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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 2020.

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, 2020]
[CITE: 21CFR520.1195]



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 520 -- ORAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 520.1195 Ivermectin liquid.

(a) Specifications. (1) Each milliliter (mL) contains 10 milligrams (mg) ivermectin.

(2) Each mL of micellar solution contains 0.8 mg ivermectin.

(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter.

(1) Nos. 000010, 000859, 054925, and 058005 for use of product described in paragraph (a)(1) of this section as in paragraphs (e)(1)(i), (e)(1)(ii)(A), and (e)(1)(iii) of this section.

(2) No. 058829 for use of product described in paragraph (a)(1) of this section as in paragraphs (e)(1)(i), (e)(1)(ii)(B), and (e)(1)(iii) of this section.

(3) Nos. 000010 and 058829 for use of product described in paragraph (a)(2) of this section as in paragraph (e)(2) 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 (mcg) per kilogram (/kg) of body weight as a single dose by stomach tube or as an oral drench.

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

(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Sheep - (i) Amount. 200 mcg/kg (3 mL/26 pounds) of body weight as a single dose oral drench.

(ii) Indications for use. For treatment and control of the adult and fourth-stage larvae of gastrointestinal roundworms (Haemonchus contortus, H. placei (adults only), Ostertagia circumcincta, Trichostrongylus axei, T. colubriformis, Cooperia oncophora (adults only), C. curticei, Oesophagostomum columbianum, O. venulosum (adults only), Nematodirus battus, N. spathiger, S. papillosus (adults only), Chabertia ovina (adult only), Trichuris ovis (adults only)); lungworms (D. filaria ); and all larval stages of the nasal bot Oestrus ovis.

(iii) Limitations. For use in sheep only. Do not use in other animal species as severe adverse reactions, including fatalities in dogs, may result. Do not treat sheep within 11 days of slaughter.

[67 FR 50597, Aug. 5, 2002, as amended at 69 FR 57173, Sept. 24, 2004; 71 FR 13542, Mar. 16, 2006; 71 FR 38072, July 5, 2006; 72 FR 9456, Feb. 21, 2008; 78 FR 17596, Mar. 22, 2013; 79 FR 10964, Feb. 27, 2014; 84 FR 39183, Aug. 9, 2019]

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