Electronic Code of Federal Regulations:

(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.

(d) 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.

(a) Specifications. Each milliliter of sterile aqueous solution contains 250 milligrams of amikacin (as the sulfate).

(c) Conditions of use —(1) Amount. Two grams (8 milliliters) diluted with 200 milliliters of sterile physiological saline per day for 3 consecutive days.

(2) Indications for use. For treating genital tract infections (endometritis, metritis, and pyometra) in mares when caused by susceptible organisms including E. coli, Pseudomonas spp., and Klebsiella spp.

(3) Limitations. For intrauterine infusion in the horse only. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[48 FR 9640, Mar. 8, 1983, as amended at 53 FR 27852, July 25, 1988; 62 FR 15110, Mar. 31, 1997; 62 FR 23358, Apr. 30, 1997]

(a) Specification. Each tablet and each 28-milliliter syringe of suspension contain 1 gram of chlorhexidine dihydrochloride.¹

(c) 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.¹

(2) Indications for use. For prevention or treatment of metritis and vaginitis in cows and mares when caused by pathogens sensitive to chlorhexidine dihydrochloride.¹

(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.¹

(a) Specifications . Each packet of lyophilized culture contains either 2,000 or 5,000 doses in frozen pellets to be reconstituted for use.

(1) For 2,000-dose packet, add contents of one 2,000-dose packet of reconstitution powder to 490 milliliters of deionized water. Mix. Add contents of one 2,000-dose packet of lyophilized culture. Mix thoroughly.

(2) For 5,000-dose packet, add contents of one 5,000-dose packet of reconstitution powder to 1,250 milliliters of deionized water. Mix. Add contents of one 5,000-dose packet of lyophilized culture. Mix thoroughly. Allow to stand for 45 minutes before use. Use within 5 hours of reconstitution.

(d) Conditions of use . Chickens —(1) Amount . Apply 25 milliliters of reconstituted culture as a topical spray on each tray of 100 chicks (0.25 milliliter per chick).

(2) Indications for use . For early establishment of intestinal microflora in chickens to reduce Salmonella colonization.

(3) Limitations . Administer as soon as possible after hatch, preferably at less than 1 day of age. Expose chicks to light for at least 5 minutes after spray treatment to encourage preening for oral uptake of the organisms. Provide access to feed and water as soon as possible after treatment. Do not administer antibiotics to treated chickens.

(a) Specifications. Each vaginal sponge contains 20 milligrams of flurogestone acetate.

(c) Conditions of use —(1) Indications for use. For synchronizing estrus/ovulation in cycling adult ewes during their normal breeding season.

(2) Limitations. Using applicator provided, insert sponge into ewe's vagina 13 days before desired start of breeding. For intravaginal use in sheep only. Do not use in young ewes that have not had lambs. Use plastic or rubber gloves when handling large numbers of sponges to minimize exposure to drug. Do not leave sponge in the vagina for more than 21 days. Ewes must not be slaughtered for food within 30 days of sponge removal.

(a) Specifications. Formalin is an aqueous solution containing approximately 37 percent by weight of formaldehyde gas, U.S.P.

(b) Sponsors . See sponsors in §510.600(c) of this chapter for uses as in paragraph (d) of this section.

(1) Nos. 049968, 050378, and 067188 for use as in paragraphs (d)(1)(iii), (d)(1)(iv), (d)(1)(v), (d)(2)(iii), (d)(2)(iv), (d)(2)(v), and (d)(3).

(2) No. 051212 for use as in paragraphs (d)(1)(i), (d)(1)(ii), (d)(2)(i), (d)(2)(ii), and (d)(3).

(1) Indications for use . (i) Select finfish. For control of external protozoa Ichthyophthirius spp., Chilodonella spp., Costia spp., Scyphidia spp., Epistylis spp., and Trichodina spp., and monogenetic trematodes Cleidodiscus spp., Gyrodactylus spp., and Dactylogyrus spp., on salmon, trout, catfish, largemouth bass, and bluegill.

