eCFR Reference Browser

---

title: "21 CFR §520.2455"

source: "https://www.ecfr.gov/current/title-21/section-520.2455"

title_number: "21"

volume_number: "6"

chapter_number: "Unknown"

subchapter_code: "E"

subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"

part_code: "520"

part_subject: "ORAL DOSAGE FORM NEW ANIMAL DRUGS"

subpart_code: "B"

subpart_subject: "Specific Administrative Rulings and Decisions"

section_number: "520.2455"

section_subject: "Tiamulin."

cfr_reference: "21 CFR 520.2455"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 500 to 599"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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 (a)(2) 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.

(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.

§520.2455 - Tiamulin.