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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: 21CFR520.1192]



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. 520.1192 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. 000010 for use of a 1.87 percent paste as in (e)(1) of this section and a 0.153 percent paste for use as in paragraph (e)(2) of this section.

(2) Nos. 000859, 051311, 054925, and 061133 for use of a 1.87 percent paste for use as in paragraph (e)(1) 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 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.

(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; 71 FR 67298, Nov. 21, 2006; 73 FR 34184, June 17, 2008; 74 FR 6542, Feb. 10, 2009; 78 FR 17596, Mar. 22, 2013; 84 FR 8972, Mar. 13, 2019; 84 FR 39183, Aug. 9, 2019]

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