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| section_id ▼ | title_number | title_name | chapter | subchapter | part_number | part_name | subpart | subpart_name | section_number | section_heading | agency | authority | source_citation | amendment_citations | full_text |
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| 21:21:6.0.1.1.12.0.1.1 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.23 Acepromazine. | FDA | [75 FR 10167, Mar. 5, 2010; 78 FR 17597, Mar. 22, 2013; 79 FR 16182, Mar. 25, 2014; 86 FR 14819, Mar. 19, 2021] | (a) Specifications. Each milliliter of solution contains 10 milligrams (mg) acepromazine maleate. (b) Sponsors. See Nos. 000010 and 058198 in § 510.600(c) of this chapter. (c) Conditions of use in dogs, cats, and horses —(1) Amount. Dogs: 0.25 to 0.5 mg per pound (/lb) of body weight; Cats: 0.5 to 1.0 mg/lb of body weight; Horses: 2.0 to 4.0 mg per 100 lbs of body weight. (2) Indications for use. For use as a tranquilizer and as a preanesthetic agent. (3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.10 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.90c Ampicillin sodium. | FDA | [72 FR 45158, Aug. 13, 2007, as amended at 79 FR 16184, Mar. 25, 2014; 86 FR 57997, Oct. 20, 2021] | (a) Specifications. Each milliliter of aqueous solution constituted from ampicillin sodium powder contains 300 milligrams (mg) ampicillin equivalents. (b) See Nos. 042791 and 054771 in § 510.600(c) of this chapter. (c) Conditions of use in horses —(1) Amount : 3 mg per pound of body weight twice daily by intravenous or intramuscular injection. (2) Indications for use. For the treatment of respiratory tract infections (pneumonia and strangles) due to Staphylococcus spp., Streptococcus spp. (including S. equi ), Escherichia coli , and Proteus mirabilis , and skin and soft tissue infections (abscesses and wounds) due to Staphylococcus spp., Streptococcus spp., E. coli , and P. mirabilis , when caused by susceptible organisms. (3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.100 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1290 Luprostiol. | FDA | [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] | (a) Specifications. Each milliliter of solution contains 7.5 milligrams (mg) luprostiol. (b) Sponsor. See No. 051311 in § 510.600(c) of this chapter. (c) Special considerations. Labeling shall bear the following statements: Warning: Women of childbearing age, asthmatics, and persons with bronchial and other respiratory problems should exercise extreme caution when handling this product. In the early stages, women may be unaware of their pregnancies. Luprostiol is readily absorbed through the skin and can cause abortion and/or bronchiospasms. Direct contact with the skin should therefore be avoided. Accidental spillage on the skin should be washed off immediately with soap and water. (d) Conditions of use in horses —(1) Amount. 7.5 mg by intramuscular injection. (2) Indications for use. For estrus control and termination of pregnancy in mares. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption. | |||||
| 21:21:6.0.1.1.12.0.1.101 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1315 Maropitant. | FDA | [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] | (a) Specifications. Each milliliter of solution contains 10 milligrams (mg) maropitant as maropitant citrate. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Dogs —(i) Amount. Administer 1.0 mg per kilogram (mg/kg) of body weight by subcutaneous or intravenous injection once daily for up to 5 consecutive days. (ii) Indications for use. For the prevention and treatment of acute vomiting. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Cats —(i) Amount. Administer 1.0 mg/kg of body weight by subcutaneous or intravenous injection once daily for up to 5 consecutive days. (ii) Indications for use. For the treatment of vomiting. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.102 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1335 Medetomidine. | FDA | [61 FR 21075, May 9, 1996, as amended at 79 FR 16191, Mar. 25, 2014; 82 FR 58556, Dec. 13, 2017] | (a) Specifications. Each milliliter of solution contains 1.0 milligrams of medetomidine hydrochloride. (b) Sponsor. See Nos. 015914 and 052483 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Amount. 750 micrograms intravenously (IV) or 1,000 micrograms intramuscularly per square meter of body surface. The IV route is more efficacious for dental care. (2) Indications for use. As a sedative and analgesic in dogs over 12 weeks of age to facilitate clinical examinations, clinical procedures, minor surgical procedures not requiring muscle relaxation, and minor dental procedures not requiring intubation. The intravenous route of administration is more efficacious for dental care. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.103 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1338 Medetomidine and vatinoxan. | FDA | [87 FR 58962, Sept. 29, 2022, as amended at 87 FR 76421, Dec. 14, 2022] | (a) Specifications. Each milliliter of solution contains 0.5 milligrams (mg) medetomidine hydrochloride and 10 mg vatinoxan hydrochloride. (b) Sponsor. See No. 043264 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Amount. Administer by intramuscular injection a dose based on body surface area (BSA). Calculate the dose using 1 mg medetomidine per square meter (/m 2 ) BSA or use the dosing table provided in labeling. (2) Indications for use. For use as a sedative and analgesic in dogs to facilitate clinical examination, clinical procedures, and minor surgical procedures. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.104 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1350 Melatonin implant. | FDA | [59 FR 37422, July 22, 1994] | (a) Specifications. The drug is a silicone rubber elastomer implant containing 2.7 milligrams of melatonin. (b) Sponsor. See No. 053923 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Amount. One implant per mink. (2) Indications for use. For use in healthy male and female kit and adult female mink ( Mustela vison ) to accelerate the fur priming cycle. (3) Limitations. For subcutaneous implantation in mink only. Do not implant potential breeding stock. Do not use in food-producing animals. | |||||
| 21:21:6.0.1.1.12.0.1.105 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1362 Melarsomine powder for injection. | FDA | [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] | (a) Specifications. The drug consists of a vial of lyophilized powder containing 50 milligrams of melarsomine dihydrochloride which is reconstituted with the provided 2 milliliters of sterile water for injection. (b) Sponsor. See Nos. 000010 and 086073 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Amount. Administer only by deep intramuscular injection in the lumbar muscles (L 3 -L 5 ). (2) Indications. Treatment of stabilized, class 1, 2, and 3 heartworm disease (asymptomatic to mild, moderate, and severe, respectively) caused by immature (4 month-old, stage L 5 ) to mature adult infections of Dirofilaria immitis in dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.106 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1367 Meloxicam. | FDA | [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] | (a) Specifications. Each milliliter of solution contains 5.0 milligrams (mg) meloxicam. (b) Sponsors. See Nos. 000010, 016729, 017033, 055529, and 086101 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Dogs —(i) Amount. Administer 0.09 mg per pound (mg/lb) body weight (0.2 mg per kilogram (mg/kg)) by intravenous or subcutaneous injection on the first day of treatment. For treatment after day 1, administer meloxicam suspension orally at 0.045 mg/lb (0.1 mg/kg) body weight once daily as in § 520.1367(c) of this chapter. (ii) Indications for use. For the control of pain and inflammation associated with osteoarthritis. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Cats —(i) Amount. Administer 0.14 mg/lb (0.3 mg/kg) body weight as a single, one-time subcutaneous injection. (ii) Indications for use. For the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy, and castration when administered prior to surgery. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.107 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1372 Mepivacaine. | FDA | [71 FR 39547, July 13, 2006, as amended at 79 FR 16191, Mar. 25, 2014; 88 FR 14898, Mar. 10, 2023] | (a) Specifications. Each milliliter (mL) of solution contains 20 milligrams mepivacaine hydrochloride. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in horses —(1) Amount. For nerve block, 3 to 15 mL; for epidural anesthesia, 5 to 20 mL; for intra-articular anesthesia, 10 to 15 mL; for infiltration, as required; for anesthesia of the laryngeal mucosa prior to ventriculectomy, by topical spray, 25 to 40 mL, by infiltration, 20 to 50 mL. (2) Indications for use. For use as a local anesthetic for infiltration, nerve block, intra-articular and epidural anesthesia, and topical and/or infiltration anesthesia of the laryngeal mucosa prior to ventriculectomy. (3) Limitations. Not for use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.108 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1380 Methocarbamol. | FDA | [79 FR 16191, Mar. 25, 2014, as amended at 82 FR 11508, Feb. 24, 2017] | (a) Specifications. Each milliliter of solution contains 100 milligrams (mg) of methocarbamol. (b) Sponsor. See No. 051031 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Amount —(i) Dogs and cats. Administer by intravenous injection 20 mg per pound of body weight for moderate conditions or 25 to 100 mg per pound of body weight for severe conditions (tetanus and strychnine poisoning). The total cumulative dose should not to exceed 150 mg per pound of body weight. (ii) Horses. Administer by intravenous injection 2 to 10 mg per pound of body weight for moderate conditions or 10 to 25 mg per pound of body weight for severe conditions (tetanus). Additional amounts may be needed to relieve residual effects and to prevent recurrence of symptoms. (2) Indications for use. As an adjunct for treating acute inflammatory and traumatic conditions of the skeletal muscles and to reduce muscular spasms. (3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.109 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1410 Methylprednisolone. | FDA | [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] | (a) Specifications. Each milliliter of suspension contains 20 or 40 milligrams (mg) of methylprednisolone acetate. (b) Sponsors. See Nos. 054771 and 069043 in § 510.600(c) of this chapter. (c) [Reserved] (d) Conditions of use —(1) Dogs —(i) Amount. Administer 2 to 40 mg (up to 120 mg in extremely large breeds or dogs with severe involvement) by intramuscular injection or up to 20 mg by intrasynovial injection. (ii) Indications for use. For treatment of inflammation and related disorders; treatment of allergic and dermatologic disorders; and as supportive therapy to antibacterial treatment of severe infections. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Cats —(i) Amount. Administer 10 to 20 mg by intramuscular injection. (ii) Indications for use. For treatment of inflammation and related disorders; treatment of allergic and dermatologic disorders; and as supportive therapy to antibacterial treatment of severe infections. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (3) Horses —(i) Amount. Administer 200 mg by intramuscular injection or 40 to 240 mg by intrasynovial injection. (ii) Indications for use. For treatment of inflammation and related disorders. (iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.11 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.144 Arsenamide. | FDA | [79 FR 16184, Mar. 25, 2014, as amended at 84 FR 39183, Aug. 9, 2019] | (a) Specifications. Each milliliter of solution contains 10.0 milligrams arsenamide sodium. (b) Sponsor. See No. 000010 in § 510.600(c) of this chapter. (c) Conditions of use in dogs —(1) Amount. Administer 0.1 milliliter (mL) per pound of body weight (1.0 mL for every 10 pounds) by intravenous injection twice a day for 2 days. (2) Indications for use. For the treatment and prevention of canine heartworm disease caused by Dirofilaria immitis. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.110 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1450 Moxidectin solution. | FDA | [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] | (a) Specifications. Each milliliter (mL) of solution contains 10 milligrams (mg) moxidectin. (b) Sponsors. See Nos. 055529, 058198, and 061133 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.426 of this chapter. (d) Special considerations. See § 500.25 of this chapter. (e) Conditions of use in cattle—(1) Amount. Administer by subcutaneous injection 1 mL for each 110 pounds (lb) (50 kilograms (kg)) body weight to provide 0.2 mg moxidectin/2.2 lb (0.2 mg/kg) body weight. (2) Indications for use. Beef and nonlactating dairy cattle: For treatment and control of Gastrointestinal roundworms: Ostertagia ostertagi (adults, fourth-stage larvae, and inhibited larvae), Haemonchus placei (adults), Trichostrongylus axei (adults and fourth-stage larvae), Trichostrongylus colubriformis (adults and fourth-stage larvae), Cooperia oncophora (adults), Cooperia pectinata (adults), Cooperia punctata (adults and fourth-stage larvae), Cooperia spatulata (adults), Cooperia surnabada (adults and fourth-stage larvae), Nematodirus helvetianus (adults), Oesophagostomum radiatum (adults and fourth-stage larvae), Trichuris spp. (adults); Lungworms: Dictyocaulus viviparus (adults and fourth-stage larvae); Cattle grubs: Hypoderma bovis and Hypoderma lineatum; Mites: Psoroptes ovis ( Psoroptes communis var. bovis ); Lice: Linognathus vituli and Solenopotes capillatus. For protection from reinfection with Dictyocaulus viviparus and Oesophagostomum radiatum for 42 days after treatment, with Haemonchus placei for 35 days after treatment, and with Ostertagia ostertagi and Trichostrongylus axei for 14 days after treatment. (3) Limitations. Cattle must not be slaughtered for human consumption within 21 days of treatment. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been establish… | |||||
