21 CFR 558.680 - Zoalene.

View all text of Subpart B [§ 558.55 - § 558.680]

§ 558.680 - Zoalene.

(a) Specifications. Type A medicated article containing 25 percent zoalene.

(b) Sponsors. See Nos. 054771 and 058198 in § 510.600(c) of this chapter.

(d) Conditions of use—(1) Chickens—

Zoalene in grams/ton	Combination in grams per ton	Indications for use	Limitations	Sponsor	(i) 36.3 to 113.5		Replacement chickens: For development of active immunity to coccidiosis	Feed continuously as sole ration. Grower ration not to be fed to birds over 14 weeks of age. Starter ration not to be fed to laying birds	054771 058198

Growing conditions	Starter ration Grams per ton	Grower ration Grams per ton	Severe exposure	113.5 (0.0125%)	75.4-113.5 (0.0083%-0.0125%)	Light to moderate exposure	75.4-113.5 (0.0083%-0.0125%)	36.3-75.4 (0.004%-0.0083%)

Zoalene in grams/ton	Combination in grams per ton	Indications for use	Limitations	Sponsor	(ii) 36.3-113.5	Bacitracin methylenedisalicylate 4 to 50	Replacement chickens: For development of active immunity to coccidiosis; and for increased rate of weight gain and improved feed efficiency	Feed continuously as sole ration as in subtable in item (i). Grower ration not to be fed to birds over 14 weeks of age. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter	054771	(iii) 36.3 to 113.5	Bacitracin methylenedisalicylate, 50	Replacement chickens: For development of active immunity to coccidiosis; and as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin	Feed continuously as the sole ration as in the subtable in item (i). Grower ration not to be fed to birds over 14 weeks of age. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter	054771 058198	(iv) 36.3 to 113.5	Bacitracin methylenedisalicylate, 100 to 200	Replacement chickens: For development of active immunity to coccidiosis; and as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin	Feed continuously as sole ration as in the subtable in item (i). To control necrotic enteritis, start medication at first clinical signs of disease; vary bacitracin dosage based on the severity of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 g/ton). Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter	054771 058198	(v) 113.5		Broiler chickens: For prevention and control of coccidiosis	Feed continuously as sole ration. Not to be fed to laying birds	054771 058198	(vi) 113.5	Bacitracin methylenedisalicylate 4 to 50	Broiler chickens: As an aid in the prevention and control of coccidiosis; and for increased rate of weight gain and improved feed efficiency	Feed continuously as sole ration. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter	054771	(vii) 113.5	Bacitracin methylenedisalicylate, 50	Broiler chickens: For prevention and control of coccidiosis; and as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin	Feed continuously as the sole ration. Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter	054771 058198	(viii) 113.5	Bacitracin methylenedisalicylate, 100 to 200	Broiler chickens: For prevention and control of coccidiosis; and as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin	Feed continuously as sole ration. To control necrotic enteritis, start medication at first clinical signs of disease; vary bacitracin dosage based on the severity of infection; administer continuously for 5 to 7 days or as long as clinical signs persist, then reduce bacitracin to prevention level (50 g/ton). Bacitracin methylenedisalicylate as provided by No. 054771 in § 510.600(c) of this chapter	054771 058198	(ix) 113.5	Bambermycins 1	Broiler chickens: As an aid in the prevention and control of coccidiosis; and for increased rate of weight gain and improved feed efficiency	Feed continuously as sole ration. Do not feed to chickens over 14 weeks of age. Bambermycins as provided by No. 016592 in § 510.600(c) of this chapter	016592

(2) Turkeys—

Zoalene in grams/ton	Combination in grams/ton	Indications for use	Limitations	Sponsor	(i) 113.5 to 170.3		Growing turkeys: For prevention and control of coccidiosis	Feed continuously as sole ration. For turkeys grown for meat purposes only. Not to be fed to laying birds	054771 058198	(ii) 113.5 to 170.3	Bacitracin methylenedisalicylate, 4 to 50	Growing turkeys: For prevention and control of coccidiosis; and for increased rate of weight gain and improved feed efficiency	Feed continuously as sole ration until 14 to 16 weeks of age. For turkeys grown for meat purposes only. Not to be fed to laying birds	054771 058198

(3) Zoalene may also be used in combination with:

(i)-(ii) [Reserved]

(iii) Lincomycin as in § 558.325.

[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; 76 FR 17027, Mar. 28, 2011; 79 FR 10983, Feb. 27, 2014; 79 FR 13546, Mar. 11, 2014; 81 FR 17610, Mar. 30, 2016; 81 FR 95025, Dec. 27, 2016; 82 FR 21693, May 10, 2017; 86 FR 14827, Mar. 19, 2021; 87 FR 17948, Mar. 29, 2022]