21 CFR Part 522 — Implantation or Injectable Dosage Form New Animal Drugs

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PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS Authority: 21 U.S.C. 360b. Source: 40 FR 13858, Mar. 27, 1975, unless otherwise noted. § 522.23 Acepromazine. (a) Specifications. (b) Sponsors. (c) Conditions of use in dogs, cats, and horses Amount. (2) Indications for use. (3) Limitations. [75 FR 10167, Mar. 5, 2010; 78 FR 17597, Mar. 22, 2013; 79 FR 16182, Mar. 25, 2014; 86 FR 14819, Mar. 19, 2021] § 522.52 Alfaxalone. (a) Specifications. (b) Sponsor. (c) Conditions of use in cats and dogs Amount Cats Induction of general anesthesia. (B) Maintenance of general anesthesia following induction. (ii) Dogs Induction of general anesthesia. (B) Maintenance of general anesthesia following induction. (2) Indications for use. (3) Limitations. [77 FR 64717, Oct. 23, 2012, as amended at 79 FR 64116, Oct. 28, 2014; 88 FR 84700, Dec. 6, 2023] § 522.56 Amikacin. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. Escherichia coli Proteus Pseudomonas E. coli. (3) Limitations. [76 FR 17338, Mar. 29, 2011, as amended at 78 FR 17597, Mar. 22, 2013; 79 FR 16183, Mar. 25, 2014; 81 FR 17608, Mar. 30, 2016] § 522.62 Aminopentamide. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs and cats Amount. (2) Indications for use. (3) Limitations. [79 FR 16183, Mar. 25, 2014] § 522.82 Aminopropazine. (a) Specifications. (b) Sponsor. (c) Conditions of use Dogs and cats Amount. (ii) Indications for use. (iii) Limitations. (2) Horses Amount. (ii) Indications for use. (iii) Limitations. [79 FR 16183, Mar. 25, 2014] § 522.88 Amoxicillin. (a) Specifications. (2) Each vial contains 25 g of amoxicillin trihydrate. Each milliliter of constituted suspension contains 250 mg amoxicillin trihydrate for use as in paragraph (d)(2) of this section. (b) Sponsor. (c) Related tolerance. (d) Conditions of use Dogs and cats Amount. (ii) Indications for use Dogs. Staphylococcus aureus, Streptococcus Escherichia coli, Proteus mirabilis; S. aureus, Streptococcus E. coli, P. mirabilis; S. aureus, Streptococcus E. coli, P. mirabilis; S. aureus, Streptococcus P. mirabilis; S. aureus, Streptococcus E. coli, P. mirabilis. (B) Cats. S. aureus, Staphylococcus Streptococcus Haemophilus E. coli, Pasteurella P. mirabilis; S. aureus, Streptococcus E. coli, P. mirabilis, Corynebacterium E. coli, Proteus Staphylococcus Streptococcus S. aureus, Staphylococcus Streptococcus E. coli, Pasteurella multocida. (iii) Limitations. (2) Cattle Amount. (ii) Indications for use. P. multocida, P. hemolytica, Haemophilus Staphylococcus Streptococcus Fusobacterium necrophorum. (iii) Limitations. [79 FR 16183, Mar. 25, 2014] § 522.90 Ampicillin injectable dosage forms. [79 FR 16183, Mar. 25, 2014] § 522.90a Ampicillin trihydrate suspension. (a) Specifications. (2) Each milliliter contains ampicillin trihydrate equivalent to 150 mg of ampicillin. (b) Sponsors. (1) No. 054771 for use of product described in paragraph (a)(1) as in paragraphs (d)(1), (d)(2), (d)(3)(i)(A), (d)(3)(ii)(A), (d)(3)(iii), and (d)(4) of this section. (2) No. 054771 for use of product described in paragraph (a)(2) as in paragraphs (d)(3)(i)(B), (d)(3)(ii)(B), and (d)(3)(iii) of this section. (c) Related tolerances. (d) Conditions of use Cattle Amount. (ii) Indications for use. Escherichia coli Pasteurella (iii) Limitations. (2) Swine Amount. (ii) Indications for use. E. coli Pasteurella (iii) Limitations. (3) Dogs Amount. (B) 3 to 5 mg of ampicillin per pound of body weight, once a day for up to 4 days. (ii) Indications for use. E. coli, Pseudomonas Proteus Staphylococcus Streptococcus E. coli, Pseudomonas Streptococcus Staphylococcus Staphylococcus Streptococcus (B) Treatment of bacterial infections of the upper respiratory tract (tonsillitis) due to Streptococcus Staphylococcus E. coli, Proteus Pasteurella Staphylococcus Streptococcus E. coli, (iii) Limitations. (4) Cats Amount. (ii) Indications for use. Staphylococcus Streptococcus Pasteurella (iii) Limitations. [79 FR 16183, Mar. 25, 2014] § 522.90b Ampicillin trihydrate powder for injection. (a) Specifications. (b) Sponsors. (c) Related tolerances. (d) Conditions of use Dogs and cats Amount. (ii) Indications for use. (iii) Limitations. (2) Cattle Amount. (ii) Indications for use. Aerobacter Klebsiella Staphylococcus Streptococcus Pasteurella multocida, Escherichia coli. (iii) Limitations. [57 FR 37331, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992; 58 FR 18304, Apr. 8, 1993; 63 FR 41420, Aug. 4, 1998; 75 FR 10167, Mar. 5, 2010; 76 FR 17338, Mar. 29, 2011; 76 FR 53051, Aug. 25, 2011; 82 FR 21690, May 10, 2017; 85 FR 4208, Jan. 24, 2020] § 522.90c Ampicillin sodium. (a) Specifications. (b) See Nos. 042791 and 054771 in § 510.600(c) of this chapter. (c) Conditions of use in horses Amount (2) Indications for use. Staphylococcus Streptococcus S. equi Escherichia coli Proteus mirabilis Staphylococcus Streptococcus E. coli P. mirabilis (3) Limitations. [72 FR 45158, Aug. 13, 2007, as amended at 79 FR 16184, Mar. 25, 2014; 86 FR 57997, Oct. 20, 2021] § 522.144 Arsenamide. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. Dirofilaria immitis. (3) Limitations. [79 FR 16184, Mar. 25, 2014, as amended at 84 FR 39183, Aug. 9, 2019] § 522.147 Atipamezole. (a) Specifications. (b) Sponsors. (c) Conditions of use in dogs Amount. 2 2 (2) Indications for use. (3) Limitations. [61 FR 48830, Sept. 17, 1996, as amended at 64 FR 71640, Dec. 22, 1999; 72 FR 264, Jan. 4, 2007; 84 FR 8973, Mar. 13, 2019; 88 FR 84700, Dec. 6, 2023; 89 FR 42357, May 15, 2024; 91 FR 41560, July 7, 2026] § 522.150 Azaperone. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use Indications for use. (2) Dosage. (3) Limitations. [74 FR 65689, Dec. 11, 2009, as amended at 77 FR 46613, Aug. 6, 2012; 81 FR 48702, July 26, 2016; 84 FR 32992, July 11, 2019] § 522.158 Bedinvetmab. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. (3) Limitations. [88 FR 55564, Aug. 16, 2023] § 522.161 Betamethasone. (a) Specifications. (1) Betamethasone acetate equivalent to 10.8 milligrams (mg) betamethasone and betamethasone disodium phosphate equivalent to 3 mg of betamethasone. (2) Betamethasone dipropionate equivalent to 5 mg betamethasone and betamethasone sodium phosphate equivalent to 2 mg of betamethasone. (b) Sponsor. (1) No. 000061 for product described in paragraph (a)(1) of this section for use as in paragraphs (c)(1), (c)(2)(i), (c)(2)(ii)(A), and (c)(2)(iii) of this section. (2) No. 000061 for product described in paragraph (a)(2) of this section for use as in paragraphs (c)(1), (c)(2)(i), (c)(2)(ii)(B), and (c)(2)(iii) of this section. (c) Conditions of use Dogs Amount. (ii) Indications for use. (iii) Limitations. (2) Horses Amount. (ii) Indications for use. (B) As an aid in the control of inflammation associated with various arthropathies. (iii) Limitations. [79 FR 16184, Mar. 25, 2014] § 522.163 Betamethasone dipropionate and betamethasone sodium phosphate aqueous suspension. (a) Specifications. (b) Sponsor. (c) Conditions of use Dogs. (ii) It is administered by intramuscular injection at a dosage of 0.25 to 0.5 milliliter per 20 pounds of body weight, depending on the severity of the condition. Frequency of dosage depends on recurrence of pruritic symptoms. Dosage may be repeated every 3 weeks or when symptoms recur, not to exceed a total of 4 injections. (2) Horses. (ii) It is administered aseptically by intraarticular injection at a dosage of 2.5 to 5 milliliters per joint, depending on the severity of the condition and the joint size. Dosage may be repeated upon recurrence of clinical signs. Injection into the joint cavity should be preceded by withdrawal of synovial fluid. (iii) Not for use in horses intended for food. (3) Clinical and experimental data. (4) Restrictions. [40 FR 13858, Mar. 27, 1975, as amended at 41 FR 27316, July 2, 1976; 52 FR 7832, Mar. 13, 1987] § 522.167 Betamethasone sodium phosphate and betamethasone acetate. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses Amount. (2) Indications for use. (3) Limitations. [80 FR 18776, Apr. 8, 2015] § 522.204 Boldenone. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses Amount. (2) Indications for use. (3) Limitations. [70 FR 70998, Nov. 25, 2005, as amended at 79 FR 16184, Mar. 25, 2014] § 522.224 Bupivacaine. (a) Specifications. (b) Sponsor. (c) Conditions of use Dogs Amount. (ii) Indications for use. (2) Cats Amount. (ii) Indications for use. [81 FR 67151, Sept. 30, 2016, as amended at 84 FR 8973, Mar. 13, 2019; 85 FR 4208, Jan. 24, 2020] § 522.230 Buprenorphine. (a) Specifications. (b) Sponsor. (c) Conditions of use in cats Amount. (2) Indications for use. (3) Limitations. [79 FR 53136, Sept. 8, 2014, as amended at 80 FR 18776, Apr. 8, 2015] § 522.234 Butamisole. (a) Specifications. (b) Sponsors. (c) Conditions of use in dogs Amount. (2) Indications for use. Trichuris vulpis Ancylostoma caninum (3) Limitations. [79 FR 16184, Mar. 25, 2014, as amended at 86 FR 14819, Mar. 19, 2021] § 522.246 Butorphanol. (a) Specifications. (1) 0.5 milligrams (mg); (2) 2 mg; or (3) 10 mg (b) Sponsors. (1) No. 054771 for use of the product described in paragraph (a)(1) as in paragraph (d)(1) of this section; for use of the product described in paragraph (a)(2) as in paragraph (d)(2) of this section; and for use of the product described in paragraph (a)(3) as in paragraph (d)(3) of this section. (2) Nos. 000061, 017033, and 059399 for use of the product described in paragraph (a)(3) of this section as in paragraph (d)(3) of this section. (c) Special considerations. (d) Conditions of use Dogs Amount. (ii) Indications for use. (2) Cats Amount. (ii) Indications for use. (3) Horses Amount. (ii) Indications for use. (iii) Limitations. [72 FR 27957, May 18, 2007, as amended at 73 FR 31358, June 2, 2008; 74 FR 61516, Nov. 25, 2009; 75 FR 22524, Apr. 29, 2010; 77 FR 60302, Oct. 3, 2012; 78 FR 17597, Mar. 22, 2013; 79 FR 16184, Mar. 25, 2014; 79 FR 74020, Dec. 15, 2014; 80 FR 13229, Mar. 13, 2015; 87 FR 17945, Mar. 29, 2022; 88 FR 16547, Mar. 20, 2023; 91 FR 41560, July 7, 2026] § 522.275 N-Butylscopolammonium. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses Amount. (2) Indications for use. (3) Limitations. [69 FR 35512, June 25, 2004] § 522.304 Carprofen. (a) Specifications. (b) Sponsors. (c) [Reserved] (d) Conditions of use in dogs Amount. (2) Conditions of use. (3) Limitations. [68 FR 26205, May 15, 2003, as amended at 68 FR 34796, June 11, 2003; 68 FR 49351, Aug. 18, 2003. Redesignated at 73 FR 29685, May 22, 2008, as amended at 79 FR 74020, Dec. 15, 2014; 82 FR 43484, Sept. 18, 2017; 88 FR 16547, Mar. 20, 2023; 89 FR 14410, Feb. 27, 2024; 89 FR 85426, Oct. 28, 2024] § 522.311 Cefovecin. (a) Specifications. (b) Sponsors. (c) Special considerations. (d) Conditions of use Dogs Amount. (ii) Indications for use. Staphylococcus intermedius Streptococcus canis (2) Cats Amount. (ii) Indications for use. Pasteurella multocida. [73 FR 29685, May 22, 2008, as amended at 79 FR 16185, Mar. 25, 2014; 90 FR 40970, Aug. 22, 2025] § 522.313 Ceftiofur injectable dosage forms. § 522.313a Ceftiofur crystalline free acid. (a) Specifications. (1) Each milliliter (mL) contains 100 milligrams (mg) ceftiofur equivalents. (2) Each mL contains 200 mg ceftiofur equivalents. (b) Sponsor. (c) Related tolerances. (d) Conditions of use Swine. (i) Amount. (ii) Indications for use. Actinobacillus pleuropneumoniae Pasteurella multocida Haemophilus parasuis Streptococcus suis. A. pleuropneumoniae, P. multocida, H. parasuis, S. suis (iii) Limitations. (2) Cattle. (i) Amount. (A) Single-dose regimen: 6.6 mg ceftiofur equivalents per kg of body weight as a single injection. (B) Two-dose regimen: 6.6 mg ceftiofur equivalents per kg of body weight given as two injections in the base of the ear approximately 72 hours apart. (ii) Indications for use. Mannheimia haemolytica, Pasteurella multocida, Histophilus somni M. haemolytica, P. multocida, H. somni. Fusobacterium necrophorum Porphyromonas levii (B) Two-dose regimen: For the treatment of acute metritis (0-to 10-days postpartum) associated with bacterial organisms susceptible to ceftiofur in lactating dairy cattle. (iii) Limitations. (3) Horses. (i) Amount. (ii) Indications for use. Streptococcus equi zooepidemicus. (iii) Limitations. [68 FR 60296, Oct. 22, 2003, as amended at 69 FR 43892, July 23, 2004. Redesignated and amended at 71 FR 39546, July 13, 2006; 73 FR 58872, Oct. 8, 2008; 75 FR 4692, Jan. 29, 2010; 75 FR 62468, Oct. 12, 2010; 77 FR 26162, May 3, 2012; 79 FR 16185, Mar. 25, 2014; 79 FR 37620, July 2, 2014] § 522.313b Ceftiofur hydrochloride. (a) Specifications. (1) Ceftiofur hydrochloride equivalent to 50 milligrams (mg) of ceftiofur equivalents in the inactive vehicles phospholipan 90H, sorbitan monooleate, and cottonseed oil; (2) Ceftiofur hydrochloride equivalent to 50 mg ceftiofur equivalents in the inactive vehicles polyoxyethylene sorbitan monooleate (polysorbate 80) in a caprylic/capric triglyceride suspension; or (3) Ceftiofur hydrochloride equivalent to 50 mg ceftiofur equivalents in the inactive vehicles aluminum monostearate, sorbitan monooleate, and medium chain triglycerides. (b) Sponsors. (1) No. 054771 for products described in paragraphs (a)(1) and (2) of this section; and (2) No. 055529 for the product described in paragraph (a)(3) of this section. (c) Related tolerances. (d) Special considerations. (e) Conditions of use Swine Amount. (ii) Indications for use. Actinobacillus pleuropneumoniae Pasteurella multocida Salmonella Streptococcus suis. (iii) Limitations. (2) Cattle Amount. (A) For bovine respiratory disease and acute bovine interdigital necrobacillosis: 1.1 to 2.2 mg/kg of body weight at 24-hour intervals for 3 to 5 consecutive days. (B) For bovine respiratory disease: 2.2 mg/kg of body weight administered twice at a 48 hour interval. (C) For acute metritis: 2.2 mg/kg of body weight at 24-hour intervals for 5 consecutive days. (ii) Indications for use. Mannheimia haemolytica P. multocida Histophilus somni Fusobacterium necrophorum Bacteroides melaninogenicus (iii) Limitations. (B) A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. [61 FR 29479, June 11, 1996, as amended at 63 FR 53578, Oct. 6, 1998; 67 FR 45901, July 11, 2002; 69 FR 47362, Aug. 5, 2004. Redesignated and amended at 71 FR 39544, July 13, 2006; 73 FR 45612, Aug. 6, 2008; 76 FR 17338, Mar. 29, 2011; 78 FR 66264, Nov. 5, 2013; 84 FR 39183, Aug. 9, 2019; 84 FR 53311, Oct. 7, 2019] § 522.313c Ceftiofur sodium. (a) Specifications. (b) Sponsors. (c) Related tolerances. (d) Special considerations. (e) Conditions of use Swine Amount. (ii) Indications for use. Actinobacillus pleuropneumoniae Pasteurella multocida Salmonella choleraesuis Streptococcus suis. (iii) Limitations. (2) Cattle Amount. (ii) Indications for use. Mannheimia haemolytica, Pasteurella multocida, Histophilus somni. Fusobacterium necrophorum Bacteroides melaninogenicus. (iii) Limitations. (3) Sheep Amount. (ii) Indications for use. Mannheimia haemolytica Pasteurella multocida. (4) Goats Amount. (ii) Indications for use. Mannheimia haemolytica Pasteurella multocida. (5) Chickens Amount. (ii) Indications for use. Escherichia coli (6) Turkeys Amount. (ii) Indications for use. E. coli (7) Horses Amount. (ii) Indications for use. Streptococcus zooepidemicus. (iii) Limitations. (8) Dogs Amount. (ii) Indications for use. E. coli Proteus mirabilis. [53 FR 5369, Feb. 24, 1988, as amended at 55 FR 13768, Apr. 12, 1990; 56 FR 12119, Mar. 22, 1991; 57 FR 41862, Sept. 14, 1992; 59 FR 41666, Aug. 15, 1994; 59 FR 54518, Nov. 1, 1994; 60 FR 51719, Oct. 3, 1995; 61 FR 35130, July 5, 1996; 61 FR 66583, Dec. 18, 1996; 66 FR 21283, Apr. 30, 2001; 66 FR 32540, June 15, 2001; 69 FR 47362, Aug. 5, 2004. Redesignated and amended at 71 FR 39544, July 13, 2006; 74 FR 34236, July 15, 2009; 77 FR 29218, May 17, 2012; 79 FR 16185, Mar. 25, 2014; 79 FR 21127, Apr. 15, 2014; 82 FR 12169, Mar. 1, 2017; 89 FR 95103, Dec. 2, 2024] § 522.380 Chloral hydrate, pentobarbital, and magnesium sulfate. