subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_code: "558"
part_subject: "NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS"
subpart_code: "B"
subpart_subject: "Specific New Animal Drugs for Use in Animal Feeds"
section_number: "558.415"
section_subject: "Novobiocin."
cfr_reference: "21 CFR 558.415"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 500 to 599"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(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—(i) Amount. Novobiocin, 6-7 mgs. per lb. body weight per day.
(a)Indications for use. Aid in the treatment of breast blisters associated with staphylococcal infections susceptible to novobiocin.
(b)Limitations. Administer, as sole ration, feed which contains not less than 200 grams of novobiocin activity per ton of feed; not for laying chickens; feed 5 to 7 days; withdraw 4 days before slaughter.
(ii)Amount. Novobiocin, 10-14 mgs. per lb. body weight per day.
(a)Indications for use. Treatment of staphylococcal synovitis and generalized staphylococcal infections susceptible to novobiocin.
(b)Limitations. Administer, as sole ration, feed which contains not less than 350 grams of novobiocin activity per ton of feed; not for laying chickens; feed 5 to 7 days; withdraw 4 days before slaughter.
(2)Turkeys—(i) Amount. Novobiocin, 4-5 mgs. per lb. body weight per day.
(a)Indications for use. Aid in the treatment of breast blisters associated with staphylococcal infections susceptible to novobiocin.
(b)Limitations. Administer, as sole ration, feed which contains not less than 200 grams of novobiocin activity per ton of feed; not for laying turkeys; feed 5 to 7 days; withdraw 4 days before slaughter.
(ii)Amount. Novobiocin, 5-8 mgs. per lb. body weight per day.
(a)Indications for use. Aid in the control of recurring outbreaks of fowl cholera caused by strains of Pasteurella multocida susceptible to novobiocin following initial treatment with 7-8 mgs. per pound body weight per day.
(b)Limitations. Administer, as sole ration, feed which contains not less than 200 grams of novobiocin activity per ton of feed; feed 5 to 7 days; not for laying turkeys; withdraw 4 days before slaughter.
(iii)Amount. Novobiocin, 7-8 mgs. per lb. body weight per day.
(a)Indications for use. Treatment of staphylococcal synovitis and generalized staphylococcal infection susceptible to novobiocin; treatment of acute outbreaks of fowl cholera caused by strains of Pasteurella multocida susceptible to novobiocin.
(b)Limitations. Administer, as sole ration, feed which contains not less than 350 grams of novobiocin activity per ton of feed; feed 5 to 7 days; not for laying turkeys; withdraw 4 days before slaughter.
(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.
(ii)Indications for use. Control of infectious serositis and fowl cholera in ducks caused by Pasteurella anatipestifer and P. multocida, susceptible to novobiocin.
(iii)Limitations. Administer, as 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.