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21 CFR § 558.68 - Avilamycin.

---
identifier: "/us/cfr/t21/s558.68"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 558.68 - Avilamycin."
title_number: 21
title_name: "Food and Drugs"
section_number: "558.68"
section_name: "Avilamycin."
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"
---

# 558.68 Avilamycin.

(a) *Specifications.* Each pound of Type A medicated article contains 45.4 or 90.7 grams of avilamycin.

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

(c) *Related tolerances.* See § 556.60 of this chapter.

(d) *Special considerations.* (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See § 558.6 for additional requirements.

(2) The expiration date of VFDs for avilamycin medicated feeds must not exceed 90 days from the date of issuance. VFDs for avilamycin shall not be refilled.

(e) *Conditions of use.* Administer in feed as follows:

(1) *Chickens*

| Avilamycin ingrams/ton | Combination in grams/ton | Indications for use | Limitations | Sponsor |
| --- | --- | --- | --- | --- |
| (i) 13.6 to 40.9 |  | Broiler chickens: For the prevention of mortality caused by necrotic enteritis associated with  in broiler chickens | Feed as the sole ration for 21 consecutive days. To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age | 058198 |
| (ii) 13.6 to 40.9 | Monensin, 90 to 110 | Broiler chickens: For the prevention of mortality caused by necrotic enteritis associated with  and as an aid in the prevention of coccidiosis caused by E   and | Feed as the sole ration for 21 consecutive days. Feed to chickens that are at risk of developing, but not yet showing clinical signs of, necrotic enteritis associated with  To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age. Monensin as provided by Nos. 016592 or 058198 in § 510.600(c) of this chapter. See § 558.355(d) | 016592
058198 |
| (iii) 13.6 to 40.9 | Narasin, 54 to 90 | Broiler chickens: For the prevention of mortality caused by necrotic enteritis associated with ; and for the prevention of coccidiosis caused by  and . | Feed as the sole ration for 21 consecutive days to chickens that are at risk of developing, but not yet showing clinical signs of, necrotic enteritis associated with . To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Narasin as provided by No. 058198 in § 510.600(c) of this chapter. | 058198 |
| (iv) 13.6 to 40.9 | Narasin, 27 to 45 plus nicarbazin, 27 to 45 | Broiler chickens: For the prevention of mortality caused by necrotic enteritis associated with  and for the prevention of coccidiosis caused by  and | Feed as the sole ration for 21 consecutive days to chickens that are at risk of developing, but not yet showing clinical signs of, necrotic enteritis associated with  Avilamycin has not been demonstrated to be effective in broiler chickens showing clinical signs of necrotic enteritis prior to the start of medication. To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age. The safety of avilamycin has not been established in chickens intended for breeding purposes. Do not allow adult turkeys, horses, or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Do not feed to chickens producing eggs for human consumption. Narasin and nicarbazin as provided by No. 058198 in § 510.600(c) of this chapter | 058198 |
| (v) 13.6 to 40.9 | Salinomycin sodium, 40 to 60 | Broiler chickens: For the prevention of mortality caused by necrotic enteritis associated with ; and for the prevention of coccidiosis caused by  and. | Feed as the sole ration for 21 consecutive days. Feed to chickens that are at risk of developing, but not yet showing clinical signs of, necrotic enteritis associated with . Not approved for use with pellet binders. To assure responsible antimicrobial drug use in broiler chickens, treatment administration must begin on or before 18 days of age. The safety of avilamycin has not been established in chickens intended for breeding purposes. Avilamycin has not been demonstrated to be effective in broiler chickens showing clinical signs of necrotic enteritis prior to the start of medication. Do not feed to laying hens producing eggs for human consumption. May be fatal if fed to adult turkeys or to horses. Salinomycin as provided by No. 016592 in § 510.600(c) of this chapter. | 058198 |

(2) *Swine*

| Avilamycin ingrams/ton | Combinationin grams/ton | Indications for use | Limitations | Sponsor |
| --- | --- | --- | --- | --- |
| (i) 73 |  | Weaned pigs less than 14 weeks of age: For the reduction in incidence and overall severity of diarrhea in the presence of pathogenic  in groups of weaned pigs | Feed as the sole ration for 21 consecutive days. To assure responsible antimicrobial drug use in pigs, do not administer to pigs 14 weeks of age or older | 058198 |
| (ii) [Reserved] |  |  |  |  |

[80 FR 61297, Oct. 13, 2015, as amended at 80 FR 76387, Dec. 9, 2015; 81 FR 17609, Mar. 30, 2016; 81 FR 48703, July 26, 2016; 81 FR 59134, Aug. 29, 2016; 81 FR 67152, Sept. 30, 2016; 82 FR 11509, Feb. 24, 2017; 83 FR 14587, Apr. 5, 2018; 83 FR 64741, Dec. 18, 2018; 84 FR 8974, Mar. 13, 2019; 84 FR 33001, July 11, 2019; 85 FR 4209, Jan. 24, 2020; 85 FR 45308, July 28, 2020; 86 FR 13188, Mar. 8, 2021; 86 FR 14821, Mar. 19, 2021; 88 FR 55567, Aug. 16, 2023; 90 FR 40971, Aug. 22, 2025]