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. (3) Limitations. [79 FR 16185, Mar. 25, 2014] § 522.390 Chloramphenicol. (a) Specifications. (b) Sponsor. (c) Conditions of use. Dogs Amount. (2) Indications for use. (3) Limitations. [57 FR 37331, Aug. 18, 1992, as amended at 65 FR 45877, July 26, 2000; 78 FR 17597, Mar. 22, 2013; 79 FR 16185, Mar. 25, 2014; 81 FR 17608, Mar. 30, 2016] § 522.454 Clodronate. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses Amount. (2) Indications for use. (3) Limitations. [79 FR 37620, July 2, 2014] § 522.460 Cloprostenol. (a) Specifications. (1) 125 micrograms (µg) of cloprostenol; or (2) 250 µg of cloprostenol. (b) Sponsors. (1) No. 000061 for use of product described in paragraph (a)(1) of this section as in paragraphs (c)(1)(i) and (c)(2) of this section. (2) No. 000061 for use of product described in paragraph (a)(2) as in paragraphs (c)(1)(ii) through (viii) and (c)(2) of this section. (3) No. 068504 for use of product described in paragraph (a)(2) as in paragraphs (c)(1)(ii) through (vii), (c)(1)(ix), and (c)(2) of this section. (c) Conditions of use in cattle Amount and indications for use. (i) Administer 375 µg by intramuscular injection to induce abortion in pregnant feedlot heifers from 1 week after mating until 4 1/2 (ii) Administer 500 µg by intramuscular injection for unobserved or non-detected estrus in beef cows, lactating dairy cows, and replacement beef and dairy heifers. (iii) Administer 500 µg by intramuscular injection for treatment of pyometra or chronic endometritis in beef cows, lactating dairy cows, and replacement beef and dairy heifers. (iv) Administer 500 µg by intramuscular injection for treatment of mummified fetus in beef cows, lactating dairy cows, and replacement beef and dairy heifers. (v) Administer 500 µg by intramuscular injection for treatment of luteal cysts in beef cows, lactating dairy cows, and replacement beef and dairy heifers. (vi) Administer 500 µg by intramuscular injection for abortion of beef cows, lactating dairy cows, and replacement beef and dairy heifers from 1 week after mating until 5 months of gestation. Not for use in heifers placed in feedlots. (vii) Administer 500 µg by intramuscular injection as a single injection regimen or double injection regimen with a second injection 11 days after the first injection, for estrus synchronization in beef cows, lactating dairy cows, and replacement beef and dairy heifers. (viii) For use with gonadorelin acetate to synchronize estrous cycles to allow for fixed time artificial insemination (FTAI) in lactating dairy cows: administer to each cow 86 µg gonadorelin by intramuscular injection, followed 6 to 8 days later by 500 µg cloprostenol by intramuscular injection, followed 30 to 72 hours later by 86 µg gonadorelin by intramuscular injection. Gonadorelin acetate as provided in § 522.1077(a)(1) of this chapter. (ix) For use with gonadorelin to synchronize estrous cycles to allow for FTAI in lactating dairy cows: administer to each cow by intramuscular injection, followed 6 to 8 days later by 500 µg cloprostenol by intramuscular injection, followed 30 to 72 hours later by gonadorelin by intramuscular injection. Gonadorelin as provided in § 522.1077(a)(1) through (3) of this chapter. (2) Limitations. [79 FR 16185, Mar. 25, 2014, as amended at 85 FR 4208, Jan. 24, 2020; 88 FR 84700, Dec. 6, 2023] § 522.468 Colistimethate sodium powder for injection. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use. (i) Dosage. (ii) Indications for use. Escherichia coli (iii) Limitations. (2) [Reserved] [63 FR 13123, Mar. 18, 1998, as amended at 79 FR 16185, Mar. 25, 2014; 84 FR 32992, July 11, 2019] § 522.480 Corticotropin. (a) Specifications. (b) Sponsor. (1) No. 061133 for use as in paragraphs (c)(1) and (2) of this section. (2) No. 043264 for use as in paragraph (c)(2) and (3) of this section. (c) Conditions of use Dogs Amount. (ii) Indications for use. (iii) Limitations. (2) Dogs and cats Amount. (ii) Indications for use. (iii) Limitations. [79 FR 16185, Mar. 25, 2014, as amended at 84 FR 8973, Mar. 13, 2019; 85 FR 45308, July 28, 2020; 90 FR 40970, Aug. 22, 2025] § 522.500 Cosyntropin injection. (a) Sponsor. (b) Specifications. (c) Conditions of use Amount. (2) Indications for use. (3) Limitations. [91 FR 20342, Apr. 16, 2026] § 522.522 Danofloxacin. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use in cattle Amount and indications for use. (i) 6 mg per kilogram (/kg) of body weight, repeated in 48 hours, for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica Pasteurella multocida; (ii) 8 mg/kg of body weight as a single dose for the treatment of BRD associated with M. haemolytica P. multocida M. haemolytica P. multocida. (2) Limitations. [67 FR 78972, Dec. 27, 2002, as amended at 77 FR 4227, Jan. 27, 2012; 79 FR 16185, Mar. 25, 2014; 79 FR 53136, Sept. 8, 2014] § 522.533 Deslorelin. (a) Specifications. (2) [Reserved] (b) Sponsors. (1) No. 051311 for use of product described in paragraph (a)(1) as in paragraph (c)(1) of this section. (2) [Reserved] (c) Conditions of use Horses and ponies Amount. (ii) Indications for use. (iii) Limitations. (2) [Reserved] [75 FR 81456, Dec. 28, 2010, as amended at 79 FR 18158, Apr. 1, 2014; 87 FR 17945, Mar. 29, 2022; 87 FR 58962, Sept. 29, 2022; 91 FR 41560, July 7, 2026] § 522.535 Desoxycorticosterone. (a) Specifications. (b) Sponsors. (1) No. 043264 for use as in paragraphs (c)(1)(i), (c)(2)(i), and (c)(3) of this section. (2) No. 058198 for use as in paragraphs (c)(1)(ii), (c)(2)(ii), and (c)(3) of this section. (c) Conditions of use Amount. (ii) Dosage requirements are variable and must be individualized on the basis of the response of the patient to therapy. Initial dose of 1 milligram per pound (0.45 kilogram) of body weight every 25 days, intramuscularly. Usual dose is 0.75 to 1.0 milligram per pound of body weight every 21 to 30 days. (2) Indications for use (ii) For use as replacement therapy for the mineralocorticoid deficit in dogs with primary adrenocortical insufficiency. (3) Limitations. [81 FR 22524, Apr. 18, 2016] § 522.536 Detomidine. (a) Specification. (b) Sponsor. (c) Conditions of use in horses Amount. (2) Indication for use. (3) Limitations. [79 FR 16186, Mar. 25, 2014, as amended at 86 FR 13184, Mar. 8, 2021; 88 FR 27699, May 3, 2023] § 522.540 Dexamethasone solution. (a)(1) Specifications. (2) Sponsors. (i) Nos. 000061, 016592, and 061133 for use as in paragraph (a)(3) of this section. (ii) No. 058005 for use as in paragraphs (a)(3)(i)(C), (a)(3)(i)(D), (a)(3)(ii)(A), and (a)(3)(iii) of this section. (3) Conditions of use Amount. (A) Dogs. (B) Cats. (C) Horses. (D) Cattle. (ii) Indications for use. (A) For the treatment of primary bovine ketosis and as an anti-inflammatory agent in cattle and horses; (B) As an anti-inflammatory agent in dogs and cats. (iii) Limitations. (b)(1) Specifications. (2) Sponsor. (3) Conditions of use Amount. (ii) Indications for use. (iii) Limitations. (c)(1) Specifications. (2) Sponsor. (3) Conditions of use Amount. (ii) Indications for use. (iii) Limitations. (d)(1) Specifications. (2) Sponsors. (i) Nos. 016592 and 051031 for intravenous or intramuscular use of 2.0 milligrams dexamethasone injection. (ii) No. 054771 for intravenous use of 2.0 milligrams dexamethasone injection. (3) Conditions of use Amount. (A) Dogs: (B) Cats: (C) Horses: (ii) Indications for use. (iii) Limitations. (e)(1) Specifications. (2) Sponsor. (3) Conditions of use Amount. (A) Dogs: (B) Horses: (ii) Indications for use. (iii) Limitations. [41 FR 28265, July 9, 1976] Editorial Note: For Federal Register www.govinfo.gov. § 522.558 Dexmedetomidine. (a) Specifications. (1) 0.1 milligrams (mg) dexmedetomidine hydrochloride; or (2) 0.5 mg dexmedetomidine hydrochloride. (b) Sponsors. (1) Nos. 017033, 068504, 069043, 086101, and 086117 for use of product described in paragraph (a)(2) of this section. (2) No. 052483 for use of products described in paragraph (a) of this section. (c) Conditions of use Dogs Indications for use and amount. 2 2 (B) For use as a preanesthetic to general anesthesia, administer 125 µg/m 2 2 (ii) Limitations. (2) Cats Amount. (ii) Indications for use. (iii) Limitations. [72 FR 263, Jan. 4, 2007, as amended at 72 FR 19797, Apr. 20, 2007; 72 FR 51365, Sept. 7, 2007; 75 FR 60308, Sept. 30, 2010; 78 FR 25183, Apr. 30, 2013; 78 FR 33699, June 5, 2013; 80 FR 13229, Mar. 13, 2015; 86 FR 57997, Oct. 20, 2021; 87 FR 10969, Feb. 28, 2022; 88 FR 27699, May 3, 2023; 88 FR 84701, Dec. 6, 2023; 91 FR 5301, Feb. 6, 2026] § 522.563 Diatrizoate. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs and cats Amount. (2) Indications for use. (3) Limitations. [79 FR 16186, Mar. 25, 2014] § 522.650 Dihydrostreptomycin sulfate injection. (a) Specifications. (b) Sponsor. (c) Related tolerance. (d) Conditions of use Amount. (2) Indications for use. Leptospira canicola, L. icterohemorrhagiae, L. pomona; L. pomona; L. pomona; L. grippotyphosa. (3) Limitations. [57 FR 37331, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992; 79 FR 16187, Mar. 25, 2014; 85 FR 18119, Apr. 1, 2020] § 522.690 Dinoprost. (a) Specifications. (1) 5 milligrams (mg) dinoprost; or (2) 12.5 mg dinoprost. (b) Sponsors. (1) Nos. 054771 and 061133 for use of product described in paragraph (a)(1) as in paragraph (d) of this section. (2) No. 054771 for use of product described in paragraph (a)(2) as in paragraph (d)(1) of this section. (c) Special considerations. (d) Conditions of use Cattle. (i) Amount. (ii) Indications for use. i.e., (A) For estrus synchronization in beef cows, beef heifers and replacement dairy heifers. (B) For unobserved (silent) estrus in lactating dairy cows with a corpus luteum. (C) For treatment of pyometra (chronic endometritis) in cattle. (D) For abortion in beef cows, beef heifers and replacement dairy heifers. (E) For use with gonadorelin injection as in § 522.1077 of this chapter to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows. (F) For use with progesterone intravaginal inserts as in § 529.1940 of this chapter for synchronization of estrus in lactating dairy cows. (G) For use with progesterone intravaginal inserts as in § 529.1940 of this chapter for synchronization of estrus in suckled beef cows and replacement beef and dairy heifers, advancement of first postpartum estrus in suckled beef cows, and advancement of first pubertal estrus in beef heifers. (2) Horses. (i) Amount. (ii) Indications for use. (B) For difficult-to-breed mares (clinically anestrous mares that have a corpus luteum). (iii) Limitations. (3) Swine. (i) Amount. (ii) Indications for use. [67 FR 41824, June 20, 2002, as amended at 79 FR 16187, Mar. 25, 2014; 79 FR 44278, July 31, 2014; 79 FR 64116, Oct. 28, 2014; 80 FR 61296, Oct. 13, 2015; 80 FR 76386, Dec. 9, 2015; 81 FR 36789, June 8, 2016; 84 FR 8973, Mar. 13, 2019; 87 FR 17945, Mar. 29, 2022] § 522.723 Diprenorphine. (a) Specifications. (b) Sponsors. (c) Conditions of use Amount. (2) Indications for use. (3) Limitations. [79 FR 16187, Mar. 25, 2014] § 522.770 Doramectin. (a) Specifications. (b) Sponsors. (c) Related tolerances. (d) Conditions of use Cattle Amount. (ii) Indications for use. Cooperia oncophora Haemonchus placei Ostertagia ostertagi C. punctata, Oesophagostomum radiatum, Dictyocaulus viviparus (iii) Limitations. (2) Swine Amount. (ii) Indications for use. (iii) Limitations. [61 FR 53321, Oct. 11, 1996, as amended at 62 FR 44410, Aug. 21, 1997; 62 FR 62242, Nov. 21, 1997; 63 FR 68183, Dec. 10, 1998; 64 FR 13509, Mar. 19, 1999; 79 FR 16187, Mar. 25, 2014; 84 FR 32992, July 11, 2019; 88 FR 55564, Aug. 16, 2023] § 522.772 Doramectin and levamisole. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use Cattle Amount. (ii) Indications for use. Ostertagia ostertagi O. lyrata, Haemonchus placei, Trichostrongylus axei, T. colubriformis, T. longispicularis Cooperia oncophora, C. pectinata C. punctata, C. surnabada, Bunostomum phlebotomum Strongyloides papillosus Oesophagostomum radiatum, Trichuris Nematodirus helvetianus Dictyocaulus viviparus; Thelazia Hypoderma bovis H. lineatum; Haematopinus eurysternus, Linognathus vituli, Solenopotes capillatus; Psoroptes bovis Sarcoptes scabiei (iii) Limitations. (2) [Reserved] [88 FR 14898, Mar. 10, 2023; 89 FR 85426, Oct. 28, 2024; 90 FR 19625, May 9, 2025] § 522.784 Doxylamine. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount Horses: (ii) Dogs and cats: (2) Indications for use. (3) Limitations. [79 FR 16187, Mar. 25, 2014] § 522.800 Droperidol and fentanyl. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (A) 1 milliliter (mL) per 15 to 20 pounds (lbs) of body weight by intramuscular injection in conjunction with atropine sulfate administered at the rate of 0.02 mg per pound of body weight; or (B) 1 mL per 25 to 60 lbs of body weight by intravenous injection in conjunction with atropine sulfate administered at the rate of 0.02 mg per pound of body weight. (ii) For general anesthesia, administer as follows: (A) Administer 1 mL per 40 lbs of body weight by intramuscular injection in conjunction with atropine sulfate administered at the rate of 0.02 mg per pound of body weight and followed in 10 minutes by an intravenous administration of sodium pentobarbital at the rate of 3 mg per pound of body weight; or (B) Administer 1 mL per 25 to 60 lbs of body weight by intravenous injection in conjunction with atropine sulfate administered at the rate of 0.02 mg per pound of body weight and followed within 15 seconds by an intravenous administration of sodium pentobarbital at the rate of 3 mg per pound of body weight. (2) Indications for use. (3) Limitations. [79 FR 16187, Mar. 25, 2014] § 522.810 Embutramide, chloroquine, and lidocaine solution. