§520.2640. Tylosin.
21 C.F.R. § 520.2640
Specifications. Each container of soluble powder contains tylosin tartrate equivalent to:
100 grams (g) tylosin base, or
256 g tylosin base.
Nos. 016592 and 058198 for use of the 100-g container as in paragraph (e) of this section
No. 061133 for use of the 100-or 256-g container as in paragraphs (e)(1)(i)(A), (e)(1)(ii), (e)(2), (e)(3), and (e)(4) of this section.
No. 061133 for use of a 100-g container as in paragraphs (e)(1)(i)(B) and (e)(1)(ii) of this section.
Related tolerances. See § 556.746 of this chapter.
Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Conditions of use—
Chickens—
Amounts and indications for use.
Administer 2 grams per gallon (528 parts per million (ppm)) for 1 to 5 days as an aid in the treatment of chronic respiratory disease (CRD) associated with Mycoplasma gallisepticum in broiler and replacement chickens. For the control of CRD associated with M. gallisepticum at time of vaccination or other stress in chickens. For the control of CRD associated with Mycoplasma synoviae in broiler chickens. Treated chickens should consume enough medicated drinking water to provide 50 milligrams (mg) tylosin per pound of body weight per day.
Administer 851 to 1,419 mg/gallon (225 to 375 ppm) for 5 days for the control of mortality caused by necrotic enteritis associated with Clostridium perfringens in broiler chickens.
Limitations. Do not use in layers producing eggs for human consumption. Do not administer within 24 hours of slaughter.
Turkeys—
Amount. 2 grams per gallon (528 ppm) 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.
Indications for use. For the reduction in severity of effects of infectious sinusitis associated with Mycoplasma gallisepticum.
Limitations. Do not use in layers producing eggs for human consumption. Do not administer within 5 days of slaughter.
Swine—
Amount. 250 mg per gallon (66 ppm) as the only source of drinking water for 3 to 10 days, depending on the severity of the condition being treated.
Indications for use.
For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae when followed immediately by tylosin phosphate medicated feed; and for the control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis when followed immediately by tylosin phosphate medicated feed.
For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae.
Limitations. Do not administer within 48 hours of slaughter. As indicated in paragraph (d)(3)(ii)(A) of this section, follow with tylosin phosphate medicated feed as in § 558.625(f)(1)(vi)(c) of this chapter.
Honey bees—
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.
Indications for use. For the control of American foulbrood (Paenibacillus larvae).
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.
Notes, amendments, and revision history
Amendments
[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; 76 FR 59024, Sept. 23, 2011; 77 FR 29217, May 17, 2012; 79 FR 37620, July 2, 2014; 79 FR 53136, Sept. 8, 2014; 79 FR 64116, Oct. 28, 2014; 80 FR 34278, June 16, 2015; 83 FR 14587, Apr. 5, 2018; 84 FR 8973, Mar. 13, 2019; 84 FR 32992, July 11, 2019; 87 FR 76421, Dec. 14, 2022; 88 FR 16547, Mar. 20, 2023]
Authority
Authority: 21 U.S.C. 360b.
Source
Source: 40 FR 13838, Mar. 27, 1975, unless otherwise noted.
Amendments
[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; 76 FR 59024, Sept. 23, 2011; 77 FR 29217, May 17, 2012; 79 FR 37620, July 2, 2014; 79 FR 53136, Sept. 8, 2014; 79 FR 64116, Oct. 28, 2014; 80 FR 34278, June 16, 2015; 83 FR 14587, Apr. 5, 2018; 84 FR 8973, Mar. 13, 2019; 84 FR 32992, July 11, 2019; 87 FR 76421, Dec. 14, 2022; 88 FR 16547, Mar. 20, 2023]