Title 21 CFR reference

Specifications.(a) Formalin is an aqueous solution containing approximately 37 percent by weight of formaldehyde gas, U.S.P. Sponsors.(b) See sponsors in § 510.600(c) of this chapter for uses as in paragraph (d) of this section. (1) No. 050378 for use as in paragraph (d) of this section. (2) Nos. 049968 and 067188 for use as in paragraphs (d)(1)(i), (ii), and (iii), (d)(2)(i), (ii), and (iii), and (d)(3) of this section. (c) [Reserved] Conditions of use.(d) It is added to environmental water as follows: Indications for usePenaeid shrimp.BodoEpistylisZoothamnium(1) —(i) For control of external protozoan parasites spp., spp., and spp. All finfish.IchthyophthiriusChilodonellaIchthyobodoAmbiphryaEpistylisTrichodinaCleidodiscusGyrodactylusDactylogyrus(ii) For control of external protozoa spp., spp., spp., spp., spp., and spp., and the monogeneans spp., spp., and spp. (iii) All finfish eggs: For control of fungi of the family Saprolegniaceae. Freshwater-reared finfish.(iv) For the control of mortality due to saprolegniasis associated with fungi in the family Saprolegniaceae. Amount.(2) The drug concentrations required are as follows: (i) For control of external protozoan…

Specifications.(a) Each milliliter of solution contains 50 or 100 milligrams gentamicin sulfate. Sponsors.(b) See Nos. 000061, 016592, 054628, 054771, 058005, 058198, and 061133 in § 510.600(c) of this chapter. Conditions of use in horsesAmount.(c) —(1) Infuse 2 to 2.5 grams per day for 3 to 5 days during estrus. Indications for use.(2) For control of bacterial infections of the uterus (metritis) and as an aid in improving conception in mares with uterine infections caused by bacteria sensitive to gentamicin. Limitations.(3) 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. [71 FR 51727, Aug. 31, 2006, as amended at 78 FR 17597, Mar. 22, 2013; 78 FR 21060, Apr. 9, 2013; 79 FR 10973, Feb. 27, 2014; 83 FR 48947, Sept. 28, 2018; 84 FR 8974, Mar. 13, 2019; 86 FR 14821, Mar. 19, 2021]

Specifications.(a) Each milliliter of solution contains gentamicin sulfate equivalent to 50 milligrams of gentamicin base. Sponsors.(b) See Nos. 000061 and 054925 in § 510.600(c) of this chapter. Conditions of use in turkeysAmount.(c) —(1) The drug is added to clean water to provide a dip solution with a gentamicin concentration of 250 to 1,000 parts per million. A concentration of 500 parts per million is recommended. Clean eggs should be held submerged in the gentamicin solution under a vacuum of about 27.5 to 38 centimeters of mercury for 5 minutes followed by additional soaking in gentamicin solution for approximately 10 minutes at atmospheric pressure. Eggs can also be treated by warming them for 3 to 6 hours at approximately 100 °F then immediately submerging them in gentamicin solution maintained at about 40 °F, keeping the eggs submerged for 10 to 15 minutes. Indications for use.Arizona hinshawiiparacolonSalmonellaMycoplasma meleagridis.(2) As an aid in the reduction or elimination of the following microorganisms from turkey-hatching eggs: (), Saintpaul, and Limitations.(3) For use in the dipping treatment of turkey-hatching eggs only. Eggs which have been dipped in…

Specifications.(a) The drug is a colorless, odorless, nonflammable, nonexplosive, heavy liquid containing 0.01 percent thymol as a preservative. Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter. Conditions of useAmount.(c) —(1) Two to 5 percent of inhaled atmosphere for induction of anesthesia; 0.5 to 2 percent for maintenance of anesthesia. Indications for use.(2) For nonfood animals for the induction and maintenance of anesthesia. Limitations.(3) Not for use in animals intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [46 FR 27915, May 22, 1981, as amended at 62 FR 29014, May 29, 1997; 79 FR 10973, Feb. 27, 2014; 85 FR 4208, Jan. 24, 2020]

