21 CFR § 520.2471 - Tilmicosin.

---
identifier: "/us/cfr/t21/s520.2471"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.2471 - Tilmicosin."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.2471"
section_name: "Tilmicosin."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "520"
part_name: "ORAL DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13838, Mar. 27, 1975, unless otherwise noted."
cfr_part: "520"
---


# 520.2471 Tilmicosin.

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

(b) *Sponsors.* See Nos. 016592 and 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; 87 FR 58962, Sept. 29, 2022]