CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS (parts 500 to 590) > PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS > 520.2640—Tylosin.

520.2640—Tylosin.

(a) Specifications. Each container contains tylosin tartrate equivalent to 100 grams tylosin base.
(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter.
(1) No. 000986 for use as in paragraph (d) of this section.
(2) No. 016592 for use as in paragraphs (d)(1), (d)(2), (d)(3)(i), (d)(3)(ii)(B), (d)(3)(iii), and (d)(4) of this section.
(c) Related tolerances. See § 556.740 of this chapter.
(d) Conditions of use— (1) Chickens— 2 grams per gallon for 1 to 5 days as the sole source of drinking water. Treated chickens should consume enough medicated drinking water to provide 50 milligrams (mg) tylosin per pound of body weight per day.
(ii) Indications for use. As an aid in the treatment of chronic respiratory disease (CRD) associated with Mycoplasma gallisepticum sensitive to tylosin in broiler and replacement chickens. For the control of chronic respiratory disease (CRD) associated with M. gallisepticum sensitive to tylosin at time of vaccination or other stress in chickens. For the control of chronic respiratory disease (CRD) associated with Mycoplasma synoviae sensitive to tylosin in broiler chickens.
(iii) Limitations. Prepare a fresh solution every 3 days. Do not use in layers producing eggs for human consumption. Do not administer within 24 hours of slaughter.
(2) Turkeys— (i) Amount. 2 grams per gallon for 2 to 5 days as the sole source of drinking water. Treated turkeys should consume enough medicated drinking water to provide 60 mg tylosin per pound of body weight per day.
(ii) Indications for use. For maintaining weight gains and feed efficiency in the presence of infectious sinusitis associated with Mycoplasma gallisepticum sensitive to tylosin.
(iii) Limitations. Prepare a fresh solution every 3 days. Do not use in layers producing eggs for human consumption. Do not administer within 5 days of slaughter.
(3) Swine— (i) Amount. 250 mg per gallon as the only source of drinking water for 3 to 10 days, depending on the severity of the condition being treated.
(ii) Indications for use— (A) For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae and for the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis.
(B) For the treatment and control of swine dysentery associated with B. hyodysenteriae.
(iii) Limitations. Prepare a fresh solution daily. Do not administer within 48 hours of slaughter. Follow with tylosin phosphate medicated feed as in § 558.625(f)(1)(vi) (c) of this chapter.
(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.

Code of Federal Regulations

[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; 73 FR 76946, Dec. 18, 2008; 75 FR 76259, Dec. 8, 2010]