| 21:21:6.0.1.1.12.0.1.111 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1451 Moxidectin microspheres for injection. | FDA | [85 FR 4208, Jan. 24, 2020] | (a) Specifications. The drug product consists of two separate vials. One vial contains 10 percent moxidectin microspheres and the second vial contains a vehicle for constitution of the moxidectin microspheres. (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. See No. 54771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs —(1) Amount. (i) Using the suspension described in paragraph (a)(1) of this section, administer 0.05 mL of the constituted suspension per kilogram (kg) of body weight (0.023 mL per pound (lb)) as a single subcutaneous injection to provide 0.17 mg/kg body weight (0.0773 mg/lb). (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 —(i) Suspension described in paragraph (a)(1) of this section. For prevention of heartworm disease caused by Dirofilaria immitis in dogs 6 months of age and older; and for treatment of existing larval and adult hookworm ( Ancylostoma caninum and Uncinaria stenocephala ) infections. (ii) Suspension described in paragraph (a)(2) of this section. For prevention of heartworm disease caused by Dirofilaria immitis for 12 months in dogs 12 months of age and older; and for treatment of existing larval and adult hookworm ( Ancylostoma caninum and Uncinaria stenocephala ) infections. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.112 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1452 Nalorphine. | FDA | [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] | (a) Specifications. Each milliliter of solution contains 5 milligrams of nalorphine hydrochloride. (b) Sponsor. See No. 000010 in § 510.600(c) of this chapter. (c) Conditions of use in dogs —(1) Amount. One milligram per 5 pounds; intravenously, intramuscularly, or subcutaneously. (2) Indications for use. Respiratory and circulatory depression in dogs resulting from overdosage of, or unusual sensitivity to, morphine and certain other narcotics. Not for depression due to any other cause. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.113 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1465 Naltrexone. | FDA | [62 FR 5320, Feb. 5, 1997, as amended at 79 FR 16191, Mar. 25, 2014] | (a) Specifications. Each milliliter of solution contains 50 milligrams of naltrexone hydrochloride. (b) Sponsor. See 053923 in § 510.600(c) of this chapter. (c) Conditions of use in elk and moose —(1) Amount. 100 milligrams of naltrexone hydrochloride for each milligram of carfentanil citrate administered. One-quarter of the dose should be administered intravenously and three-quarters of the dose should be administered subcutaneously. (2) Indications for use. As an antagonist to carfentanil citrate immobilization in free-ranging or confined elk and moose ( Cervidae ). (3) Limitations. Do not use in domestic food-producing animals. Do not use in free-ranging animals for 45 days before or during hunting season. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.114 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1468 Naproxen for injection. | FDA | [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] | (a) Specifications. The drug is a lyophilized powder which is reconstituted with sterile water for injection to form a 10 percent sterile aqueous solution (100 milligrams per milliliter). (b) Sponsor. See 054771 in § 510.600(c) of this chapter. (c) Conditions of use in horses —(1) Dosage. Five milligrams per kilogram of body weight intravenously followed by maintenance oral therapy of 10 milligrams per kilogram of body weight twice daily for up to 14 consecutive days. (2) Indications for use. For the relief of inflammation and associated pain and lameness exhibited with arthritis, as well as myositis and other soft tissue diseases of the musculoskeletal system of the horse. (3) Limitations. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.115 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1484 Neomycin. | FDA | [79 FR 16192, Mar. 25, 2014] | (a) Specifications. Each milliliter of solution contains 50 milligrams (mg) of neomycin sulfate (equivalent to 35 mg of neomycin base). (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats —(1) Amount. Administer 5 mg per pound of body weight daily by intramuscular or intravenous injection, divided into portions administered every 6 to 8 hours for 3 to 5 days. (2) Indications for use. For the treatment of acute and chronic bacterial infections due to organisms susceptible to neomycin. (3) Limitations. Not for parenteral use in food-producing animals because of prolonged residues in edible tissues. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.116 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1503 Neostigmine. | FDA | [40 FR 13858, Mar. 27, 1975, as amended at 62 FR 61625, Nov. 19, 1997; 79 FR 16192, Mar. 25, 2014] | (a) Specifications. Each milliliter of solution contains 2 milligrams (mg) neostigmine methylsulfate. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Amount. Administer to cattle and horses at a dosage level of 1 mg per (/) 100 pounds (lbs) of body weight subcutaneously. Administer to sheep at a dosage level of 1 to 1 1/2 mg/100 lbs body weight subcutaneously. Administer to swine at a dosage level of 2 to 3 mg/100 lbs body weight intramuscularly. These doses may be repeated as indicated. (2) Indications for use. For treating rumen atony; initiating peristalsis which causes evacuation of the bowel; emptying the urinary bladder; and stimulating skeletal muscle contractions. (3) Limitations. Not for use in animals producing milk, since this use will result in contamination of the milk. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.117 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1610 Oleate sodium. | FDA | [41 FR 27034, July 1, 1976, as amended at 50 FR 40966, Oct. 8, 1985; 79 FR 16192, Mar. 25, 2014] | (a) Specifications. Each milliliter of solution contains 50 milligrams (mg) of sodium oleate. (b) Sponsor. See No. 037990 in § 510.600(c) of this chapter. (c) Conditions of use in horses —(1) Amount. Administer by parenteral injection depending on the area of response desired. An injection of 1 milliliter (mL) will produce a response of approximately 15 square centimeters. Do not inject more than 2 mL per injection site. Regardless of the number of injection sites, the total volume used should not exceed 10 mL. (2) Indications for use. It is used in horses to stimulate infiltration of cellular blood components that subsequently differentiate into fibrous and/or fibrocartilagenous tissue. (3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.118 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1660 Oxytetracycline injectable dosage forms. | FDA | |||||||
| 21:21:6.0.1.1.12.0.1.119 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1660a Oxytetracycline solution, 200 milligrams/milliliter. | FDA | [45 FR 16479, Mar. 14, 1980. Redesignated and amended at 69 FR 31879, June 8, 2004] | (a) Specifications. Each milliliter of sterile solution contains 200 milligrams of oxytetracycline base. (b) Sponsors. See Nos. 000010, 016592, 054771, 055529, 061133, and 069254 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.500 of this chapter; and for No. 061133, see also § 500.1410 of this chapter. (d) Conditions of use —(1) Beef cattle, dairy cattle, and calves including prerumenative (veal) calves —(i) Amounts and indications for use. (A) 3 to 5 mg per pound of body weight (mg/lb BW) per day (/day) intramuscularly, subcutaneously, or intravenously for treatment of pneumonia and shipping fever complex associated with Pasteurella spp. and Haemophilus spp., foot-rot and diphtheria caused by Fusobacterium necrophorum, bacterial enteritis (scours) caused by Escherichia coli, wooden tongue caused by Actinobacillus lignieresii, leptospirosis caused by Leptospira pomona, wound infections and acute metritis caused by Staphylococcus spp. and Streptococcus spp., and anthrax caused by Bacillus anthracis. (B) 5 mg/lb BW/day intramuscularly or intravenously for treatment of anaplasmosis caused by Anaplasma marginale, 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, for treatment of infectious bovine keratoconjunctivitis (pinkeye) caused by Moraxella bovis, or where retreatment for anaplasmosis is impractical. (ii) Limitations. Discontinue treatment at least 28 days prior to slaughter. Milk taken from animals during treatment and for 96 hours after the last treatment must not be used for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Swine —(i) Amounts and indications for use. (A) Sows: 3 mg/lb BW intramuscularly once, approximately 8 hours before farrowing or immediately after completion of farrowing, as an aid in control of infectious enteritis (bab… | |||||
| 21:21:6.0.1.1.12.0.1.12 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.147 Atipamezole. | FDA | [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] | (a) Specifications. Each milliliter of solution contains 5.0 milligrams atipamezole hydrochloride. (b) Sponsors. See Nos. 015914, 052483, 068504, and 069043 in § 510.600(c) of this chapter. (c) Conditions of use in dogs —(1) Amount. Administer 3,750 mcg/m 2 intramuscularly for the reversal of intravenous dexmedetomidine hydrochloride or medetomidine hydrochloride and 5,000 mcg/m 2 intramuscularly for the reversal of intramuscular dexmedetomidine hydrochloride or medetomidine hydrochloride. (2) Indications for use. For the reversal of the sedative and analgesic effects of dexmedetomidine hydrochloride and medetomidine hydrochloride. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.120 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1660b Oxytetracycline solution, 300 milligrams/milliliter. | FDA | [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] | (a) Specifications. Each milliliter (mL) of solution contains 300 milligrams (mg) oxytetracycline base. (b) Sponsor. See No. 055529 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.500 of this chapter. (d) Special considerations. When labeled for use as in paragraph (e)(1)(i)(D) or (e)(1)(i)(E) of this section, labeling shall also bear the following: “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”. (e) Conditions of use —(1) Beef cattle, nonlactating dairy cattle, and calves including preruminating (veal) calves —(i) Amounts and indications for use. (A) 3 to 5 mg per pound of bodyweight (mg/lb BW) per day (/day) intramuscularly, subcutaneously, or intravenously for treatment of pneumonia and shipping fever complex associated with Pasteurella spp. and Histophilus spp., foot-rot and diphtheria caused by Fusobacterium necrophorum, bacterial enteritis (scours) caused by Escherichia coli, wooden tongue caused by Actinobacillus lignieresii, leptospirosis caused by Leptospira pomona, wound infections and acute metritis caused by Staphylococcus spp. and Streptococcus spp. (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. … | |||||
| 21:21:6.0.1.1.12.0.1.121 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1662 Oxytetracycline. | FDA | [40 FR 13858, Mar. 27, 1975. Redesignated at 88 FR 14898, Mar. 10, 2023] | (a) For related tolerances see § 556.500 of this chapter. (b)(1) Specifications. Each milliliter (mL) of solution contains 50 milligrams (mg) oxytetracycline hydrochloride. (2) Sponsor. See No. 069043 in § 510.600(c) of this chapter. (3) Conditions of use —(i) Amount. Administer 3 to 5 mg per pound of body weight (mg/lb) per day by intramuscular injection. Leptospirosis, severe foot-rot, and severe forms of the indicated diseases should be treated with 5 mg/lb per day. Treatment should be continued for 24 to 48 hours following remission of clinical signs of disease, not to exceed 4 consecutive days. Not more than 10 mL should be injected per injection site in adult cattle, and only 2 mL per injection site in calves weighing 100 pounds or less. (ii) Indications for use. Beef cattle, beef calves, nonlactating dairy cattle, and dairy calves; for treatment of diseases due to oxytetracycline-susceptible organisms as follows: Pneumonia and shipping fever complex ( Pasteurella spp ., Haemophilus spp ., Klebsiella spp.), bacterial enteritis (scours) ( Escherichia coli ), foot-rot ( Spherophorus necrophorus ), diphtheria ( Spherophorus necrophorus ), wooden tongue ( Actinobacillus lignieresii ), leptospirosis ( Leptospira pomona ), and wound infections and acute metritis caused by Staphylococcus spp. and Streptococcus spp. (iii) Limitations. Discontinue treatment at least 20 days prior to slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (c)(1) Specifications. Each milliliter (mL) of solution contains 50 or 100 milligrams (mg) oxytetracycline hydrochloride. (2) Sponsor. See No. 069043 in § 510.600(c) of this chapter. (3) Conditions of use —(i) Beef cattle and nonlactating dairy cattle —(A) Amount. Administer 3 to 5 mg per pound of body weight (mg/lb) per day; 5 mg/lb per day for the treatment of anaplasmosis, severe foot-rot, and severe cases of other indicated diseases. For 50-mg/mL solution, administer intramuscularly or intravenously; for … | |||||
