracin 100 to 500.. Replacement chickens; As bacitracin zinc; treatment of chronic grower ration not to respiratory disease be fed to birds over (air-sac infection); 14 weeks of age; feed blue comb (nonspecific as in subtable in item infectious enteritis); (i). development of active immunity to coccidiosis.. Chlortetracycline 100 Replacement chickens; Do not feed to chickens to 200.. development of active producing eggs for immunity to human consumption; coccidiosis; control grower ration not to of infectious be fed to birds over synovitis caused by 14 weeks of age; feed Mycoplasma synoviae as in subtable in item susceptible to (i). chlortetracycline.. Chlortetracycline 200 Replacement chickens; Do not feed to chickens to 400.. development of active producing eggs for immunity to human consumption; coccidiosis; control grower ration not to of chronic respiratory be fed to birds over disease (CRD) and air 14 weeks of age; feed sac infection caused as in subtable in item by M. gallisepticum (i). and Escherichia coli susceptible to chlortetracycline.. Erythromycin 4.6 to Replacement chickens; As erythromycin 18.5.. growth promotion and thiocyanate; grower feed efficiency; ration not to be fed development of active to birds over 14 weeks immunity to of age; feed as in coccidiosis.. subtable in item (i). Erythromycin 92.5...... 1. Replacement Feed for 2 d before chickens, as an aid in stress and 3 to 6 the prevention of after stress; withdraw chronic respiratory 24 hours (h) before disease during periods slaughter; as of stress; development erythromycin of active immunity to thiocyanate; grower coccidiosis.. ration not to be fed to birds over 14 weeks of age; feed as in subtable in item (i). ....................... 2. Replacement Feed for 7 to 14 d; chickens; as an aid in withdraw 24 h before the prevention of slaughter; as infectious coryza; erythromycin development of active thiocyanate; grower immunity to ration not to be fed coccidiosis.. to birds over 14 weeks of age; feed as in subtable in item (i). Erythromycin 185....... Replacement chickens; Feed for 5 to 8 d; do as an aid in the not use in birds prevention and producing eggs for reduction of lesions food purposes; and in lowering withdraw 48 h before severity of chronic slaughter; grower respiratory disease; ration not to be fed development of active to birds over 14 weeks immunity to of age; feed as in coccidiosis.. subtable in item (i). Hygromycin B 8 to 12... Replacement chickens; Grower ration not to be development of active fed to birds over 14 immunity to weeks of age; feed as coccidiosis; control in subtable in item of infestation of (i). large round worms (Ascaris galli) cecal worms (Heterakis gallinae) and capillary worms (Capillaria obsignate).. Penicillin 2.4 to 50... Replacement chickens; As procaine penicillin; growth promotion and grower ration not to feed efficiency; be fed to birds over development of active 14 weeks of age; feed immunity to as in subtable in item coccidiosis.. (i). Penicillin 2.4 to 50 Replacement chickens; As procaine penicillin; plus roxarsone 22.7 to growth promotion and grower ration not to 45.4 (0.0025% to feed efficiency; be fed to birds over 0.005%).. development of active 14 weeks of age; immunity to withdraw 5 d before coccidiosis; improving slaughter; as sole pigmentation.. source of organic arsenic; feed as in subtable in item (i). Roxarsone 22.7 to 45.5 Replacement chickens; Grower ration not to be (0.0025% to 0.005%).. development of active fed to birds over 14 immunity to weeks of age; withdraw coccidiosis; growth 5 d before slaughter; promotion and feed as sole source of efficiency; improving organic arsenic; feed pigmentation.. as in subtable in item (i).