21 C.F.R. § 558.612

Current through September 30, 2024
Section 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) 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) The effects of tiamulin on swine reproductive performance, pregnancy, and lactation have not been determined.
(3) Use as sole source of tiamulin.
(e)Conditions of use -
(1)Swine. It is used as follows:

Tiamulin hydrogen fumarate in grams per tonCombination in grams per tonIndications for useLimitationsSponsor
(i) 351. For control of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema) hyodysenteriae susceptible to tiamulinFeed 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 slaughter058198
2. For control of porcine proliferative enteropathies (ileitis) associated with Lawsonia intracellularisFeed continuously as the sole ration for not less than 10 days. Withdraw 2 days before slaughter058198
(ii) 200For treatment of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema) hyodysenteriae susceptible to tiamulinFeed continuously as the sole feed for 14 consecutive days. Withdraw feed 7 days before slaughter058198

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

21 C.F.R. §558.612

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
81 FR 95015, 12/27/2016; 86 FR 14827, 3/19/2021