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [70 FR 36337, June 23, 2005, as amended at 78 FR 17597, Mar. 22, 2013; 81 FR 17608, Mar. 30, 2016] § 522.812 Enrofloxacin. (a) Specifications. (1) 22.7 milligrams (mg) enrofloxacin or (2) 100 mg enrofloxacin. (b) Sponsors. (1) Nos. 016729, 017033, 055529, 058198, 069043, and 086101 for use of product described in paragraph (a)(1) as in paragraph (e)(1) of this section; and (2) Nos. 051311, 055529, 058005, 058198, 061133, 069043, and 086101 for use of product described in paragraph (a)(2) as in paragraphs (e)(2) and (3) of this section. (c) Related tolerance. (d) Special considerations. (e) Conditions of use Dogs. (i) Amount. (ii) Indications for use. (2) Cattle. (i) Amount Single-dose therapy: (B) Multiple-day therapy: (ii) Indications for use Single-dose therapy: Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, Mycoplasma bovis M. haemolytica, P. multocida, H. somni M. bovis. (B) Multiple-day therapy: Mannheimia haemolytica, Pasteurella multocida, Histophilus somni (iii) Limitations. (3) Swine. (i) Amounts and indications for use. Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica, and Mycoplasma hyopneumoniae. (B) Administer 7.5 mg/kg of body weight once, by intramuscular or subcutaneous injection behind the ear, for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli (ii) Limitations. [72 FR 10597, Mar. 9, 2007, as amended at 73 FR 17890, Apr. 2, 2008; 73 FR 21819, Apr. 23, 2008; 76 FR 22611, Apr. 22, 2011; 77 FR 55415, Sept. 10, 2012; 77 FR 76863, Dec. 31, 2012; 78 FR 19987, Apr. 3, 2013; 79 FR 37620, July 2, 2014; 80 FR 13229, Mar. 13, 2015; 80 FR 18776, Apr. 8, 2015; 80 FR 61296, Oct. 13, 2015; 84 FR 8973, Mar. 13, 2019; 84 FR 53311, Oct. 7, 2019; 86 FR 14819, Mar. 19, 2021; 86 FR 61685, Nov. 8, 2021; 87 FR 10969, Feb. 28, 2022; 87 FR 58962, Sept. 29, 2022; 89 FR 14410, Feb. 27, 2024] § 522.814 Eprinomectin. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use in cattle on pasture Amount. (2) Indications for use. Bunostomum phlebotomum, Cooperia oncophora, C. punctata, C. surnabada, Trichostrongylus axei, Ostertagia ostertagi Haemonchus placei, Oesophagostomum radiatum, O. lyrata, T. colubriformis; Dictyocaulus viviparus; Hypoderma bovis; Sarcoptes scabiei bovis. C. oncophora, C. punctata, T. axei H. placei, O. radiatum, O. lyrata, O. ostertagi B. phlebotomum D. viviparus (3) Limitations. [76 FR 72618, Nov. 25, 2011, as amended at 79 FR 37620, July 2, 2014; 84 FR 39184, Aug. 9, 2019] § 522.820 Erythromycin. (a) Specifications (2) Each mL of solution contains 200 mg erythromycin base. (b) Sponsor. (c) Related tolerances. (d) Conditions of use Dog. (i) Amount. (ii) Indications for use. Staphylococcus Streptococcus Corynebacterium (iii) Limitations. (2) Cats. (i) Amount. (ii) Indications for use. Staphylococcus Streptococcus (iii) Limitations. (3) Cattle. (i) Amount. (ii) Indications for use. Pasteurella multocida (iii) Limitations. [72 FR 69142, Dec. 7, 2007, as amended at 79 FR 16187, Mar. 25, 2014; 84 FR 8973, Mar. 13, 2019; 88 FR 27699, May 3, 2023] § 522.840 Estradiol. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use Beef steer calves 2 months of age and older Amount and indications for use. (B) An extended-release implant containing 43.9 mg estradiol for increased rate of weight gain for up to 400 days. (ii) Limitations. (2) Growing beef steers and heifers on pasture (stocker, feeder, and slaughter) Amount and indications for use. (B) An extended-release implant containing 43.9 mg estradiol for increased rate of weight gain for up to 400 days. (ii) Limitations. (3) Growing beef steers and heifers fed in confinement for slaughter Amount and indications for use. (B) An extended-release implant containing 43.9 mg estradiol for increased rate of weight gain and improved feed efficiency for up to 400 days. (ii) Limitations. [69 FR 67818, Nov. 22, 2004, as amended at 77 FR 31723, May 30, 2012; 81 FR 48702, July 26, 2016; 87 FR 10969, Feb. 28, 2022; 88 FR 14898, Mar. 10, 2023; 89 FR 42357, May 15, 2024] § 522.850 Estradiol valerate and norgestomet in combination. (a) Specifications. (1) An implant containing 6.0 milligrams of norgestomet. (2) An injectable solution (sesame oil) containing 3.0 milligrams of norgestomet and 5.0 milligrams of estradiol valerate per 2 milliliters. (b) Sponsor. (c) Related tolerances. (d) Conditions of use Amount. (2) Indications for use. (3) Limitations. [47 FR 55477, Dec. 10, 1982, as amended at 48 FR 49656, Oct. 27, 1983; 51 FR 33592, Sept. 22, 1986; 54 FR 1165, Jan. 12, 1989; 84 FR 39184, Aug. 9, 2019; 84 FR 32992, July 11, 2019] § 522.863 Ethylisobutrazine. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [79 FR 16187, Mar. 25, 2014] § 522.883 Etorphine. (a) Specifications. (b) Sponsor. (c) Special considerations. (d) Conditions of use Amount. (2) Indications for use. (3) Limitations. [79 FR 16188, Mar. 25, 2014] § 522.914 Fenprostalene. (a) Specifications. (2) Each milliliter of solution contains 0.25 mg fenprostalene. (b) Sponsor. (c) Related tolerances. (d) Special considerations. (e) Conditions of use Cattle Indications for use and amount. (B) For beef or nonlactating dairy cattle for estrus synchronization, administer a single or two 1-mg (2-mL) doses subcutaneously, 11 to 13 days apart. (ii) Limitations. (2) Swine Amount. (ii) Indications for use. (iii) Limitations. [79 FR 16188, Mar. 25, 2014] § 522.930 Firocoxib. (a) Specifications. (b) Sponsors. (c) Conditions of use in horses Amount. (2) Indications for use. (3) Limitations. [75 FR 59611, Sept. 28, 2010, as amended at 84 FR 39184, Aug. 9, 2019] § 522.955 Florfenicol. (a) Specifications. (1) 300 milligrams (mg) florfenicol in the inactive vehicles 2-pyrrolidone and triacetin. (2) 300 mg florfenicol in the inactive vehicles n-methyl-2-pyrrolidone, propylene glycol, and polyethylene glycol. (3) 300 mg florfenicol in the inactive vehicles 2-pyrrolidone and glycerol formal. (b) Sponsors. (1) No. 000061 for use of product described in paragraph (a)(1) as in paragraph (d)(1)(i); and (2) No. 000061 for use of product described in paragraph (a)(2) of this section as in paragraphs (d)(1)(ii) and (d)(2) of this section. (3) Nos. 054771, 058005, and 069043 for use of product described in paragraph (a)(2) of this section as in paragraph (d)(1)(ii) of this section. (4) No. 055529 for use of product described in paragraph (a)(3) as in paragraph (d)(1)(ii). (c) Related tolerances. (d) Conditions of use Beef and non-lactating dairy cattle. (A) Amount. (B) Indications for use. Mannheimia haemolytica Pasteurella multocida Histophilus somni Mycoplasma bovis (C) Limitations. (ii) 300 mg/mL florfenicol in the inactive vehicles n-methyl-2- pyrrolidone, propylene glycol, and polyethylene glycol, or in 2-pyrrolidone and glycerol formal: (A)( 1 Amount. ( 2 Indications for use. Mannheimia haemolytica, Pasteurella multocida Histophilus somni. Fusobacterium necrophorum Bacteroides melaninogenicus. (B)( 1 Amount. ( 2 Indications for use. Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni. (C) Limitations. (2) Swine (A) Amount. (B) Indications for use. Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella Streptococcus suis, Bordetella bronchiseptica, Glaesserella (Haemophilus) parasuis (C) Limitations. (ii) [Reserved] [73 FR 21041, Apr. 18, 2008, as amended at 74 FR 66574, Dec. 16, 2009; 79 FR 18158, Apr. 1, 2014; 79 FR 53136, Sept. 8, 2014; 80 FR 61296, Oct. 13, 2015; 80 FR 76386, Dec. 9, 2015; 86 FR 14819, Mar. 19, 2021; 87 FR 10969, Feb. 28, 2022; 87 FR 17945, Mar. 29, 2022; 87 FR 76421, Dec. 14, 2022; 89 FR 14410, Feb. 27, 2024; 89 FR 85426, Oct. 28, 2024] § 522.956 Florfenicol and flunixin. (a) Specifications. (b) Sponsor. (c) Tolerances. (d) Conditions for use in cattle Amount. (2) Indications for use. Mannheimia haemolytica Pasteurella multocida Histophilus somni Mycoplasma bovis (3) Limitations. [75 FR 1275, Jan. 11, 2010, as amended at 75 FR 54018, Sept. 3, 2010; 79 FR 18158, Apr. 1, 2014; 91 FR 41560, July 7, 2026] § 522.960 Flumethasone injectable dosage forms. § 522.960a Flumethasone suspension. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses Amount. (2) Indications for use. (3) Limitations. [79 FR 16188, Mar. 25, 2014] § 522.960b Flumethasone acetate solution. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [79 FR 16188, Mar. 25, 2014] § 522.960c Flumethasone solution. (a) Specifications. (b) Sponsors. (c) Conditions of use. (1) Horses Amount. (ii) Indications for use. (iii) Limitations. (2) Dogs Amount. (ii) Indications for use. (iii) Limitations. (3) Cats Amount. (ii) Indications for use. (iii) Limitations. [79 FR 16188, Mar. 25, 2014, as amended at 88 FR 55564, Aug. 16, 2023] § 522.970 Flunixin. (a) Specifications. (b) Sponsors. (1) See Nos. 000061, 055529, 061133, and 069043 for use as in paragraph (e) of this section. (2) See No. 054771 for use as in paragraph (e)(1) of this section. (3) See Nos. 016592 and 058198 for use as in paragraphs (e)(1) and (2) of this section. (c) Related tolerances. (d) Special considerations. (e) Conditions of use Horses Amount. (ii) Indications for use. (iii) Limitations. (2) Cattle Amounts and indications for use (B) Administer 2.2 mg/kg (1.0 mg/lb) of body weight once intravenously for control of pyrexia associated with acute bovine mastitis. (ii) Limitations. (B) [Reserved] (3) Swine Amount. (ii) Indications for use. (iii) Limitations. [42 FR 39103, Aug. 2, 1977, as amended at 52 FR 7832, Mar. 13, 1987; 60 FR 54942, Oct. 27, 1995; 62 FR 22888, Apr. 28, 1997; 63 FR 38749, July 20, 1998; 67 FR 9400, Mar. 1, 2002; 68 FR 70701, Dec. 19, 2003; 69 FR 53618, Sept. 2, 2004; 69 FR 60308, Oct. 8, 2004; 70 FR 48868, Aug. 22, 2005; 70 FR 70998, Nov. 25, 2005; 71 FR 15564, Mar. 29, 2006; 71 FR 16222, Mar. 31, 2006; 73 FR 2809, Jan. 16, 2008; 73 FR 28037, May 15, 2008; 74 FR 6994, Feb. 12, 2009; 74 FR 34236, July 15, 2009; 75 FR 13225, Mar. 19, 2010; 75 FR 76260, Dec. 8, 2010; 79 FR 16189, Mar. 25, 2014; 82 FR 43484, Sept. 18, 2017; 86 FR 57997, Oct. 20, 2021; 89 FR 85426, Oct. 28, 2024; 90 FR 40970, Aug. 22, 2025] § 522.995 Fluprostenol. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses Amount. (2) Indications for use. (3) Limitations. [79 FR 16189, Mar. 25, 2014, as amended at 86 FR 14820, Mar. 19, 2021] § 522.998 Fluralaner. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. Amblyomma americanum (2) Indications for use. Ctenocephalides felis Ixodes scapularis Dermacentor variabilis Rhipicephalus sanguineus Amblyomma maculatum Amblyomma americanum (3) Limitations. [91 FR 5301, Feb. 6, 2026, as amended at 91 FR 41560, July 7, 2026] § 522.1002 Follicle stimulating hormone. (a)(1) Specifications. (2) Sponsor. (3) Conditions of use Dosage. (ii) Indications for use. (iii) Limitations. (b)(1) Specifications Single pack. (ii) Dual pack. (2) Sponsor. (3) Conditions of use Dosage. (ii) Indications for use. (iii) Limitations. [58 FR 47377, Sept. 9, 1993, as amended at 62 FR 62242, Nov. 21, 1997; 76 FR 2808, Jan. 18, 2011; 79 FR 53136, Sept. 8, 2014; 79 FR 74020, Dec. 15, 2014; 82 FR 21690, May 10, 2017; 82 FR 43484, Sept. 18, 2017] § 522.1008 Frunevetmab. (a) Specifications. (b) Sponsor. (c) Conditions of use Cats Amount. (ii) Indications for use. (iii) Limitations. (2) [Reserved] [87 FR 58962, Sept. 29, 2022] § 522.1010 Furosemide. (a) Specifications. (2) Each mL of solution contains 50 mg furosemide diethanolamine. (b) Sponsors. (1) No. 000010 as described in paragraph (a)(1) of this section for use as in paragraphs (d)(1) and (d)(2)(ii) of this section. (2) No. 061133 as described in paragraph (a)(2) of this section for use as in paragraph (d)(2)(ii) of this section. (3) No. 058198 as described in paragraph (a)(2) of this section for use as in paragraphs (d)(1), (d)(2)(i), and (d)(3) of this section. (4) No. 000061 as described in paragraph (a)(2) for use as in paragraphs (d)(1), (d)(2)(iii), and (d)(3) of this section. (c) Special considerations. (d) Conditions of use Dogs and cats Amount. (ii) Indications for use. (2) Horses Amount. (A) Indications for use. (B) Limitations. (ii) Amount. (A) Indications for use. (B) Limitations. (iii) Amount. (A) Indications for use. (B) Limitations. (3) Cattle Amount. (ii) Indications for use. (iii) Limitations. [66 FR 47961, Sept. 17, 2001, as amended at 67 FR 18086, Apr. 15, 2002; 68 FR 59881, Oct. 20, 2003; 69 FR 17585, Apr. 5, 2004; 71 FR 39548, July 13, 2006; 74 FR 61516, Nov. 25, 2009; 76 FR 17338, Mar. 29, 2011; 78 FR 17597, Mar. 22, 2013; 79 FR 16189, Mar. 25, 2014; 84 FR 8973, Mar. 13, 2019; 86 FR 14820, Mar. 19, 2021] § 522.1014 Gamithromycin. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use Cattle Amount. (ii) Indications for use. Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, Mycoplasma bovis M. haemolytica P. multocida. (iii) Limitations. (2) [Reserved] [76 FR 57906, Sept. 19, 2011, as amended at 77 FR 26162, May 3, 2012; 84 FR 39184, Aug. 9, 2019; 91 FR 5301, Feb. 6, 2026] § 522.1020 Gelatin. