21 CFR § 558.415
Novobiocin
June 25, 2020
(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—
Open Table
| 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—
Open Table
| 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 Pasteurella multocida 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 Pasteurella multocida 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—
Open Table
| 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 Pasteurella anatipestifer and P. multocida, 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]
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