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21 C.F.R. § 520.1192   Ivermectin paste.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

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§ 520.1192   Ivermectin paste.

(a) Specifications. Each milligram (mg) of paste contains 0.0187 mg (1.87 percent) or 0.00153 mg (0.153 percent) of ivermectin.

(b) Sponsors. See sponsors in §510.600(c) of this chapter for use as in paragraph (e) of this section:

(1) No. 050604 for use of a 1.87-percent paste as in (e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) of this section and a 0.153-percent paste for use as in paragraph (e)(2) of this section.

(2) Nos. 051311 and 059130 for use of a 1.87-percent paste for use as in paragraph (e)(1)(i), (e)(1)(ii)(B), and (e)(1)(iii) of this section.

(3) No. 061623 for use of a 1.87 percent paste for use as in paragraph (e)(1)(i), (e)(1)(ii)(C), and (e)(1)(iii) of this section.

(4) No. 054925 for use of a 1.87 percent paste as in paragraphs (e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) of this section.

(c) Related tolerances. See §556.344 of this chapter.

(d) Special considerations. See §500.25 of this chapter.

(e) Conditions of use—(1) Horses—(i) Amount. 200 micrograms per kilogram (91 micrograms per pound) of body weight.

(ii) Indications for use. For treatment and control of:

(A) Large Strongyles (adults): Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, Triodontophorus spp. including T. brevicauda and T. serratus, and Craterostomum acuticaudatum; Small Strongyles (adults, including those resistant to some benzimidazole class compounds): Coronocyclus spp. including C. coronatus, C. labiatus, and C. labratus, Cyathostomum spp. including C. catinatum and C. pateratum, Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus, Cylicodontophorus spp., Cylicostephanus spp., including C. calicatus, C. goldi, C. longibursatus, and C. minutus, and Petrovinema poculatum; Small Strongyles (fourth-stage larvae); Pinworms (adults and fourth stage larvae): Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae): Parascaris equorum; Hairworms (adults): Trichostrongylus axei; Large mouth Stomach Worms (adults), Habronema muscae; Bots (oral and gastric stages): Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms (adults and fourth-stage larvae): Dictyocaulus arnfieldi; Intestinal Threadworms (adults): Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.

(B) Large Strongyles (adult) (Strongylus equinus), (adult and arterial larval stages) (Strongylus vulgaris), (adult and migrating tissue stages) (Strongylus edentatus), (adult) (Triodontophorus spp.); Small Strongyles, including those resistant to some benzimidazole class compounds (adult and fourth-stage larvae) (Cyathostomum spp., Cylicocyclus spp., Cylicodontophorus spp., Cylicostephanus spp.); Pinworms (adult and fourth-stage larvae) (Oxyuris equi); Ascarids (third- and fourth-stage larvae and adults) (Parascaris equorum); hairworms (adult) (Trichostrongylus axei); Large mouth Stomach Worms (adult) (Habronema muscae); Stomach Bots (oral and gastric stages) (Gastrophilus spp.); Lungworms (adults and fourth-stage larvae) (Dictyocaulus arnfieldi); Intestinal Threadworms (adults) (Strongyloides westeri); Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; and Dermatitis caused by neck threadworm microfilariae (Onchocerca sp.).

(C) Large strongyles (adults)—Strongylus vulgaris (also early forms in blood vessels), S. edentatus (also tissue stages), S. equinus, and Triodontophorus spp. including T. brevicauda and T. serratus; Small Strongyles (adults, including those resistant to some benzimidazole class compounds)—Cyathostomum spp. including C. catinatum and C. pateratum, Cylicocyclus spp. including C. insigne, C. leptostomum, C. nassatus, and C. brevicapsulatus, Cylicodontophorus spp., and Cylicostephanus spp. including C. calicatus, C. goldi, C. longibursatus, and C. minutus; Small Strongyles—fourth-stage larvae; Pinworms (adults and fourth-stage larvae)—Oxyuris equi; Ascarids (adults and third- and fourth-stage larvae)—Parascaris equorum; Hairworms (adults)—Trichostrongylus axei; Large-mouth Stomach Worms (adults)—Habronema muscae; Bots (oral and gastric stages)—Gasterophilus spp. including G. intestinalis and G. nasalis; Lungworms (adults and fourth-stage larvae)—Dictyocaulus arnfieldi; Intestinal Threadworms (adults)—Strongyloides westeri; Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae; Dermatitis caused by neck threadworm microfilariae, Onchocerca sp.

(iii) Limitations. For oral use only. Do not use in horses intended for human consumption.

(2) Cattle—(i) Amount. 23 milligrams per 250 pounds of body weight.

(ii) Indications for use. It is used in cattle for the treatment and control of gastrointestinal roundworms (adults and fourth-stage larvae) (Ostertagia ostertagi (including inhibited forms), O. lyrata, Haemonchus placei, Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. punctata, Nematodirus helvetianus, Bunostomum phlebotomum, Strongyloides papillosus (adults only), Oesophagostomum radiatum, Trichuris ovis (adults only)); lungworms (adults and fourth-stage larvae) (Dictyocaulus viviparus); grubs (first, second, and third instars) (Hypoderma bovis, H. lineatum); and sucking lice (Linognathus vituli, Haematopinus eurysternus).

(iii) Limitations. For oral use only. Do not treat cattle within 24 days of slaughter. Because withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age.

[49 FR 22275, May 29, 1984, as amended at 50 FR 27819, July 8, 1985; 51 FR 44449, Dec. 10, 1986; 53 FR 51273, Dec. 21, 1988; 62 FR 63270, Nov. 28, 1997; 65 FR 70661, Nov. 27, 2000; 67 FR 71820, Dec. 3, 2002; 68 FR 43294, July 22, 2003; 69 FR 59131, Oct. 4, 2004; 70 FR 8514, Feb. 22, 2005; 71 FR 40010, July 14, 2006]

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