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. (3) Limitations. [79 FR 16189, Mar. 25, 2014] § 522.1044 Gentamicin. (a) Specifications. (b) Sponsors. (1) No. 000061 for use of 5 mg per milliliter (/mL) solution in swine as in paragraph (d)(4), 50 mg/mL solution in dogs and cats as in paragraph (d)(1), 50 mg/mL and 100 mg/mL solution in chickens and turkeys as in paragraphs (d)(2) and (d)(3) of this section. (2) No. 058005 for use of 5 mg/mL solution in swine as in paragraph (d)(4) of this section. (3) No. 069043 for use of 50 mg/mL solution in dogs as in paragraph (d)(5) of this section. (4) Nos. 016592 and 061133 for use of 100 mg/mL solution in turkeys as in paragraph (d)(2) and in chickens as in paragraph (d)(3) of this section. (c) Related tolerances. (d) Conditions of use Dogs and cats Amount. (ii) Indications for use a Dogs. ( b Cats. (iii) Limitations. (2) Turkeys Amount. (ii) Indications for use. Arizona paracolon (iii) Limitations. (3) Chickens Amount. (ii) Indications for use. Escherichia coli, Salmonella typhimurium, Pseudomonas aeruginosa (iii) Limitations. (4) Swine Amount. (ii) Indications for use. Escherichia coli (iii) Limitations. (5) Dogs Amount. (ii) Indications for use. Proteus mirabilis, Escherichia coli, Staphylococcus aureus. (iii) Limitations. [43 FR 1942, Jan. 13, 1978, as amended at 48 FR 791, Jan. 7, 1983; 51 FR 15606, Apr. 25, 1986; 52 FR 7832, Mar. 13, 1987; 53 FR 40727, Oct. 18, 1988; 60 FR 29985, June 7, 1995; 61 FR 24441, May 15, 1996; 62 FR 45157, Aug. 26, 1997; 63 FR 59714, Nov. 5, 1998; 63 FR 68182, Dec. 10, 1998; 65 FR 45877, July 26, 2000; 71 FR 76901, Dec. 22, 2006; 78 FR 17597, Mar. 22, 2013; 78 FR 21060, Apr. 9, 2013; 79 FR 21127, Apr. 15, 2014; 81 FR 22524, Apr. 18, 2016; 83 FR 48946, Sept. 28, 2018; 84 FR 8973, Mar. 13, 2019; 88 FR 16547, Mar. 20, 2023] § 522.1055 Gleptoferron. (a) Specifications. (b) Sponsors. (c) Conditions of use in swine Indications for use and amounts. (ii) Treatment of anemia due to iron deficiency: Administer 1 mL (200 mg iron) per pig by intramuscular injection as soon as signs of deficiency appear. (2) [Reserved] [81 FR 59134, Aug. 29, 2016, as amended at 82 FR 11508, Feb. 24, 2017; 82 FR 21690, May 10, 2017] § 522.1066 Glycopyrrolate. (a) Specifications. (b) Sponsors. (c) Conditions of use in dogs and cats Amount. (2) Indications for use. (3) Limitations. [71 FR 64451, Nov. 2, 2006, as amended at 78 FR 17597, Mar. 22, 2013; 79 FR 16189, Mar. 25, 2014; 81 FR 17608, Mar. 30, 2016] § 522.1077 Gonadorelin. (a) Specifications. (1) 43 micrograms (µg) of gonadorelin as gonadorelin acetate; (2) 100 µg of gonadorelin as gonadorelin acetate; (3) 50 µg of gonadorelin as gonadorelin diacetate tetrahydrate (equivalent to 43 µg gonadorelin); or (4) 50 µg of gonadorelin as gonadorelin hydrochloride. (b) Sponsors. (1) No. 000061 for use of the 43-µg/mL product described in paragraph (a)(1) as in paragraphs (e)(1)(i) and (iii) of this section. (2) No. 068504 for use of the 100-µg/mL product described in paragraph (a)(2) as in paragraphs (d)(1)(i) and (iv) of this section. (3) Nos. 000010 and 061133 for use of the 50-µg/mL product described in paragraph (a)(3) of this section as in paragraphs (e)(1)(i) and (v) of this section. (4) No. 054771 for use of the 50-µg/mL product described in paragraph (a)(4) as in paragraphs (e)(1)(ii) and (vi) of this section. (c) Related tolerances. (d) Special considerations. (i) Cloprostenol injection for use as in paragraph (e)(1)(iii) of this section as provided by No. 000061 in § 510.600(c) of this chapter. (ii) Cloprostenol injection for use as in paragraph (e)(1)(iv) of this section as provided by No. 068504 in § 510.600(c) of this chapter. (iii) Cloprostenol injection for use as in paragraph (e)(1)(v) of this section as provided by Nos. 000010 in § 510.600(c) of this chapter. (iv) Dinoprost injection for use as in paragraph (e)(1)(vi) of this section as provided by No. 054771 in § 510.600(c) of this chapter. (2) Federal law restricts this drug to use by or on the order of a licensed veterinarian. (e) Conditions of use in cattle Indications for use and amounts. (ii) For the treatment of ovarian follicular cysts in cattle: Administer 100 µg gonadorelin hydrochloride by intramuscular injection. (iii) For use with cloprostenol sodium to synchronize estrous cycles to allow for fixed-time artificial insemination (FTAI) in beef cows and lactating dairy cows: Administer to each cow 86 µg gonadorelin by intramuscular injection, followed 6 to 8 days later by 500 µg cloprostenol by intramuscular injection, followed 30 to 72 hours later by 86 µg gonadorelin by intramuscular injection. (iv) For use with cloprostenol sodium to synchronize estrous cycles to allow for fixed-time artificial insemination (FTAI) in lactating dairy cows and beef cows: Administer to each cow 100 µg gonadorelin by intramuscular injection, followed 6 to 8 days later by 500 µg cloprostenol by intramuscular injection, followed 30 to 72 hours later by 100 µg gonadorelin by intramuscular injection. (v) For use with cloprostenol sodium to synchronize estrous cycles to allow for fixed-time artificial insemination (FTAI) in lactating dairy cows and beef cows: Administer to each cow 100 µg gonadorelin diacetate tetrahydrate by intramuscular injection, followed 6 to 8 days later by 500 µg cloprostenol by intramuscular injection, followed 30 to 72 hours later by 100 µg gonadorelin diacetate tetrahydrate by intramuscular injection. (vi) For use with dinoprost injection to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows: Administer to each cow 100 to 200 µg gonadorelin by intramuscular injection, followed 6 to 8 days later by 25 mg dinoprost by intramuscular injection, followed 30 to 72 hours later by 100 to 200 µg gonadorelin by intramuscular injection. (2) [Reserved] [83 FR 64740, Dec. 18, 2018, as amended at 84 FR 8973, Mar. 13, 2019; 84 FR 39184, Aug. 9, 2019; 84 FR 32992, July 11, 2019; 86 FR 13184, Mar. 8, 2021; 86 FR 14820, Mar. 19, 2021; 87 FR 17946, Mar. 29, 2022; 88 FR 27699, May 3, 2023] § 522.1079 Serum gonadotropin and chorionic gonadotropin. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use in swine Amount. (2) Indications for use Gilts. (ii) Sows. (3) Limitations. (i) Gilts. 1/2 (ii) Sows. [55 FR 1405, Jan. 16, 1990, as amended at 58 FR 52222, Oct. 7, 1993; 74 FR 61516, Nov. 25, 2009; 84 FR 32992, July 11, 2019] § 522.1081 Chorionic gonadotropin. (a) Specifications. (b) Sponsors. (1) No. 054771 for use as in paragraphs (d)(1)(i)(A), (d)(1)(i)(B) and (d)(1)(i)(C) of this section. (2) [Reserved] (3) No. 000061 for use as in paragraphs (d)(1)(i)(A) and (d)(2) of this section. (c) Related tolerances. (d) Conditions of use Cattle Amount. per rectum (A) 10,000 USP units by intramuscular injection. (B) 500 to 2,500 USP units by intrafollicular injection. (C) 2,500 to 5,000 USP units by intravenous injection. (ii) Indications for use. (iii) Limitations. (2) Finfish Amount. (ii) Indications for use. (iii) Limitations. [74 FR 61516, Nov. 25, 2009, as amended at 76 FR 17778, Mar. 31, 2011; 77 FR 55414, Sept. 10, 2012; 79 FR 16189, Mar. 25, 2014; 83 FR 13635, Mar. 30, 2018] § 522.1083 Gonadotropin releasing factor analog-diphtheria toxoid conjugate. (a) Specifications. (b) Sponsor. (c) Conditions of use in swine Amount. (2) Indications for use Intact male pigs intended for slaughter: (ii) Gilts intended for slaughter: (3) Limitations. [76 FR 27889, May 13, 2011, as amended at 77 FR 4227, Jan. 27, 2012; 79 FR 16189, Mar. 25, 2014; 85 FR 45308, July 28, 2020] § 522.1085 Guaifenesin powder for injection. (a) Specifications. (b) Sponsors. (c) Conditions of use in horses Amount. (2) Indications for use. (3) Limitations. [79 FR 16189, Mar. 25, 2014] § 522.1086 Guaifenesin solution. (a) Specifications. (b) Sponsors. (c) Conditions of use in horses Amount. (2) Indications for use. (3) Limitations. [79 FR 16189, Mar. 25, 2014, as amended at 86 FR 14820, Mar. 19, 2021] § 522.1125 Hemoglobin glutamer-200 (bovine). (a) Specifications. (b) Sponsor. (c) [Reserved] (d) Conditions of use Amount. (2) Indications for use. (3) Limitations. [63 FR 11598, Mar. 10, 1998, as amended at 65 FR 20732, Apr. 18, 2000; 79 FR 16189, Mar. 25, 2014] § 522.1145 Hyaluronate. (a)(1) Specifications. (2) Sponsor. (3) Conditions of use Amount. (ii) Indications for use. (iii) Limitations. (b)(1) Specifications. (2) Sponsor. (3) Conditions of use Amount. (ii) Indications for use. (iii) Limitations. (c)(1) Specifications. (2) Sponsor. (3) Conditions of use Amount. (ii) Indications for use. (iii) Limitations. (d)(1) Specifications. (2) Sponsor. (3) Conditions of use Amount. (ii) Indications for use. (iii) Limitations. (e)(1) Specifications. (i) 10 milligrams (mg) hyaluronate sodium; or (ii) 10 mg hyaluronate sodium with benzyl alcohol as a preservative. (2) Sponsors. (i) No. 000010 for use of products described in paragraph (e)(1) as in paragraph (e)(3) of this section. (ii) No. 017030 for use of product described in paragraph (e)(1)(i) as in paragraph (e)(3) of this section. (3) Conditions of use Amount. (ii) Indications for use. (iii) Limitations. (f)(1) Specifications. (2) Sponsor. (3) Conditions of use Amount. (ii) Indications for use. (iii) Limitations. [49 FR 45124, Nov. 15, 1984, as amended at 51 FR 11438, Apr. 3, 1986; 51 FR 25032, July 10, 1986; 53 FR 19773, May 31, 1988; 53 FR 22297, June 15, 1988; 56 FR 50814, Oct. 9, 1991; 57 FR 2837, Jan. 24, 1992; 59 FR 33198, June 28, 1994; 61 FR 59003, Nov. 20, 1996; 63 FR 59216, Nov. 3, 1998; 71 FR 1689, Jan. 11, 2006; 71 FR 39204, July 12, 2006; 75 FR 1274, Jan. 11, 2010; 75 FR 10167, Mar. 5, 2010; 78 FR 73698, Dec. 9, 2013; 79 FR 16189, Mar. 25, 2014; 79 FR 74020, Dec. 15, 2014; 80 FR 34279, June 16, 2015; 84 FR 39184, Aug. 9, 2019] § 522.1155 Imidocarb powder for injection. (a) Specifications. (b) Sponsor. (c) Special considerations. (d) Conditions of use in horses and zebras Amount. Babesia caballi Babesia equi (2) Indications for use. Babesia caballi Babesia equi. (3) Limitations. [79 FR 16190, Mar. 25, 2014] § 522.1156 Imidocarb solution. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. Babesia (3) Limitations. [79 FR 16190, Mar. 25, 2014, as amended at 87 FR 10969, Feb. 28, 2022] § 522.1160 Insulin. (a) Specifications. (2) Each mL of protamine zinc recombinant human insulin suspension contains 40 IU of insulin. (b) Sponsors. (1) No. 000061 for use of product described in paragraph (a)(1) as in paragraphs (c)(1)(i)(A), (c)(1)(ii), (c)(1)(iii), (c)(2)(i)(A), (c)(2)(ii), and (c)(2)(iii) of this section. (2) No. 000010 for use of product described in paragraph (a)(2) as in paragraphs (c)(1)(i)(B), (c)(1)(ii), (c)(1)(iii), (c)(2)(i)(B), (c)(2)(ii), and (c)(2)(iii) of this section. (c) Conditions of use Dogs Amount Porcine zinc insulin zinc. (B) Protamine zinc recombinant human insulin. (ii) Indications for use. (iii) Limitations. (2) Cats Amount Porcine insulin zinc. (B) Protamine zinc recombinant human insulin. (ii) Indications for use. (iii) Limitations. [69 FR 25827, May 10, 2004, as amended at 73 FR 21042, Apr. 18, 2008; 74 FR 61517, Nov. 25, 2009; 74 FR 66048, Dec. 14, 2009; 84 FR 39184, Aug. 9, 2019] § 522.1182 Iron injection. (a) Specifications. (1) 100 milligrams (mg) of elemental iron derived from: (i) Ferric hydroxide; (ii) Ferric oxide; or (iii) Elemental iron. (2) 200 mg of elemental iron derived from ferric hydroxide. (b) Sponsors and conditions of us (1) Nos. 016592 and 042552 for use of product described in paragraph (a)(1)(i) of this section as follows: (i) For prevention of iron deficiency anemia, inject 100 mg (1 mL) by intramuscular injection at 2 to 4 days of age. (ii) For treatment of iron deficiency anemia, inject 100 mg (1 mL) by intramuscular injection. Dosage may be repeated in approximately 10 days. (2) No. 054771 for use of product described in paragraph (a)(1)(i) of this section as follows: (i) For the prevention of anemia due to iron deficiency, administer an initial intramuscular injection of 100 mg at 2 to 4 days of age. Dosage may be repeated in 14 to 21 days. (ii) For the treatment of anemia due to iron deficiency, administer an intramuscular injection of 200 mg. (3) Nos. 000061 and 013744 for use of product described in paragraph (a)(1)(i) of this section as follows: (i) For the prevention of iron deficiency anemia, administer intramuscularly an amount of drug containing 100 to 150 mg of elemental iron to animals from 1 to 3 days of age. (ii) For the treatment of iron deficiency anemia, administer intramuscularly an amount of drug containing 100 to 200 mg of elemental iron per animal. Dosage may be repeated in 10 days to 2 weeks. (4) No. 054771 for use of product described in paragraph (a)(1)(ii) of this section as follows: (i) For prevention of iron deficiency anemia, administer 1 mL by intramuscular injection at 2 to 5 days of age. Dosage may be repeated at 2 weeks of age. (ii) For treatment of iron deficiency anemia, administer 1 to 2 mL by intramuscular injection at 5 to 28 days of age. (5) No. 054771 for use of product described in paragraph (a)(1)(iii) of this section as follows: (i) For prevention of anemia due to iron deficiency, administer 100 mg by intramuscular or subcutaneous injection at 2 to 4 days of age. (ii) For treatment of anemia due to iron deficiency, administer 100 mg by intramuscular or subcutaneous injection up to 4 weeks of age. (6) Nos. 016592 and 058005 for use of product described in paragraph (a)(1)(iii) of this section as follows: (i) For prevention of anemia due to iron deficiency, administer 100 mg by intramuscular injection at 2 to 4 days of age. (ii) For treatment of anemia due to iron deficiency, administer 100 mg by intramuscular injection. Treatment may be repeated in 10 days. (7) Nos. 016592, 042552, and 058005 for use product described in paragraph (a)(2) of this section as follows: (i) For prevention of anemia due to iron deficiency, intramuscularly inject 200 mg of elemental iron (1 mL) at 1 to 3 days of age. (ii) For treatment of anemia due to iron deficiency, intramuscularly inject 200 mg of elemental iron at the first sign of anemia. [73 FR 12635, Mar. 10, 2008, as amended at 73 FR 14385, Mar. 18, 2008; 78 FR 17597, Mar. 22, 2013; 78 FR 44433, July 24, 2013; 79 FR 16190, Mar. 25, 2014; 81 FR 22524, Apr. 18, 2016; 81 FR 59134, Aug. 29, 2016; 82 FR 11508, Feb. 24, 2017; 83 FR 48946, Sept. 28, 2018; 86 FR 14820, Mar. 19, 2021; 89 FR 85427, Oct. 28, 2024] § 522.1185 Isoflupredone. (a) Specifications. (b) Sponsor. (c) Conditions of use Cattle Amount. (ii) Indications for use. (iii) Limitations. (2) Horses and swine Amount Horses. (B) Swine. (ii) Indications for use. (iii) Limitations. [79 FR 16190, Mar. 25, 2014] § 522.1192 Ivermectin. (a) Specifications. (2) Each mL of solution contains 10 mg ivermectin. (3) Each mL of solution contains 2.7 mg ivermectin. (b) Sponsors. (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. (d) Special considerations. (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 (2) Cattle Amount. (ii) Indications for use. Haemonchus placei Ostertagia ostertagi O. lyrata Trichostrongylus axei T. colubriformis Cooperia oncophora C. punctata C. pectinata Oesophagostomum radiatum Nematodirus helvetianus N. spathiger Bunostomum phlebotomum Dictyocaulus viviparus Hypoderma bovis H. lineatum Linognathus vituli Haematopinus eurysternus Solenopotes capillatus scabies Psoroptes ovis P. communis bovis Sarcoptes scabiei bovis D. viviparus O. radiatum O. ostertagi T. axei C. punctata H. placei C. oncophora (iii) Limitations. (3) Swine Amount. (ii) Indications for use. Ascaris suum Hyostrongylus rubidus Oesophagostomum Strongyloides ransomi S. ransomi Metastrongylus H. suis S. scabiei suis (iii) Limitations. (4) American bison Amount. (ii) Indications for use. H. bovis (iii) Limitations. (5) Reindeer Amount. (ii) Indications for use. Oedemagena tarandi (iii) Limitations. (6) Ranch-raised foxes Amount. (ii) Indications for use. 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] § 522.1193 Ivermectin and clorsulon. (a) Specifications. (b) Sponsors. (c) Related tolerances. (d) Special considerations. (e) Conditions of use in cattle Amount. (2) Indications for use. Haemonchus placei, Ostertagia ostertagi O. lyrata, Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. punctata, C. pectinata, Oesophagostomum radiatum, Nematodirus helvetianus N. spathiger Bunostomum phlebotomum; Dictyocaulus viviparus Fasciola hepatica Hypoderma bovis, H. lineatum Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus Psoroptes ovis P. communis bovis Sarcoptes scabiei bovis D. viviparus O. radiatum O. ostertagi, T. axei, C. punctata H. placei C. oncophora (3) Limitations. [55 FR 38984, Sept. 24, 1990, as amended at 62 FR 14302, Mar. 26, 1997; 62 FR 63271, Nov. 28, 1997; 64 FR 26671, May 17, 1999; 69 FR 31735, June 7, 2004; 72 FR 27734, May 17, 2007; 77 FR 64717, Oct. 23, 2012; 79 FR 64116, Oct. 28, 2014; 84 FR 39184, Aug. 9, 2019; 86 FR 14820, Mar. 19, 2021; 86 FR 57997, Oct. 20, 2021] Editorial Note: At 81 FR 22524, Apr. 18, 2016, § 522.1193 was amended; however, the amendment could not be incorporated due to inaccurate amendatory instruction. § 522.1204 Kanamycin. