Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 558  /  Sec. 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 in Sec. 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; 5, 10, 20, or 40 grams per pound each for use as in paragraph (e)(2)(ii) of this section; and 40 grams per pound each for use as in paragraph (e)(2)(iii) of this section.

(2) Nos. 054771 and 069254: 5, 10, 20, or 40 grams per pound each for use as in paragraph (e)(2)(ii) 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 Sec. Sec. 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.

(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; 76 FR 17778, Mar. 31, 2011; 77 FR 4897, Feb. 1, 2012; 78 FR 14669, Mar. 7, 2013; 79 FR 13546, Mar. 11, 2014; 79 FR 19815, Apr. 10, 2014; 80 FR 13232, Mar. 13, 2015]