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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Oct 01, 2021.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR520.2455]



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

PART 520 -- ORAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 520.2455 Tiamulin.

(a) Specifications. (1) Each gram of soluble powder contains 450 milligrams (mg) tiamulin hydrogen fumarate.

(2) Each milliliter (mL) of solution contains 125 mg (12.5 percent) tiamulin hydrogen fumarate.

(3) Each mL of solution contains 123 mg (12.3 percent) tiamulin hydrogen fumarate.

(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter for use as in paragraph (d) of this section.

(1) No. 058198 for products described in paragraphs (a)(1) and (3) of this section.

(2) No. 066104 for the product described in paragraph (a)(1) of this section.

(3) No. 054771 for the product described in paragraph (a)(3) of this section.

(4) Nos. 016592 and 061133 for product described in paragraph (a)(2) of this section.

(c) Related tolerances. See § 556.732 of this chapter.

(d) Conditions of use in swine - (1) Amounts and indications for use. Administer in drinking water for 5 consecutive days:

(i) 3.5 mg per (/) lb of body weight daily for treatment of swine dysentery associated with Brachyspira hyodysenteriae susceptible to tiamulin.

(ii) 10.5 mg/lb of body weight daily for treatment of swine pneumonia due to Actinobacillus pleuropneumoniae susceptible to tiamulin.

(2) Limitations. Use as only source of drinking water. Prepare fresh medicated water daily. Withdraw medication 3 days before slaughter following treatment at 3.5 mg/lb and 7 days before slaughter following treatment at 10.5 mg/lb of body weight. 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. The effects of tiamulin on swine reproductive performance, pregnancy, and lactation have not been determined.

[70 FR 75017, Dec. 19, 2005, as amended at 74 FR 7180, Feb. 13, 2009; 75 FR 54492, Sept. 8, 2010; 77 FR 56770, Sept. 14, 2012; 78 FR 17596, Mar. 22, 2013; 80 FR 13229, Mar. 13, 2015; 85 FR 18119, Apr. 1, 2020; 86 FR 13184, Mar. 8, 2021; 86 FR 14819, Mar. 19, 2021]

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