(ii) 113.5 (0.0125%)................. ....................... Broiler chickens; prevention and control of coccidiosis.. Arsanilate sodium 90 Broiler chickens; Withdraw 5 d before (0.01%).. prevention and control slaughter; as sole of coccidiosis; growth source of organic promotion and feed arsenic. efficiency; improving pigmentation.. Arsanilic acid 90 Broiler chickens; Withdraw 5 d before (0.01%).. growth promotion and slaughter; as sole feed efficiency; source of organic prevention and control arsenic. of coccidiosis; improving pigmentation.. Arsanilic acid 90 Broiler chickens; As erythromycin (0.01%) plus growth prevention and thiocyanate; withdraw erythromycin 4.6 to control of 5 d before slaughter; 18.5.. coccidiosis; improving as sole source of pigmentation.. organic arsenic. Arsanilic acid 90 1. Broiler chickens; as Do. (0.01%) plus an aid in the erythromycin 92.5.. prevention of chronic respiratory disease during periods of stress; growth promotion and feed efficiency; improving pigmentation; control of coccidiosis.. ....................... 2. Broiler chickens; Do. prevention and control of coccidiosis; growth promotion and feed efficiency; improving pigmentation; as an aid in the prevention of infectious coryza.. Arsanilic acid 90 Broiler chickens; as an Feed for 5 to 8 d; do (0.01%) plus aid in the prevention not use in birds erythromycin 185.. and reduction of producing eggs for lesions and in food purposes; as lowering severity of erythromycin chronic respiratory thiocyanate; withdraw disease; prevention 5 d before slaughter; and control of as sole source of coccidiosis; growth organic arsenic. promotion and feed efficiency; improving pigmentation.. Arsanilic acid 90 Broiler chickens; As procaine penicillin; (0.01%) plus growth promotion and withdraw 5 d before penicillin 2.4 to 50.. feed efficiency; slaughter; as sole prevention and control source of organic of coccidiosis; arsenic. improving pigmentation.. Arsanilic acid 90 Broiler chickens; Withdraw 5 d before (0.01%) plus prevention and control slaughter; as sole bacitracin 4 to 50.. of coccidiosis; source of organic improving arsenic; as bacitracin pigmentation; growth methylene promotion and feed disalicylate. efficiency.. Bacitracin 4 to 50..... Broiler chickens; As bacitracin methylene growth promotion and disalicylate or zinc feed efficiency; bacitracin. prevention and control of coccidiosis.. Bacitracin 4 to 50 plus Broiler chickens; As bacitracin methylene roxarsone 22.7 to 45.4 growth promotion and disalicylate or zinc (0.0025 to 0.005%).. feed efficiency; bacitracin; withdraw 5 prevention and control d before slaughter; as of coccidiosis; sole source of organic improving arsenic. pigmentation.. Bacitracin methylene Broiler chickens; Feed continuously as disalicylate 50. prevention and control sole ration. of coccidiosis; as an Bacitracin methylene aid in the prevention disalicylate as of necrotic enteritis provided by 046573 in caused or complicated § 510.600(c) of by Clostridium spp. or this chapter. other organisms susceptible to bacitracin.. Bacitracin methylene Broiler chickens; Feed continuously as disalicylate 100 to prevention and control sole ration. To 200. of coccidiosis; as an control necrotic aid in the control of enteritis, start necrotic enteritis medication at first caused or complicated clinical signs of by Clostridium spp. or disease; vary other organisms bacitracin dosage susceptible to based on the severity bacitracin.. of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 grams/ton). Bacitracin methylene disalicylate as provided by 046573 in § 510.600(c) of this chapter. Bacitracin 100 to 500.. Broiler chickens; As zinc bacitrain. treatment of chronic respiratory disease (air-sac infection); blue comb (nonspecific infectious enteritis); prevention and control of coccidiosis.. Bambermycins 1......... Broiler chickens: As an Feed continuously as aid in the prevention sole ration. Do not and control of feed to chickens over coccidiosis; and for 14 weeks of age. increased rate of Bambermycins as weight gain and provided by No. 016592 improved feed in § 510.600(c) efficiency.. of this chapter. Bambermycins 1 plus Broiler chickens: As an Feed continuously as roxarsone 22.7. aid in the prevention sole ration. Do not and control of feed to chickens over coccidiosis; and for 14 weeks of age; feed increased rate of as sole source of weight gain and organic arsenic; improved feed withdraw 5 days before efficiency.. slaughter. Bambermycins as provided by No. 016592, roxarsone by No. 046573 in § 