Source: https://www.ecfr.gov/cgi-bin/text-idx?mc=true&node=pt21.6.529&rgn=div5
Timestamp: 2019-11-17 21:20:04
Document Index: 736592291

Matched Legal Cases: ['art 529', '§529', '§529', '§529', '§529', '§529', '§529', '§529', '§529', '§529', '§529', '§529', '§529', '§529', '§529', '§529', '§529', '§529', '§529', '§529', '§529', '§529', '§510', '§510', '§510', '§556', '§556', '§529', '§510', '§510', '§510', '§510', '§510', '§510', '§556', '§510', '§556', '§522', '§510', '§510', '§510', '§510']

Title 21 → Chapter I → Subchapter E → Part 529
§529.40 Albuterol.
§529.56 Amikacin.
§529.382 Chloramine-T.
§529.400 Chlorhexidine tablets and suspension.
§529.536 Detomidine.
§529.539 Dexmedetomidine.
§529.778 Doxycycline.
§529.1030 Formalin.
§529.1044 Gentamicin in certain other dosage forms.
§529.1044a Gentamicin solution for infusion.
§529.1044b Gentamicin solution for dipping eggs.
§529.1115 Halothane.
§529.1150 Hydrogen peroxide.
§529.1186 Isoflurane.
§529.1350 Meloxicam.
§529.1660 Oxytetracycline.
§529.1940 Progesterone intravaginal inserts.
§529.2150 Sevoflurane.
§529.2464 Ticarcillin.
§529.2503 Tricaine methanesulfonate.
§529.2620 Triptorelin.
Source: 40 FR 13881, Mar. 27, 1975, unless otherwise noted.
(a) Specifications. A net weight of 6.7 grams of formulated albuterol sulfate is supplied in a pressurized aluminum canister within an actuator system equipped with a detachable nasal delivery bulb.
(b) Approvals. See No. 000010 in §510.600(c) of this chapter for uses as in paragraph (d) of this section.
(c) Conditions of use—(1) Amount. Each valve actuation (puff) of the device delivers 120 micrograms (mcg) of albuterol sulfate. One dose is three (3) puffs, totaling 360 mcg.
(2) Indications for use. For the immediate relief of bronchospasm and bronchoconstriction associated with reversible airway obstruction in horses.
[67 FR 7072, Feb. 15, 2002, as amended at 79 FR 10973, Feb. 27 , 2014]
(a) Specifications. Each milliliter (mL) of solution contains 250 milligrams of amikacin as amikacin sulfate.
(b) Sponsors. See Nos. 000859 and 054771 in §510.600(c) of this chapter.
(c) Conditions of use in horses—(1) Amount. Administer 2 grams (8 mL) diluted with 200 mL of sterile physiological saline by intrauterine infusion daily for 3 consecutive days.
(2) Indications for use. For treating genital tract infections (endometritis, metritis, and pyometra) in mares caused by susceptible organisms including Escherichia coli, Pseudomonas spp., and Klebsiella spp.
[76 FR 17339, Mar. 29, 2011, as amended at 78 FR 17597, Mar. 22, 2013; 79 FR 10973, Feb. 27, 2014]
(a) Specifications. Chloramine-T trihydrate powder for solution.
(b) Sponsor. See No. 086009 in §510.600(c) of this chapter.
(c) Related tolerances. See §556.118 of this chapter.
(d) Conditions of use—(1) Freshwater-reared salmonids—(i) Amount. 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.
(ii) Indications for use. For the control of mortality in freshwater-reared salmonids due to bacterial gill disease associated with Flavobacterium spp.
(2) Walleye—(i) Amount. 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.
(ii) Indications for use. For the control of mortality in walleye due to external columnaris disease associated with Flavobacterium columnare.
(3) Freshwater-reared warmwater finfish—(i) Amount. 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.
(ii) Indications for use. For the control of mortality in freshwater-reared warmwater finfish due to external columnaris disease associated with F. columnare.
(a) Specification. Each tablet and each 28-milliliter syringe of suspension contain 1 gram of chlorhexidine dihydrochloride.
(c) Related tolerances. See §556.120 of this chapter.
(d) Conditions of use—(1) Amount. 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.
(2) Indications for use. For prevention or treatment of metritis and vaginitis in cows and mares when caused by pathogens sensitive to chlorhexidine dihydrochloride.
