21 CFR 558.550: Salinomycin.

(a) Specifications. Type A medicated articles containing 30 or 60 grams of salinomycin sodium activity per pound.

(b) Sponsor. See No. 016592 in § 510.600(c) of this chapter for use as in paragraph (e) of this section.

(c) Related tolerances. See § 556.592 of this chapter.

(d) Special considerations. Not approved for use with pellet binders.

(e) Conditions of use. It is used as follows:

(1) Chickens—

Salinomycin in grams/ton Combination in grams/ton Indications for use Limitations Sponsor

(i) 40 to 60 Broiler, roaster, and replacement (breeder and layer) chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati Feed continuously as sole ration. Do not feed to birds producing eggs for human consumption. May be fatal if accidentally fed to adult turkeys or horses 016592

(ii) 40 to 60 Bacitracin (as feed grade bacitracin methylenedisalicylate) 4 to 50 Broiler chickens and replacement chickens. Not for use in laying hens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain and improved feed efficiency Feed continuously as sole ration. Discontinue use prior to sexual maturity. The dosage of salinomycin sodium should be adjusted to meet the severity of the coccidial challenge, which varies with environmental and management conditions. May be fatal if fed to adult turkeys or horses. Salinomycin as provided by No. 016592; bacitracin methylenedisalicylate as provided by No. 066104 in § 510.600(c) of this chapter 016592 066104

(iii) 40 to 60 Bacitracin (as feed grade bacitracin methylenedisalicylate) 50 Broiler chickens and replacement chickens. Not for use in laying hens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and as an aid in the prevention of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin methylenedisalicylate Feed continuously as sole ration. Discontinue use prior to sexual maturity. The dosage of salinomycin sodium should be adjusted to meet the severity of the coccidial challenge, which varies with environmental and management conditions. May be fatal if fed to adult turkeys or horses. Salinomycin as provided by No. 016592; bacitracin methylenedisalicylate as provided by No. 066104 in § 510.600(c) of this chapter 066104

(iv) 40 to 60 Bacitracin (as feed grade bacitracin methylenedisalicylate) 100 to 200 Broiler chickens and replacement chickens. Not for use in laying hens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and as an aid in the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to bacitracin methylenedisalicylate Feed continuously as the sole ration. Discontinue use prior to sexual maturity. The dosage of salinomycin sodium should be adjusted to meet the severity of the coccidial challenge, which varies with environmental and management conditions. To control a necrotic enteritis outbreak, start medication at the first clinical signs of disease. The bacitracin methylenedisalicylate dosage range permitted provides for different levels based on severity of the infection. Consult a poultry diagnostic laboratory or pathologist to determine the diagnosis and advice regarding the optimal level of bacitracin methylenedisalicylate. Administer continuously for 5-7 days or as long as clinical signs persist, and then reduce bacitracin methylenedisalicylate dosage to prevention level (50 g/ton). May be fatal if fed to adult turkeys or to horses. Salinomycin as provided by No. 016592; bacitracin methylenedisalicylate as provided by No. 066104 in § 510.600(c) in this chapter 066104

(v) 40 to 60 Bacitracin (as feed grade bacitracin zinc), 10 to 50 Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for increased rate of weight gain Feed as the sole ration. The dosage of salinomycin sodium should be adjusted to meet the severity of coccidial challenge, which varies with environmental and management conditions. Do not feed to chickens producing eggs for human consumption. May be fatal if accidently fed to adult turkeys or horses. Do not use in Type C medicated feeds containing pellet binders. Bacitracin zinc as provided by No. 054771 in § 510.600(c) of this chapter 016592 066104

(vi) 40 to 60 Bambermycins, 1 to 3 Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati, and for improved feed efficiency Feed continuously as sole ration. Do not feed to laying chickens. Not approved for use with pellet binders. May be fatal if accidentally fed to adult turkeys or horses. Salinomycin and bambermycins as provided by No. 016592 in § 510.600(c) in this chapter 016592

(2) Game birds—

Salinomycin in grams/ton Combination in grams per ton Indications for use Limitations Sponsor

(i) 50 Quail: For the prevention of coccidiosis caused by Eimeria dispersa and E. lettyae Feed continuously as sole ration. Do not feed to birds producing eggs for human consumption. May be fatal if accidentally fed to adult turkeys or horses 016592

(ii) [Reserved]

(3) Combinations. Salinomycin may also be used in combination with:

(i) Avilamycin as in § 558.68.

(ii) Chlortetracycline as in § 558.128.

(iii) Lincomycin as in § 558.325.

(iv) Oxytetracycline as in § 558.450.

(v) Virginiamycin as in § 558.635.