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21 C.F.R. § 558.630   Tylosin and sulfamethazine.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
Subpart B—Specific New Animal Drugs for Use in Animal Feeds

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§ 558.630   Tylosin and sulfamethazine.

(a) [Reserved]

(b) Approvals. Type A medicated article levels, a combination of equal amounts of tylosin and sulfamethazine, granted to firms as sponsor(s) and identified by drug listing numbers in §510.600(c) of this chapter for the conditions of use indicated in paragraph (f) of this section.

(1) To 000986: 40 grams per pound each, paragraph (f)(2)(i).

(2) To 000986: 10 grams per pound each, paragraph (f)(2)(i).

(3) To 017519: 10 grams per pound each, paragraph (f)(2)(ii) of this section.

(4) [Reserved]

(5) To No. 051311: 40 grams per pound each, paragraph (f)(2)(ii) of this section.

(6) To 017139: 4, 10, or 20 grams per pound each, paragraph (f)(2)(ii) of this section.

(7) To 021930: 2 grams per pound each, paragraph (f)(2)(i) of this section; 5, 10, 20, or 40 grams per pound each, paragraph (f)(2)(ii) of this section.

(8) To 017519: 5 or 10 grams per pound each, paragraph (f)(2)(ii) of this section.

(9) [Reserved]

(10) To 000986, 010439, 011749, 016968, 017473, 017519, 024174, 030841, 034936, 035098, 043733, 046573, 046987, 048164, and 051359: 5, 10, 20, or 40 grams per pound each, paragraph (f)(2)(ii) of this section.

(c)–(d) [Reserved]

(e) Related tolerances. See §§556.670 and 556.740 of this chapter.

(f) Conditions of use. It is used in feed for swine as follows:

(1) Amount per ton. Tylosin, 100 grams plus sulfamethazine, 100 grams.

(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 (P. multocida and/or C. 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).

(3) Limitations. As tylosin phosphate; withdraw 15 days before slaughter.

[40 FR 13959, Mar. 27, 1975]

Editorial Note:  For Federal Register citations affecting §558.630, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.

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