Code of Federal Regulations (Last Updated: November 8, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter E - Animal Drugs, Feeds, and Related Products |
Part 558 - New Animal Drugs for Use in Animal Feeds |
Subpart B - Specific New Animal Drugs for Use in Animal Feeds |
§ 558.415 - Novobiocin.
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§ 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 -
Amount. Novobiocin, 6-7 mgs. per lb.Novobiocin amount Indications for use Limitations Sponsor (i) (a) Indications for use. AidTo provide 6 to 7 milligrams per pound (mg/lb) of body weight per day. (b) Limitations.Chickens: As an aid in the treatment of breast blisters associated with staphylococcal infections susceptible to novobiocin. , as sole ration,Administer ; not for laying chickens; feedfeed which contains not less than 200 grams of novobiocin activity per ton of feed ; withdrawas the sole ration for 5 to 7 days Amount. Novobiocin, 10-14 mgs. per lb.. Not for laying chickens. Withdraw 4 days before slaughter. 054771 (ii) (a) Indications for use. TreatmentTo provide 10 to 14 mg/lb of body weight per day. (b) Limitations.Chickens: For the treatment of staphylococcal synovitis and generalized staphylococcal infections susceptible to novobiocin. , as sole ration,Administer ; not for laying chickens; feedfeed which contains not less than 350 grams of novobiocin activity per ton of feed ; withdrawas the sole ration for 5 to 7 days . Not for laying chickens. Withdraw 4 days before slaughter. 054771 (ii) Indications for use. Control(2) Turkeys -
Amount. Novobiocin, 4-5 mgs. per lb.Novobiocin amount Indications for use Limitations Sponsor (i) (a) Indications for use. AidTo provide 4 to 5 mg/lb of body weight per day. (b) Limitations.Turkeys: As an aid in the treatment of breast blisters associated with staphylococcal infections susceptible to novobiocin. , as sole ration,Administer ; not for laying turkeys; feedfeed which contains not less than 200 grams of novobiocin activity per ton of feed ; withdrawas the sole ration for 5 to 7 days Amount. Novobiocin, 5-8 mgs. per lb.. Not for laying turkeys. Withdraw 4 days before slaughter. 054771 (ii) (a) Indications for use. AidTo provide 5 to 8 mg/lb of body weight per day. -8 mgs. per poundTurkeys: 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 (b) Limitations.to 8 mg/lb of body weight per day. , as sole ration,Administer ; feedfeed which contains not less than 200 grams of novobiocin activity per ton of feed ; notas the sole ration for 5 to 7 days ; withdraw. Not for laying turkeys Amount. Novobiocin, 7-8 mgs. per lb.. Withdraw 4 days before slaughter. 054771 (iii) (a) Indications for use. TreatmentTo provide 7 to 8 mg/lb of body weight per day. infectionTurkeys: For the treatment of staphylococcal synovitis and generalized staphylococcal (b) Limitations.infections susceptible to novobiocin; and treatment of acute outbreaks of fowl cholera caused by strains of Pasteurella multocida susceptible to novobiocin. , as sole ration,Administer ; feedfeed which contains not less than 350 grams of novobiocin activity per ton of feed ; notas the sole ration for 5 to 7 days ; withdraw. Not for laying turkeys . Withdraw 4 days before slaughter. 054771 (3) Mink -
(i) Amount. 20 mgs. per lb. body weight per day.
(ii) Indications for use. For treatment of generalized infections, abscesses, or urinary infections caused by staphylococcal or other novobiocin sensitive organisms.
(iii) Limitations. Administer, as sole ration, feed which contains not less than 200 grams of novobiocin activity per ton of feed; feed for 7 days.
(4) Ducks -
(i) Amount. Novobiocin, 350 grams per ton.
Minor species -
(iii) Limitations.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 , continuefor 5 to 7 days , repeat. Continue medication for 14 days if necessary ; discontinue. Repeat if reinfection occurs ; not. 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]