(3) Limitations. 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]
Editorial Note: At 79 FR 10973, Feb. 27, 2014, §529.400 was amended by revising the section heading, however, the section heading was not provided, therefore, the amendment could not be incorporated because of an inaccurate amendatory instruction.
(b) Sponsor. See No. 052483 in §510.600(c) of this chapter.
(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.
[75 FR 21163, Apr. 23, 2010, as amended at 76 FR 16533, Mar. 24, 2011]
(a) Specifications. Each milliliter of gel contains 0.09 milligrams (mg) dexmedetomidine (equivalent to 0.1 mg dexmedetomidine hydrochloride).
(c) Conditions of use—(1) Amount. Administer onto the oral mucosa between the dog's cheek and gum at a dose of 125 micrograms per square meter.
(2) Indications for use. For the treatment of noise aversion in dogs.
[81 FR 17608, Mar. 30, 2016]
(a) Specifications. Formalin is an aqueous solution containing approximately 37 percent by weight of formaldehyde gas, U.S.P.
(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.
(d) Conditions of use. It is added to environmental water as follows:
(1) Indications for use. (i) Penaeid shrimp. For control of external protozoan parasites Bodo spp., Epistylis spp., and Zoothamnium spp.
(ii) All finfish. For control of external protozoa Ichthyophthirius spp., Chilodonella spp., Ichthyobodo spp., Ambiphrya spp., Epistylis spp., and Trichodina spp., and the monogeneans Cleidodiscus spp., Gyrodactylus spp., and Dactylogyrus spp.
(iii) All finfish eggs: For control of fungi of the family Saprolegniaceae.
(iv) Freshwater-reared finfish. For the control of mortality due to saprolegniasis associated with fungi in the family Saprolegniaceae.
(2) Amount. The drug concentrations required are as follows:
(i) For control of external protozoan parasites on shrimp:
Concentration of formalin (microliters per liter)
Tanks and raceways (up to 4 hours daily)
Earthen ponds (single treatment)
Penaeid Shrimp 50 to 1001 252
1Treat for up to 4 hours daily. Treatment may be repeated daily until parasite control is achieved. Use the lower concentration when tanks or raceways are heavily loaded with phytoplankton or shrimp, to avoid oxygen depletion due to the biological oxygen demand created by decay of dead phytoplankton. Alternatively, a higher concentration might be used if dissolved oxygen is strictly monitored.
2Single treatment. Treatment may be repeated in 5 to 10 days if needed.
Administer in tanks and raceways for up to 1 hour (microliter/liter or part per million (µL/L or ppm))
Administer in earthen ponds single treatment (µL/L or ppm)
Above 50 °F Up to 170 15 to 251 2
Below 50 °F Up to 250 15 to 251 2
All other finfish Up to 250 15 to 251 2
1Use the lower concentration when ponds, tanks, or raceways are heavily loaded with phytoplankton or fish to avoid oxygen depletion due to the biological oxygen demand by decay of dead phytoplankton. Alternatively, a higher concentration may be used if dissolved oxygen is strictly monitored.
2Although the indicated concentrations are considered safe for cold and warm water finfish, a small number of each lot or pond to be treated should always be used to check for any unusual sensitivity to formalin before proceeding.
(iii) For control of fungi of the family Saprolegniaceae on finfish eggs: Eggs of all finfish except Acipenseriformes, 1,000 to 2,000 µL/L (ppm) for 15 minutes; eggs of Acipenseriformes, up to 1,500 µL/L (ppm) for 15 minutes. A preliminary bioassay should be conducted on a small subsample of fish eggs to determine sensitivity before treating an entire group. This is necessary for all species because egg sensitivity can vary with species or strain and the unique conditions at each facility.
(iv) For the control of mortality in freshwater-reared finfish due to saprolegniasis associated with fungi in the family Saprolegniaceae: In tanks and raceways, administer 150 µL/L (ppm) for 60 minutes per day on alternate days for three treatments.