| 21:21:6.0.1.1.12.0.1.122 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1663 Oxytetracycline hydrochloride with lidocaine injection. | FDA | [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] | (a) Specifications. The drug contains 50 or 100 milligrams of oxytetracycline hydrochloride and 2 percent lidocaine in each milliliter of sterile aqueous solution. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use. (1) The drug is indicated for use in the treatment of diseases of dogs caused by pathogens sensitive to oxytetracycline hydrochloride including treatment for the following conditions in dogs caused by susceptible microorganisms: Bacterial infections of the urinary tract caused by Hemolytic staphylococcus, Streptococcus spp., Bacterial pulmonary infections caused by Brucella bronchiseptica, Streptococcus pyogenes, Staphylococcus aureus, secondary bacterial infections caused by 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. | |||||
| 21:21:6.0.1.1.12.0.1.123 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1664 Oxytetracycline and flunixin. | FDA | [76 FR 3489, Jan. 20, 2011, as amended at 79 FR 16192, Mar. 25, 2014] | (a) Specifications. Each milliliter (mL) of solution contains 300 milligrams (mg) oxytetracycline base as amphoteric oxytetracycline and 20 mg flunixin base as flunixin meglumine. (b) Sponsor. See No. 055529 in § 510.600(c) of this chapter. (c) Related tolerances. See §§ 556.286 and 556.500 of this chapter. (d) Conditions of use cattle —(1) Amount. Administer once as an intramuscular or subcutaneous injection of 1 mL per 22 pounds (lb) body weight (BW) (13.6 mg oxytetracycline and 0.9 mg flunixin per lb BW) where retreatment of calves and yearlings for bacterial pneumonia is impractical due to husbandry conditions, such as cattle on range, or where their repeated restraint is inadvisable. (2) Indications for use. For the treatment of bacterial pneumonia associated with Pasteurella spp. and for the control of associated pyrexia in beef and nonlactating dairy cattle. (3) Limitations. Discontinue treatment at least 21 days prior to slaughter of cattle. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.124 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1680 Oxytocin. | FDA | [44 FR 63097, Nov. 2, 1979; 45 FR 1019, Jan. 4, 1980] | (a) Specifications. Each milliliter (mL) of solution contains 20 USP units oxytocin. (b) Sponsors. See Nos. 054771 and 061133 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Amount —(i) Obstetrical. Administer drug intravenously, intramuscularly, or subcutaneously under aseptic conditions as indicated. The following dosages are recommended and may be repeated as conditions require: (ii) Milk letdown. Intravenous administration is desirable. The following dosage is recommended and may be repeated as conditions require: (2) Indications for use. Oxytocin may be used as a uterine contractor to precipitate and accelerate normal parturition and postpartum evacuation of uterine debris. In surgery it may be used postoperatively following cesarean section to facilitate involution and resistance to the large inflow of blood. It will contract smooth muscle cells of the mammary gland for milk letdown if the udder is in proper physiological state. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.125 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1684 Pegbovigrastim. | FDA | [81 FR 36789, June 8, 2016, as amended at 81 FR 48702, July 26, 2016] | (a) Specifications. Each pre-filled, single-dose syringe contains 15 milligrams of pegbovigrastim. (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. (c) Conditions of use in cattle —(1) Amount. Administer the first dose (syringe) by subcutaneous injection 7 days prior to the cow's or heifer's anticipated calving date. If necessary, the first dose may be administered within a range of 4 to 10 days prior to the anticipated calving date to accommodate management schedules. Administer the second dose (syringe) by subcutaneous injection within 24 hours after calving. (2) Indications for use. For the reduction in the incidence of clinical mastitis in the first 30 days of lactation in periparturient dairy cows and periparturient replacement dairy heifers. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.126 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1696 Penicillin G procaine injectable dosage forms. | FDA | |||||||
| 21:21:6.0.1.1.12.0.1.127 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1696a Penicillin G benzathine and penicillin G procaine suspension. | FDA | [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] | (a) Specifications. Each milliliter of aqueous suspension contains penicillin G benzathine and penicillin G procaine, each equivalent to 150,000 units of penicillin G. (b) Sponsors. See sponsors in § 510.600(c) of this chapter for the conditions of use in paragraph (d) of this section as follows: (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. See § 556.510 of this chapter. (d) Conditions of use —(1) Horses, dogs, and beef cattle —(i) Amount —(A) Beef cattle. 2 milliliters per 150 pounds of body weight intramuscularly or subcutaneously. Repeat dosage in 48 hours. (B) Horses. 2 milliliters per 150 pounds of body weight intramuscularly. Repeat dosage in 48 hours. (C) Dogs. 1 milliliter per 10 to 25 pounds of body weight intramuscularly or subcutaneously. Repeat dosage in 48 hours. (ii) Indications for use. Treatment of bacterial infections susceptible to penicillin G. (iii) Limitations. Not for use in beef cattle within 30 days of slaughter. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Beef cattle —(i) Amount. 2 milliliters per 150 pounds of body weight subcutaneously. Repeat dosage in 48 hours. (ii) Indications for use. (A) Treatment of bacterial pneumonia ( Streptococcus spp., Actinomyces pyogenes , Staphylococcus aureus ); upper respiratory infections such as rhinitis or pharyngitis ( A. pyogenes ); blackleg ( 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. Not for use within 30 days of slaughter. For No. 016592: A withdrawal period has not been established for this product in pre-ruminating calves.… | |||||
| 21:21:6.0.1.1.12.0.1.128 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1696b Penicillin G procaine aqueous suspension. | FDA | [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] | (a) Specifications. Each milliliter contains penicillin G procaine equivalent to 300,000 units of penicillin G. (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter as follows: (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. See § 556.510 of this chapter. (d) Conditions of use —(1) Dogs and cats —(i) Amount. 10,000 units per pound body weight daily by intramuscular injection. (ii) Indications for use. Treatment of infections caused by penicillin-sensitive organisms. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Cattle, sheep, swine, and horses —(i) Amount. 3,000 units per pound body weight (1 milliliter per 100 pounds body weight) daily by intramuscular injection. (ii) Indications for use. Treatment of cattle and sheep for bacterial pneumonia (shipping fever) caused by Pasteurella multocida ; swine for erysipelas caused by Erysipelothrix rhusiopathiae ; and horses for strangles caused by Streptococcus equi. (iii) Limitations. Not for use in horses intended for food. Milk that has been taken during treatment and for 48 hours after the last treatment must not be used for food. (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. | |||||
| 21:21:6.0.1.1.12.0.1.129 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1696c Penicillin G procaine in oil. | FDA | [57 FR 37333, Aug. 18, 1992, as amended at 79 FR 16193, Mar. 25, 2014] | (a) Specifications. Each milliliter contains penicillin G procaine equivalent to 300,000 units of penicillin G. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Amount. Dogs and cats—10,000 units per pound of body weight once daily. Horses—3,000 units per pound of body weight once daily. (2) Indications for use. Treatment of infections of dogs, cats, and horses caused by penicillin-susceptible organisms such as Streptococci, Staphylococci, and Corynebacteria. (3) Limitations. Not for use in food-producing animals. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.13 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.150 Azaperone. | FDA | [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] | (a) Specifications. Each milliliter of solution contains 40 milligrams (mg) azaperone. (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.68 of this chapter. (d) Conditions of use —(1) Indications for use. For control of aggressiveness when mixing or regrouping weanling or feeder pigs weighing up to 80 pounds. (2) Dosage. 2.2 mg per kilogram (1 mg per pound) by deep intramuscular injection. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.130 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1698 Pentazocine. | FDA | [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] | (a) Specifications. Each milliliter of solution contains pentazocine lactate equivalent to 30 milligrams (mg) of pentazocine base. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Horses —(i) Amount. Administer 0.15 mg pentazocine base per pound of body weight daily by intravenous or intramuscular injection. In cases of severe pain, a second dose is recommended by intramuscular injection 10 to 15 minutes after the initial dose at the same level. (ii) Indications for use. For symptomatic relief of pain due to colic. (iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Dogs —(i) Amount. Administer 0.75 to 1.50 mg of pentazocine base per pound of body weight by intramuscular injection. (ii) Indications for use. For amelioration of pain accompanying postoperative recovery, fracture, trauma, and spinal disorders. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.131 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1700 Pentobarbital and phenytoin. | FDA | [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] | (a) Specifications. Each milliliter (mL) of solution contains 390 milligrams (mg) pentobarbital sodium and 50 mg phenytoin sodium. (b) Sponsors. See Nos. 000061, 051311, 054925, and 086119 in § 510.600(c) of this chapter. (c) Special considerations. Product labeling shall bear the following warning statements: “ENVIRONMENTAL HAZARD: This product is toxic to wildlife. Birds and mammals feeding on treated animals may be killed. Euthanized animals must be properly disposed of by deep burial, incineration, or other method in compliance with State and local laws, to prevent consumption of carcass material by scavenging wildlife.” (d) Conditions of use in dogs —(1) Amount. Administer 1 mL per 10 pounds of body weight as a single, bolus intravenous or intracardiac injection. (2) Indications for use. For humane, painless, and rapid euthanasia. (3) Limitations. Do not use in animals intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.132 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1703 Pentobarbital. | FDA | [79 FR 16193, Mar. 25, 2014. Redesignated at 86 FR 61685, Nov. 8, 2021] | (a) Specifications. Each milliliter of solution contains 64.8 milligrams (mg) of sodium pentobarbital. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Amount. The drug is administered intravenously “to effect”. For general surgical anesthesia, the usual dose is 11 to 13 mg per pound of body weight. For sedation, the usual dose is approximately 2 mg per pound of body weight. For relieving convulsive seizures caused by strychnine in dogs, the injection should be administered intravenously “to effect”. The drug may be administered intraperitoneally. When given intraperitoneally, it is administered at the same dosage level as for intravenous administration. (2) Indications for use. The drug is indicated for use as a general anesthetic in dogs and cats. Although it may be used as a general surgical anesthetic for horses, it is usually given at a lower dose to cause sedation and hypnosis and may be supplemented with a local anesthetic. It may also be used in dogs for the symptomatic treatment of strychnine poisoning. (3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.133 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1704 Pentosan polysulfate sodium. | FDA | [88 FR 16548, Mar. 20, 2023, as amended at 88 FR 84701, Dec. 6, 2023] | (a) Specifications. Each milliliter of solution contains 250 milligrams (mg) of pentosan polysulfate sodium. (b) Sponsor. See No. 043264 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Amount. Administer 3 mg per kilogram of body weight (1.4 mg per pound) by intramuscular injection once weekly for 4 weeks for a total of four doses. (2) Indications for use. For the control of clinical signs associated with osteoarthritis in horses. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.134 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1720 Phenylbutazone. | FDA | [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] | (a) Specifications. (1) Each milliliter of solution contains 100 milligrams (mg) of phenylbutazone. (2) Each milliliter of solution contains 200 mg of phenylbutazone. (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter for use as in paragraph (c) of this section: (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 —(1) Dogs —(i) Amount. Administer by intravenous injection 10 mg per pound of body weight daily in three divided doses, not to exceed 800 mg daily regardless of weight. Limit intravenous administration to 2 successive days. Oral medication may follow. (ii) Indications for use. It is used for the relief of inflammatory conditions associated with the musculoskeletal system. