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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2018.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2018]
[CITE: 21CFR558.680]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E--ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 558 -- NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

Subpart B--Specific New Animal Drugs for Use in Animal Feeds

Sec. 558.680 Zoalene.

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

(b) Approvals. See No. 054771 in 510.600(c) of this chapter.

(c) Related tolerances. See 556.770 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 113.5Replacement chickens: For development of active immunity to coccidiosisGrower ration not to be fed to birds over 14 weeks of age; as follows:054771
Growing conditions Starter ration
Grams per ton
Grower ration
Grams per ton
Severe exposure113.5 (0.0125%)75.4-113.5
(0.0083%-0.0125%)
Light to moderate exposure75.4-113.5
(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) 36.3-113.5Bacitracin methylenedisalicylate 4 to 50Replacement chickens: For development of active immunity to coccidiosis; and for increased rate of weight gain and improved feed efficiencyFeed 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 chapter054771
(iii) 36.3-113.5Bacitracin methylenedisalicylate 50Replacement chickens: For development of active immunity to coccidiosis; and as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracinFeed 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 chapter054771
(iv) 36.3-113.5Bacitracin methylenedisalicylate 100 to 200Replacement 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 bacitracinFeed continuously as sole ration as in 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 chapter054771
(v) 113.5Broiler chickens: For prevention and control of coccidiosisFeed continuously as sole ration054771
(vi) 113.5Bacitracin methylenedisalicylate 4 to 50Broiler chickens: As an aid in the prevention and control of coccidiosis; and for increased rate of weight gain and improved feed efficiencyFeed continuously as sole ration. Bacitracin methylenedisalicylate as provided by No. 054771 in 510.600(c) of this chapter054771
(vii) 113.5Bacitracin methylenedisalicylate 50Broiler 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 bacitracinFeed continuously as sole ration. Bacitracin methylenedisalicylate as provided by No. 054771 in 510.600(c) of this chapter054771
(viii) 113.5Bacitracin methylenedisalicylate 100 to 200Broiler 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 bacitracinFeed 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
(ix) 113.5Bambermycins 1Broiler chickens: As an aid in the prevention and control of coccidiosis; and for increased rate of weight gain and improved feed efficiencyFeed 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 chapter016592

(2) Turkeys --

Zoalene in grams/ton Combination in grams per ton Indications for use Limitations Sponsor
(i) 113.5 to 170.3Growing turkeys: For prevention and control of coccidiosisFeed continuously as sole ration. For turkeys grown for meat purposes only. Do not feed to laying birds054771
(ii) 113.5 to 170.3Bacitracin methylenedisalicylate 4 to 50Growing turkeys: For prevention and control of coccidiosis; and for increased rate of weight gain and improved feed efficiencyFeed continuously as sole ration until 14 to 16 weeks of age. For turkeys grown for meat purposes only. Do not feed to laying birds054771

(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]

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