21 C.F.R. § 520.2640 Tylosin.
Title 21 - Food and Drugs
(a) Specifications. Tylosin is the antibiotic substance produced by growth of Streptromyces fradiae or the same antibiotic substance produced by any other means. Tylosin, present as the tartrate salt, conforms to the appropriate antibiotic standard. Tylosin contains at least 95 percent tylosin as a combination of tylosin A, tylosin B, tylosin C, and tylosin D of which at least 80 percent is tylosin A as determined by a method entitled “Determination of Factor Content in Tylosin by High Performance Liquid Chromatography,” which is incorporated by reference. Copies are available from the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.php. (b) Sponsor. See No. 000986 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 §556.740 of this chapter. (e) Conditions of use—(1) Chickens—(i) Amount. 2 grams per gallon. (ii) Indications for use. Aid in the treatment of chronic respiratory disease (CRD) caused by Mycoplasma gallisepticum sensitive to tylosin in broiler and replacement chickens. For the control of chronic respiratory disease (CRD) caused by Mycoplasma gallisepticum sensitive to tylosin at time of vaccination or other stress in chickens. For the control of chronic respiratory disease (CRD) caused by Mycoplasma synoviae sensitive to tylosin in broiler chickens. (iii) Limitations. Do not use in layers producing eggs for human consumption; administer from 1 to 5 days as sole source of drinking water; treated chickens should consume enough medicated drinking water to provide 50 milligrams of tylosin per pound of body weight per day; prepare a fresh solution every 3 days; do not administer within 24 hours of slaughter . (2) Turkeys—(i) Amount. 2 grams per gallon. (ii) Indications for use. Maintaining weight gains and feed efficiency in the presence of infectious sinusitis caused by Mycoplasma gallisepticum sensitive to tylosin. (iii) Limitations. Do not use in layers producing eggs for human consumption; administer from 2 to 5 days as sole source of drinking water; treated turkeys should consume enough medicated drinking water to provide 60 milligrams of tylosin per pound of body weight per day; prepare a fresh solution every 3 days; when sinus swelling is present, inject the sinus with tylosin injectable simultaneously with the drinking water treatment; do not administer within 5 days of slaughter. (3) Swine—(i) Amount. 0.25 gram per gallon. (ii) Indications for use. For the control and treatment of swine dysentery (bloody scours) caused by pathogens sensitive to tylosin. (iii) Limitations. As only source of drinking water for 3 to 10 days, depending on the severity of the condition being treated: mix fresh solution daily; medication must be withheld from animals 48 hours prior to slaughter. (4) Honey bees—(i) Amount. Mix 200 milligrams tylosin in 20 grams confectioners'/powdered sugar. Use immediately. Apply (dust) this mixture over the top bars of the brood chamber once weekly for 3 weeks. (ii) Indications for use. For the control of American foulbrood (Paenibacillus larvae). (iii) Limitations. The drug should be fed early in the spring or fall and consumed by the bees before the main honey flow begins, to avoid contamination of production honey. Complete treatments at least 4 weeks before main honey flow. [40 FR 13838, Mar. 27, 1975, as amended at 50 FR 49841, Dec. 5, 1985; 59 FR 14365, Mar. 28, 1994; 62 FR 39443, July 23, 1997; 68 FR 24879, May 9, 2003; 70 FR 69439, Nov. 16, 2005]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.2640 Tylosin.
