Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 558  /  Sec. 558.550 Salinomycin.

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

(b) Approvals. See sponsors in Sec. 510.600(c) of this chapter for use as in paragraph (d) of this section:

(1) No. 054771 for use as in paragraph (d) of this section.

(2) No. 016592 for use as in paragraphs (d)(1)(i), (d)(1)(iii) through (d)(1)(xvi), (d)(1)(xxiii) and (d)(1)(xxiv), (d)(2)(i), (d)(3)(i), and (d)(4) of this section.

(3) No. 069254 for use as in paragraphs (d)(1)(xv) and (d)(1)(xvi) of this section.

(c) [Reserved]

(d) Conditions of use. (1) Broilers: It is used as follows:

(1) Broilers: It is used as follows:

(i)(a) Amount per ton. Salinomycin 40 to 60 grams.

(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati.

(c) Limitations. Feed continuously as sole ration. Do not feed to laying hens producing eggs for human consumption. Not approved for use with pellet binders. May be fatal if accidentally fed to adult turkeys or horses.

(ii) [Reserved]

(iii)(a) Amount per ton. Salinomycin 40 to 60 grams and bacitracin methylene disalicylate 4 to 30 grams.

(b) Indications for use. For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati for incresed rate of weight gain and improved feed efficiency.

(c) Limitation. Feed continuously as sole ration. Not approved for use with pellet binders. Do not feed to layers. May be fatal if accidentially fed to adult turkeys or horses. Bacitracin methylene disalicylate as provided by No. 054771 in Sec. 510.600(c) of this chapter.

(iv)-(v) [Reserved]

(vi)(a) Amount per ton. Salinomycin 40 to 60 grams and bacitracin methylene disalicylate 4 to 50 grams.

(b) Indications for use. 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.

(c) Limitations. 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 MD as provided by No. 054771 in Sec. 510.600(c) of this chapter.

(vii)(a) Amount per ton. Salinomycin 40 to 60 grams and bacitracin zinc 10 to 50 grams.

(b) Indications for use. 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.

(c) Limitations. 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 Sec. 510.600(c) of this chapter.

(viii)-(ix) [Reserved]

(x)(a) Amount per ton. Salinomycin 40 to 60 grams and virginiamycin 5 grams.

(b) Indications for use. 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.

(c) Limitations. Feed continuously as sole ration. Not approved for use with pellet binders. Do not feed to layers or to chickens over 16 weeks of age. May be fatal if accidentally fed to adult turkeys or horses. Virginiamycin as provided by No. 066104 in Sec. 510.600(c) of this chapter.

(xi)(a) Amount per ton. Salinomycin 40 to 60 grams and virginiamycin 5 to 15 grams.

(b) Indications for use. 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.

(c) Limitations. See paragraph (d)(1)(x)(c) of this section.

(xii) [Reserved]

(xiii)(a) Amount per ton. Salinomycin 40 to 60 grams and lincomycin 2 to 4 grams.

(b) Indications for use. 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.

(c) Limitations. Feed continuously as sole ration. Not approved for use with pellet binders. Do not feed to layers. Do not allow horses, adult turkeys, guinea pigs, rabbits, hamsters, or ruminants access to this feed. Ingestion by these species may result in severe gastrointestinal effects or may be fatal. Lincomycin hydrochloride monohydrate as provided by No. 054771 in Sec. 510.600(c) of this chapter.

(xiv)-(xv) [Reserved]

(xvi)(a) Amount per ton. Salinomycin 40 to 60 grams and chlortetracycline 500 grams.

(b) Indications for use. 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 reduction of mortality due to E. coli infections susceptible to such treatment.

(c) Limitations. Do not feed to layers. In feeds containing 0.8 percent dietary calcium. Not to be fed for more than 5 days. Not approved for use with pellet binders. Withdraw 24 hours before slaughter. May be fatal if accidentally fed to adult turkeys or horses. Chlortetracycline as provided by Nos. 054771 and 069254; salinomycin as provided by Nos. 054771 and 016592 in Sec. 510.600(c) of this chapter.

(xvii)-(xix) [Reserved]

(xx)(A) Amount per ton. Salinomycin, 40 to 60 grams; and bacitracin methylene disalicylate, 50 grams.

(A) Amount per ton. Salinomycin, 40 to 60 grams; and bacitracin methylene disalicylate, 50 grams.

(B) Indications for use. 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.

(C) Limitations. 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 054771; bacitracin methylene disalicylate as provided by 054771 in Sec. 510.600(c) in this chapter.