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Horses —(i) Amount. Administer by intravenous injection 1 to 2 grams (g) per 1,000 pounds of body weight daily in three divided doses, not to exceed 4 g daily. Limit intravenous administration to not more than 5 successive days. (ii) Indications for use. For the relief of inflammatory conditions associated with the musculoskeletal system. (iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.135 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1820 Pituitary luteinizing hormone powder for injection. | FDA | [40 FR 13858, Mar. 27, 1975, as amended at 52 FR 7832, Mar. 13, 1987; 79 FR 16193, Mar. 25, 2014] | (a) Specifications. The drug is a lyophilized pituitary extract. Each 6-milliliter vial contains an amount equivalent to 25 milligrams of standard pituitary luteinizing hormone and is reconstituted for use by addition of 5 milliliters of 0.9 percent aqueous sodium chloride solution. (b) Sponsor. No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Amount. Cattle and horses: 25 milligrams; swine: 5 milligrams; sheep: 2.5 milligrams; and dogs: 1.0 milligram. Preferably given by intravenous injection, it may be administered subcutaneously. Treatment may be repeated in 1 to 4 weeks, or as indicated. (2) Indications for use. As an aid in the treatment of breeding disorders related to pituitary hypofunction in cattle, horses, swine, sheep, and dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.136 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1850 Polysulfated glycosaminoglycan. | FDA | [72 FR 56896, Oct. 5, 2007, as amended at 74 FR 67816, Dec. 21, 2009] | (a) Specifications. (1) Each 1-milliliter (mL) ampule of solution contains 250 milligrams (mg) polysulfated glycosaminoglycan. (2) Each mL of solution packaged in 5-mL ampules or 20-, 30-, or 50-mL vials contains 100 mg polysulfated glycosaminoglycan. (b) Sponsor. See No. 010797 in § 510.600(c) of this chapter. (c) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (d) Conditions of use —(1) Horses —(i) Indications for use. For the treatment of noninfectious degenerative and/or traumatic joint dysfunction and associated lameness of the carpal and hock joints in horses. (ii) Amount —(A) Intra-articular use (carpal) : 250 mg once a week for 5 weeks. (B) Intramuscular use (carpal and hock) : 500 mg every 4 days for 28 days. (iii) Limitations. Do not use in horses intended for human consumption. (2) Dogs —(i) Indications for use. For control of signs associated with noninfectious degenerative and/or traumatic arthritis of canine synovial joints. (ii) Amount. 2 mg per pound of body weight by intramuscular injection twice weekly for up to 4 weeks (maximum of 8 injections). | |||||
| 21:21:6.0.1.1.12.0.1.137 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1860 Pradofloxacin. | FDA | [89 FR 85427, Oct. 28, 2024] | (a) Specifications. Each milliliter (mL) of solution contains 200 milligrams (mg) pradofloxacin. (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.530 of this chapter. (d) Conditions of use —(1) Cattle —(i) Amount. Administer a single dose of 10 mg/kg (2.3 mL/100 lb) body weight by subcutaneous injection. (ii) Indications for use. Cattle intended for slaughter (beef calves 2 months of age and older, growing beef steers, growing beef heifers, and beef bulls intended for slaughter), and in cattle intended for breeding less than 1 year of age (replacement beef and dairy heifers less than 1 year of age and beef and dairy bulls less than 1 year of age): for the treatment of bovine respiratory disease associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis. (iii) Limitations. Cattle intended for human consumption must not be slaughtered within 4 days of treatment. Not for use in female dairy cattle 1 year of age and older, including dry dairy cows; use in these cattle may cause drug residues in milk and/or in calves born to these cows. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals. (2) Swine —(i) Amount. Administer a single dose of 7.5 mg/kg (1.7 mL/100 lb) body weight by intramuscular injection. (ii) Indications for use. Weaned swine intended for slaughter (nursery, growing, and finishing swine, boars intended for slaughter, barrows, gilts intended for slaughter, and sows intended for slaughter): for the treatment of swine respiratory disease associated with Bordetella bronchiseptica, Glaesserella (Haemophilus) parasuis, Pasteurella multocida, Streptococcus suis, and Mycoplasma hyopneumoniae. (iii) Limitati… | |||||
| 21:21:6.0.1.1.12.0.1.138 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1862 Pralidoxime powder for injection. | FDA | [79 FR 16193, Mar. 25, 2014] | (a) Specifications. Each vial contains 1 gram (g) of pralidoxime chloride powder for mixing with 20 cubic centimeters of sterile water for injection. Each milliliter of constituted solution contains 50 milligrams (mg) pralidoxime chloride. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Amount. Administer as soon as possible after exposure to the poison. Before administration of the sterile pralidoxime chloride, atropine is administered intravenously at a dosage rate of 0.05 mg per pound of body weight, followed by administration of an additional 0.15 mg of atropine per pound of body weight administered intramuscularly. Then the appropriate dosage of sterile pralidoxime chloride is administered slowly intravenously. The dosage rate for sterile pralidoxime chloride when administered to horses is 2 g per horse. When administered to dogs and cats, it is 25 mg per pound of body weight. For small dogs and cats, sterile pralidoxime chloride may be administered either intraperitoneally or intramuscularly. A mild degree of atropinization should be maintained for at least 48 hours. Following severe poisoning, a second dose of sterile pralidoxime chloride may be given after 1 hour if muscle weakness has not been relieved. (2) Indications for use. It is used in horses, dogs, and cats as an antidote in the treatment of poisoning due to those pesticides and chemicals of the organophosphate class which have anticholinesterase activity in horses, dogs, and cats. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.139 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1870 Praziquantel. | FDA | [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] | (a) Specifications. Each milliliter (mL) of solution contains 56.8 milligrams of praziquantel. (b) Sponsors. See Nos. 058198 and 061133 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Dogs —(i) Amount. Administer by subcutaneous or intramuscular injection for dogs and puppies 5 pounds (lb) and under, 0.3 mL; for 6 to 10 lb, 0.5 mL; for 11 to 25 lb, 1.0 mL; if over 25 lb, 0.2 mL/5 lb body weight to a maximum of 3 mL. (ii) Indications for use. For removal of canine cestodes Dipylidium caninum, Taenia pisiformis, and Echinococcus granulosus, and removal and control of canine cestode Echinococcus multilocularis. (iii) Limitations. Federal law restricts the drug to use by or on the order of a licensed veterinarian. (2) Cats —(i) Amount. Administer by subcutaneous or intramuscular injection for cats and kittens under 5 lb, 0.2 mL; 5 to 10 lb, 0.4 mL; 11 lb and over, 0.6 mL maximum. (ii) Indications for use. For removal of feline cestodes Dipylidium caninum and Taenia taeniaeformis. (iii) Limitations. Federal law restricts the drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.14 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.158 Bedinvetmab. | FDA | [88 FR 55564, Aug. 16, 2023] | (a) Specifications. Each single-use vial contains 5, 10, 15, 20, or 30 milligrams (mg) bedinvetmab in an extractable volume of 1 milliliter. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Amount. Administer 0.23 mg/pound (0.5 mg/kilogram) body weight monthly by subcutaneous injection. (2) Indications for use. For the control of pain associated with osteoarthritis in dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.140 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1881 Prednisolone acetate. | FDA | [79 FR 16194, Mar. 25, 2014] | (a) Specifications. Each milliliter of suspension contains 25 milligrams (mg) of prednisolone acetate. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Amount. The drug is administered to horses intra-articularly at a dosage level of 50 to 100 mg. The dose may be repeated when necessary. The drug is administered to dogs and cats intramuscularly at a dosage level of 10 to 50 mg. The dosage may be repeated when necessary. If the condition is of a chronic nature, an oral corticosteroid may be given as a maintenance dosage. The drug may be given intra-articularly to dogs and cats at a dosage level of 5 to 25 mg. The dose may be repeated when necessary after 7 days for two or three doses. (2) Indications for use. The drug is indicated in the treatment of dogs, cats, and horses for conditions requiring an anti-inflammatory agent. The drug is indicated for the treatment of acute musculoskeletal inflammations such as bursitis, carpitis, and spondylitis. The drug is indicated as supportive therapy in nonspecific dermatosis such as summer eczema and atopy. The drug may be used as supportive therapy pre- and postoperatively and for various stress conditions when corticosteroids are required while the animal is being treated for a specific condition. (3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.141 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1883 Prednisolone sodium phosphate. | FDA | [68 FR 59881, Oct. 20, 2003, as amended at 84 FR 8974, Mar. 13, 2019] | (a) Specifications. Each milliliter of solution contains 20 milligrams (mg) prednisolone sodium phosphate (equivalent to 14.88 mg of prednisolone). (b) Sponsor. See No. 061133 in § 510.600(c) of this chapter. (c) Conditions of use in dogs —(1) Amount. Administer intravenously in a dosage of 2 1/2 to 5 mg per pound of body weight, initially for shock and shock-like states, followed by equal maintenance doses at 1-, 3-, 6-, or 10-hour intervals as determined by the condition of the animal. (2) Indications for use. Administer when a rapid adrenal glucocorticoid and/or anti-inflammatory effect is necessary. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.142 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1884 Prednisolone sodium succinate. | FDA | [79 FR 16194, Mar. 25, 2014] | (a) Specifications. Each milliliter of prednisolone sodium succinate injection contains: Prednisolone sodium succinate equivalent in activity to 10, 20, or 50 milligrams (mg) of prednisolone. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter for products containing 10, 20, and 50 mg equivalent prednisolone activity per milliliter for use in horses, dogs, and cats as provided in paragraphs (c)(1)(i), (ii), and (iii) of this section. (c) Conditions of use —(1) Amount and indications for use —(i) Horses. Administer 50 to 100 mg as an initial dose by intravenous injection over a period of one-half to 1 minute, or by intramuscular injection, and may be repeated in inflammatory, allergic, or other stress conditions at intervals of 12, 24, or 48 hours, depending upon the size of the animal, the severity of the condition and the response to treatment. (ii) Dogs. Administer by intravenous injection at a range of 2.5 to 5 mg per pound of body weight as an initial dose followed by maintenance doses at 1, 3, 6, or 10 hour intervals, as determined by the condition of the animal, for treatment of shock. (iii) Dogs and cats. Administer by intramuscular injection for treatment of inflammatory, allergic, and less severe stress conditions, where immediate effect is not required, at 1 to 5 mg ranging upward to 30 to 50 mg in large breeds of dogs. Dosage may be repeated in 12 to 24 hours and continued for 3 to 5 days if necessary. If permanent corticosteroid effect is required, oral therapy with prednisolone tablets may be substituted. (2) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.143 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1890 Prednisone suspension. | FDA | [79 FR 16194, Mar. 25, 2014] | (a) Specifications. Each milliliter of suspension contains 10 to 40 milligrams (mg) of prednisone. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Amount —(i) Horses. Administer 100 to 400 mg by intramuscular injection, repeating if necessary. (ii) Dogs and cats. Administer 0.25 to 1.0 mg per pound of body weight by intramuscular injection for 3 to 5 days or until a response is noted. Treatment may be continued with an orally administered dose. (2) Indications for use. It is used for conditions requiring an anti-inflammatory agent. (3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.144 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1920 Prochlorperazine and isopropamide. | FDA | [79 FR 16194, Mar. 25, 2014] | (a) Specifications. Each milliliter of solution contains prochlorperazine edisylate equivalent to 4 milligrams (mg) prochlorperazine and isopropamide iodide equivalent to 0.28 mg of isopropamide. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Amount. (i) Dosage is administered by subcutaneous injection twice daily as follows: (ii) Following the last injection, administer prochlorperazine and isopropamide sustained release capsules as indicated. (2) Indications for use. For use in dogs and cats in which gastrointestinal disturbances are associated with emotional stress. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.145 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1940 Progesterone and estradiol benzoate. | FDA | [89 FR 42358, May 15, 2024] | (a) Specifications —(1) Each implant consists of progesterone and estradiol benzoate. (i) 100 mg progesterone and 10 mg estradiol benzoate (one implant consisting of four pellets, each containing 25 mg progesterone and 2.5 mg 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. (i) 100 mg progesterone, 10 mg estradiol benzoate, and 29 mg tylosin tartrate (one implant consisting of four pellets, each containing 25 mg progesterone and 2.5 mg estradiol benzoate, and one pellet containing 29 mg 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. See sponsors in § 510.600(c) of this chapter for use as in paragraph (c) of this section: (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. See §§ 556.240 and 556.540 of this chapter. (d) Special considerations. Labeling of implants described in paragraphs (a)(2)(i) and (a)(2)(ii) for use in paragraphs (e)(1)(i)(B), (e)(1)(ii), (e)(3)(i), and (e)(3)(ii) of this section shall bear the following: “Federal law restricts this drug to use by or on the order of a licensed veterinarian.” (e) Conditions of use —(1) Beef calves 45 days of age and older and weighing up to 400 lbs —(i) Amounts and indications for use. (A) An implant containing 100 mg progesterone and 10 mg estradiol benzoate as described in paragraph (a)(1)(i) of this section for increased rate of weight gain. (B) An implant containing 100 mg progesterone, 10 mg estr… | |||||
