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Amendment from September 23, 2011
21 CFR--PART 520
View Printed Federal Register page 76 FR 59024 in PDF format.
Amendment(s) published September 23, 2011, in 76 FR 59024
Effective Dates: September 23, 2011
2. In §520.2640, add paragraph (b)(3); and revise paragraphs (a), (b)(1), (b)(2), (d)(2)(ii), (d)(3)(ii)(A), (d)(3)(ii)(B), and (d)(3)(iii) to read as follows:
(a)Specifications.Each container of soluble powder contains tylosin tartrate equivalent to either 100 or 256 grams tylosin base.
(b) * * *
(1) No. 000986 for use of a 100-gram jar as in paragraph (d) of this section.
(2) No. 016592 for use of a 100-gram jar or pouch as in paragraphs (d)(1), (d)(2), (d)(3)(i), (d)(3)(ii)(B), (d)(3)(iii), and (d)(4) of this section.
(3) No. 061623 for use of a 100- or 256-gram jar or pouch as in paragraphs (d)(1), (d)(2), (d)(3)(i), (d)(3)(ii)(B), (d)(3)(iii), and (d)(4) of this section.
* * * * *
(d) * * *
(2) * * *
(ii)Indications for use.For maintaining weight gain and feed efficiency in the presence of infectious sinusitis associated withMycoplasma gallisepticumsensitive to tylosin.
* * * * *
(3) * * *
(ii) * * *
(A) For the treatment and control of swine dysentery associated withBrachyspira hyodysenteriaewhen followed immediately by tylosin phosphate medicated feed; and for the control of porcine proliferative enteropathies (PPE, ileitis) associated withLawsonia intracellulariswhen followed immediately by tylosin phosphate medicated feed.
(B) For the treatment and control of swine dysentery associated withBrachyspira hyodysenteriae.
(iii)Limitations.Prepare a fresh solution daily. 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.
* * * * *