§ 522.1192 Ivermectin.

Specifications.(a) (1) [Reserved]

(2) Each mL of solution contains 10 mg ivermectin.

(3) Each mL of solution contains 2.7 mg ivermectin.

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

(1) Nos. 000010, 016592, 055529, 058005, and 061133 for use of the product described in paragraph (a)(2) of this section as in paragraphs (e)(2) through (e)(5) of this section; and

(2) No. 000010 for use of the product described in paragraph (a)(3) of this section as in paragraphs (e)(3) and (e)(6) of this section.

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

Special considerations.(d) (1) See § 500.25 of this chapter.

(2) Labeling shall bear the following precaution: “This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.”

Conditions of use(e) —(1) [Reserved]

CattleAmount.(2) —(i) 200 micrograms per kilogram (µg/kg) of body weight by subcutaneous injection.

Indications for use.Haemonchus placeiOstertagia ostertagiO. lyrataTrichostrongylus axeiT. colubriformisCooperia oncophoraC. punctataC. pectinataOesophagostomum radiatumNematodirus helvetianusN. spathigerBunostomum phlebotomumDictyocaulus viviparusHypoderma bovisH. lineatumLinognathus vituliHaematopinus eurysternusSolenopotes capillatusscabiesPsoroptes ovisP. communisbovisSarcoptes scabieibovisD. viviparusO. radiatumO. ostertagiT. axeiC. punctataH. placeiC. oncophora(ii) For the treatment and control of gastrointestinal nematodes (adults and fourth-stage larvae) (, (including inhibited larvae), , , , , , , , (adults only), (adults only), ); lungworms (adults and fourth-stage larvae) (); grubs (parasitic stages) (, ); sucking lice (, , ); mites () ( (syn. var. ), var. ). For control of infections and to protect from reinfection with and for 28 days after treatment; , , and for 21 days after treatment; and for 14 days after treatment.

Limitations.(iii) Do not treat cattle within 35 days of slaughter. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

SwineAmount.(3) —(i) 300 µg/kg of body weight by subcutaneous injection.

Indications for use.Ascaris suumHyostrongylus rubidusOesophagostomumStrongyloides ransomiS. ransomiMetastrongylusH. suisS. scabieisuis(ii) For the treatment and control of gastrointestinal roundworms (adults and fourth-stage larvae) (large roundworm, ; red stomach worm, ; nodular worm, spp.; threadworm, (adults only)); somatic roundworm larvae (threadworm, (somatic larvae)); lungworms ( spp. (adults only)); lice (); and mites ( var. ).

Limitations.(iii) Do not treat swine within 18 days of slaughter.

American bisonAmount.(4) —(i) 200 µg/kg of body weight by subcutaneous injection.

Indications for use.H. bovis(ii) For the treatment and control of grubs ().

Limitations.(iii) Do not slaughter within 56 days of last treatment.

ReindeerAmount.(5) —(i) 200 µg/kg of body weight by subcutaneous injection.

Indications for use.Oedemagena tarandi(ii) For the treatment and control of warbles ().

Limitations.(iii) Do not treat reindeer within 56 days of slaughter.

Ranch-raised foxesAmount.(6) —(i) 200 µg/kg of body weight by subcutaneous injection. Repeat in 3 weeks.

Indications for use.Otodectes cynotis(ii) For treatment and control of ear mites ().

[72 FR 27735, May 17, 2007, as amended at 72 FR 62771, Nov. 7, 2007; 74 FR 9049, Mar. 2, 2009; 75 FR 26647, May 12, 2010; 76 FR 57906, Sept. 19, 2011; 78 FR 17597, Mar. 22, 2013; 81 FR 59134, Aug. 29, 2016; 84 FR 8974, Mar. 13, 2019; 84 FR 32992, July 11, 2019; 84 FR 39184, Aug. 9, 2019; 88 FR 27699, May 3, 2023]