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs and cats Amount. (2) Indications for use. (3) Limitations. [79 FR 16190, Mar. 25, 2014] § 522.1222 Ketamine. (a) Specifications. (b) Sponsors. (c) Special considerations. (d) Conditions of use Cats Amount. (ii) Indications for use. (2) Subhuman primates Amount. (ii) Indications for use. [67 FR 17283, Apr. 10, 2002, as amended at 73 FR 8192, Feb. 13, 2008. Redesignated at 79 FR 16191, Mar. 25, 2014, as amended at 80 FR 13229, Mar. 13, 2015; 83 FR 48946, Sept. 28, 2018; 86 FR 14820, Mar. 19, 2021; 88 FR 27699, May 3, 2023; 88 FR 55564, Aug. 16, 2023] § 522.1223 Ketamine, promazine, and aminopentamide. (a) Specifications. (b) Sponsor. (c) Conditions of use in cats Amount. (2) Indications for use. (3) Limitations. [79 FR 16191, Mar. 25, 2014] § 522.1225 Ketoprofen. (a) Specifications. (b) Sponsors. (1) No. 054771 for use as in paragraphs (d)(1) and (d)(2) of this section. (2) No. 061133 for use as in paragraph (d)(1) of this section. (c) Related tolerances. (d) Conditions of use Horses Amount. (ii) Indications for use. (iii) Limitations. (2) Cattle Amount. (ii) Indications for use. (iii) Limitations. [86 FR 61685, Nov. 8, 2021] § 522.1242 Levamisole. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use Amount. (2) Indications for use. Haemonchus, Trichostrongylus, Ostertagia Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum, Chabertia Dictyocaulus (ii) The 18.2 percent injection is used as an anthelmintic in cattle for treatment of the following parasites: stomach worms ( Haemonchus, Trichostrongylus, Ostertagia Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum Dictyocaulus (3) Limitations. [43 FR 20489, May 12, 1978, as amended at 43 FR 29289, July 7, 1978; 43 FR 60895, Dec. 29, 1978; 47 FR 10807, Mar. 12, 1982; 62 FR 61625, Nov. 19, 1997; 65 FR 61090, Oct. 16, 2000; 67 FR 63055, Oct. 10, 2002. Redesignated and amended at 79 FR 16191, Mar. 25, 2014; 83 FR 48946, Sept. 28, 2018; 84 FR 32992, July 11, 2019] § 522.1260 Lincomycin. (a) Specifications. (1) 25, 50, 100, or 300 milligrams (mg) lincomycin. (2) 25, 100, or 300 mg lincomycin. (3) 300 mg lincomycin. (4) 100 or 300 mg lincomycin. (b) Sponsors. (1) No. 054771 for use of concentrations in paragraph (a)(1) of this section as in paragraph (e) of this section. (2) Nos. 016592 and 058005 for use of concentrations in paragraph (a)(2) of this section as in paragraph (e)(2) of this section. (3) No. 054771 for use of concentration in paragraph (a)(3) of this section as in paragraph (e)(2) of this section. (4) No. 061133 for use of concentrations in paragraph (a)(4) of this section as in paragraph (e)(2) of this section. (c) Special considerations. (d) Related tolerances. (e) Conditions of use. (1) Dogs and cats Amount. (ii) Indications for use. (iii) Limitations. (2) Swine Amount. (ii) Indications for use. (iii) Limitations. [40 FR 13858, Mar. 27, 1975, as amended at 50 FR 31351, Aug. 2, 1985; 67 FR 34388, May 14, 2002; 68 FR 51705, Aug. 28, 2003; 69 FR 11507, Mar. 11, 2004; 69 FR 47361, Aug. 5, 2004; 71 FR 51996, Sept. 1, 2006; 78 FR 17597, Mar. 22, 2013; 79 FR 16191, Mar. 25, 2014; 81 FR 59134, Aug. 29, 2016; 84 FR 8974, Mar. 13, 2019; 88 FR 16548, Mar. 20, 2023; 90 FR 40970, Aug. 22, 2025] § 522.1289 Lufenuron. (a) Specifications. (b) Sponsor. (c) Conditions of use in cats Amount. (2) Indications for use. (3) Limitations. [79 FR 16191, Mar. 25, 2014, as amended at 80 FR 61297, Oct. 13, 2015] § 522.1290 Luprostiol. (a) Specifications. (b) Sponsor. (c) Special considerations. Warning: (d) Conditions of use in horses Amount. (2) Indications for use. For estrus control and termination of pregnancy in mares. (3) Limitations. [55 FR 1185, Jan. 12, 1990, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995; 61 FR 66582, Dec. 18, 1996; 74 FR 25146, May 27, 2009] § 522.1315 Maropitant. (a) Specifications. (b) Sponsor. (c) Conditions of use Dogs Amount. (ii) Indications for use. (iii) Limitations. (2) Cats Amount. (ii) Indications for use. (iii) Limitations. [72 FR 9243, Mar. 1, 2007, as amended at 77 FR 39391, July 3, 2012; 79 FR 16191, Mar. 25, 2014; 81 FR 22524, Apr. 18, 2016; 91 FR 20342, Apr. 16, 2026] § 522.1335 Medetomidine. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. (3) Limitations. [61 FR 21075, May 9, 1996, as amended at 79 FR 16191, Mar. 25, 2014; 82 FR 58556, Dec. 13, 2017] § 522.1338 Medetomidine and vatinoxan. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. 2 (2) Indications for use. (3) Limitations. [87 FR 58962, Sept. 29, 2022, as amended at 87 FR 76421, Dec. 14, 2022] § 522.1350 Melatonin implant. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. Mustela vison (3) Limitations. [59 FR 37422, July 22, 1994] § 522.1362 Melarsomine powder for injection. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. 3 5 (2) Indications. 5 Dirofilaria immitis (3) Limitations. [60 FR 49340, Sept. 25, 1995, as amended at 79 FR 16191, Mar. 25, 2014; 82 FR 21690, May 10, 2017; 84 FR 39184, Aug. 9, 2019] § 522.1367 Meloxicam. (a) Specifications. (b) Sponsors. (c) Conditions of use Dogs Amount. (ii) Indications for use. (iii) Limitations. (2) Cats Amount. (ii) Indications for use. (iii) Limitations. [68 FR 68724, Dec. 10, 2003, as amended at 69 FR 69523, Nov. 30, 2004; 78 FR 5715, Jan. 28, 2013; 79 FR 74020, Dec. 15, 2014; 85 FR 18119, Apr. 1, 2020; 88 FR 14898, Mar. 10, 2023] § 522.1372 Mepivacaine. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses Amount. (2) Indications for use. (3) Limitations. [71 FR 39547, July 13, 2006, as amended at 79 FR 16191, Mar. 25, 2014; 88 FR 14898, Mar. 10, 2023] § 522.1380 Methocarbamol. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount Dogs and cats. (ii) Horses. (2) Indications for use. (3) Limitations. [79 FR 16191, Mar. 25, 2014, as amended at 82 FR 11508, Feb. 24, 2017] § 522.1410 Methylprednisolone. (a) Specifications. (b) Sponsors. (c) [Reserved] (d) Conditions of use Dogs Amount. (ii) Indications for use. (iii) Limitations. (2) Cats Amount. (ii) Indications for use. (iii) Limitations. (3) Horses Amount. (ii) Indications for use. (iii) Limitations. [43 FR 59058, Dec. 19, 1978, as amended at 51 FR 741, Jan. 8, 1986; 53 FR 40728, Oct. 18, 1988; 62 FR 35076, June 30, 1997; 76 FR 53051, Aug. 25, 2011; 78 FR 21060, Apr. 9, 2013; 79 FR 16191, Mar. 25, 2014; 83 FR 48946, Sept. 28, 2018] § 522.1450 Moxidectin solution. (a) Specifications. (b) Sponsors. (c) Related tolerances. (d) Special considerations. (e) Conditions of use in cattle—(1) Amount. (2) Indications for use. Ostertagia ostertagi Haemonchus placei Trichostrongylus axei Trichostrongylus colubriformis Cooperia oncophora Cooperia pectinata Cooperia punctata Cooperia spatulata Cooperia surnabada Nematodirus helvetianus Oesophagostomum radiatum Trichuris Dictyocaulus viviparus Hypoderma bovis Hypoderma lineatum; Psoroptes ovis Psoroptes communis bovis Linognathus vituli Solenopotes capillatus. Dictyocaulus viviparus Oesophagostomum radiatum Haemonchus placei Ostertagia ostertagi Trichostrongylus axei (3) Limitations. [70 FR 36337, June 23, 2005, as amended at 71 FR 7414, Feb. 13, 2006; 76 FR 48714, Aug. 9, 2011; 82 FR 21690, May 10, 2017; 86 FR 14820, Mar. 19, 2021; 88 FR 27699, May 3, 2023; 89 FR 95103, Dec. 2, 2024] § 522.1451 Moxidectin microspheres for injection. (a) Specifications. (1) Each milliliter (mL) of constituted suspension contains 3.4 milligrams (mg) moxidectin. (2) Each mL of constituted suspension contains 10 mg moxidectin. (b) Sponsor. (c) Conditions of use in dogs Amount. (ii) Using the suspension described in paragraph (a)(2) of this section, administer 0.05 mL of the constituted suspension/kg of body weight (0.023 mL/lb) as a single subcutaneous injection to provide 0.5 mg/kg body weight (0.23 mg/lb). (2) Indications for use Suspension described in paragraph (a)(1) of this section. Dirofilaria immitis Ancylostoma caninum Uncinaria stenocephala (ii) Suspension described in paragraph (a)(2) of this section. Dirofilaria immitis Ancylostoma caninum Uncinaria stenocephala (3) Limitations. [85 FR 4208, Jan. 24, 2020] § 522.1452 Nalorphine. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [44 FR 6707, Feb. 2, 1979, as amended at 47 FR 36418, Aug. 20, 1982; 62 FR 63271, Nov. 28, 1997; 79 FR 16191, Mar. 25, 2014; 84 FR 39184, Aug. 9, 2019] § 522.1465 Naltrexone. (a) Specifications. (b) Sponsor. (c) Conditions of use in elk and moose Amount. (2) Indications for use. Cervidae (3) Limitations. [62 FR 5320, Feb. 5, 1997, as amended at 79 FR 16191, Mar. 25, 2014] § 522.1468 Naproxen for injection. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses Dosage. (2) Indications for use. (3) Limitations. [46 FR 26763, May 15, 1981. Redesignated and amended at 51 FR 24525, July 7, 1986; 61 FR 5507, Feb. 13, 1996; 79 FR 16192, Mar. 25, 2014] § 522.1484 Neomycin. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs and cats Amount. (2) Indications for use. (3) Limitations. [79 FR 16192, Mar. 25, 2014] § 522.1503 Neostigmine. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. 1/2 (2) Indications for use. (3) Limitations. [40 FR 13858, Mar. 27, 1975, as amended at 62 FR 61625, Nov. 19, 1997; 79 FR 16192, Mar. 25, 2014] § 522.1610 Oleate sodium. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses Amount. (2) Indications for use. (3) Limitations. [41 FR 27034, July 1, 1976, as amended at 50 FR 40966, Oct. 8, 1985; 79 FR 16192, Mar. 25, 2014] § 522.1660 Oxytetracycline injectable dosage forms. § 522.1660a Oxytetracycline solution, 200 milligrams/milliliter. (a) Specifications. (b) Sponsors. (c) Related tolerances. (d) Conditions of use Beef cattle, dairy cattle, and calves including prerumenative (veal) calves Amounts and indications for use. Pasteurella Haemophilus Fusobacterium necrophorum, Escherichia coli, Actinobacillus lignieresii, Leptospira pomona, Staphylococcus Streptococcus Bacillus anthracis. (B) 5 mg/lb BW/day intramuscularly or intravenously for treatment of anaplasmosis caused by Anaplasma marginale, (C) 9 mg/lb BW intramuscularly or subcutaneously as single dosage where retreatment of calves and yearlings for bacterial pneumonia is impractical, for treatment of infectious bovine keratoconjunctivitis (pinkeye) caused by Moraxella bovis, (ii) Limitations. (2) Swine Amounts and indications for use. E. coli. (B) 3 to 5 mg/lb BW/day intramuscularly for treatment of bacterial enteritis (scours, colibacillosis) caused by E. coli, Pasteurella multocida, Leptospira pomona. (C) 9 mg/lb BW as a single dosage where retreatment for pneumonia is impractical. (ii) Limitations. [45 FR 16479, Mar. 14, 1980. Redesignated and amended at 69 FR 31879, June 8, 2004] Editorial Note: For Federal Register www.govinfo.gov. § 522.1660b Oxytetracycline solution, 300 milligrams/milliliter. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Special considerations. (e) Conditions of use Beef cattle, nonlactating dairy cattle, and calves including preruminating (veal) calves Amounts and indications for use. Pasteurella Histophilus Fusobacterium necrophorum, Escherichia coli, Actinobacillus lignieresii, Leptospira pomona, Staphylococcus Streptococcus (B) 5 mg/lb BW/day intramuscularly, subcutaneously, or intravenously for treatment of severe foot-rot, and advanced cases of other indicated diseases. (C) 9 mg/lb BW intramuscularly or subcutaneously as single dosage where retreatment of calves and yearlings for bacterial pneumonia is impractical or for treatment of infectious bovine keratoconjunctivitis (pinkeye) caused by Moraxella bovis. (D) 9 to 13.6 mg/lb BW intramuscularly or subcutaneously as single dosage where retreatment of calves and yearlings for bacterial pneumonia is impractical or for treatment of infectious bovine keratoconjunctivitis (pinkeye) caused by Moraxella bovis. (E) 13.6 mg/lb BW intramuscularly or subcutaneously as a single dosage for control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia Pasteurella haemolytica. (ii) Limitations. (2) Swine Amounts and indications for use. E. coli. (B) 3 to 5 mg/lb BW/day intramuscularly for treatment of bacterial enteritis (scours, colibacillosis) caused by E. coli, Pasteurella multocida, Leptospira pomona. (C) 9 mg/lb BW as a single dosage where retreatment for pneumonia is impractical. (ii) Limitations. [68 FR 54805, Sept. 19, 2003. Redesignated and amended at 69 FR 31879, June 8, 2004; 73 FR 14926, Mar. 20, 2008; 88 FR 16548, Mar. 20, 2023] § 522.1662 Oxytetracycline. (a) For related tolerances see § 556.500 of this chapter. (b)(1) Specifications. (2) Sponsor. (3) Conditions of use Amount. (ii) Indications for use. Pasteurella ., Haemophilus ., Klebsiella Escherichia coli Spherophorus necrophorus Spherophorus necrophorus Actinobacillus lignieresii Leptospira pomona Staphylococcus Streptococcus (iii) Limitations. (c)(1) Specifications. (2) Sponsor. (3) Conditions of use Beef cattle and nonlactating dairy cattle Amount. (B) Indications for use. Pasteurella ., Haemophilus ., Klebsiella ., Spherophorus necrophorus, Escherichia coli, Actinobacillus lignieresii, Leptospira pomona, Anaplasma marginale; Staphylococcus Streptococcus (C) Limitations. (ii) Swine Amount. (B) Indications for use. Escherichia coli, Pasteurella multocida, Leptospira pomona. Escherichia coli. (C) Limitations. (d)(1) Specifications. (2) Sponsor. (3) Conditions of use in beef cattle and nonlactating dairy cattle Amount. (ii) Indications for use. Pasteurella Haemophilus Fusobacterium necrophorum, Escherichia coli, Actinobacillus lignieresii, Leptospira pomona, Staphylococcus Streptococcus Anaplasma marginale Bacillus anthracis. (iii) Limitations. (e)(1) Specifications. (2) Sponsor. (3) Conditions of use in beef cattle and nonlactating dairy cattle. (i) Amount. (ii) Indications for use. Pasteurella spp. Haemophilus spp.; Spherophorus necrophorus; Escherichia coli; Actinobacillus lignieresii; Leptospira pomona; Anaplasma marginale Bacillus anthracis. (iii) Limitations. (4) Conditions of use in swine. (i) Amount. (ii) Indications for use. Escherichia coli; Pasteurella multocida; Leptospira pomona. Escherichia coli. (iii) Limitations. (5) Poultry (broilers, turkeys, and breeding chickens). (i) Amount. (ii) Indications for use. Mycoplasma gallisepticum Escherichia coli; Pasteurella multocida; Mycoplasma gallisepticum; Mycoplasma synoviae. (iii) Limitations. (f)(1) Specifications. (2) Sponsor. (3) Conditions of use in beef cattle and nonlactating dairy cattle Amount. (ii) Indications for use. Pasteurella Haemophilus Fusobacterium necrophorum, Escherichia coli, Actinobacillus lignieresii, Leptospira pomona, Staphylococcus Streptococcus Anaplasma marginale Bacillus anthracis. (iii) Limitations. (g)(1) Specifications. (2) Sponsor. (3) Conditions of use. (i) Beef cattle, beef calves, nonlactating dairy cattle, and dairy calves Amount. (B) Indications for use. Pasteurella Haemophilus Klebsiella (C) Limitations. (ii) Swine Amount. (B) Indications for use. Escherichia coli, Pasteurella multocida, Leptospira pomona. Escherichia coli. (C) Limitations. (h)(1) Specifications. (2) Sponsors. (3) Conditions of use in beef cattle, beef calves, nonlactating dairy cattle, and dairy calves Amount. (ii) Indications for use. Pasteurella Fusobacterium necrophorum, Escherichia coli, Actinobacillus lignieresii; Staphylococcus Streptococcus (iii) Limitations. (i)(1) Specifications. (2) Sponsor. (3) Conditions of use in beef cattle, beef calves, nonlactating dairy cattle, and dairy calves Amount. (ii) Indications for use. Pasteurella spp.; Spherophorus necrophorus; Escherichia coli; Actinobacillus lignieresii; (iii) Limitations. (j)(1) Specifications. (2) Sponsor. (3) Conditions of use in beef cattle and nonlactating dairy cattle Amount. (ii) Indications for use. Pasteurella Haemophilus Fusobacterium necrophorum, Escherichia coli, Actinobacillus lignieresii, Leptospira pomona, Anaplasma marginale Bacillus anthracis; (iii) Limitations. [40 FR 13858, Mar. 27, 1975. Redesignated at 88 FR 14898, Mar. 10, 2023] Editorial Note: For Federal Register www.govinfo.gov. § 522.1663 Oxytetracycline hydrochloride with lidocaine injection. (a) Specifications. (b) Sponsor. (c) Conditions of use. Hemolytic staphylococcus, Streptococcus spp., Brucella bronchiseptica, Streptococcus pyogenes, Staphylococcus aureus, Micrococcus pyogenes var. albus, Brucella bronchiseptica, Streptococcus spp. (2) The drug is administered intramuscularly at a recommended daily dosage to dogs at 5 milligrams per pound of body weight administered in divided doses at 6 to 12 hour intervals. Therapy should be continued for at least 24 hours after all symptoms have subsided. (3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [40 FR 13858, Mar. 27, 1975, as amended at 48 FR 30615, July 5, 1983; 79 FR 16192, Mar. 25, 2014. Redesignated at 88 FR 14898, Mar. 10, 2023] § 522.1664 Oxytetracycline and flunixin. