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21 CFR § 558.415 - Novobiocin.

---
identifier: "/us/cfr/t21/s558.415"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 558.415 - Novobiocin."
title_number: 21
title_name: "Food and Drugs"
section_number: "558.415"
section_name: "Novobiocin."
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"
---

# 558.415 Novobiocin.

(a) *Specifications.* Type A medicated article containing 25 grams of novobiocin activity per pound.

(b) *Sponsor.* See No. 054771 in § 510.600(c) of this chapter.

(c) *Related tolerances.* See § 556.460 of this chapter.

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

(1) *Chickens*

| Novobiocin amount | Indications for use | Limitations | Sponsor |
| --- | --- | --- | --- |
| (i) To provide 6 to 7 milligrams per pound (mg/lb) of body weight per day. | Chickens: As an aid in the treatment of breast blisters associated with staphylococcal infections susceptible to novobiocin. | Administer feed which contains not less than 200 grams of novobiocin activity per ton of feed as the sole ration for 5 to 7 days. Not for laying chickens. Withdraw 4 days before slaughter. | 054771 |
| (ii) To provide 10 to 14 mg/lb of body weight per day. | Chickens: For the treatment of staphylococcal synovitis and generalized staphylococcal infections susceptible to novobiocin. | Administer feed which contains not less than 350 grams of novobiocin activity per ton of feed as the sole ration for 5 to 7 days. Not for laying chickens. Withdraw 4 days before slaughter. | 054771 |

(2) *Turkeys*

| Novobiocin amount | Indications for use | Limitations | Sponsor |
| --- | --- | --- | --- |
| (i) To provide 4 to 5 mg/lb of body weight per day. | Turkeys: As an aid in the treatment of breast blisters associated with staphylococcal infections susceptible to novobiocin. | Administer feed which contains not less than 200 grams of novobiocin activity per ton of feed as the sole ration for 5 to 7 days. Not for laying turkeys. Withdraw 4 days before slaughter. | 054771 |
| (ii) To provide 5 to 8 mg/lb of body weight per day. | Turkeys: As an aid in the control of recurring outbreaks of fowl cholera caused by strains of  susceptible to novobiocin following initial treatment with 7 to 8 mg/lb of body weight per day. | Administer feed which contains not less than 200 grams of novobiocin activity per ton of feed as the sole ration for 5 to 7 days. Not for laying turkeys. Withdraw 4 days before slaughter. | 054771 |
| (iii) To provide 7 to 8 mg/lb of body weight per day. | Turkeys: For the treatment of staphylococcal synovitis and generalized staphylococcal infections susceptible to novobiocin; and treatment of acute outbreaks of fowl cholera caused by strains of  susceptible to novobiocin. | Administer feed which contains not less than 350 grams of novobiocin activity per ton of feed as the sole ration for 5 to 7 days. Not for laying turkeys. Withdraw 4 days before slaughter. | 054771 |

(3) *Minor species*

| Novobiocin amount | Indications for use | Limitations | Sponsor |
| --- | --- | --- | --- |
| (i) 350 grams per ton. | Ducks: For the control of infectious serositis and fowl cholera in ducks caused by  and  susceptible to novobiocin. | Administer as the sole ration for 5 to 7 days. Continue medication for 14 days if necessary. Repeat if reinfection occurs. Discontinue use at least 3 days before slaughter. Not for use in laying ducks. | 054771 |
| (ii) To provide 20 mg/lb of body weight per day. | Mink: For the treatment of generalized infections, abscesses, or urinary infections caused by staphylococcal or other novobiocin sensitive organisms. | Administer feed which contains not less than 200 grams of novobiocin activity per ton of feed as the sole ration for 7 days. | 054771 |

[40 FR 13959, Mar. 27, 1975, as amended at 45 FR 42263, June 24, 1980; 51 FR 7399, Mar. 3, 1986; 52 FR 36402, Sept. 29, 1987; 79 FR 13545, Mar. 11, 2014; 84 FR 12501, Apr. 2, 2019]