510.600(c) of this chapter. Chlortetracycline 100 Broiler chickens; Do not feed to chickens to 200. prevention and control producing eggs for of coccidiosis; human consumption; control of infectious feed continuously for synovitis caused by M. 7 to 14 d. synoviae susceptible to chlortetracycline.. Chlortetracycline 200 Broiler chickens; Do not feed to chickens to 400. prevention and control producing eggs for of coccidiosis; human consumption; control of chronic feed continuously 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 Broiler chickens; As erythromycin 18.5.. growth promotion and thiocyanate. feed efficiency; prevention and control of coccidiosis.. Erythromycin 92.5...... 1. Broiler chickens; as Feed for 2 d before an aid in the stress and 3 to 6 d prevention of chronic after stress; withdraw respiratory disease 24 h before slaughter; during period of as erythromycin stress; prevention and thiocyanate. control of coccidiosis.. ....................... 2. Broiler chicken; as Feed for 7 to 14 d; an aid in the withdraw 24 h before prevention of slaughter; as infectious coryza; erythromycin prevention and control thiocyanate. of coccidiosis.. Erythromycin 185....... Broiler chickens; as an Feed for 5 to 8 d; do aid in the prevention not use in birds and reduction of producing eggs for lesions and in food purposes; lowering severity of withdraw 48 h before chronic respiratory slaughter; as disease; prevention erythromycin and control of thiocyanate. coccidiosis.. Hygromycin B 8 to 12... Broiler chickens; ....................... prevention and control of coccidiosis; control of infestation of large round worms (Ascaris galli) cecal worms (Heterakis gallinae) and capillary worms (Capillaria obsignate) .. Lincomycin 2........... Broiler chickens; Do not feed to laying increase in rate of chickens; to be fed as weight gain; improved the sole ration; as feed efficiency; as an lincomycin aid in the prevention hydrochloride and control of monohydrate provided coccidiosis.. by No. 000009 in § 510.600(c) of this chapter. Penicillin 2.4 to 50... Broiler chickens; As procaine penicillin. growth promotion and feed efficiency; prevention and control of coccidiosis.. Penicillin 2.4 to 50 Broiler chickens; Withdraw 5 d before plus roxarsone 22.7 to prevention and control slaughter; as sole 45.4 (0.0025 to of coccidiosis; growth source of organic 0.005%).. promotion and feed arsenic; as procaine efficiency; improving penicillin. pigmentation.. Roxarsone 22.7 to 45.4 Broiler chickens; Withdraw 5 d before (0.0025 to 0.005%).. prevention and control slaugher; as sole of coccidiosis; growth source of organic promotion and feed arsenic. efficiency; improving pigmentation..(iii) 113.5 to 170.3 (0.0125 to ....................... Turkeys; prevention and For turkeys grown for 0.01875%).. control of meat purposes only. coccidiosis.. Arsanilate sodium 90 Turkeys; growth For turkeys grown for (0.01%).. promotion and feed meat purposes only; efficiency; improving withdraw 5 d before pigmentation.. slaughter; as sole source of organic arsenic. Arsanilic acid do.................... Do. 90(0.01%).. Bacitracin methylene Turkeys; prevention and For turkeys grown for disalicylate 4-50.. control of meat purposes only, coccidiosis, and not to be fed to increased rate of laying birds, feed weight gain and continuously as sole improved feed ration until 14 to 16 efficiency.. weeks of age. Carbarsone (not U.S.P.) Turkeys; prevention and For turkeys grown for 277 to 340.5 (0.025% control of meat purposes only; to 0.0375%).. coccidiosis; aid in feed continuously the prevention of beginning 2 weeks blackhead.. before blackhead and coccidiosis are expected and continue as long as prevention of blackhead and prevention and control of coccidiosis is needed; withdraw 5 d before slaughter; as sole source of organic arsenic. Roxarsone 22.7 to 45.4 Turkeys; growth Withdraw 5 d before (0.0025% to 0.005%).. promotion and feed slaughter; as sole efficiency; improving source of organic pigmentation.. arsenic.----------------------------------------------------------------------------------------------------------------
