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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2017.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2017]
[CITE: 21CFR520.2640]



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

PART 520 -- ORAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 520.2640 Tylosin.

(a) Specifications. Each container of soluble powder contains tylosin tartrate equivalent to either 100 or 256 grams tylosin base.

(b) Sponsors --(1) No. 058198 for use as in paragraph (e) of this section.

(2) Nos. 016592 and 061623 for use as in paragraphs (e)(1)(i)(A), (e)(1)(ii), (e)(2), (e)(3), and (e)(4) of this section.

(c) Related tolerances. See 556.740 of this chapter.

(d) Special considerations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(e) Conditions of use --(1) Chickens --(i) Amounts and indications for use. (A) 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.

(B) 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.

(ii) Limitations. 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 the reduction in severity of effects of infectious sinusitis associated with Mycoplasma gallisepticum.

(iii) Limitations. 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 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.

(B) For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae.

(iii) 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.

(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; 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; 81 FR 48702, July 26, 2016]

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