(ii) Select finfish eggs. For control of fungi of the family Saprolegniaceae on salmon, trout, and esocid eggs.

(iii) Penaeid shrimp. For control of external protozoan parasites Bodo spp., Epistylis spp., and Zoothamnium spp.

(iv) All finfish. For control of external protozoa Ichthyophthirius spp., Chilodonella spp., Costia spp., Scyphidia spp., Epistylis spp., and Trichodina spp., and monogenetic trematodes Cleidodiscus spp., Gyrodactylus spp., and Dactylogyrus spp.

Fish	Concentration of formalin (microliters per liter)
Fish	Tanks and raceways (for up to 1 hour daily)	Earthen ponds (indefinitely)
Salmon and trout:
Above 50 °F	Up to 170	15–25
Below 50 °F	Up to 250	15–25
Catfish, largemouth bass, and bluegill	Up to 250	¹15–25

¹Use the lower concentrations when pond is heavily loaded with fish or phytoplankton.

(ii) For control of fungi of the Saprolegniaceae on salmon, trout, and esocid eggs: Apply in constant flow water supply of incubating facilities for 15 minutes. Concentration of formalin used is 1,000 to 2,000 microliters per liter.

Shrimp	Concentration of formalin (microliters per liter)
Shrimp	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 the tanks and raceways are heavily loaded.

²Single treatment. Treatment may be repeated in 5 to 10 days if needed.

Aquatic species	Administer in tanks and raceways for up to 1 hour (microliter/liter or part per million (µL/L or ppm))	Administer in earthen ponds indefinitely (µL/L or ppm)
Salmon and trout:
Above 50 °F	Up to 170	15 to 25^1,2
Below 50 °F	Up to 250	15 to 25^1,2
All other finfish	Up to 250	15 to 25^1,2

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.

(v) For control of fungi of the family Saprolegniaceae on all 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.

(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 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. Do not treat ponds containing striped bass. Treatments in tanks should never exceed 1 hour even if fish show no signs of stress. 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]

(a) Specifications . Each milliliter of solution contains 50 or 100 milligrams gentamicin sulfate.

(b) Sponsors . See Nos. 000010, 000061, 000856, 057561, 058005, 059130, and 061623 in §510.600(c) of this chapter.

(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.

(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.

(a) Specifications. Each milliliter of solution contains gentamicin sulfate equivalent to 50 milligrams of gentamicin base.

(c) Conditions of use. (1) The drug is recommended as an aid in the reduction or elimination of the following microorganisms from turkey-hatching eggs: Arizona hinshawii ( paracolon ), Salmonella st. paul, and Mycoplasma meleagridis.

(2) 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.

(3) For use in the dipping treatment of turkey-hatching eggs only. Eggs which have been dipped in the drug shall not be used for food.

[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]

(a) Specifications. The drug is a colorless, odorless, nonflammable, nonexplosive, heavy liquid containing 0.01 percent thymol as a preservative.

(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.¹

(2) Indications for use. For nonfood animals for the induction and maintenance of anesthesia.¹

(3) Limitations. Administered by inhalation. May be administered with either oxygen or a mixture of oxygen and nitrous oxide. Place drug vaporizer between the gas supply and breathing bag to prevent overdosage. Not recommended for obstetrical anesthesia except when uterine relaxation is required. Do not use in pregnant animals; information on possible adverse effects on fetal development is not available. Operating rooms should have adequate ventilation to prevent accumulation of anesthetic gases. Not for use in animals intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.¹

(a) Specifications . Each milliliter of solution contains 396.1 milligrams (mg) hydrogen peroxide (a 35% w/w solution).

(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.

(b) Sponsors . See Nos. 000074, 000209, 010019, 012164, 060307, and 066112 in §510.600(c) of this chapter.

(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.

(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.

