§ 522.1192 Ivermectin. ( a ) *Specifications.* ( 1 ) [Reserved]
( 2 ) Each mL of solution contains 10 mg ivermectin.
( 3 ) Each mL of solution contains 2.7 mg ivermectin.
( b ) *Sponsors.* 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.
( c ) *Related tolerances.* See § 556.344 of this chapter.
( d ) *Special considerations.* ( 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.”
( e ) *Conditions of use* — ( 1 ) [Reserved]
( 2 ) *Cattle* — ( i ) *Amount.* 200 micrograms per kilogram (μg/kg) of body weight by subcutaneous injection.
( ii ) *Indications for use.* For the treatment and control of gastrointestinal nematodes (adults and fourth-stage larvae) (*Haemonchus placei*, *Ostertagia ostertagi* (including inhibited larvae), *O. lyrata*, *Trichostrongylus axei*, *T. colubriformis*, *Cooperia oncophora*, *C. punctata*, *C. pectinata*, *Oesophagostomum radiatum*, *Nematodirus helvetianus* (adults only), *N. spathiger* (adults only), *Bunostomum phlebotomum*); lungworms (adults and fourth-stage larvae) (*Dictyocaulus viviparus*); grubs (parasitic stages) (*Hypoderma bovis*, *H. lineatum*); sucking lice (*Linognathus vituli*, *Haematopinus eurysternus*, *Solenopotes capillatus*); mites (*scabies*) (*Psoroptes ovis* (syn. *P. communis* var. *bovis*), *Sarcoptes scabiei* var. *bovis*). For control of infections and to protect from reinfection with *D. viviparus* and *O. radiatum* for 28 days after treatment; *O. ostertagi*, *T. axei*, and *C. punctata* for 21 days after treatment; *H. placei* and *C. oncophora* for 14 days after treatment.
( iii ) *Limitations.* 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.
( 3 ) *Swine* — ( i ) *Amount.* 300 μg/kg of body weight by subcutaneous injection.
( ii ) *Indications for use.* For the treatment and control of gastrointestinal roundworms (adults and fourth-stage larvae) (large roundworm, *Ascaris suum*; red stomach worm, *Hyostrongylus rubidus*; nodular worm, *Oesophagostomum* spp.; threadworm, *Strongyloides ransomi* (adults only)); somatic roundworm larvae (threadworm, *S. ransomi* (somatic larvae)); lungworms (*Metastrongylus* spp. (adults only)); lice (*H. suis*); and mites (*S. scabiei* var. *suis*).
( iii ) *Limitations.* Do not treat swine within 18 days of slaughter.
( 4 ) *American bison* — ( i ) *Amount.* 200 μg/kg of body weight by subcutaneous injection.
( ii ) *Indications for use.* For the treatment and control of grubs (*H. bovis*).
( iii ) *Limitations.* Do not slaughter within 56 days of last treatment.
( 5 ) *Reindeer* — ( i ) *Amount.* 200 μg/kg of body weight by subcutaneous injection.
( ii ) *Indications for use.* For the treatment and control of warbles (*Oedemagena tarandi*).
( iii ) *Limitations.* Do not treat reindeer within 56 days of slaughter.
( 6 ) *Ranch-raised foxes* — ( i ) *Amount.* 200 μg/kg of body weight by subcutaneous injection. Repeat in 3 weeks.
( ii ) *Indications for use.* For treatment and control of ear mites (*Otodectes cynotis*).
[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]