| 21:21:6.0.1.1.12.0.1.146 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.1962 Promazine. | FDA | [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] | (a) Specifications. Each milliliter of solution contains 50 milligrams (mg) promazine hydrochloride. (b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (c) of this section: (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 —(1) Horses —(i) Amount. (A) 0.2 to 0.5 milligrams per pounds (mg/lb) body weight intramuscularly or intravenously every 4 to 6 hours. (B) 0.2 to 0.5 mg/lb body weight intravenously as required. (ii) Indications for use. (A) For use as a tranquilizer, preanesthetic, or for minor operative procedures in conjunction with local anesthesia; and as adjunctive therapy for tetanus. (B) For use as a tranquilizer and preanesthetic. (iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Dogs and cats —(i) Amount. 1 to 2 mg/lb body weight intramuscularly or intravenously every 4 to 6 hours. (ii) Indications for use. For use as a tranquilizer, preanesthetic, for minor operative procedures in conjunction with local anesthesia, as adjunctive therapy for tetanus, and as an antiemetic prior to worming; or to prevent motion sickness in dogs. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.147 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2002 Propiopromazine. | FDA | [79 FR 16195, Mar. 25, 2014] | (a) Specifications. Each milliliter of solution contains 5 or 10 milligrams (mg) propiopromazine hydrochloride. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats —(1) Amounts and indications for use. Administer 0.05 to 0.5 mg per pound of body weight by intravenous or intramuscular injection for tranquilization. Administer 0.25 mg per pound of body weight by intravenous injection as a preanesthetic. (2) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.148 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2005 Propofol. | FDA | [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] | (a) Specifications. Each milliliter of emulsion contains 10 milligrams (mg) propofol. (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter. (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 —(1) Amount. Administer by intravenous injection according to label directions. The use of preanesthetic medication reduces propofol dose requirements. (2) Indications for use. (i) As a single injection to provide general anesthesia for short procedures; for induction and maintenance of general anesthesia using incremental doses to effect; and for induction of general anesthesia where maintenance is provided by inhalant anesthetics. (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. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (d) Conditions of use in cats —(1) Amount. Administer by intravenous injection according to label directions. The use of preanesthetic medication reduces propofol dose requirements. (2) Indications for use. (i) As a single injection to provide general anesthesia for short procedures; for induction and maintenance of general anesthesia using incremental doses to effect; and for induction of general anesthesia where maintenance is provided by inhalant anesthetics. (ii) For induction and maintenance of general anesthesia; and for induction of general anesthesia followed by maintenance with an inhalant anesthetic. (3) Lim… | |||||
| 21:21:6.0.1.1.12.0.1.149 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2012 Prostalene. | FDA | [79 FR 16195, Mar. 25, 2014] | (a) Specifications. Each milliliter of solution contains 1 milligram of prostalene. (b) Sponsor. No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in horses —(1) Amount. Administer 5 micrograms per kilogram of body weight as a single subcutaneous injection. (2) Indications for use. For the control of estrus in mares. (3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.15 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.161 Betamethasone. | FDA | [79 FR 16184, Mar. 25, 2014] | (a) Specifications. Each milliliter of suspension contains: (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. See sponsor numbers in § 510.600(c) of this chapter: (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 —(1) Dogs —(i) Amount. Administer by intramuscular injection 0.25 to 0.5 milliliter (mL) 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 four injections. (ii) Indications for use. As an aid in the control of pruritus associated with dermatoses. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Horses —(i) Amount. Administer 2.5 to 5 mL by intra-articular injection. (ii) Indications for use. (A) For the treatment of various inflammatory joint conditions; for example, acute and traumatic lameness involving the carpel and fetlock joints. (B) As an aid in the control of inflammation associated with various arthropathies. (iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.150 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2063 Pyrilamine. | FDA | [79 FR 16195, Mar. 25, 2014, as amended at 84 FR 8974, Mar. 13, 2019] | (a) Specifications. Each milliliter of solution contains 20 milligrams (mg) of pyrilamine maleate. (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter for uses in paragraph (c) of this section. (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 —(1) Amount. (i) Horses, 40 to 60 mg per 100 pounds (lbs) body weight; foals, 20 mg/100 lbs body weight. Administer by intramuscular, subcutaneous, or intravenous injection. Dosage may be repeated every 6 to 12 hours whenever necessary. (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. It is intended for treating horses in conditions in which antihistaminic therapy may be expected to lead to alleviation of some signs of disease. (3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.151 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2065 Rabacfosadine. | FDA | [87 FR 10969, Feb. 28, 2022] | (a) Specifications. Each vial of powder contains 16.4 milligrams (mg) rabacfosadine. Each milliliter of constituted solution contains 8.2 mg rabacfosadine. (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. (c) Conditions of use in dogs —(1) Amount. Administer rabacfosadine at 1 mg/kilogram body weight as a 30-minute intravenous infusion, once every 3 weeks, for up to 5 doses. (2) Indications for use. For the treatment of lymphoma in dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.152 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2075 Robenacoxib. | FDA | [80 FR 61297, Oct. 13, 2015, as amended at 82 FR 12170, Mar. 1, 2017] | (a) Specifications. Each milliliter of solution contains 20 milligrams (mg) robenacoxib. (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Dogs —(i) Amount. Administer 0.91 mg per pound (2 mg/kilogram (kg)) by subcutaneous injection, once daily, for a maximum of 3 days. After the initial subcutaneous dose, subsequent doses can be given by subcutaneous injection or as the oral tablet in dogs weighing at least 5.5 pounds (2.5 kg) and at least 4 months of age, for a maximum of 3 total doses over 3 days, not to exceed 1 dose per day. See § 520.2075(c)(1) of this chapter. (ii) Indications for use. For the control of postoperative pain and inflammation associated with soft tissue surgery in dogs at least 4 months of age for a maximum of 3 days. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Cats —(i) Amount. Administer 0.91 mg per pound (2 mg/kg) by subcutaneous injection, once daily, for a maximum of 3 days. (ii) Indications for use. For the control of postoperative pain and inflammation associated with orthopedic surgery, ovariohysterectomy, and castration in cats at least 4 months of age for a maximum of 3 days. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.153 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2076 Romifidine. | FDA | [69 FR 47363, Aug. 5, 2004, as amended at 79 FR 16195, Mar. 25, 2014] | (a) Specifications. Each milliliter of solution contains 10 milligrams (mg) romifidine hydrochloride. (b) Sponsor. See No. 000010 in § 510.600(c) of this chapter. (c) Conditions of use in horses —(1) Amount. 40 to 120 micrograms per kilogram of body weight (mcg/kg BW) intravenously for sedation and analgesia; 100 mcg/kg BW intravenously as a preanesthetic. (2) Indications for use. For use as a sedative and analgesic to facilitate handling, clinical examinations, clinical procedures, and minor surgical procedures in adult horses; and for use as a preanesthetic prior to the induction of general anesthesia in adult horses. (3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.154 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2092 Secobarbital and dibucaine. | FDA | [85 FR 18120, Apr. 1, 2020] | (a) Specifications. Each milliliter (mL) of solution contains 400 milligram (mg) secobarbital sodium and 25 mg dibucaine hydrochloride. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Special considerations. Product labeling shall bear the following warning statements: “ENVIRONMENTAL HAZARD: This product is toxic to wildlife. Birds and mammals feeding on treated animals may be killed. Euthanized animals must be properly disposed of by deep burial, incineration, or other method in compliance with State and local laws, to prevent consumption of carcass material by scavenging wildlife.” (d) Conditions of use in dogs —(1) Amount. Administer 1 mL per 10 pounds of body weight as a single, bolus intravenous injection. (2) Indications for use. For humane, painless, and rapid euthanasia. (3) Limitations. Do not use in animals intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.155 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2100 Selenium and vitamin E. | FDA | [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] | (a)(1) Specifications. Each milliliter of emulsion contains 5.48 milligrams (mg) sodium selenite (equivalent to 2.5 mg selenium) and 50 mg of vitamin E (68 I.U.) (as d-alpha tocopheryl acetate). (2) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (3) Conditions of use in horses —(i) Amount. Administer 1 milliliter (mL) per (/) 100 pounds (lbs) of body weight by intravenous injection or by deep intramuscular injection in divided doses in two or more sites in the gluteal or cervical muscles. Administration may be repeated at 5 to 10 day intervals. (ii) Indications for use. For the prevention and treatment of selenium-tocopherol deficiency syndrome in horses. (iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (b)(1) Specifications. Each milliliter contains 2.19 mg of sodium selenite (equivalent to 1 mg of selenium), 50 mg of vitamin E (68 I.U.) (as d-alpha tocopheryl acetate). (2) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (3) Conditions of use in dogs —(i) Amount. Administer by subcutaneous or intramuscular injection in divided doses in two or more sites at 1 mL/20 lbs of body weight with a minimum dosage of 1/4 mL and a maximum dosage of 5 mL. The dose is repeated at 3-day intervals until a satisfactory therapeutic response is observed. A maintenance regimen is then initiated which consists of 1 mL per 40 lbs of body weight with a minimum dosage of 1/4 mL which is repeated every 3 days or 7 days, or longer, as required to maintain continued improvement or an asymptomatic condition; or the drug may be used in capsule form for oral maintenance therapy. (ii) Indications for use. As an aid in alleviating and controlling inflammation, pain, and lameness associated with certain arthropathies in dogs. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (c)(1) Specifications. Each milliliter contains 2.… | |||||
| 21:21:6.0.1.1.12.0.1.156 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2112 Sometribove zinc suspension. | FDA | [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] | (a) Specifications. Each single-dose syringe contains 500 milligrams (mg) sometribove zinc in a prolonged-release suspension. (b) Sponsor. See No. 086106 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Amount. Inject 500 mg every 14 days starting during the 9th or 10th week (57 to 70 days) after calving and continue until the end of lactation. (2) Indications for use. To increase production of marketable milk in healthy lactating dairy cows. (3) Limitations. Use in lactating dairy cows only. Safety to replacement bulls born to treated dairy cows has not been established. Inject subcutaneously. Avoid injections within 2 weeks of expected slaughter to minimize injection site blemishes on carcass. There is no milk discard or preslaughter withdrawal period. Use may reduce pregnancy rates and increase days open. Treated cows are at an increased risk for mastitis and higher milk somatic cell counts. Use care to differentiate increased body temperature due to use of this product from an increased body temperature that may occur due to illness. Cows treated with this product may have more enlarged hocks and disorders of the foot region. Use may reduce hemoglobin and hematocrit values during treatment. Human warning: Avoid prolonged or repeated contact with eyes and skin. | |||||
