21 CFR § 558.265 - Halofuginone.

---
identifier: "/us/cfr/t21/s558.265"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 558.265 - Halofuginone."
title_number: 21
title_name: "Food and Drugs"
section_number: "558.265"
section_name: "Halofuginone."
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: "558"
part_name: "NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS"
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. 354, 360b, 360ccc, 360ccc-1, 371."
regulatory_source: "40 FR 13959, Mar. 27, 1975, unless otherwise noted."
cfr_part: "558"
---


# 558.265 Halofuginone.

(a) *Specifications.* Type A medicated articles containing 6 grams of halofuginone hydrobromide per kilogram.

(b) *Sponsor.* See No. 016592 in § 510.600(c) of this chapter.

(c) *Related tolerances.* See § 556.308 of this chapter.

(d) *Conditions of use.* It is used in feed as follows:

(1) *Chickens*—

| Halofuginone in grams/ton | Combination in grams/ton | Indications for use | Limitations | Sponsor |
| --- | --- | --- | --- | --- |
| (i) 2.72 |  | Broiler chickens: For the prevention of coccidiosis caused by  and | Feed continuously as sole ration. Do not feed to layers. Withdraw 4 days before slaughter | 016592 |
| (ii) 2.72 | Bacitracin methylenedisalicylate, 10 to 50 | Broiler chickens: For the prevention of coccidiosis caused by  and  for improved feed efficiency | Feed continuously as sole ration. Do not feed to layers. Withdraw 5 days before slaughter | 016592 |
| (iii) 2.72 | Bambermycins, 1 to 2 | Broiler chickens: For the prevention of coccidiosis caused by  and  for increased rate of weight gain and improved feed efficiency | Feed continuously as sole ration. Do not feed to layers. Withdraw 5 days before slaughter | 016592 |
| (iv) 2.72 |  | Replacement broiler breeder chickens and replacement cage laying chickens: For the prevention of coccidiosis caused by / and | Feed continuously as sole ration to replacement cage laying chickens until 20 weeks of age. Feed continuously as sole ration to replacement broiler breeder chickens until 16 weeks of age. Do not feed to laying chickens or water fowl. Withdraw 4 days before slaughter | 016592 |

(2) *Turkeys*—

| Halofuginone in grams/ton | Combination in grams/ton | Indications for use | Limitations | Sponsor |
| --- | --- | --- | --- | --- |
| (i) 1.36 to 2.72 |  | Growing turkeys: For the prevention of coccidiosis caused by  and | Feed continuously as sole ration. Withdraw 7 days before slaughter. Do not feed to layers or water fowl | 016592 |
| (ii) 1.36 to 2.72 | Bacitracin methylenedisalicylate, 10 to 50 | Growing turkeys: For the prevention of coccidiosis caused by  and  and for increased rate of weight gain | Feed continuously as sole ration. Withdraw 7 days before slaughter. Do not feed to laying chickens or water fowl | 016592 |
| (iii) 1.36 to 2.72 | Bambermycins, 2 | Growing turkeys: For the prevention of coccidiosis caused by  and  and for increased rate of weight gain | Feed continuously as sole ration. Withdraw 7 days before slaughter. Do not feed to laying chickens or waterfowl | 016592 |

(3) Halofuginone may also be used in combination with:

(i) Lincomycin as in § 558.325.

(ii) [Reserved]

[50 FR 33719, Aug. 21, 1985, as amended at 50 FR 42518, Oct. 21, 1985; 51 FR 7397, Mar. 3, 1986; 51 FR 11439, Apr. 3, 1986; 51 FR 14989, Apr. 22, 1986; 51 FR 23737, July 1, 1986; 53 FR 1018, Jan. 15, 1988; 53 FR 11065, Apr. 5, 1988; 54 FR 11519, Mar. 21, 1989; 54 FR 28052, July 5, 1989; 59 FR 51498, Oct. 12, 1994; 61 FR 21076, May 9, 1996; 61 FR 24694, May 16, 1996; 64 FR 42597, Aug. 5, 1999; 65 FR 45712, July 25, 2000; 66 FR 47962, Sept. 17, 2001; 71 FR 27956, May 15, 2006; 79 FR 10982, Feb. 27, 2014; 84 FR 8975, Mar. 13, 2019]