CFR > 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 (parts 500 to 590) > PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS > SUBPART B—Specific New Animal Drugs for Use in Animal Feeds (§558.55 to §558.680) > 558.630—Tylosin and sulfamethazine.

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.

Code of Federal Regulations

[73 FR 34185, June 17, 2008, as amended at 73 FR 35341, June 23, 2008; 75 FR 55677, Sept. 14, 2010]

Code of Federal Regulations

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.