21 C.F.R. § 558.612 – Tiamulin.

(a) Specifications. Type A article containing 363.2 grams of tiamulin hydrogen fumarate per pound.
(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.732 of this chapter.
(d) Special considerations.
1. (1) Swine being treated with tiamulin should not have access to feeds containing polyether ionophores (e.g., lasalocid, monensin, narasin, salinomycin, or semduramycin) as adverse reactions may occur. If signs of toxicity occur, discontinue use.
2. (2) The effects of tiamulin on swine reproductive performance, pregnancy, and lactation have not been determined.
3. (3) Use as sole source of tiamulin.

(e) Conditions of use—(1) Swine. It is used as follows:

Tiamulin hydrogen fumarate in grams per ton	Indications for use	Limitations	Sponsor
(i) 35	1. For control of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema) hyodysenteriae susceptible to tiamulin	Feed continuously as sole ration on premises with a history of swine dysentery but where signs of disease have not yet occurred or following approved treatment of disease. Withdraw 2 days before slaughter	058198
	2. For control of porcine proliferative enteropathies (ileitis) associated with Lawsonia intracellularis	Feed continuously as the sole ration for not less than 10 days. Withdraw 2 days before slaughter	058198
(ii) 200	For treatment of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema) hyodysenteriae susceptible to tiamulin	Feed continuously as the sole feed for 14 consecutive days. Withdraw feed 7 days before slaughter	058198

(2) Tiamulin may also be used in combination with chlortetracycline as in § 558.128.

[67 FR 7268, Feb. 19, 2002, as amended at 69 FR 62407, Oct. 26, 2004; 70 FR 75018, Dec. 19, 2005; 74 FR 6, Jan. 2, 2009; 77 FR 24139, Apr. 23, 2012; 79 FR 13546, Mar. 11, 2014. Redesignated and amended at 80 FR 13232, Mar. 13, 2015; 81 FR 95015, Dec. 27, 2016; 86 FR 14827, Mar. 19, 2021]