| 21:21:6.0.1.1.12.0.1.157 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2120 Spectinomycin hydrochloride. | FDA | [86 FR 14820, Mar. 19, 2021, as amended at 88 FR 27700, May 3, 2023] | (a) Specifications. Each milliliter of solution contains 100 milligrams (mg) spectinomycin hydrochloride (as spectinomycin dihydrochloride pentahydrate). (b) Sponsors. See sponsors in § 510.600(c) of this chapter: (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. See § 556.600 of this chapter. (d) Conditions of use. It is administered as follows: (1) Turkeys (1- to 3-day-old poults) and chickens (newly hatched chicks) —(i) Amounts and indications for use. (A) Administer 5 mg per poult subcutaneously as an aid in the control of chronic respiratory disease (CRD) associated with Escherichia coli in 1- to 3-day-old turkey poults. (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 sensitive to spectinomycin in 1- to 3-day-old turkey poults. (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, and E. coli. (ii) Limitations. For use only in 1- to 3-day-old turkey poults and newly hatched chicks. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Dogs —(i) Amount. Administer 2.5 to 5.0 mg per pound of body weight by intramuscular injection twice daily. Treatment may be continued for 4 days. (ii) Indications for use. For treatment of infections caused by gram-negative and gram-positive organisms susceptible to spectinomycin. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.158 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2121 Spectinomycin sulfate. | FDA | [72 FR 31178, June 6, 2007, as amended at 79 FR 16195, Mar. 25, 2014; 88 FR 14899, Mar. 10, 2023] | (a) Specifications. Each milliliter of solution contains spectinomycin sulfate tetrahydrate equivalent to 100 milligrams (mg) spectinomycin. (b) Sponsor. See Nos. 054771 and 061133 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.600 of this chapter. (d) Conditions of use in cattle —(1) Amount. 10 to 15 mg per kilogram of body weight at 24-hour intervals for 3 to 5 consecutive days. (2) Indications for use. For the treatment of bovine respiratory disease (pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida , and Histophilus somni. (3) Limitations. Do not slaughter within 11 days of last treatment. Do not use in female dairy cattle 20 months of age or older. Use in this class of cattle may cause residues in milk. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.159 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2150 Stanozolol. | FDA | [79 FR 16195, Mar. 25, 2014] | (a) Specifications. Each milliliter of suspension contains 50 milligrams (mg) of stanozolol. (b) Sponsor. No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Amount —(i) Dogs and cats. For cats and small breeds of dogs: 25 mg. For larger dogs: 50 mg. Administer by deep intramuscular injection in the thigh at weekly intervals, for several weeks. (ii) Horses. Administer 25 mg per 100 pounds of body weight by deep intramuscular injection in the gluteal region at weekly intervals, for not more than 4 weeks. (2) Indications for use. For use as an anabolic steroid treatment. (3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.16 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.163 Betamethasone dipropionate and betamethasone sodium phosphate aqueous suspension. | FDA | [40 FR 13858, Mar. 27, 1975, as amended at 41 FR 27316, July 2, 1976; 52 FR 7832, Mar. 13, 1987] | (a) Specifications. Betamethasone dipropionate and betamethasone sodium phosphate aqueous suspension is a sterile aqueous suspension. Each milliliter of the suspension contains the equivalent of 5 milligrams of betamethasone as betamethasone dipropionate and 2 milligrams of betamethasone as betamethasone sodium phosphate. (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Dogs. (i) It is used as an aid in the control of pruritus associated with dermatoses. (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. (i) It is used as an aid in the control of inflammation associated with various arthropathies. (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. It has been demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. (4) Restrictions. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.160 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2220 Sulfadimethoxine. | FDA | [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] | (a) Specifications. Each milliliter of solution contains: (1) 100 milligrams (mg) of sulfadimethoxine sodium. (2) 400 mg of sulfadimethoxine sodium. (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter for use as in paragraph (d) of this section. (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. See § 556.640 of this chapter. (d) Conditions of use —(1) Dogs —(i) Amount. Administer by subcutaneous, intramuscular, or intravenous injection at an initial dose of 25 mg per pound of body weight followed by 12.5 mg per pound of body weight every 24 hours thereafter. Continue treatment until the animal is free from symptoms for 48 hours. (ii) Indications for use. For use in the treatment of sulfadimethoxine-susceptible bacterial infections in dogs. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Dogs and cats —(i) Amount. Administer by intravenous or subcutaneous injection at an initial dose of 55 mg per kilogram of body weight followed by 27.5 mg per kilogram of body weight every 24 hours. (ii) Indications for use. For the treatment of respiratory, genitourinary tract, enteric, and soft tissue infections when caused by Streptococci, Staphylococci, Escherichia, Salmonella, Klebsiella, Proteus, or Shigella organisms sensitive to sulfadimethoxine, and in the treatment of canine bacterial enteritis associated with coccidiosis and canine Salmonellosis. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (3) Horses —(i) Amount. Administer by intravenous injection at an initial dose of 55 mg per kilogram of body weight followed by 27.5 mg… | |||||
| 21:21:6.0.1.1.12.0.1.161 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2240 Sulfaethoxypyridazine. | FDA | [79 FR 16196, Mar. 25, 2014] | (a) Specifications. The drug is an aqueous solution of sulfaethoxypyridazine. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.650 of this chapter. (d) Conditions of use in cattle —(1) Amount. Administer 2.5 grams per 100 pounds of body weight per day by intravenous injection for not more than 4 days; or first treatment may be followed by 3 days of treatment with sulfaethoxypyridazine in drinking water or tablets in accordance with §§ 520.2240a(e) and 520.2240b(e) of this chapter. (2) Indications for use. For treatment of respiratory infection (pneumonia, shipping fever), foot rot, calf scours; as adjunctive therapy in septicemia accompanying mastitis and metritis. (3) Limitations. Do not treat within 16 days of slaughter. Milk that has been taken from animals during treatment and for 72 hours (6 milkings) after the latest treatment must not be used for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.162 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2260 Sulfamethazine. | FDA | [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] | (a) Specifications. Each milliliter (mL) of solution contains 250 milligrams (mg) sulfamethazine sodium. (b) Sponsor. See No. 016592 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.670 of this chapter. (d) Conditions of use in cattle —(1) Amount. Initially administer 20 mL for each 50 pounds (lb) of body weight (100 mg/lb) by intravenous injection, followed by 20 mL per 100 lb of body weight (50 mg/lb) by intravenous injection, daily thereafter. Treatment should not exceed a total of 5 consecutive days. (2) Indications for use. For cattle for treatment of bacterial pneumonia and bovine respiratory disease complex (shipping fever complex) ( Pasteurella spp.), colibacillosis (bacterial scours) ( Escherichia coli ), necrotic pododermatitis (foot rot) ( Fusobacterium necrophorum ), calf diphtheria ( Fusobacterium necrophorum ), acute mastitis and acute metritis ( Streptococcus spp.) when caused by one or more pathogenic organisms sensitive to sulfamethazine. (3) Limitations. Withdraw medication from cattle 10 days prior to slaughter. Do not use in female dairy cattle 20 months of age or older. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.163 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2340 Sulfomyxin. | FDA | [40 FR 13858, Mar. 27, 1975, as amended at 79 FR 16196, Mar. 25, 2014; 88 FR 14900, Mar. 10, 2023] | (a) Specifications. Sulfomyxin for injection is sterile. It is derived from the antibiotic substance produced by the growth of Bacillus polymyxa or is the same substance produced by any other means. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Special considerations. The quantities of antibiotic in paragraph (e) of this section refer to the activity of the appropriate standard. (d) Related tolerances. See § 556.700 of this chapter. (e) Conditions of use. (1) It is used or intended for use in chickens and turkeys as an aid in the treatment of disease caused or complicated by E. coli, such as colibacillosis and complicated chronic respiratory disease. (2) It is administered by subcutaneous injection as follows: (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. | |||||
| 21:21:6.0.1.1.12.0.1.164 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2343 Testosterone propionate and estradiol benzoate. | FDA | [89 FR 42358, May 15, 2024] | (a) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section. (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. See §§ 556.240 and 556.710 of this chapter. (c) Special considerations. Labeling of the implants described in paragraph (d)(2) of this section shall bear the following: “Federal law restricts this drug to use by or on the order of a licensed veterinarian.” (d) Conditions of use —(1) Growing beef heifers fed in confinement for slaughter —(i) Amounts and indications for use. An implant containing 200 mg testosterone propionate and 20 mg estradiol benzoate (one implant consisting of eight pellets, each containing 25 mg testosterone propionate and 2.5 mg estradiol benzoate) for increased rate of weight gain and improved feed efficiency. (ii) Limitations. Implant pellets subcutaneously in ear only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because safety and effectiveness have not been evaluated. Do not use in dairy cows or in animals intended for subsequent breeding. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. (2) Growing beef heifers weighing 400 lbs or more —(i) Amounts and indications for use. An implant containing 200 mg testosterone propionate, 20 mg estradiol benzoate, and 29 mg tylosin tartrate (one implant consisting of eight pellets, each containing 25 mg testosterone propionate and 2.5 mg estradiol benzoate, and one pellet containing 29 mg tylosin tartrate) for increased rate of weight gain and improved feed efficiency. (ii) Limitations. Implant pellets subcutaneously in ear only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant. Do not use in beef calves less than 2 months of age, dairy calves, and veal… | |||||
| 21:21:6.0.1.1.12.0.1.165 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2404 Thialbarbitone sodium for injection. | FDA | [40 FR 13858, Mar. 27, 1975, as amended at 79 FR 16196, Mar. 25, 2014] | (a) Specifications. Thialbarbitone sodium for injection when reconstituted with sterile distilled water provides 94 milligrams of thialbarbitone sodium per milliliter of solution. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use. (1) The drug is administered as a general anesthetic in surgical procedures on dogs, cats, swine, sheep, cattle, and horses. The drug is used for procedures of relatively short duration. However, the period of anesthesia can be lengthened by slower initial injection and supplemental administration during surgery. (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: (3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.166 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2424 Thiamylal. | FDA | [79 FR 16196, Mar. 25, 2014, as amended at 83 FR 48946, Sept. 28, 2018] | (a) Specifications. The drug is a sterile powder. It is reconstituted with sterile distilled water, water for injection, or sodium chloride injection, to a desired concentration of 0.5 to 4 percent sodium thiamylal. (b) Sponsors. See Nos. 054771 and 069043 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Amount. Administer by intravenous injection to effect. The average single dose is: (i) Dogs and cats: 8 milligrams (mg) per pound of body weight (when used with a preanesthetic, generally one-half the normal dose). (ii) Swine: 40 mg per 5 pounds (lbs) of body weight. (iii) Horses: Light anesthesia, 1 gram per 500 lbs to 1,100 lbs of body weight; deep anethesia, 1 gram per 300 lbs of body weight (40 mg/12 lbs of body weight). (iv) Cattle: Short duration, 20 mg/5 lbs of body weight; longer duration, 40 mg/7 lbs of body weight. (2) Indications for use. It is used as an ultra-short-acting anesthetic in dogs, cats, swine, horses, and cattle. (3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.167 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2444 Thiopental injectable dosage forms. | FDA | |||||||