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use cattle Amount. (2) Indications for use. Pasteurella (3) Limitations. [76 FR 3489, Jan. 20, 2011, as amended at 79 FR 16192, Mar. 25, 2014] § 522.1680 Oxytocin. (a) Specifications. (b) Sponsors. (c) Conditions of use Amount Obstetrical. mL U.S.P. units Cats 0.25 to 0.5 5 to 10. Dogs 0.25 to 1.5 5 to 30. Ewes, Sows 1.5 to 2.5 30 to 50. Cows, Horses 5.0 100. (ii) Milk letdown. mL U.S.P. units Cows 0.5 to 1.0 10 to 20. Sows 0.25 to 1.0 5 to 20. (2) Indications for use. (3) Limitations. [44 FR 63097, Nov. 2, 1979; 45 FR 1019, Jan. 4, 1980] Editorial Note: For Federal Register www.govinfo.gov. § 522.1684 Pegbovigrastim. (a) Specifications. (b) Sponsor. (c) Conditions of use in cattle Amount. (2) Indications for use. (3) Limitations. [81 FR 36789, June 8, 2016, as amended at 81 FR 48702, July 26, 2016] § 522.1696 Penicillin G procaine injectable dosage forms. § 522.1696a Penicillin G benzathine and penicillin G procaine suspension. (a) Specifications. (b) Sponsors. (1) Nos. 054771 and 061133 for use as in paragraph (d)(1) of this section. (2) Nos. 016592 and 061133 for use as in paragraphs (d)(2)(i), (d)(2)(ii)(A), and (d)(2)(iii) of this section. (3) No. 054771 for use as in paragraphs (d)(2)(i), (d)(2)(ii)(B), and (d)(2)(iii) of this section. (c) Related tolerances. (d) Conditions of use Horses, dogs, and beef cattle Amount Beef cattle. (B) Horses. (C) Dogs. (ii) Indications for use. (iii) Limitations. (2) Beef cattle Amount. (ii) Indications for use. Streptococcus Actinomyces pyogenes Staphylococcus aureus A. pyogenes Clostridium chauvoei (B) As in paragraph (d)(2)(ii)(A) of this section; and prophylaxis of bovine shipping fever in 300- to 500-pound beef calves. (iii) Limitations. [66 FR 711, Jan. 4, 2001, as amended at 68 FR 34534, June 10, 2003; 70 FR 21947, Apr. 28, 2005; 70 FR 50182, Aug. 26, 2005; 73 FR 16754, Mar. 31, 2008; 75 FR 54017, Sept. 3, 2010; 77 FR 4897, Feb. 1, 2012; 78 FR 17597, Mar. 22, 2013; 79 FR 16192, Mar. 25, 2014; 81 FR 22524, Apr. 18, 2016; 84 FR 8974, Mar. 13, 2019; 85 FR 18120, Apr. 1, 2020; 88 FR 16548, Mar. 20, 2023] § 522.1696b Penicillin G procaine aqueous suspension. (a) Specifications. (b) Sponsors. (1) Nos. 016592 and 054771 for use as in paragraph (d) of this section. (2) Nos. 055529 and 061133 for use as in paragraph (d)(2) of this section. (c) Related tolerances. (d) Conditions of use Dogs and cats Amount. (ii) Indications for use. (iii) Limitations. (2) Cattle, sheep, swine, and horses Amount. (ii) Indications for use. Pasteurella multocida Erysipelothrix rhusiopathiae Streptococcus equi. (iii) Limitations. (A) For Nos. 054771 and 061133: Do not exceed 7 days of treatment in nonlactating dairy and beef cattle, sheep, and swine, or 5 days in lactating cattle. Discontinue treatment for the following number of days before slaughter: Nonruminating cattle (calves)—7; all other cattle—4; sheep—8; and swine—6. (B) For Nos. 016592 and 055529: treatment should not exceed 4 consecutive days. A withdrawal period has not been established for this product in pre-ruminating calves. Discontinue treatment for the following number of days before slaughter: cattle—14; sheep—9; and swine—7. (C) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [66 FR 712, Jan. 4, 2001, as amended at 68 FR 34534, June 10, 2003; 68 FR 42589, July 18, 2003; 69 FR 17586, Apr. 5, 2004; 70 FR 16935, Apr. 4, 2005; 73 FR 14177, Mar. 17, 2008; 75 FR 54017, Sept. 3, 2010; 78 FR 17597, Mar. 22, 2013; 79 FR 16192, Mar. 25, 2014; 81 FR 22524, Apr. 18, 2016; 84 FR 8974, Mar. 13, 2019; 85 FR 18120, Apr. 1, 2020; 88 FR 14899, Mar. 10, 2023; 88 FR 16548, Mar. 20, 2023; 88 FR 27700, May 3, 2023; 89 FR 85427, Oct. 28, 2024] § 522.1696c Penicillin G procaine in oil. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. (3) Limitations. [57 FR 37333, Aug. 18, 1992, as amended at 79 FR 16193, Mar. 25, 2014] § 522.1698 Pentazocine. (a) Specifications. (b) Sponsor. (c) Conditions of use Horses Amount. (ii) Indications for use. (iii) Limitations. (2) Dogs Amount. (ii) Indications for use. (iii) Limitations. [42 FR 31450, June 21, 1977, as amended at 42 FR 36995, July 19, 1977; 47 FR 5409, Feb. 5, 1982; 55 FR 23076, June 6, 1990; 79 FR 16193, Mar. 25, 2014. Redesignated at 86 FR 61685, Nov. 8, 2021, and further redesignated at 88 FR 14899, Mar. 10, 2023] § 522.1700 Pentobarbital and phenytoin. (a) Specifications. (b) Sponsors. (c) Special considerations. (d) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [85 FR 18120, Apr. 1, 2020, as amended at 85 FR 45308, July 28, 2020. Redesignated at 86 FR 61685, Nov. 8, 2021; 88 FR 84701, Dec. 6, 2023] § 522.1703 Pentobarbital. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. (3) Limitations. [79 FR 16193, Mar. 25, 2014. Redesignated at 86 FR 61685, Nov. 8, 2021] § 522.1704 Pentosan polysulfate sodium. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. (3) Limitations. [88 FR 16548, Mar. 20, 2023, as amended at 88 FR 84701, Dec. 6, 2023] § 522.1720 Phenylbutazone. (a) Specifications. (2) Each milliliter of solution contains 200 mg of phenylbutazone. (b) Sponsors. (1) No. 054771 for use of product described in paragraph (a)(1) as in paragraph (c) of this section. (2) Nos. 000061, 054771, 058198, and 061133 for use of product described in paragraph (a)(2) of this section as in paragraph (c) of this section. (3) Nos. 058005 and 069043 for use of product described in paragraph (a)(2) as in paragraph (c)(2) of this section. (c) Conditions of use Dogs Amount. (ii) Indications for use. (iii) Limitations. (2) Horses Amount. (ii) Indications for use. (iii) Limitations. [79 FR 16193, Mar. 25, 2014, as amended at 83 FR 48946, Sept. 28, 2018; 84 FR 8974, Mar. 13, 2019; 86 FR 14820, Mar. 19, 2021] § 522.1820 Pituitary luteinizing hormone powder for injection. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. (3) Limitations. [40 FR 13858, Mar. 27, 1975, as amended at 52 FR 7832, Mar. 13, 1987; 79 FR 16193, Mar. 25, 2014] § 522.1850 Polysulfated glycosaminoglycan. (a) Specifications. (2) Each mL of solution packaged in 5-mL ampules or 20-, 30-, or 50-mL vials contains 100 mg polysulfated glycosaminoglycan. (b) Sponsor. (c) Special considerations. (d) Conditions of use Horses Indications for use. (ii) Amount Intra-articular use (carpal) (B) Intramuscular use (carpal and hock) (iii) Limitations. (2) Dogs Indications for use. (ii) Amount. [72 FR 56896, Oct. 5, 2007, as amended at 74 FR 67816, Dec. 21, 2009] § 522.1860 Pradofloxacin. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use Cattle Amount. (ii) Indications for use. Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, Mycoplasma bovis. (iii) Limitations. (2) Swine Amount. (ii) Indications for use. Bordetella bronchiseptica, Glaesserella (Haemophilus) parasuis, Pasteurella multocida, Streptococcus suis, Mycoplasma hyopneumoniae. (iii) Limitations. [89 FR 85427, Oct. 28, 2024] § 522.1862 Pralidoxime powder for injection. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. (3) Limitations. [79 FR 16193, Mar. 25, 2014] § 522.1870 Praziquantel. (a) Specifications. (b) Sponsors. (c) Conditions of use Dogs Amount. (ii) Indications for use. Dipylidium caninum, Taenia pisiformis, Echinococcus granulosus, Echinococcus multilocularis. (iii) Limitations. (2) Cats Amount. (ii) Indications for use. Dipylidium caninum Taenia taeniaeformis. (iii) Limitations. [46 FR 10464, Feb. 3, 1981, as amended at 47 FR 6617, Feb. 16, 1982; 58 FR 42853, Aug. 12, 1993; 67 FR 79853, Dec. 31, 2002; 78 FR 17868, Mar. 25, 2013; 81 FR 67151, Sept. 30, 2016; 84 FR 8974, Mar. 13, 2019; 86 FR 14820, Mar. 19, 2021] § 522.1881 Prednisolone acetate. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. (3) Limitations. [79 FR 16194, Mar. 25, 2014] § 522.1883 Prednisolone sodium phosphate. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. 1/2 (2) Indications for use. (3) Limitations. [68 FR 59881, Oct. 20, 2003, as amended at 84 FR 8974, Mar. 13, 2019] § 522.1884 Prednisolone sodium succinate. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount and indications for use Horses. (ii) Dogs. (iii) Dogs and cats. (2) Limitations. [79 FR 16194, Mar. 25, 2014] § 522.1890 Prednisone suspension. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount Horses. (ii) Dogs and cats. (2) Indications for use. (3) Limitations. [79 FR 16194, Mar. 25, 2014] § 522.1920 Prochlorperazine and isopropamide. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. Weight of animal in pounds Dosage in Up to 4 0.25 5 to 14 0.5-1 15 to 30 2-3 30 to 45 3-4 45 to 60 4-5 Over 60 6 (ii) Following the last injection, administer prochlorperazine and isopropamide sustained release capsules as indicated. (2) Indications for use. (3) Limitations. [79 FR 16194, Mar. 25, 2014] § 522.1940 Progesterone and estradiol benzoate. (a) Specifications Each implant consists of progesterone and estradiol benzoate. (ii) 200 mg progesterone and 20 mg estradiol benzoate (one implant consisting of eight pellets, each containing 25 mg progesterone and 2.5 mg estradiol benzoate). (2) Each implant consists of progesterone and estradiol benzoate and tylosin tartrate. (ii) 200 mg progesterone, 20 mg estradiol benzoate, and 29 mg tylosin tartrate (one implant consisting of eight pellets, each containing 25 mg progesterone and 2.5 mg estradiol benzoate, and one pellet containing 29 mg tylosin tartrate). (b) Sponsors. (1) No. 054771 for use as in paragraphs (e)(1)(i)(A), (e)(1)(ii), (e)(2)(i)(A), (B), (C), and (e)(2)(ii) of this section. (2) No. 058198 for use as in paragraphs (e)(1)(i)(A), (e)(1)(i)(B), (e)(1)(ii), and (e)(3) of this section. (c) Related tolerances. (d) Special considerations. (e) Conditions of use Beef calves 45 days of age and older and weighing up to 400 lbs Amounts and indications for use. (B) An implant containing 100 mg progesterone, 10 mg estradiol benzoate, and 29 mg tylosin tartrate as described in paragraph (a)(2)(i) of this section for increased rate of weight gain. (ii) Limitations. (2) Growing beef steers fed in confinement for slaughter Amounts and indications for use. (B) An implant containing 200 mg progesterone and 20 mg estradiol benzoate as described in paragraph (a)(1)(ii) of this section for increased rate of weight gain in a reimplantation program where an implant as described in paragraph (a)(1)(i) of this section is the first implant and an implant as described in paragraph (a)(1)(ii) of this section is administered approximately 70 days later. (C) An implant containing 200 mg progesterone and 20 mg estradiol benzoate as described in paragraph (a)(1)(ii) of this section for increased rate of weight gain in a reimplantation program where an implant as described in paragraph (a)(1)(ii) of this section is the first implant and an implant as described in paragraph (a)(1)(ii) of this section is administered approximately 70 days later. (ii) Limitations. (3) Growing beef steers weighing 400 lbs or more Amounts and indications for use. (ii) Limitations. [89 FR 42358, May 15, 2024] § 522.1962 Promazine. (a) Specifications. (b) Sponsors. (1) No. 054771 for use as in paragraphs (c)(1)(i)(A), (c)(1)(ii)(A), (c)(1)(iii), and (c)(2) of this section. (2) No. 061133 for use as in paragraphs (c)(1)(i)(B), (c)(1)(ii)(B), and (c)(1)(iii) of this section. (c) Conditions of use Horses Amount. (B) 0.2 to 0.5 mg/lb body weight intravenously as required. (ii) Indications for use. (B) For use as a tranquilizer and preanesthetic. (iii) Limitations. (2) Dogs and cats Amount. (ii) Indications for use. (iii) Limitations. [46 FR 18962, Mar. 27, 1981, as amended at 68 FR 59881, Oct. 20, 2003; 70 FR 50183, Aug. 26, 2005; 79 FR 16194, Mar. 25, 2014; 84 FR 8974, Mar. 13, 2019] § 522.2002 Propiopromazine. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs and cats Amounts and indications for use. (2) Limitations. [79 FR 16195, Mar. 25, 2014] § 522.2005 Propofol. (a) Specifications. (b) Sponsors. (1) No. 086064 for use as in paragraphs (c)(1), (c)(2)(i), (c)(3), (d)(1), (d)(2)(i), and (d)(3) of this section. (2) No. 054771 for use as in paragraphs (c)(1), (c)(2)(ii), (c)(3), (d)(1), (d)(2)(ii), and (d)(3) of this section. (3) Nos. 054771 and 068504 for use as in paragraphs (c)(1), (c)(2)(iii), and (c)(3) of this section. (c) Conditions of use in dogs Amount. (2) Indications for use. (ii) For induction of general anesthesia; for maintenance of anesthesia for up to 20 minutes; and for induction of general anesthesia followed by maintenance with an inhalant anesthetic. (iii) For induction and maintenance of general anesthesia; and for induction of general anesthesia followed by maintenance with an inhalant anesthetic. (3) Limitations. (d) Conditions of use in cats Amount. (2) Indications for use. (ii) For induction and maintenance of general anesthesia; and for induction of general anesthesia followed by maintenance with an inhalant anesthetic. (3) Limitations. [75 FR 20269, Apr. 19, 2010, as amended at 75 FR 38700, July 6, 2010; 78 FR 17868, Mar. 25, 2013; 79 FR 16195, Mar. 25, 2014; 80 FR 18776, Apr. 8, 2015; 81 FR 36789, June 8, 2016; 90 FR 6800, Jan. 21, 2025; 90 FR 19625, May 9, 2025] § 522.2012 Prostalene. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses Amount. (2) Indications for use. (3) Limitations. [79 FR 16195, Mar. 25, 2014] § 522.2063 Pyrilamine. (a) Specifications. (b) Sponsors. (1) No. 000061 for use as in paragraph (c)(1)(i), (2), and (3) of this section. (2) No. 061133 for use as in paragraph (c)(1)(ii), (2), and (3) of this section. (c) Conditions of use Amount. (ii) Horses, 40 to 60 mg/100 lbs body weight; foals, 20 mg/100 lbs body weight. Administer by slow intravenous injection. Dosage may be repeated every 6 to 12 hours if necessary. (2) Indications for use. (3) Limitations. [79 FR 16195, Mar. 25, 2014, as amended at 84 FR 8974, Mar. 13, 2019] § 522.2065 Rabacfosadine. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [87 FR 10969, Feb. 28, 2022] § 522.2075 Robenacoxib. (a) Specifications. (b) Sponsor. (c) Conditions of use Dogs Amount. (ii) Indications for use. (iii) Limitations. (2) Cats Amount. (ii) Indications for use. (iii) Limitations. [80 FR 61297, Oct. 13, 2015, as amended at 82 FR 12170, Mar. 1, 2017; 91 FR 41560, July 7, 2026] § 522.2076 Romifidine. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses Amount. (2) Indications for use. (3) Limitations. [69 FR 47363, Aug. 5, 2004, as amended at 79 FR 16195, Mar. 25, 2014] § 522.2092 Secobarbital and dibucaine. (a) Specifications. (b) Sponsor. (c) Special considerations. (d) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [85 FR 18120, Apr. 1, 2020] § 522.2100 Selenium and vitamin E. (a)(1) Specifications. (2) Sponsor. (3) Conditions of use in horses Amount. (ii) Indications for use. (iii) Limitations. (b)(1) Specifications. (2) Sponsor. (3) Conditions of use in dogs Amount. 1/4 1/4 (ii) Indications for use. (iii) Limitations. (c)(1) Specifications. (2) Sponsor. (3) Conditions of use Dosage. (ii) Indications for use. (iii) Limitations. (d)(1) Specifications. (2) Sponsors. (3) Conditions of use Dosage. (ii) Indications for use. (iii) Limitations. (e)(1) Specifications. (2) Sponsor. (3) Conditions of use Dosage. (ii) Indications for use. (iii) Limitations. [40 FR 13858, Mar. 27, 1975, as amended at 52 FR 7832, Mar. 13, 1987; 57 FR 21209, May 19, 1992; 58 FR 57556, Oct. 26, 1993; 60 FR 57833, Nov. 22, 1995; 64 FR 27916, May 24, 1999; 79 FR 16195, Mar. 25, 2014; 91 FR 20342, Apr. 16, 2026] § 522.2112 Sometribove zinc suspension. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. (3) Limitations. [58 FR 59947, Nov. 12, 1993, as amended at 67 FR 18085, Apr. 15, 2002; 68 FR 62006, Oct. 31, 2003; 74 FR 53164, Oct. 16, 2009; 81 FR 48702, July 26, 2016; 85 FR 4208, Jan. 24, 2020] § 522.2120 Spectinomycin hydrochloride. (a) Specifications. (b) Sponsors. (1) Nos. 016592 and 054771 for use as in paragraph (d)(1) of this section; and (2) No. 058198 for use as in paragraph (d)(2) of this section. (c) Related tolerances. (d) Conditions of use. (1) Turkeys (1- to 3-day-old poults) and chickens (newly hatched chicks) Amounts and indications for use. Escherichia coli (B) Administer 10 mg per poult as a single subcutaneous injection in the nape of the neck as an aid in the control of airsacculitis associated with Mycoplasma meleagridis (C) Administer 2.5 to 5 mg per chick as an aid in the control of mortality and to lessen severity of infections caused by M. synoviae, Salmonella typhimurium, S. infantis, E. coli. (ii) Limitations. (2) Dogs Amount. (ii) Indications for use. (iii) Limitations. [86 FR 14820, Mar. 19, 2021, as amended at 88 FR 27700, May 3, 2023] § 522.2121 Spectinomycin sulfate. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use in cattle Amount. (2) Indications for use. Mannheimia haemolytica, Pasteurella multocida Histophilus somni. (3) Limitations. [72 FR 31178, June 6, 2007, as amended at 79 FR 16195, Mar. 25, 2014; 88 FR 14899, Mar. 10, 2023] § 522.2150 Stanozolol. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount Dogs and cats. (ii) Horses. (2) Indications for use. (3) Limitations. [79 FR 16195, Mar. 25, 2014] § 522.2220 Sulfadimethoxine. (a) Specifications. (1) 100 milligrams (mg) of sulfadimethoxine sodium. (2) 400 mg of sulfadimethoxine sodium. (b) Sponsors. (1) No. 069043 for use of the product described in paragraph (a)(1) as in paragraph (d)(1) of this section. (2) No. 054771 for use of the product described in paragraph (a)(2) as in paragraphs (d)(2), (3), and (4) of this section. (3) Nos. 016592 and 061133 for use of the product described in paragraph (a)(2) as in paragraph (d)(4) of this section. (c) Related tolerances. (d) Conditions of use Dogs Amount. (ii) Indications for use. (iii) Limitations. (2) Dogs and cats Amount. (ii) Indications for use. Streptococci, Staphylococci, Escherichia, Salmonella, Klebsiella, Proteus, Shigella (iii) Limitations. (3) Horses Amount. (ii) Indications for use. (iii) Limitations. (4) Cattle Amount. (ii) Indications for use. Pasteurella Fusobacterium necrophorum (iii) Limitations. [79 FR 16196, Mar. 25, 2014, as amended at 81 FR 22524, Apr. 18, 2016; 83 FR 48946, Sept. 28, 2018; 84 FR 8974, Mar. 13, 2019; 88 FR 14900, Mar. 10, 2023] § 522.2240 Sulfaethoxypyridazine. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use in cattle Amount. (2) Indications for use. (3) Limitations. [79 FR 16196, Mar. 25, 2014] § 522.2260 Sulfamethazine. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use in cattle Amount. (2) Indications for use. Pasteurella Escherichia coli Fusobacterium necrophorum Fusobacterium necrophorum Streptococcus (3) Limitations. [46 FR 62055, Dec. 22, 1981, as amended at 67 FR 78355, Dec. 24, 2002; 75 FR 10167, Mar. 5, 2010; 76 FR 53051, Aug. 25, 2011; 81 FR 17608, Mar. 30, 2016] § 522.2340 Sulfomyxin. (a) Specifications. Bacillus polymyxa (b) Sponsor. (c) Special considerations. (d) Related tolerances. (e) Conditions of use. E. coli, (2) It is administered by subcutaneous injection as follows: Age of birds in days Antibiotic activity Chickens (units) Turkeys (units) 1 to 14 12,500 12,500 15 to 28 25,000 25,000 29 to 63 50,000 50,000 Over 63 50,000 100,000 (3) A second injection may be given 3 days later if symptoms persist. (4) Not for use in laying hens; do not treat chickens within 5 days of slaughter. Do not treat turkeys within 7 days of slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [40 FR 13858, Mar. 27, 1975, as amended at 79 FR 16196, Mar. 25, 2014; 88 FR 14900, Mar. 10, 2023] § 522.2343 Testosterone propionate and estradiol benzoate. (a) Sponsors. (1) No. 054771 for use as in paragraph (d)(1) of this section. (2) No. 058198 for use as in paragraph (d)(2) of this section. (b) Related tolerances. (c) Special considerations. (d) Conditions of use Growing beef heifers fed in confinement for slaughter Amounts and indications for use. (ii) Limitations. (2) Growing beef heifers weighing 400 lbs or more Amounts and indications for use. (ii) Limitations. [89 FR 42358, May 15, 2024] § 522.2404 Thialbarbitone sodium for injection. (a) Specifications. (b) Sponsor. (c) Conditions of use. (2) It is administered intravenously. The drug is injected slowly to dogs, cats, cattle, sheep, and swine. For horses, it is recommended that a pre-anesthetic sedation be administered to the horse 30 minutes before the drug is administered. The drug is then injected rapidly and completely. The drug is used at the following dosage levels: Species Weight of animal in pounds Dosage in milligrams per pound Dog Over 50 14.1 Do 30-50 18.8 Do 10-30 23.5 Do Under 10 28.2 Cat 31.3-37.6 Horse 6.3-7.8 Cattle and swine 6.7-9.4 Calves and sheep 9.4-11.8 (3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [40 FR 13858, Mar. 27, 1975, as amended at 79 FR 16196, Mar. 25, 2014] § 522.2424 Thiamylal. (a) Specifications. (b) Sponsors. (c) Conditions of use Amount. (i) Dogs and cats: (ii) Swine: (iii) Horses: (iv) Cattle: (2) Indications for use. (3) Limitations. [79 FR 16196, Mar. 25, 2014, as amended at 83 FR 48946, Sept. 28, 2018] § 522.2444 Thiopental injectable dosage forms. § 522.2444a Thiopental powder for injection. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs and cats Amount. (i) 6 to 9 milligrams (mg) per pound of body weight for brief anesthesia (6 to 10 minutes). (ii) 10 to 12 mg per pound of body weight for anesthesia of 15 to 25 minutes duration. (2) Indications for use. (3) Limitations. [79 FR 16196, Mar. 25, 2014] § 522.2444b Thiopental and pentobarbital powder for injection. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. 1/2 2/3 (2) Indications for use. (3) Limitations. [79 FR 16197, Mar. 25, 2014, as amended at 84 FR 8974, Mar. 13, 2019] § 522.2450 Tigilanol. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [86 FR 17064, Apr. 1, 2021] § 522.2460 Tildipirosin. (a) Specifications. (1) 180 milligrams (mg) tildipirosin. (2) [Reserved] (b) Sponsor. (c) Related tolerances. (d) Conditions of use Cattle Amount. (ii) Indications for use. Mannheimia haemolytica, Pasteurella multocida, Histophilus somni M. haemolytica, P. multocida, H. somni. (iii) Limitations. (2) [Reserved] [77 FR 39391, July 3, 2012] § 522.2470 Tiletamine and zolazepam. (a) Specifications. (b) Sponsors. (c) Conditions of use Dogs Amount. (A) An initial intramuscular dosage of 3 to 4.5 milligrams per pound (mg/lb) of body weight for diagnostic purposes; 4.5 to 6 mg/lb of body weight for minor procedures of short duration such as repair of lacerations and wounds, castrations, and other procedures requiring mild to moderate analgesia. Supplemental doses when required should be less than the initial dose and the total dose given should not exceed 12 mg/lb of body weight. The maximum total safe dose is 13.6 mg/lb of body weight. (B) Administer intravenously at 1 to 2 mg/lb (2.2 to 4.4 mg/kg) body weight to effect for induction of anesthesia followed by maintenance with an inhalant anesthetic. (ii) Indications for use. (B) Intravenous administration in dogs for induction of anesthesia followed by maintenance with an inhalant anesthetic. (iii) Limitations. (2) Cats Amount. (ii) Indications for use. (iii) Limitations. [79 FR 16197, Mar. 25, 2014, as amended at 83 FR 14587, Apr. 5, 2018; 86 FR 17064, Apr. 1, 2021; 87 FR 10969, Feb. 28, 2022; 88 FR 16548, Mar. 20, 2023; 89 FR 95103, Dec. 2, 2024] § 522.2471 Tilmicosin. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use Cattle Amount. (ii) Indications for use. Mannheimia haemolytica Pasteurella multocida Histophilus somni. M. haemolytica. (iii) Limitations. (2) Sheep Amount. (ii) Indications for use. Mannheimia P.) haemolytica. (iii) Limitations. [67 FR 72367, Dec. 5, 2002, as amended at 75 FR 9334, Mar. 2, 2010; 81 FR 48703, July 26, 2016; 88 FR 16548, Mar. 20, 2023] § 522.2473 Tiludronate. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses Amount. (2) Indication for use. (3) Limitations. [79 FR 18159, Apr. 1, 2014, as amended at 82 FR 21691, May 10, 2017; 84 FR 8974, Mar. 13, 2019] § 522.2474 Tolazoline. (a) Specifications. (b) Sponsor. (c) Conditions of use in horses Amount. (2) Indications for use. (3) Limitations. [79 FR 16197, Mar. 25, 2014, as amended at 79 FR 74020, Dec. 15, 2014; 80 FR 13230, Mar. 13, 2015] § 522.2476 Trenbolone acetate. (a) Sponsors. (1) No. 000061 for use as in paragraphs (d)(1)(i)(A), (d)(1)(ii) and (iii), (d)(2)(i)(A), and (d)(2)(ii) and (iii) of this section. (2) No. 058198 for use as in paragraph (d) of this section. (b) Related tolerances. (c) Special considerations. (d) Conditions of use Steers fed in confinement for slaughter Amount. (A) 140 milligrams (mg) trenbolone acetate (one implant consisting of 7 pellets, each pellet containing 20 mg trenbolone acetate) per implant dose. (B) 140 mg trenbolone acetate (one implant consisting of 8 pellets, each of 7 pellets containing 20 milligrams trenbolone acetate, and 1 pellet containing 29 mg tylosin tartrate) per implant dose. (ii) Indications for use. (iii) Limitations. (2) Heifers fed in confinement for slaughter Amount. (A) 200 mg trenbolone acetate (one implant consisting of 10 pellets, each pellet containing 20 mg trenbolone acetate) per implant dose. (B) 200 mg of trenbolone acetate (one implant consisting of 11 pellets, each of 10 pellets containing 20 mg of trenbolone acetate, and 1 pellet containing 29 mg of tylosin tartrate) per implant dose. (ii) Indications for use. (iii) Limitations. [66 FR 47961, Sept. 17, 2001, as amended at 69 FR 70056, Dec. 2, 2004; 74 FR 61517, Nov. 25, 2009; 81 FR 48703, July 26, 2016; 88 FR 55566, Aug. 16, 2023] § 522.2477 Trenbolone acetate and estradiol. (a) Sponsors. (1) No. 058198 for use in paragraphs (d)(1)(i)(B), (d)(1)(ii), (d)(2)(i)(B), (d)(2)(i)(D), (d)(2)(ii), (d)(3)(i)(B), (d)(3)(i)(D), (d)(3)(ii), (d)(4)(i)(A), (d)(4)(i)(B), and (d)(4)(ii) of this section. (2) No. 000061 for use in paragraphs (d)(1)(i)(A), (d)(1)(i)(C), (d)(1)(ii), (d)(2)(i)(A), (d)(2)(i)(C), (d)(2)(i)(E), (d)(2)(ii), (d)(3)(i)(A), (d)(3)(i)(C), (d)(3)(i)(E), (d)(3)(ii), (d)(4)(i)(A), and (d)(4)(ii) of this section. (3) No. 054771 for use in paragraphs (d)(2)(i)(A), (C), (d)(2)(ii), (d)(4)(i)(A), and (d)(4)(ii) of this section. (b) Related tolerances. (c) Special considerations. (d) Conditions of use rowing beef steers and heifers fed in confinement for slaughter Amounts and indications. (B) An implant containing 200 mg trenbolone acetate, 20 mg estradiol, and 29 mg tylosin tartrate (one implant consisting of 10 pellets, each containing 20 mg trenbolone acetate and 2 mg estradiol, and 1 pellet containing 29 mg tylosin tartrate) for increased rate of weight gain and improved feed efficiency. (C) An extended- and delayed-release implant containing 200 mg trenbolone acetate and 20 mg estradiol (1 implant consisting of 10 coated pellets, each containing 20 mg trenbolone acetate and 2 mg estradiol) for increased rate of weight gain and improved feed efficiency during 70 to 200 days after implantation. (ii) Limitations. (2) Growing beef steers fed in confinement for slaughter Amounts and indications. (B) An implant containing 80 mg trenbolone acetate, 16 mg estradiol, and 29 mg tylosin tartrate (one implant consisting of four pellets, each containing 20 mg trenbolone acetate and 4 mg estradiol, and one pellet containing 29 mg tylosin tartrate) for increased rate of weight gain and improved feed efficiency. (C) An implant containing 120 mg trenbolone acetate and 24 mg estradiol (one implant consisting of six pellets, each containing 20 mg trenbolone acetate and 4 mg estradiol) for increased rate of weight gain and improved feed efficiency. (D) An implant containing 120 mg trenbolone acetate, 24 mg estradiol, and 29 mg tylosin tartrate (one implant consisting of six pellets, each containing 20 mg trenbolone acetate and 4 mg estradiol, and one pellet containing 29 mg tylosin tartrate) for increased rate of weight gain and improved feed efficiency. (E) An extended-release implant containing 200 mg trenbolone acetate and 40 mg estradiol (one implant consisting of six coated pellets and four uncoated pellets, each containing 20 mg trenbolone acetate and 4 mg estradiol) for increased rate of weight gain and improved