Specifications.(a) Each milliliter of solution contains 396.1 milligrams (mg) hydrogen peroxide (a 35% w/w solution). Sponsor.(b) See No. 050378 in § 510.600(c) of this chapter. Conditions of useIndications and amount.(c) —(1) (i) Freshwater-reared finfish eggs for the control of mortality in due to saprolegniasis associated with fungi in the family Saprolegniaceae: (A) For all coldwater and coolwater species of freshwater-reared finfish eggs: 500 to 1,000 mg per liter (/L) of culture water for 15 minutes in a continuous flow system once per day on consecutive or alternate days until hatch, or (B) For all freshwater-reared warmwater finfish eggs: 750 to 1,000 mg/L for 15 minutes in a continuous flow system once per day on consecutive or alternate days until hatch. (ii) Freshwater-reared finfish for the control of mortality due to saprolegniasis associated with the fungi in the family Saprolegniaceae: For freshwater-reared coldwater finfish including salmonids (all life stages), freshwater-reared coolwater finfish fingerlings and adults, and freshwater-reared warmwater finfish fingerlings and adults: 75 mg/L for 60 minutes in continuous flow water supply or as a static bath…

Specifications.(a) The drug is a clear, colorless, stable liquid. Sponsors.(b) See Nos. 017033, 054771, 065085, and 066794 in § 510.600(c) of this chapter. Conditions of use.(c) Administer by inhalation: AmountHorses:(1) —(i) For induction of surgical anesthesia: 3 to 5 percent isoflurane (with oxygen) for 5 to 10 minutes. For maintenance of surgical anesthesia: 1.5 to 1.8 percent isoflurane (with oxygen). Dogs:(ii) For induction of surgical anesthesia: 2 to 2.5 percent isoflurane (with oxygen) for 5 to 10 minutes. For maintenance of surgical anesthesia: 1.5 to 1.8 percent isoflurane (with oxygen). Indications for use.(2) For induction and maintenance of general anesthesia in horses and dogs. Limitations.(3) 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. [51 FR 594, Jan. 7, 1986, as amended at 54 FR 23472, June 1, 1989; 58 FR 17346, Apr. 2, 1993; 59 FR 44315, Aug. 29, 1994; 60 FR 40456, Aug. 9, 1995; 63 FR 8122, Feb. 18, 1998; 63 FR 24106, May 1, 1998; 66 FR 17510, Apr. 2, 2001; 71 FR 43967, Aug. 3, 2006; 74 FR 68530, Dec. 28, 2009; 76 FR 16533, Mar. 24, 2011; 78 FR 14669, Mar. 7,…

Specifications.(a) Each milliliter of solution contains 5 milligrams (mg) meloxicam. Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter. Conditions of use in dogsAmount.(c) —(1) Administer 0.1 mg per kilogram of body weight once daily using the metered dose pump. Indications for use.(2) For the control of pain and inflammation associated with osteoarthritis in dogs. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [77 FR 76863, Dec. 31, 2012, as amended at 80 FR 18776, Apr. 8, 2015]

Specifications.(a) (1) Each gram of powder contains 366 milligrams (mg) oxytetracycline hydrochloride. (2) Each gram of powder contains 753 mg oxytetracycline hydrochloride. Sponsors.(b) See sponsors in § 510.600(c) of this chapter for use of products described in paragraph (a) of this section as in paragraph (d) of this section. (1) Nos. 054771 and 061133 for use of product in paragraph (a)(1) of this section. (2) Nos. 054771, 061133, and 069254 for use of product described in paragraph (a)(2) of this section. Related tolerances. See(c) § 556.500 of this chapter. Conditions of use in finfishAmount.(d) —(1) Immerse fish in a solution containing 200 to 700 mg oxytetracycline hydrochloride (buffered) per liter of water for 2 to 6 hours. Indications for use.(2) For skeletal marking of finfish fry and fingerlings. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [69 FR 6557, Feb. 11, 2004, as amended at 69 FR 61999, Oct. 22, 2004; 70 FR 41140, July 18, 2005; 72 FR 26289, May 9, 2007; 76 FR 17026, Mar. 28, 2011; 79 FR 10973, Feb. 27, 2014; 81 FR 22524, Apr. 18, 2016; 81 FR 94991, Dec. 27, 2016; 84 FR 8974, Mar. 13, 2019]

Specifications.(a) Each insert contains: (1) 1.38 grams (g) progesterone in molded silicone over a nylon spine. (2) 0.3 g progesterone in molded silicone over a flexible nylon spine. Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter for use of the product described in paragraph (a)(1) of this section as in paragraph (e)(1) of this section; and the product described in paragraph (a)(2) of this section as in paragraph (e)(2) of this section. Related tolerances.(c) See § 556.540 of this chapter. Special considerations.(d) Product labeling shall bear the following warning: “Avoid contact with skin by wearing protective gloves when handling inserts. Store removed inserts in a sealable container until they can be disposed of in accordance with applicable local, state, and Federal regulations.” Conditions of useCowsAmount.(e) —(1) —(i) Administer one intravaginal insert per animal for 7 days. When used for indications listed in paragraph (e)(1)(ii)(A) of this section, administer 25 mg dinoprost as a single intramuscular injection 1 day prior to insert removal (Day 6). When used for indications listed in paragraph (e)(1)(ii)(B) of this section, administer 25 mg dinoprost as…

