21 CFR § 558.550
Salinomycin
June 25, 2020
(a) Specifications. Type A medicated articles containing 30 or 60 grams of salinomycin activity per pound (as salinomycin sodium biomass).
(b) Sponsor. See No. 016592 in §510.600(c) of this chapter.
(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—
Open Table
| 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 laying hens producing eggs for human consumption. May be fatal if accidentally fed to adult turkeys or horses | 016592 | |
| (ii) 40 to 60 | Bacitracin methylenedisalicylate, 4 to 50 | 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, and for increased rate of weight gain and improved feed efficiency | Feed continuously as sole ration. Do not feed to laying chickens. May be fatal if fed to adult turkeys or horses. Salinomycin as provided by No. 016592; bacitracin methylenedisalicylate as provided by No. 054771 in §510.600(c) of this chapter | 016592 054771 |
| (iii) 40 to 60 | Bacitracin methylenedisalicylate, 50 | Broiler chickens: 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 | Feed continuously as sole ration. Do not feed to laying chickens. May be fatal if fed to adult turkeys or to horses. Salinomycin as provided by No. 016592; bacitracin methylenedisalicylate as provided by No. 054771 in §510.600(c) in this chapter | 054771 |
| (iv) 40 to 60 | Bacitracin methylenedisalicylate, 100 to 200 | Broiler chickens: 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 | Feed continuously as sole ration. To control necrotic enteritis, start medication at first clinical signs of disease; vary 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 grams per ton). Do not feed to laying chickens. May be fatal if fed to adult turkeys or to horses. Salinomycin as provided by No. 016592; bacitracin methylenedisalicylate as provided by No. 054771 in §510.600(c) in this chapter | 054771 |
| (v) 40 to 60 | 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 continuously as sole ration. Not approved for use with pellet binders. Do not feed to layers. May be fatal if accidentally fed to adult turkeys or horses. Bacitracin zinc as provided by No. 054771 in §510.600(c) of this chapter | 016592 054771 |
| (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—
Open Table
| Salinomycin in grams/ton | Combination in grams per ton |
Indications for use | Limitations | Sponsor |
|---|---|---|---|---|
| (i) 50 | Quail: For the prevention of coccidiosis caused by E. dispersa and E. lettyae | Feed continuously as sole ration. Not approved for use with pellet binders. Do not feed to laying hens producing eggs for human consumption. May be fatal if accidentally fed to adult turkeys or horses | ||
| (ii) [Reserved] |
(3) Salinomycin may also be used in combination with:
(i) Chlortetracycline as in §558.128.
(ii) Lincomycin as in §558.325.
(iii) Oxytetracycline as in §558.450.
(iv) Virginiamycin as in §558.635.
[48 FR 30616, July 5, 1983]
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