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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Oct 01, 2021.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR558.415]



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

Sec. 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 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 -

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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