Specifications.(a) Sevoflurane liquid. Sponsors.(b) See Nos. 017033, 054771, and 066794 in § 510.600(c) of this chapter. Conditions of useAmount.(c) —(1) For induction of surgical anesthesia: up to 7 percent sevoflurane. For maintenance of surgical anesthesia: 3.7 to 4 percent sevoflurane with oxygen in the absence of premedication and 3.3 to 3.6 percent in the presence of premedication. Indications for use.(2) For induction and maintenance of general anesthesia in dogs. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [64 FR 71640, Dec. 22, 1999, as amended at 73 FR 25508, May 7, 2008; 74 FR 10484, Mar. 11, 2009, 75 FR 1021, Jan. 8, 2010; 76 FR 16533, Mar. 24, 2011; 78 FR 17868, Mar. 25, 2013; 80 FR 18776, Apr. 8, 2015. Redesignated at 86 FR 13188, Mar. 8, 2021, as amended at 87 FR 58963, Sept. 29, 2022]

Specifications.(a) Each vial contains ticarcillin disodium powder equivalent to 6 grams of ticarcillin for reconstitution with 25 milliliters of sterile water for injection or sterile physiological saline. Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter. Conditions of use in horsesAmount.(c) —(1) Administer 6 grams daily by intrauterine infusion for 3 consecutive days during estrus. Indications for use.(2) For the treatment of endometritis caused by beta-hemolytic streptococci. Limitations.(3) 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. [79 FR 10974, Feb. 27, 2014]

Specifications.m(a) The drug is ethyl--amino-benzoate methanesulfonate. Sponsor.(b) See Nos. 050378 and 051212 in § 510.600(c) of this chapter. Conditions of useAmount.(c) —(1) It is used as follows: Fish.(i) The drug is added to ambient water at a concentration of from 15 to 330 milligrams per liter depending upon the degree of anesthetization or sedation desired, the species and size of the fish, and the temperature and softness of the water. Preliminary tests of solutions must be made with small numbers of fish to determine the desired rates of sedation or anesthesia and the appropriate exposure times for the specific lots of fish under prevailing conditions. Amphibians and other aquatic coldblooded animals.(ii) The drug is added to ambient water in concentrations of from 1:1000 to 1:20,000 depending upon species and stage of development. Indications for use.(2) For the temporary immobilization of fish, amphibians, and other aquatic coldblooded animals (poikilotherms) as an aid in handling during manual spawning (fish stripping), weighing, measuring, marking, surgical operations, transport, photography, and research. Limitations.(3) Do not use within 21 days of harvesting…

Specifications.(a) Each milliliter of gel contains 100 micrograms (mcg) triptorelin as triptorelin acetate. Sponsor.(b) See No. 051233 in § 510.600(c) of this chapter. Conditions of use in swineAmount.(c) —(1) Administer 200 mcg intravaginally approximately 96 hours after weaning. Indications for use.(2) For the synchronization of time of insemination in weaned sows to facilitate a single fixed-time artificial insemination. Limitations.(3) Not approved for use in gilts. Safety and effectiveness have not been evaluated in these animals. Should not be used in sows with obvious reproductive tract abnormalities. [77 FR 64717, Oct. 23, 2012]

Specifications.(a) Chloramine-T trihydrate powder for solution. Sponsor.(b) See No. 086009 in § 510.600(c) of this chapter. Related tolerances.(c) See § 556.118 of this chapter. Conditions of useFreshwater-reared salmonidsAmount.(d) —(1) —(i) 12 to 20 milligrams per liter (mg/L) water in a continuous flow water supply or as a static bath once per day for 60 minutes on consecutive or alternative days for three treatments. Indications for use.Flavobacterium(ii) For the control of mortality in freshwater-reared salmonids due to bacterial gill disease associated with spp. WalleyeAmount.(2) —(i) 10 to 20 mg/L water in a continuous flow water supply or as a static bath once per day for 60 minutes on consecutive or alternative days for three treatments. Indications for use.Flavobacterium columnare.(ii) For the control of mortality in walleye due to external columnaris disease associated with Freshwater-reared warmwater finfishAmount.(3) —(i) 20 mg/L water in a continuous flow water supply or as a static bath once per day for 60 minutes on consecutive or alternative days for three treatments. Indications for use.F. columnare.(ii) For the control of mortality in freshwater-reared…