| 21:21:6.0.1.1.12.0.1.168 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2444a Thiopental powder for injection. | FDA | [79 FR 16196, Mar. 25, 2014] | (a) Specifications. The drug contains sodium thiopental powder for constitution with sterile water for injection. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in dogs and cats —(1) Amount. Administer by intravenous injection as follows: (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. It is used as an anesthetic for intravenous administration to dogs and cats during short to moderately long surgical and other procedures. It is also used to induce anesthesia in dogs and cats which then have surgical anesthesia maintained by use of a volatile anesthetic. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.169 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2444b Thiopental and pentobarbital powder for injection. | FDA | [79 FR 16197, Mar. 25, 2014, as amended at 84 FR 8974, Mar. 13, 2019] | (a) Specifications. Each gram of powder contains 750 milligrams (mg) of sodium thiopental and 250 mg of sodium pentobarbital powder for dilution with sterile water for injection. (b) Sponsor. See No. 061133 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Amount. For total anesthesia, it is given at approximately 10 to 12 mg per pound of body weight over a period of 3.5 to 5 minutes. When preanesthetic medication is used, wait at least an hour before administering thiopental and sodium pentobarbital for injection, and the dosage necessary for anesthesia is reduced. Usually 1/2 to 2/3 the normal amount is adequate. (2) Indications for use. It is used as an anesthetic for intravenous administration to dogs and cats during short to moderately long surgical procedures. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.17 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.167 Betamethasone sodium phosphate and betamethasone acetate. | FDA | [80 FR 18776, Apr. 8, 2015] | (a) Specifications. Each milliliter (mL) of suspension contains 6 milligrams (mg) betamethasone (3.15 mg betamethasone sodium phosphate and 2.85 mg betamethasone acetate). (b) Sponsor. See No. 010797 in § 510.600(c) of this chapter. (c) Conditions of use in horses —(1) Amount. Administer 1.5 mL (9 mg total betamethasone) per joint by intra-articular injection. May be administered concurrently in up to two joints per horse. (2) Indications for use. For the control of pain and inflammation associated with osteoarthritis in horses. (3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.170 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2450 Tigilanol. | FDA | [86 FR 17064, Apr. 1, 2021] | (a) Specifications. Each milliliter (mL) of solution contains 1 milligram tigilanol tiglate. (b) Sponsor. See No. 086132 in § 510.600(c) of this chapter. (c) Conditions of use in dogs —(1) Amount. Administer as an intratumoral injection at a dose of 0.5 mL per cubic centimeter of tumor volume. (2) Indications for use. For the treatment of non-metastatic cutaneous mast cell tumors and non-metastatic subcutaneous mast cell tumors located at or distal to the elbow or the hock in dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.171 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2460 Tildipirosin. | FDA | [77 FR 39391, July 3, 2012] | (a) Specifications. Each milliliter of solution contains: (1) 180 milligrams (mg) tildipirosin. (2) [Reserved] (b) Sponsor. See No. 000061 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.733 of this chapter. (d) Conditions of use —(1) Cattle —(i) Amount. Administer 4 mg/kg of bodyweight one time by subcutaneous injection in the neck. (ii) Indications for use. For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in beef and non-lactating dairy cattle; and for the control of respiratory disease in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, and H. somni. (iii) Limitations. Cattle intended for human consumption must not be slaughtered within 21 days from the last treatment. Do not use in female dairy cattle 20 months of age or older. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) [Reserved] | |||||
| 21:21:6.0.1.1.12.0.1.172 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2470 Tiletamine and zolazepam. | FDA | [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] | (a) Specifications. The drug is a sterile powder. Each milliliter of constituted solution contains tiletamine hydrochloride equivalent to 50 milligrams (mg) of tiletamine base and zolazepam hydrochloride equivalent to 50 mg of zolazepam base. (b) Sponsors. See Nos. 017033, 051311, and 054771 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Dogs —(i) Amount. Expressed as milligrams of the drug combination: (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. (A) Intramuscular administration in dogs for restraint and minor procedures of short duration (30 minutes average) requiring mild to moderate analgesia. (B) Intravenous administration in dogs for induction of anesthesia followed by maintenance with an inhalant anesthetic. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Cats —(i) Amount. An initial intramuscular dosage of 4.4 to 5.4 mg/lb of body weight is recommended for such procedures as dentistry, treatment of abscesses, foreign body removal, and related types of surgery; 4.8 to 5.7 mg/lb of body weight for minor procedures requiring mild to moderate analgesia, such as repair of lacerations, castrations, and other procedures of short duration. Initial dosages of 6.5 to 7.2 mg/lb of body weight are recommended for ovariohysterectomy and onychectomy. When supplemental doses are required, such… | |||||
| 21:21:6.0.1.1.12.0.1.173 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2471 Tilmicosin. | FDA | [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] | (a) Specifications. Each milliliter of solution contains 300 milligrams (mg) tilmicosin base as tilmicosin phosphate. (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.735 of this chapter. (d) Conditions of use —(1) Cattle —(i) Amount. 10 to 20 milligrams per kilograms (mg/kg) of body weight as a single subcutaneous injection. (ii) Indications for use. For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica , Pasteurella multocida , and Histophilus somni. For the control of respiratory disease in cattle at high risk of developing BRD associated with M. haemolytica. (iii) Limitations. Animals intended for human consumption must not be slaughtered within 42 days of last treatment. Do not use in lactating dairy cattle 20 months of age or older. Use of tilmicosin in this class of cattle may cause milk residues. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Sheep —(i) Amount. 10 mg/kg body weight as a single subcutaneous injection. (ii) Indications for use. For the treatment of ovine respiratory disease (ORD) associated with Mannheimia ( P.) haemolytica. (iii) Limitations. Not for use in lactating ewes producing milk for human consumption. Animals intended for human consumption must not be slaughtered within 42 days of last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.174 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2473 Tiludronate. | FDA | [79 FR 18159, Apr. 1, 2014, as amended at 82 FR 21691, May 10, 2017; 84 FR 8974, Mar. 13, 2019] | (a) Specifications. Each vial of powder contains 500 milligrams (mg) tiludronate disodium. Each milliliter of constituted solution contains 20 mg tiludronate disodium. (b) Sponsor. See No. 061133 in § 510.600(c) of this chapter. (c) Conditions of use in horses —(1) Amount. Administer a single dose of 1 mg per kilogram (0.45 mg/pound) of body weight by intravenous infusion. (2) Indication for use. For the control of clinical signs associated with navicular syndrome. (3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.175 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2474 Tolazoline. | FDA | [79 FR 16197, Mar. 25, 2014, as amended at 79 FR 74020, Dec. 15, 2014; 80 FR 13230, Mar. 13, 2015] | (a) Specifications. Each milliliter of solution contains tolazoline hydrochloride equivalent to 100 milligrams (mg) of base activity. (b) Sponsor. See No. 059399 in § 510.600(c) of this chapter. (c) Conditions of use in horses —(1) Amount. Administer slowly by intravenous injection 4 mg per kilogram of body weight or 1.8 mg per pound (4 milliliters (mL) per 100 kilograms or 4 mL per 220 pounds). (2) Indications for use. For use in horses when it is desirable to reverse the effects of sedation and analgesia caused by xylazine. (3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.176 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2476 Trenbolone acetate. | FDA | [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] | (a) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section. (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. See § 556.739 of this chapter. (c) Special considerations. Labeling of implants described in paragraph (d)(1)(i)(B) and (d)(2)(i)(B) of this section shall bear the following: “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”. (d) Conditions of use —(1) Steers fed in confinement for slaughter —(i) Amount. Use 126 days prior to slaughter; should be reimplanted once after 63 days. (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. For improved feed efficiency. (iii) Limitations. Implant subcutaneously in ear only. Do not use in animals intended for subsequent breeding or in dairy animals. Safety and effectiveness have not been established in veal calves. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. (2) Heifers fed in confinement for slaughter —(i) Amount. Use last 63 days prior to slaughter. (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. For increased rate of weight gain and improved feed efficiency. (iii) Limitations. I… | |||||
| 21:21:6.0.1.1.12.0.1.177 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2477 Trenbolone acetate and estradiol. | FDA | [89 FR 42359, May 15, 2024] | (a) Sponsors. See sponsors in § 510.600(c) of this chapter for uses as in paragraph (d) of this section. (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. See §§ 556.240 and 556.739 of this chapter. (c) Special considerations. Labeling of implants described in paragraphs (d)(1)(i)(B), (d)(2)(i)(B), (d)(2)(i)(D), (d)(3)(i)(B), (d)(3)(i)(D), and (d)(4)(i)(B) of this section shall bear the following: “Federal law restricts this drug to use by or on the order of a licensed veterinarian.” (d) Conditions of use —(1) G rowing beef steers and heifers fed in confinement for slaughter —(i) Amounts and indications. (A) An implant containing 200 mg trenbolone acetate and 20 mg estradiol (one implant consisting of 10 pellets each containing 20 mg trenbolone acetate and 2 mg estradiol) for increased rate of weight gain and improved feed efficiency. (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. Implant pellets subc… | |||||
| 21:21:6.0.1.1.12.0.1.178 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2478 Trenbolone acetate and estradiol benzoate. | FDA | [88 FR 14900, Mar. 10, 2023; 89 FR 85427, Oct. 28, 2024, as amended at 90 FR 6801, Jan. 21, 2025] | (a) Specifications. (1) Each implant consists of: (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. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See §§ 556.240 and 556.739 of this chapter. (d) Conditions of use —(1) Growing beef steers and heifers fed in confinement for slaughter —(i) 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)(… | |||||
| 21:21:6.0.1.1.12.0.1.179 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2483 Triamcinolone. | FDA | [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] | (a) Specifications. Each milliliter of suspension contains 2 or 6 milligrams (mg) triamcinolone acetonide. (b) Sponsors. See Nos. 000010 and 069043 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Dogs and cats —(i) Amount —(A) Intramuscular or subcutaneous. For inflammatory, arthritic, or allergic disorders, administer 0.05 to 0.1 mg per pound (/lb) of body weight as a single injection. For dermatologic disorders, administer 0.1 mg per pound (/lb) of body weight as a single injection. If symptoms recur, the dose may be repeated, or oral corticosteroid therapy may be instituted. (B) Intralesional. Administer 1.2 to 1.8 mg, divided in several injections around the lesion, spaced 0.5 to 2.5 centimeters apart, depending on lesion size. At any one site, the dose injected should not exceed 0.6 mg. and should be well into the cutis to prevent rupture of the epidermis. When treating animals with multiple lesions, do not exceed a total dose of 6 mg. (C) Intra-articular and intrasynovial. Administer 1 to 3 mg as a single injection, depending on the size of the joint and severity of symptoms. After 3 or 4 days, repeat dosage if indicated. If initial results are inadequate or too transient, dosage may be increased, not to exceed 3 mg. (ii) Indications for use. For the treatment of inflammation and related disorders, and the management and treatment of acute arthritis and allergic and dermatologic disorders. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Horses —(i) Amount —(A) Intramuscular or subcutaneous. Administer 0.01 to 0.02 mg/lb of body weight as a single injection. Usual dose is 12 to 20 mg. (B) Intra-articular and intrasynovial. Administer 6 to 18 mg as a single injection, depending on the size of the joint and severity of symptoms. After 3 or 4 days, repeat dosage if indicated. If initial results are inadequate or too transient, dosage may be increased, not to exceed 18 mg. (ii) Indications for use. For the … | |||||
