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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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[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR520.2471]



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. 520.2471 Tilmicosin.

(a) Specifications. Each milliliter of concentrate solution contains 250 milligrams (mg) tilmicosin as tilmicosin phosphate.

(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.

(c) Tolerances. See § 556.735 of this chapter.

(d) Conditions of use in swine - (1) Amount. Administer in drinking water at a concentration of 200 mg per liter for 5 consecutive days.

(2) Indications for use. (i) For the control of swine respiratory disease associated with Pasteurella multocida and Haemophilus parasuis in groups of swine in buildings where a respiratory disease outbreak is diagnosed.

(ii) For the control of swine respiratory disease associated with Mycoplasma hyopneumoniae in the presence of Porcine Reproductive and Respiratory Syndrome Virus (PRRSV) in groups of swine in buildings where a respiratory disease outbreak is diagnosed.

(3) Limitations. Swine intended for human consumption must not be slaughtered within 7 days of the last treatment with this product. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[79 FR 18158, Apr. 1, 2014, as amended at 81 FR 17608, Mar. 30, 2016; 81 FR 48702, July 26, 2016]

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