21 C.F.R. § 558.630

Current through September 30, 2024

Section 558.630 - Tylosin and sulfamethazine

(a)Specifications. Type A medicated articles containing equal amounts of tylosin phosphate and sulfamethazine, available in concentrations of 5, 10, 20, or 40 grams each, per pound.

(b)Sponsors. See sponsor numbers in § 510.600(c) of this chapter.

(1) No. 058198 for use as in paragraph (e)(1) of this section.

(2) No. 054771: 10 or 40 grams per pound each for use as in paragraph (e)(2) of this section.

(c)Related tolerances. See §§ 556.670 and 556.746 of this chapter.

(d)Special considerations.

(1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.

(2) The expiration date of VFDs for tylosin and sulfamethazine medicated feeds must not exceed 6 months from the date of issuance. VFDs for tylosin and sulfamethazine shall not be refilled.

(3) Labeling shall bear the statement: "Do not use in medicated feeds containing in excess of 2% bentonite."

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

Tylosin phosphate and sulfamethazine in grams/ton	Combination in grams/ton	Indications for use	Limitations	Sponsors
(1) 100 each		For reduction in the severity of effects of atrophic rhinitis; lowering the incidence and severity of Bordetella bronchiseptica rhinitis; prevention of swine dysentery associated with Brachyspira hyodysenteriae; control of swine pneumonias caused by bacterial pathogens (Pasteurella multocida and/or Arcanobacterium pyogenes); 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	Withdraw 15 days before swine are slaughtered	058198
(2) 100 each		For reduction in the severity of effects 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)	Withdraw 15 days before swine are slaughtered	054771

21 C.F.R. §558.630

81 FR 95021, Dec. 27, 2016, as amended at 84 FR 33002, July 11, 2019

81 FR 48703, 7/26/2016; 81 FR 59135, 9/8/2016; 81 FR 95021, 12/27/2016; 84 FR 33002, 9/9/2019