feed efficiency for up to 200 days after implantation. (ii) Limitations. (3) Growing beef heifers fed in confinement for slaughter Amounts and indications. (B) An implant containing 80 mg trenbolone acetate, 8 mg estradiol, and 29 mg tylosin tartrate (one implant consisting of four pellets, each containing 20 mg trenbolone acetate and 2 mg estradiol, and one pellet containing 29 mg tylosin tartrate) for increased rate of weight gain and improved feed efficiency. (C) An implant containing 140 mg trenbolone acetate and 14 mg estradiol (one implant consisting of seven pellets, each containing 20 mg trenbolone acetate and 2 mg estradiol) for increased rate of weight gain and improved feed efficiency. (D) An implant containing 140 mg trenbolone acetate, 14 mg estradiol, and 29 mg tylosin tartrate (one implant consisting of seven pellets, each containing 20 mg trenbolone acetate and 2 mg estradiol, and one pellet containing 29 mg tylosin tartrate) for increased rate of weight gain and improved feed efficiency. (E) An extended-release implant containing 200 mg trenbolone acetate and 20 mg estradiol (one implant consisting of six coated pellets and four uncoated pellets, each containing 20 mg trenbolone acetate and 2 mg estradiol) for increased rate of weight gain and improved feed efficiency for up to 200 days after implantation. (ii) Limitations. (4) Growing beef steers and heifers on pasture (stocker, feeder, and slaughter) Amounts and indications for use. (B) An implant containing 40 mg trenbolone acetate, 8 mg estradiol, and 29 mg tylosin tartrate (one implant consisting of two pellets, each containing 20 mg trenbolone acetate and 4 mg estradiol, and one pellet containing 29 mg tylosin tartrate) for increased rate of weight gain. (ii) Limitations. [89 FR 42359, May 15, 2024] § 522.2478 Trenbolone acetate and estradiol benzoate. (a) Specifications. (i) 50 milligrams (mg) trenbolone acetate and 7 mg estradiol benzoate (one implant consisting of two pellets, each pellet containing 25 mg trenbolone acetate and 3.5 mg estradiol benzoate) per implant dose. (ii) 100 milligrams (mg) trenbolone acetate and 14 mg estradiol benzoate (one implant consisting of four pellets, each pellet containing 25 mg trenbolone acetate and 3.5 mg estradiol benzoate) per implant dose. (iii) 200 mg trenbolone acetate and 28 mg estradiol benzoate (one implant consisting of eight pellets, each pellet containing 25 mg trenbolone acetate and 3.5 mg estradiol benzoate) per implant dose. (2) Each extended-release implant consists of: (i) 150 mg trenbolone acetate and 21 mg estradiol benzoate (one implant consisting of six pellets with a porous polymer film coating, each pellet containing 25 mg trenbolone acetate and 3.5 mg estradiol benzoate) per implant dose. (ii) 200 mg trenbolone acetate and 28 mg estradiol benzoate (one implant consisting of eight pellets with a porous polymer film coating, each pellet containing 25 mg trenbolone acetate and 3.5 mg estradiol benzoate) per implant dose. (b) Sponsor. (c) Related tolerances. (d) Conditions of use Growing beef steers and heifers fed in confinement for slaughter Amounts and indications for use (A) An implant containing 100 mg trenbolone acetate and 14 mg estradiol benzoate as described in paragraph (a)(1)(ii) of this section for increased rate of weight gain in growing beef steers fed in confinement for slaughter and for increased rate of weight gain and improved feed efficiency in growing beef heifers fed in confinement for slaughter. For increased rate of weight gain for up to 200 days in a reimplantation program where an implant as described in paragraph (a)(1)(ii) of this section is the first implant and an implant as described in paragraph (a)(1)(ii) or (iii) or (a)(2)(ii) of this section is administered 60 to 120 days later. (B) An implant containing 200 mg trenbolone acetate and 28 mg estradiol benzoate as described in paragraph (a)(1)(iii) of this section for increased rate of weight gain and improved feed efficiency in growing beef steers fed in confinement for slaughter and for increased rate of weight gain in growing beef heifers fed in confinement for slaughter. For increased rate of weight gain for up to 200 days in a reimplantation program where an implant as described in paragraph (a)(1)(ii) of this section is the first implant and an implant as described in paragraph (a)(1)(iii) of this section is administered 60 to 120 days later. (C) An extended-release implant containing 150 mg trenbolone acetate and 21 mg estradiol benzoate as described in paragraph (a)(2)(i) of this section for increased rate of weight gain for up to 200 days. (D) An extended-release implant containing 200 mg trenbolone acetate and 28 mg estradiol benzoate as described in paragraph (a)(2)(ii) of this section for increased rate of weight gain and improved feed efficiency for up to 200 days. For increased rate of weight gain for up to 200 days in a reimplantation program where an implant as described in paragraph (a)(1)(ii) of this section is the first implant and an implant as described in paragraph (a)(2)(ii) of this section is administered 60 to 120 days later. (ii) Limitations. (2) Growing beef steers and heifers on pasture (stocker, feeder, and slaughter) Amounts and indications for use. (B) An implant containing 100 mg trenbolone acetate and 14 mg estradiol benzoate as described in paragraph (a)(1)(ii) of this section for increased rate of weight gain. (C) An extended-release implant containing 150 mg trenbolone acetate and 21 mg estradiol benzoate as described in paragraph (a)(2)(i) of this section for increased rate of weight gain for up to 200 days. (ii) Limitations. (3) Growing beef steers and heifers in a dry lot Amount and indications for use. (B) An implant containing 100 mg trenbolone acetate and 14 mg estradiol benzoate as described in paragraph (a)(1)(ii) of this section for increased rate of weight gain in growing beef steers and heifers in a dry lot. (ii) Limitations. [88 FR 14900, Mar. 10, 2023; 89 FR 85427, Oct. 28, 2024, as amended at 90 FR 6801, Jan. 21, 2025] § 522.2483 Triamcinolone. (a) Specifications. (b) Sponsors. (c) Conditions of use Dogs and cats Amount Intramuscular or subcutaneous. (B) Intralesional. (C) Intra-articular and intrasynovial. (ii) Indications for use. (iii) Limitations. (2) Horses Amount Intramuscular or subcutaneous. (B) Intra-articular and intrasynovial. (ii) Indications for use. (iii) Limitations. [75 FR 10167, Mar. 5, 2010, as amended at 78 FR 21060, Apr. 9, 2013; 80 FR 34279, June 16, 2015; 83 FR 48946, Sept. 28, 2018] § 522.2582 Triflupromazine. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount Dogs. (ii) Cats. (iii) Horses. (2) Indications for use. (3) Limitations. [79 FR 16197, Mar. 25, 2014] § 522.2610 Trimethoprim and sulfadiazine. (a) Specifications. (1) 40 milligrams (mg) trimethoprim suspended in a solution containing 200 mg sulfadiazine; or (2) 80 mg trimethoprim suspended in a solution containing 400 mg sulfadiazine (as the sodium salt). (b) Sponsors. (c) Conditions of use Dogs Amount. (ii) Indications for use. (iii) Limitations. (2) Horses Amount. (ii) Indications for use. (iii) Limitations. [71 FR 30803, May 31, 2006, as amended at 79 FR 16197, Mar. 25, 2014] § 522.2615 Tripelennamine. (a) Specifications. (b) Sponsors. (c) Related tolerances. (d) Conditions of use Dogs and cats Amount. (ii) Indications for use. (iii) Limitations. (2) Horses Amount. (ii) Indications for use. (iii) Limitations. (3) Cattle Amount. (ii) Indications for use. (iii) Limitations. [51 FR 44450, Dec. 10, 1986, as amended at 61 FR 29480, June 11, 1996; 62 FR 4164, Jan. 29, 1997; 78 FR 17597, Mar. 22, 2013; 79 FR 16198, Mar. 25, 2014; 81 FR 22524, Apr. 18, 2016; 82 FR 11508, Feb. 24, 2017; 87 FR 58962, Sept. 29, 2022] § 522.2630 Tulathromycin. (a) Specifications. (1) 100 milligrams (mg) tulathromycin (2) 25 mg tulathromycin (b) Sponsors. (1) Nos. 000061, 013744, 051311, 054771, 055529, 058198, 061133, 068504, and 069043 for use of product described in paragraph (a)(1) as in paragraphs (d)(1)(i), (d)(1)(ii), (d)(1)(iii)(A), and (d)(2) of this section. (2) Nos. 013744, 051311, 054771, 058198, 068504, and 069043 for use of product described in paragraph (a)(2) as in paragraphs (d)(1)(i), (d)(1)(ii)(B), (d)(1)(iii)(B), and (d)(2) of this section. (c) Related tolerances. (d) Conditions of use Cattle Amount. (ii) Indications for use Beef and non-lactating dairy cattle. Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, Mycoplasma bovis. M. haemolytica, P. multocida, H. somni, M. bovis. Moraxella bovis. Fusobacterium necrophorum Porphyromonas levii. (B) Suckling calves, dairy calves, and veal calves. Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, Mycoplasma bovis. (iii) Limitations. (B) Calves intended for human consumption must not be slaughtered within 22 days from the last treatment. Not for use in ruminating cattle. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Swine Amount. (ii) Indications for use. Actinobacillus pleuropneumoniae P. multocida Bordetella bronchiseptica Haemophilus parasuis Mycoplasma hyopneumoniae A. pleuropneumoniae P. multocida M. hyopneumoniae (iii) Limitations. [70 FR 39918, July 12, 2005, as amended at 71 FR 57416, Sept. 29, 2006; 72 FR 54540, Sept. 26, 2007; 73 FR 6018, Feb. 1, 2008; 73 FR 58872, Oct. 8, 2008; 74 FR 53165, Oct. 16, 2009; 78 FR 63872, Oct. 25, 2013; 79 FR 74020, Dec. 15, 2014; 80 FR 13230, Mar. 13, 2015; 81 FR 67151, Sept. 30, 2016; 86 FR 57997, Oct. 20, 2021; 87 FR 58962, Sept. 29, 2022; 88 FR 16548, Mar. 20, 2023; 88 FR 27700, May 3, 2023; 89 FR 95103, Dec. 2, 2024; 90 FR 6801, Jan. 21, 2025] § 522.2632 Tulathromycin and ketoprofen. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use Cattle Amount. (ii) Indications for use. Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, Mycoplasma bovis, (iii) Limitations. (2) [Reserved] [86 FR 61685, Nov. 8, 2021] § 522.2640 Tylosin. (a) Specifications. (b) Sponsors. (1) Nos. 016592 and 058198 for use of 50- or 200-mg/mL solutions as in paragraph (e) of this section. (2) No. 061133 for use of a 200-mg/mL solution as in paragraphs (e)(1) and (2) of this section. (c) Related tolerances. (d) Special considerations. (e) Conditions of use Beef cattle and nonlactating dairy cattle Amount. (ii) Indications for use. Pasteurella multocida Arcanobacterium pyogenes; Fusobacterium necrophorum A. pyogenes. (iii) Limitations. (2) Swine Amount. (ii) Indications for use. Mycoplasma hyosynoviae; Pasteurella Erysipelothrix rhusiopathiae; Treponema hyodysenteriae (iii) Limitations. (3) Dogs and cats Amount. (ii) Indications for use Dogs. Staphylococci Streptococci Pasteurella multocida. (B) Cats. Staphylococci Streptococci (iii) Limitations. [81 FR 67151, Sept. 30, 2016, as amended at 84 FR 8974, Mar. 13, 2019; 84 FR 32992, July 11, 2019; 88 FR 14900, Mar. 10, 2023; 88 FR 16549, Mar. 20, 2023; 88 FR 84701, Dec. 6, 2023] § 522.2662 Xylazine. (a) Specifications. (1) 20 milligrams (mg) xylazine. (2) 100 mg xylazine. (3) 300 mg xylazine. (b) Sponsors. (1) No. 069043 for use of product described in paragraph (a)(2) of this section as in paragraph (d)(2) of this section. (2) No. 061133 for use of product described in paragraph (a)(2) of this section as in paragraphs (d)(2), (d)(3)(i), (d)(3)(ii)(A), and (d)(3)(iii) of this section. (3) No. 061651 for use of product described in paragraph (a)(1) of this section as in paragraph (d)(1) of this section; and product described in paragraph (a)(2) of this section as in paragraphs (d)(2), (d)(3)(i), (d)(3)(ii)(A), and (d)(3)(iii) of this section. (4) No. 059399 for use of product described in paragraph (a)(1) of this section as in paragraph (d)(1) of this section; product described in paragraph (a)(2) of this section as in paragraphs (d)(2), (d)(3)(i), (d)(3)(ii)(A), and (d)(3)(iii) of this section; and product described in paragraph (a)(3) of this section as in paragraphs (d)(3)(i), (d)(3)(ii)(B), and (d)(3)(iii) of this section. (c) Special considerations. (d) Conditions of use Dogs and cats Amount. (ii) Indications for use. (2) Horses Amount. (ii) Indications for use. (iii) Limitations. (3) Elk and deer Amount. (A) Elk ( Cervus canadensis (B) Mule deer ( Odocoileus hemionus Cervus nippon Odocoileus virginianus (C) Fallow deer ( Dama dama (ii) Indications for use. (B) To produce sedation, accompanied by a shorter period of analgesia. May be used to calm and facilitate handling of fractious animals for diagnostic procedures, for minor surgical procedures, for therapeutic medication for sedation and relief of pain following injury or surgery, and as a preanesthetic to local anesthetic. At the recommended dosages, can be used in conjunction with local anesthetics, such as procaine or lidocaine. (iii) Limitations. [68 FR 26206, May 15, 2003, as amended at 75 FR 10167, Mar. 5, 2010, 78 FR 21060, Apr. 9, 2013; 79 FR 16198, Mar. 25, 2014; 79 FR 21127, Apr. 15, 2014; 79 FR 74020, Dec. 15, 2014; 80 FR 13230, Mar. 13, 2015; 83 FR 48946, Sept. 28, 2018; 84 FR 8974, Mar. 13, 2019; 87 FR 17946, Mar. 29, 2022; 90 FR 19625, May 9, 2025; 91 FR 41560, July 7, 2026] § 522.2670 Yohimbine. (a) Specifications. (b) Sponsors. (1) No. 059399 for use of in 2 mg/mL solution as in paragraph (c)(1) of this section. (2) No. 053923 for use of in 5 mg/mL solution as in paragraph (c)(2) of this section. (c) Conditions of use Dogs Amount. (ii) Indications for use. (iii) Limitations. (2) Deer and elk Amount. (ii) Indications for use. (iii) Limitations. [79 FR 74020, Dec. 15, 2014, as amended at 80 FR 13230, Mar. 13, 2015] § 522.2680 Zeranol. (a) Specifications. (b) Sponsor. (c) Related tolerances. (d) Conditions of use Beef cattle Amount. (ii) Indications for use. (B) For increased rate of weight gain in beef calves 2 months of age or older, in growing beef steers and heifers on pasture (stocker, feeder, and slaughter), and in growing beef steers and heifers in a dry lot. (iii) Limitations. (2) Feedlot lambs Amount. (ii) Indications for use. (iii) Limitations. (3) Steers fed in confinement for slaughter Amount. (ii) Indications for use. (iii) Limitations. (4) Pasture cattle (slaughter, stocker, feeder steers, and heifers) Amount. (ii) Indications for use. (iii) Limitations. [59 FR 19639, Apr. 25, 1994; 60 FR 26360, May 17, 1995, as amended at 62 FR 61625, Nov. 19, 1997; 64 FR 46840, Aug. 27, 1999; 67 FR 6867, Feb. 14, 2002; 70 FR 6764, Feb. 9, 2005; 88 FR 55566, Aug. 16, 2023; 91 FR 5301, Feb. 6, 2026] § 522.2690 Zinc gluconate. (a) Specifications. (b) Sponsor. (c) Conditions of use in dogs Amount. (2) Indications for use. (3) Limitations. [68 FR 26995, May 19, 2003, as amended at 76 FR 79064, Dec. 21, 2011; 87 FR 76422, Dec. 14, 2022] § 522.2694 Zinc, copper, manganese, and selenium. (a) Specifications. (b) Sponsor. (c) Conditions of use Amount. (2) Indications for use. (3) Limitations. [89 FR 85428, Oct. 28, 2024]

21 CFR Part 522 — Implantation or Injectable Dosage Form New Animal Drugs

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