(xxi)(A) Amount per ton. Salinomycin, 40 to 60 grams; and bacitracin methylene disalicylate, 100 to 200 grams.

(A) Amount per ton. Salinomycin, 40 to 60 grams; and bacitracin methylene disalicylate, 100 to 200 grams.

(B) Indications for use. 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.

(C) Limitations. 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 054771; bacitracin methylene disalicylate as provided by 054771 in Sec. 510.600(c) in this chapter.

(xxii) Amount per ton. Salinomycin, 40 to 60 grams; plus tylosin, 4 to 50 grams.

(A) Indications for use. As an aid in 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.

(B) Limitations. For broiler chickens only. Feed continuously as sole ration. Do not feed to laying hens. Not approved for use with pellet binders. May be fatal if accidentally fed to adult turkeys or horses. Salinomycin as provided by Nos. 016592 and 054771; tylosin phosphate as provided by Nos. 000986 and 016592 in Sec. 510.600(c) of this chapter.

(xxiii) Amount per ton. Salinomycin, 40 to 60 grams; plus bambermycins, 1 to 3 grams.

(a) Indications for use. Broiler chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; and for improved feed efficiency.

(b) Limitations. 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 as provided by Nos. 054771 and 016592; bambermycins by No. 016592 in Sec. 510.600(c) of this chapter.

(xxiv) [Reserved]

(2) Quail--(i)(a) Amount per ton. Salinomycin 50 grams.

(b) Indications for use. For the prevention of coccidiosis caused by E. dispersa and E. lettyae.

(c) Limitations. Feed continuously as sole ration. Not approved for use with pellet binders. May be fatal if accidentally fed to adult turkeys or horses. Do not feed to laying hens producing eggs for human consumption.

(ii) [Reserved]

(3) Roaster and replacement (breeder and layer) chickens: It is used as follows:

(i)(A) Amount per ton. Salinomycin 40 to 60 grams.

(A) Amount per ton. Salinomycin 40 to 60 grams.

(B) Indications for use. For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati.

(C) Limitations. Feed continuously as sole ration. Do not feed to laying hens producing eggs for human consumption. Not approved for use with pellet binders. May be fatal if accidentally fed to horses or adult turkeys.

(ii) Amount per ton. Salinomycin, 40 to 60 grams, and bacitracin methylene disalicylate, 4 to 50 grams.

(A) Indications for use. 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.

(B) Limitations. Feed continuously as sole ration. Discontinue use prior to sexual maturity. Do not feed to laying chickens. May be fatal if fed to adult turkeys or to horses. Salinomycin as provided by 054771; bacitracin methylene disalicylate as provided by 054771 in Sec. 510.600(c) of this chapter.

(iii) Amount per ton. Salinomycin, 40 to 60 grams, and bacitracin methylene disalicylate, 50 grams.

(A) Indications for use. 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.

(B) Limitations. Feed continuously as sole ration. Discontinue use prior to sexual maturity. Do not feed to laying chickens. May be fatal if fed to adult turkeys or to horses. Salinomycin as provided by 054771; bacitracin methylene disalicylate as provided by 054771 in Sec. 510.600(c) of this chapter.

(iv) [Reserved]

(v) Amount per ton. Salinomycin, 40 to 60 grams, and bacitracin methylene disalicylate, 100 to 200 grams.

(A) Indications for use. 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.

(B) Limitations. 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). Discontinue use prior to sexual maturity. Do not feed to laying chickens. May be fatal if fed to adult turkeys or to horses. Salinomycin as provided by 054771 ; bacitracin methylene disalicylate as provided by 054771 in Sec. 510.600(c) of this chapter.

(vi)-(vii) [Reserved]

(4) Chickens: It is used in chicken feed as follows:

(i) Amount per ton. Salinomycin, 40 to 60 grams; plus oxytetracycline, 500 grams.

(a) Indications for use. For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; and for reduction of mortality due to air sacculitis (air-sac-infection) caused by Escherichia coli susceptible to oxytetracycline.

(b) Limitations. Feed continuously for 5 days; do not feed to chickens producing eggs for human consumption; withdraw 24 hours before slaughter; in low calcium feeds withdraw 3 d before slaughter. Salinomycin as provided by Nos. 054771 and 016592; oxytetracycline as provided by No. 066104 in Sec. 510.600(c) of this chapter.

(ii) [Reserved] [48 FR 30616, July 5, 1983]

Editorial Note: For Federal Register citations affecting Sec. 558.550, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.