| 21:21:6.0.1.1.12.0.1.18 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.204 Boldenone. | FDA | [70 FR 70998, Nov. 25, 2005, as amended at 79 FR 16184, Mar. 25, 2014] | (a) Specifications. Each milliliter of solution contains 25 or 50 milligrams (mg) boldenone undecylenate. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use in horses —(1) Amount. 0.5 mg per pound body weight by intramuscular injection. Treatment may be repeated at 3-week intervals. (2) Indications for use. As an aid for treating debilitated horses when an improvement in weight, hair coat, or general physical condition is desired. (3) Limitations. Do not administer to horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.180 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2582 Triflupromazine. | FDA | [79 FR 16197, Mar. 25, 2014] | (a) Specifications. Each milliliter of solution contains 20 milligrams (mg) of triflupromazine hydrochloride. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Amount —(i) Dogs. Administer by intravenous injection at a dosage of 0.5 to 1 mg per pound of body weight daily, or by intramuscular injection at a dosage of 1 to 2 mg per pound of body weight daily. (ii) Cats. Administer by intramuscular injection at a dosage of 2 to 4 mg per pound of body weight daily. (iii) Horses. Administer by intravenous or intramuscular injection at a dosage of 10 to 15 mg per 100 pounds of body weight daily to a maximum dose of 100 mg. (2) Indications for use. For use in dogs, cats, and horses to relieve anxiety and to help control psychomotor overactivity as well as to increase the tolerance of animals to pain and pruritus. The drug is indicated in various office and clinical procedures which require the aid of a tranquilizer, antiemetic, or preanesthetic. (3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.181 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2610 Trimethoprim and sulfadiazine. | FDA | [71 FR 30803, May 31, 2006, as amended at 79 FR 16197, Mar. 25, 2014] | (a) Specifications. Each milliliter (mL) contains: (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. See Nos. 000061 and 054771 in § 510.600(c) of this chapter. (c) Conditions of use —(1) Dogs —(i) Amount. 1 mL of the product described in paragraph (a)(1) of this section (40 mg trimethoprim and 200 mg sulfadiazine) per 20 pounds (9 kilograms) of body weight per day by subcutaneous injection. (ii) Indications for use. For the treatment of acute urinary tract infections, acute bacterial complications of distemper, acute respiratory tract infections, acute alimentary tract infections, and acute septicemia due to Streptococcus zooepidemicus. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Horses —(i) Amount. 2 mL of the product described in paragraph (a)(2) of this section (160 mg trimethoprim and 800 mg sulfadiazine) per 100 pounds (45 kilograms) of body weight per day by intravenous injection as single, daily dose for 5 to 7 days. The daily dose may also be halved and given morning and evening. (ii) Indications for use. For use where systemic antibacterial action against sensitive organisms is required during treatment of acute strangles, respiratory tract infections, acute urogenital infections, and wound infections and abscesses. (iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.182 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2615 Tripelennamine. | FDA | [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] | (a) Specifications. Each milliliter of solution contains 20 milligrams (mg) of tripelennamine hydrochloride. (b) Sponsors. See Nos. 016592 and 051031 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.741 of this chapter. (d) Conditions of use —(1) Dogs and cats —(i) Amount. Administer 0.5 mg per pound of body weight by intramuscular injection. (ii) Indications for use. For use in treating conditions in which antihistaminic therapy may be expected to lead to alleviation of some signs of disease. (iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Horses —(i) Amount. Administer 0.5 mg per pound of body weight by intramuscular injection. (ii) Indications for use. For use in treating conditions in which antihistaminic therapy may be expected to lead to alleviation of some signs of disease. (iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (3) Cattle —(i) Amount. Administer 0.5 mg per pound of body weight by intravenous or intramuscular injection. (ii) Indications for use. For use in treating conditions in which antihistaminic therapy may be expected to lead to alleviation of some signs of disease. (iii) Limitations. Milk taken during treatment and for 24 hours after the last treatment must not be used for human consumption. Cattle must not be slaughtered for human consumption within 4 days following the last treatment with this drug product. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.183 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2630 Tulathromycin. | FDA | [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] | (a) Specifications. Each milliliter of solution contains: (1) 100 milligrams (mg) tulathromycin (2) 25 mg tulathromycin (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter. (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. See § 556.745 of this chapter. (d) Conditions of use —(1) Cattle —(i) Amount. 2.5 mg per kilogram (/kg) body weight as a single subcutaneous injection in the neck. (ii) Indications for use —(A) Beef and non-lactating dairy cattle. For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis. For the control of respiratory disease in cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni, and M. bovis. For the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis. For the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii. (B) Suckling calves, dairy calves, and veal calves. For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis. (iii) Limitations. (A) Cattle intended for human consumption must not be slaughtered within 18 days from the last treatment. This drug is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. Federal law restricts this drug to use by or on the order of a licen… | |||||
| 21:21:6.0.1.1.12.0.1.184 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2632 Tulathromycin and ketoprofen. | FDA | [86 FR 61685, Nov. 8, 2021] | (a) Specifications. Each milliliter of solution contains 100 milligrams (mg) tulathromycin and 120 milligrams (mg) ketoprofen. (b) Sponsor. See No. 054771 in § 510.600(c) of this chapter. (c) Related tolerances. See §§ 556.345 and 556.745 of this chapter. (d) Conditions of use —(1) Cattle —(i) Amount. Administer as a single subcutaneous injection 2.5 mg tulathromycin and 3 mg ketoprofen per kilogram (1.1 mL/100 lb) of body weight. (ii) Indications for use. For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis, and control of pyrexia associated with BRD in beef steers, beef heifers, beef calves 2 months of age and older, beef bulls, dairy bulls, and replacement dairy heifers. (iii) Limitations. Not for use in reproducing animals over 1 year of age. Cattle must not be slaughtered for human consumption within 18 days following last treatment with this drug product. Not for use in female dairy cattle 1 year of age or older, including dry dairy cows; use in these cattle may cause drug residues in milk and/or in calves born to these cows or heifers. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in pre-ruminating calves. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) [Reserved] | |||||
| 21:21:6.0.1.1.12.0.1.185 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2640 Tylosin. | FDA | [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] | (a) Specifications. Each milliliter (mL) of solution contains 50 or 200 milligrams (mg) of tylosin activity (as tylosin base). (b) Sponsors. See sponsors in § 510.600(c) of this chapter as follows: (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. See § 556.746 of this chapter. (d) Special considerations. Labeling must bear the warning statements: “Do not administer to horses or other equines. Injection of tylosin in equines has been fatal.” (e) Conditions of use —(1) Beef cattle and nonlactating dairy cattle —(i) Amount. Administer 8 mg per pound (mg/lb) of body weight by intramuscular injection once daily for not more than 5 consecutive days. Continue treatment 24 hours after symptoms disappear. (ii) Indications for use. Treatment of bovine respiratory complex (shipping fever, pneumonia) usually associated with Pasteurella multocida and Arcanobacterium pyogenes; foot rot (necrotic pododermatitis) and calf diphtheria caused by Fusobacterium necrophorum and metritis caused by A. pyogenes. (iii) Limitations. Cattle intended for human consumption must not be slaughtered within 21 days of the last use of this drug product. This drug product is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. This product is not approved for use in calves intended to be processed for veal. A withdrawal period has not been established in preruminating calves. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Swine —(i) Amount. Administer 4 mg/lb of body weight by intramuscular injection twice daily for not more than 3 consecutive days. Continue treatment 24 hours after symptoms disappear. If tylosin medicated drinking water is used as a followup treatment fo… | |||||
| 21:21:6.0.1.1.12.0.1.186 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2662 Xylazine. | FDA | [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] | (a) Specifications. Each milliliter (mL) of solution contains xylazine hydrochloride equivalent to: (1) 20 milligrams (mg) xylazine. (2) 100 mg xylazine. (3) 300 mg xylazine. (b) Sponsors. See sponsors in § 510.600(c) of this chapter for uses as in paragraph (d) of this section. (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) Nos. 043264 and 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. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (d) Conditions of use —(1) Dogs and cats —(i) Amount. 0.5 mg/pound (lb) intravenously or 1.0 mg/lb subcutaneously. (ii) Indications for use. To produce sedation, as an analgesic, and as a preanesthetic to local or general anesthesia. (2) Horses —(i) Amount. 0.5 mg/lb intravenously or 1.0 mg/lb intramuscularly. (ii) Indications for use. To produce sedation, as an analgesic, and as a preanesthetic to local or general anesthesia. (iii) Limitations. Do not use in horses intended for human consumption. (3) Elk and deer —(i) Amount. Administer intramuscularly, by hand syringe, or by syringe dart, in the heavy muscles of the croup or shoulder as follows: (A) Elk ( … | |||||
| 21:21:6.0.1.1.12.0.1.187 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2670 Yohimbine. | FDA | [79 FR 74020, Dec. 15, 2014, as amended at 80 FR 13230, Mar. 13, 2015] | (a) Specifications. Each milliliter (mL) of solution contains 2 or 5 milligrams (mg) of yohimbine (as hydrochloride). (b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (c) of this section. (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 —(1) Dogs —(i) Amount. Administer 0.05 mg per pound (0.11 mg per kilogram) of body weight by intravenous injection. (ii) Indications for use. To reverse the effects of xylazine in dogs. (iii) Limitations. Not for use in food-producing animals. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Deer and elk —(i) Amount. Administer 0.2 to 0.3 mg per kilogram of body weight by intravenous injection. (ii) Indications for use. A s an antagonist to xylazine sedation in free ranging or confined members of the family Cervidae (deer and elk). (iii) Limitations. Do not use in domestic food-producing animals. Do not use for 30 days before or during hunting season. Federal law restricts this drug to use by or on the order of a licensed veterinarian. | |||||
| 21:21:6.0.1.1.12.0.1.188 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2680 Zeranol. | FDA | [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] | (a) Specifications. Each pellet contains 12, 18, or 20 milligrams (mg) zeranol. (b) Sponsor. See 000061 in § 510.600(c) of this chapter. (c) Related tolerances. See § 556.760 of this chapter. (d) Conditions of use —(1) Beef cattle —(i) Amount. 36 mg zeranol (one implant consisting of 3 pellets, each pellet containing 12 mg zeranol) per implant dose. (ii) Indications for use. (A) For increased rate of weight gain and improved feed efficiency in growing beef steers and heifers fed in confinement for slaughter. (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. Implant pellets subcutaneously only. Not approved for repeated implantation (reimplantation) with this or any other cattle ear implant within a single production phase as safety and effectiveness have not been evaluated. Do not use in beef calves less than 2 months of age, dairy calves, and veal calves because effectiveness and safety have not been evaluated. A withdrawal period has not been established for this product in preruminating calves. Do not use in replacement beef heifers after weaning or in bulls, dairy cows, or replacement dairy heifers. (2) Feedlot lambs —(i) Amount. 12 mg zeranol (one implant consisting of 1 pellet containing 12 mg zeranol) per implant dose. (ii) Indications for use. For increased rate of weight gain and improved feed conversion. (iii) Limitations. Implant subcutaneously in ear only. Do not use in breeding animals. Do not implant animals within 40 days of slaughter. Safety and effectiveness have not been established in veal calves. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. (3) Steers fed in confinement for slaughter —(i) Amount. 72 mg zeranol (one implant consisting of 6 pellets, each pellet containing 12 mg zeranol) per implant… | |||||
| 21:21:6.0.1.1.12.0.1.189 | 21 | Food and Drugs | I | E | 522 | PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS | § 522.2690 Zinc gluconate. | FDA | [68 FR 26995, May 19, 2003, as amended at 76 FR 79064, Dec. 21, 2011; 87 FR 76422, Dec. 14, 2022] | (a) Specifications. Each milliliter of solution contains 13.1 milligrams zinc as zinc gluconate neutralized to pH 7.0 with L-arginine. (b) Sponsor. See No. 011788 in § 510.600(c) of this chapter. (c) Conditions of use in dogs —(1) Amount. The volume injected into each testicle is based on testicular width as determined by measuring each testicle at its widest point using a metric scale (millimeter) caliper. (2) Indications for use. Intratesticular injection for chemical sterilization of 3- to 10-month-old male dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. |
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