[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]

(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. 046573 and 061623 for use of product in paragraph (a)(1) of this section.

(2) Nos. 000069 and 059130 for use of product described in paragraph (a)(2) of this section.

(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.

[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]

(a) Specifications . Each insert contains 1.38 grams of progesterone in molded silicone over a nylon spine.

(d) Special considerations . (1) Product labeling shall bear the following warnings: “Avoid contact with skin by wearing latex gloves when handling inserts. Store removed inserts in a plastic bag or other sealable container until they can be disposed of in accordance with applicable local, State, and Federal regulations.”

(2) This product is approved with the concurrent use of dinoprost solution on day 6 of the 7-day administration period when used for indications listed in paragraph (e)(2)(i) of this section. See §522.690(c) of this chapter.

(e) Conditions of use —(1) Amount . Administer one intravaginal insert per animal for 7 days. When used for indications listed in paragraph (e)(2)(i) of this section, administer 25 milligrams (mg) dinoprost (5 milliliters (mL) of 5 mg/mL solution as in §522.690(a) of this chapter) as a single intramuscular injection one day prior to insert removal.

(2) Indications for use —(i) 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.

(ii) For synchronization of the return to estrus in lactating dairy cows inseminated at the immediately preceding estrus.

(3) Limitations . Do not use in animals with abnormal, immature, or infected genital tracts; or in beef cows that are fewer than 20 days postpartum; or in beef or dairy heifers of insufficient size or age for breeding. 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 solution as provided by No. 000009 in §510.600(c) of this chapter.

[67 FR 41824, June 20, 2002, as amended at 67 FR 51080, Aug. 7, 2002; 68 FR 57613, Oct. 6, 2003]

(c) Conditions of use —(1) Amount. For induction of surgical anesthesia: 5 to 7 percent sevoflurane with oxygen. 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.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(a) Specifications. Each vial contains ticarcillin disodium equivalent to 6 grams of ticarcillin to be reconstituted with 25 milliliters of sterile water for injection or sterile physiological saline.

(2) Indications for use. Horses. Intrauterine treatment of endometritis caused by beta-hemolytic streptococci.

(3) Limitations . For intrauterine use in horses only. Infuse aseptically. Not for use in horses raised for food production. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(c) Conditions of use. (1) It is used 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.

(i) For fish 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.

(ii) For amphibians and other aquatic coldblooded animals, the drug is added to ambient water in concentrations of from 1:1000 to 1:20,000 depending upon species and stage of development.

(iii) Do not use within 21 days of harvesting fish for food. Use in fish intended for food should be restricted to Ictaluridae, Salmonidae, Esocidae, and Percidae, and water temperature should exceed 10 °C. (50 °F.). In other fish and in cold-blooded animals, the drug should be limited to hatchery or laboratory use.

[40 FR 13881, Mar. 27, 1975, as amended at 49 FR 5748, Feb. 15, 1984; 51 FR 11439, Apr. 3, 1986; 63 FR 7702, Feb. 17, 1998]

PART 529—CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

§ 529.40 Albuterol.

§ 529.50 Amikacin sulfate intrauterine solution.

§ 529.400 Chlorhexidine tablets and suspension.

§ 529.469 Competitive exclusion culture.

§ 529.1003 Flurogestone acetate-impregnated vaginal sponge.

§ 529.1030 Formalin.

§ 529.1044 Gentamicin sulfate in certain other dosage forms.

§ 529.1044a Gentamicin sulfate intrauterine solution.

§ 529.1044b Gentamicin sulfate solution.

§ 529.1115 Halothane.

§ 529.1150 Hydrogen peroxide.

§ 529.1186 Isoflurane.

§ 529.1660 Oxytetracycline.

§ 529.1940 Progesterone intravaginal inserts.

§ 529.2150 Sevoflurane.

§ 529.2464 Ticarcillin powder.

§ 529.2503 Tricaine methanesulfonate.