(3) Limitations. Fish tanks and raceways may be treated daily until parasite control is achieved. Pond treatment may be repeated in 5 to 10 days if needed. However, pond treatments for Ichthyophthirius spp. should be made at 2-day intervals until control is achieved. Egg tanks may be treated as often as necessary to prevent growth of fungi. Do not use formalin which has been subjected to temperatures below 40 °F, or allowed to freeze. Treatments in tanks and raceways should never exceed 1 hour for fish or 4 hours for penaeid shrimp (even if they show no sign of distress), nor should it exceed 15 minutes for fish eggs. Do not apply formalin to ponds with water warmer than 27 °C (80 °F), when a heavy bloom of phytoplankton is present, or when the concentration of dissolved oxygen is less than 5 milligrams per liter.
[51 FR 11441, Apr. 3, 1986, as amended at 58 FR 59169, Nov. 8, 1993; 59 FR 60076, Nov. 22, 1994; 63 FR 38304, July 16, 1998; 68 FR 5563; Feb. 4, 2003; 72 FR 45158, Aug. 13, 2007; 76 FR 17339, Mar. 29, 2011; 79 FR 2786, Jan. 16, 2014; 82 FR 58556, Dec. 13, 2017; 84 FR 53311, Oct. 7, 2019]
(a) Specifications. Each milliliter of solution contains 50 or 100 milligrams gentamicin sulfate.
(b) Sponsors. See Nos. 000061, 000859, 016592, 054628, 054771, 058005, and 061133 in §510.600(c) of this chapter.
(c) Conditions of use in horses—(1) Amount. Infuse 2 to 2.5 grams per day for 3 to 5 days during estrus.
(2) Indications for use. 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.
[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]
(a) Specifications. Each milliliter of solution contains gentamicin sulfate equivalent to 50 milligrams of gentamicin base.
[40 FR 13881, Mar. 27, 1975, as amended at 52 FR 7833, Mar. 13, 1987; 62 FR 22889, Apr. 28, 1997; 71 FR 13543, Mar. 16, 2006; 79 FR 10973, Feb. 27, 2014]
(a) Specifications. The drug is a colorless, odorless, nonflammable, nonexplosive, heavy liquid containing 0.01 percent thymol as a preservative.
(b) Sponsor. See Nos. 012164 and 054771 in §510.600(c) of this chapter.
(c) Conditions of use—(1) Amount. Two to 5 percent of inhaled atmosphere for induction of anesthesia; 0.5 to 2 percent for maintenance of anesthesia.
(2) Indications for use. For nonfood animals for the induction and maintenance of anesthesia.
[46 FR 27915, May 22, 1981, as amended at 62 FR 29014, May 29, 1997; 79 FR 10973, Feb. 27, 2014]
(a) Specifications. Each milliliter of solution contains 396.1 milligrams (mg) hydrogen peroxide (a 35% w/w solution).
(b) Sponsor. See No. 050378 in §510.600(c) of this chapter.
(c) Conditions of use in finfish—(1) Amount. (i) 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 for all coldwater and coolwater species of freshwater-reared finfish eggs or 750 to 1,000 mg/L for 15 minutes in a continuous flow system once per day on consecutive or alternate days until hatch for all warmwater species of freshwater-reared finfish eggs.
(ii) Freshwater-reared salmonids: 100 mg/L for 30 minutes or 50 to 100 mg/L for 60 minutes once per day on alternate days for three treatments in a continuous flow water supply or as a static bath.
(iii) Coolwater species of freshwater-reared finfish fingerlings and adults (except northern pike & paddlefish) and channel catfish fingerlings and adults: 50 to 75 mg/L for 60 minutes once per day on alternate days for three treatments in continuous flow water supply or as a static bath. Coolwater species of freshwater-reared finfish fry (except northern pike, pallid sturgeon & paddlefish) and channel catfish fry: 50 mg/L for 60 minutes once per day on alternate days for three treatments in continuous flow water supply or as a static bath.
(2) Indications for use. For control of mortality in freshwater-reared finfish eggs due to saprolegniasis; for control of mortality in freshwater-reared salmonids due to bacterial gill disease associated with Flavobacterium branchiophilum; and for control of mortality in freshwater-reared coolwater finfish and channel catfish due to external columnaris disease associated with Flavobacterium columnare (Flexibacter columnaris).
(3) Limitations. Initial bioassay on a small number is recommended before treating the entire group. Eggs: Some strains of rainbow trout eggs are sensitive to hydrogen peroxide treatment at a time during incubation concurrent with blastopore formation through closure, about 70 to 140 Daily Temperature Units, °C. Consider withholding treatment or using an alternate therapeutant during that sensitive time to reduce egg mortalities due to drug toxicity. Finfish: Use with caution on walleye. Preharvest withdrawal time: zero days.