Specification.(a) Each tablet and each 28-milliliter syringe of suspension contain 1 gram of chlorhexidine dihydrochloride. Sponsor.(b) See No. 054771 in § 510.600(c) of this chapter. Related tolerances.(c) See § 556.120 of this chapter. Conditions of useAmount.(d) —(1) Place 1 or 2 tablets deep in each uterine horn; or infuse a solution of 1 tablet disolved in an appropriate amount of clean boiled water; or infuse one syringe of suspension into the uterus. Indications for use.(2) For prevention or treatment of metritis and vaginitis in cows and mares when caused by pathogens sensitive to chlorhexidine dihydrochloride. Limitations.(3) Prior to administration, remove any unattached placental membranes, any excess uterine fluid or debris, and carefully clean external genitalia. Use a clean, sterile inseminating pipette for administrating solutions and suspensions. Treatment may be repeated in 48 to 72 hours. [43 FR 10705, Feb. 23, 1979, as amended at 79 FR 10973, Feb. 27, 2014; 81 FR 67152, Sept. 30, 2016; 84 FR 32993, July 11, 2019]

Specifications.(a) A non-pressurized metered dose inhaler and drug cartridge combination containing a solution of 30 milligrams/milliliter of the prodrug ciclesonide. Each actuation releases 343 micrograms (mcg) of ciclesonide. Sponsor.(b) See No. 000010 in § 510.600(c) of this chapter. Conditions of useAmount.(c) —(1) Administer an initial dose of 8 actuations (2,744 mcg ciclesonide) twice daily for 5 days, followed by 12 actuations (4,116 mcg ciclesonide) once daily for 5 days. Indications for use.(2) For the management of clinical signs associated with severe equine asthma. Limitations.(3) 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. [86 FR 13188, Mar. 8, 2021]

Specifications.(a) Each milliliter of gel contains 7.6 milligrams (mg) of detomidine hydrochloride. Sponsor.(b) See No. 052483 in § 510.600(c) of this chapter. Conditions of use in horsesAmount.(c) —(1) Administer 0.018 mg per pound (mg/lb) (0.040 mg/kilogram (kg) sublingually. Indications for use.(2) For sedation and restraint. Limitations.(3) 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. [75 FR 21163, Apr. 23, 2010, as amended at 76 FR 16533, Mar. 24, 2011]

Specifications.(a) Each milliliter of gel contains 0.09 milligrams (mg) dexmedetomidine (equivalent to 0.1 mg dexmedetomidine hydrochloride). Sponsor.(b) See No. 052483 in § 510.600(c) of this chapter. Conditions of useAmount.(c) —(1) Administer onto the oral mucosa between the dog's cheek and gum at a dose of 125 micrograms per square meter. Indications for use.(2) For the treatment of noise aversion in dogs. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [81 FR 17608, Mar. 30, 2016]

Specifications.(a) Each milliliter (mL) of solution contains 250 milligrams of amikacin as amikacin sulfate. Sponsors.(b) See Nos. 054771 and 058198 in § 510.600(c) of this chapter. Conditions of use in horsesAmount.(c) —(1) Administer 2 grams (8 mL) diluted with 200 mL of sterile physiological saline by intrauterine infusion daily for 3 consecutive days. Indications for use.Escherichia coli, PseudomonasKlebsiella(2) For treating genital tract infections (endometritis, metritis, and pyometra) in mares caused by susceptible organisms including spp., and spp. Limitations.(3) 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. [76 FR 17339, Mar. 29, 2011, as amended at 78 FR 17597, Mar. 22, 2013; 79 FR 10973, Feb. 27, 2014; 86 FR 14821, Mar. 19, 2021]

Specifications.(a) Doxycycline hyclate solution contains 8.5 percent doxycycline activity. A syringe of N-methyl-2-pyrrolidone and poly (DL-lactide) mixed with a syringe of doxycycline produces 0.5 milliliter of solution. Sponsor.(b) See 054771 in § 510.600(c) of this chapter. Conditions of use in dogsAmount.(c) —(1) Apply subgingivally to periodontal pocket(s) of affected teeth. Indications for use.(2) For treatment and control of periodontal disease. Limitations.(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian. [79 FR 10973, Feb. 27, 2014]