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Title 21: Food and Drugs
CHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
SUBCHAPTER E: ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
PART 558: NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
Subpart B: Specific New Animal Drugs for Use in Animal Feeds
558.630 - Tylosin and sulfamethazine.
(a) Specifications. Type A medicated articles containing equal amounts of tylosin phosphate and sulfamethazine, available in concentrations of 4, 5, 10, 20, or 40 grams each, per pound.
(b) Approvals. See sponsor numbers in ? 510.600(c) of this chapter for use as in paragraph (e) of this section.
(1) No. 000986: 10 or 40 grams per pound each for use as in paragraph (e)(2)(i) of this section.
(2) No. 012286: 2 grams per pound each for use as in paragraph (e)(2)(i) of this section.
(3) No. 051311: 40 grams per pound each for use as in paragraph (e)(2)(ii) of this section.
(4) No. 017139: 4, 10, or 20 grams per pound each for use as in paragraph (e)(2)(ii) of this section.
(5) Nos. 000986, 010439, 012286, 016968, 024174, 034936, 035098, 046573, 046987, and 051359: 5, 10, 20, or 40 grams per pound each for use as in paragraph (e)(2)(ii) of this section.
(6) No. 000986: 40 grams per pound each for use as in paragraph (e)(2)(iii) of this section.
(c) Special considerations. Labeling shall bear the statement: ?Do not use in medicated feeds containing in excess of 2% bentonite.?
(d) Related tolerances. See ?? 556.670 and 556.740 of this chapter.
(e) Conditions of use. It is used in feed for swine as follows:
(1) Amount per ton. 100 grams tylosin and 100 grams sulfamethazine.
(2) Indications for use-(i) Maintaining weight gains and feed efficiency in the presence of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery (vibrionic); control of swine pneumonias caused by bacterial pathogens (Pasteurella multocida and/or Corynebacterium pyogenes); for reducing the incidence of cervical lymphadenitis (jowl abscesses) caused by Group E Streptococci. Only the sulfamethazine portion of this combination is active in controlling jowl abscesses.
(ii) Maintaining weight gains and feed efficiency in the presence of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery (vibrionic); control of swine pneumonias caused by bacterial pathogens (Pasteurella multocida and/or Corynebacterium pyogenes).
(iii) For maintaining weight gains and feed efficiency in the presence of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery associated with Brachyspira hyodysenteriae; and control of swine pneumonias caused by bacterial pathogens (Pasteurella multocida and/or Arcanobacterium pyogenes).
(3) Limitations. Withdraw 15 days before swine are slaughtered.
[73 FR 34185, June 17, 2008, as amended at 73 FR 35341, June 23, 2008; 75 FR 55677, Sept. 14, 2010]
Effective Date Note:
At 76 FR 17778, Mar. 31, 2011, ? 558.630 was amended by removing and reserving paragraph (b)(4); and in paragraph (b)(5), removing ?010439,? and ?016968,?, effective April 11, 2011.
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