[72 FR 5330, Feb. 6, 2007, as amended at 78 FR 73698, Dec. 9, 2013]
(a) Specifications. The drug is a clear, colorless, stable liquid.
(b) Sponsors. See Nos. 012164, 054771, 065085, and 066794 in §510.600(c) of this chapter.
(c) Conditions of use. Administer by inhalation:
(1) Amount—(i) Horses: 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).
(ii) Dogs: 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).
(2) Indications for use. For induction and maintenance of general anesthesia in horses and dogs.
[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, 2013; 78 FR 17868, Mar. 25, 2013; 80 FR 18776, Apr. 8, 2015; 82 FR 12170, Mar. 1, 2017]
(a) Specifications. Each milliliter of solution contains 5 milligrams (mg) meloxicam.
(c) Conditions of use in dogs—(1) Amount. Administer 0.1 mg per kilogram of body weight once daily using the metered dose pump.
(2) Indications for use. For the control of pain and inflammation associated with osteoarthritis in dogs.
[77 FR 76863, Dec. 31, 2012, as amended at 80 FR 18776, Apr. 8, 2015]
(a) Specifications. (1) Each gram of powder contains 366 milligrams (mg) oxytetracycline hydrochloride.
(b) Sponsors. 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.
(c) Related tolerances. See §556.500 of this chapter.
(d) Conditions of use in finfish—(1) Amount. Immerse fish in a solution containing 200 to 700 mg oxytetracycline hydrochloride (buffered) per liter of water for 2 to 6 hours.
(2) Indications for use. For skeletal marking of finfish fry and fingerlings.
[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]
(a) Specifications. 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.
(b) Sponsor. 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.
(c) Related tolerances. See §556.540 of this chapter.
(d) Special considerations. 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.”
(e) Conditions of use—(1) Cows—(i) Amount. 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 a single intramuscular injection on the day of insert removal (Day 7).
(ii) Indications for use. (A) For synchronization of estrus in suckled beef cows and replacement beef and dairy heifers; for advancement of first postpartum estrus in suckled beef cows; and for advancement of first pubertal estrus in replacement beef heifers.
(B) For synchronization of estrus in lactating dairy cows.
(C) For synchronization of the return to estrus in lactating dairy cows inseminated at the immediately preceding estrus.
(D) For induction of estrous cycles in anestrous lactating dairy cows.
(iii) Limitations. Do not use in beef or dairy heifers of insufficient size or age for breeding or in animals with abnormal, immature, or infected genital tracts. Do not use in beef cows that are fewer than 20 days postpartum. Do not use an insert more than once. To prevent the potential transmission of venereal and bloodborne diseases, the inserts should be disposed after a single use. Administration of vaginal inserts for periods greater than 7 days may result in reduced fertility. Dinoprost injection for use in paragraphs (e)(1)(ii)(A) and (e)(1)(ii)(B) of this section as in §522.690 of this chapter, provided by No. 054771 in §510.600(c) of this chapter.
(2) Ewes—(i) Amount. Administer one intravaginal insert per animal for 5 days.
(ii) Indications for use. For induction of estrus in ewes (sheep) during seasonal anestrus.
(iii) Limitations. Do not use in animals with abnormal, immature, or infected genital tracts; or in ewes that have never lambed. Do not use an insert more than once. To prevent the potential transmission of venereal and bloodborne diseases, the inserts should be disposed after a single use.
[74 FR 59074, Nov. 17, 2009, as amended at 75 FR 63085, Oct. 14, 2010; 79 FR 10965, 10974, Feb. 27, 2014; 79 FR 44278, July 31, 2014]
(a) Specifications. Sevoflurane liquid.
(b) Sponsors. See Nos. 012164, 054771, and 066794 in §510.600(c) of this chapter.
(c) Conditions of use—(1) Amount. 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.
(2) Indications for use. For induction and maintenance of general anesthesia in dogs.
[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]
(b) Sponsor. See Nos. 050378 and 051212 in §510.600(c) of this chapter.
(b) Sponsor. See No. 051233 in §510.600(c) of this chapter.
[77 FR 64717, Oct. 23, 2012]