21 C.F.R. § 558.455   Oxytetracycline and neomycin.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
Subpart B—Specific New Animal Drugs for Use in Animal Feeds

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§ 558.455   Oxytetracycline and neomycin.

(a) Specifications. Type A medicated articles containing oxytetracycline equivalent to 50 grams per pound (g/lb) oxytetracycline hydrochloride and 50 g/lb neomycin sulfate or oxytetracycline equivalent to 100 g/lb oxytetracycline hydrochloride and 100 g/lb neomycin sulfate.

(b) Sponsors. See No. 066104 in §510.600(c) of this chapter.

(c) Related tolerances. See §§556.430 and 556.500 of this chapter.

(d) Indications for use—(1) Chickens. It is used in feed as follows:

 ----------------------------------------------------------------------------------------------------------------   Oxytetracycline and neomycin sulfate     amount in grams per ton of feed            Indications for use               Limitations           Sponsors----------------------------------------------------------------------------------------------------------------(i) 10 to 50.............................  Chickens: For increased rate  Feed continuously; do not        066104                                            of weight gain and improved   feed to chickens producing                                            feed efficiency.              eggs for human consumption.(ii) 100 to 200..........................  Chickens: For control of      Feed continuously for 7 to       066104                                            infectious synovitis caused   14 days (d); do not feed to                                            by Mycoplasma synoviae;       chickens producing eggs for                                            control of fowl cholera       human consumption; in low                                            caused by Pasteurella         calcium feed, withdraw 3 d                                            multocida susceptible to      before slaughter.                                            oxytetracycline.(iii) 400................................  Chickens: For control of      Feed continuously for 7 to       066104                                            chronic respiratory disease   14 d; do not feed to                                            (CRD) and air sac infection   chickens producing eggs for                                            caused by M. gallisepticum    human consumption; in low                                            and Escherichia coli          calcium feeds, withdraw 3 d                                            susceptible to                before slaughter.                                            oxytetracycline.(iv) 500.................................  Chickens: For reduction of    Feed continuously for 5 d;       066104                                            mortality due to air          do not feed to chickens                                            sacculitis (air-sac-          producing eggs for human                                            infection) caused by E.       consumption; withdraw 24                                            coli susceptible to           hours before slaughter; in                                            oxytetracycline.              low calcium feeds withdraw                                                                          3 d before slaughter.----------------------------------------------------------------------------------------------------------------

(2) Turkeys. It is used in feed as follows:

 ----------------------------------------------------------------------------------------------------------------   Oxytetracycline and neomycin sulfate                  amount                        Indications for use               Limitations           Sponsors----------------------------------------------------------------------------------------------------------------(i) 10 to 50 g/ton of feed...............  Growing turkeys: For          Feed continuously; do not        066104                                            increased rate of weight      feed to turkeys producing                                            gain and improved feed        eggs for human consumption.                                            efficiency.(ii) 100 g/ton of feed...................  Turkeys: For control of       Feed continuously for 7 to       066104                                            hexamitiasis caused by        14 d; do not feed to                                            Hexamita meleagridis          turkeys producing eggs for                                            susceptible to                human consumption.                                            oxytetracycline.(iii) 200 g/ton of feed..................  Turkeys: For control of       Feed continuously for 7 to       066104                                            infectious synovitis caused   14 d; withdraw 5 d before                                            by M. synoviae susceptible    slaughter; do not feed to                                            to oxytetracycline.           turkeys producing eggs for                                                                          human consumption.(iv) To provide 25 mg/lb of body weight    Turkeys: For control of       Feed continuously for 7 to       066104 daily.                                     complicating bacterial        14 d; withdraw 5 d before                                            organisms associated with     slaughter; do not feed to                                            bluecomb (transmissible       turkeys producing eggs for                                            enteritis; coronaviral        human consumption.                                            enteritis) susceptible to                                            oxytetracycline.----------------------------------------------------------------------------------------------------------------

(3) Swine. It is used in feed as follows:

 ----------------------------------------------------------------------------------------------------------------   Oxytetracycline and neomycin sulfate                  amount                        Indications for use               Limitations           Sponsor----------------------------------------------------------------------------------------------------------------(i) 10 to 50 g/ton of feed...............  Swine: For increased rate of  ............................     066104                                            weight gain and improved                                            feed efficiency.(ii) To provide 10 mg/lb of body weight    1. Swine: For treatment of    Feed continuously for 7 to       066104 daily.                                     bacterial enteritis caused    14 d; withdraw 5 d before                                            by E. coli and Salmonella     slaughter.                                            choleraesuis and treatment                                            of bacterial pneumonia                                            caused by P. multocida                                            susceptible to                                            oxytetracycline; treatment                                            and control of                                            colibacillosis (bacterial                                            enteritis) caused by E.                                            coli susceptible to                                            neomycin.                                           2. Breeding swine: For        Feed continuously for not        066104                                            control and treatment of      more than 14 d; withdraw 5                                            leptospirosis (reducing the   d before slaughter.                                            incidence of abortion and                                            shedding of leptospirae)                                            caused by Leptospira pomona                                            susceptible to                                            oxytetracycline.----------------------------------------------------------------------------------------------------------------

(4) Cattle and sheep. It is used in feed as follows:

 ----------------------------------------------------------------------------------------------------------------   Oxytetracycline and neomycin sulfate                  amount                        Indications for use               Limitations           Sponsor----------------------------------------------------------------------------------------------------------------(i) 10 to 20 grams per ton of feed.......  Sheep: For increased rate of  ............................     066104                                            weight gain and improved                                            feed efficiency.(ii) To provide 0.05 to 0.1 mg/lb of body  Calves (up to 250 lb): For    Feed continuously; in milk       066104 weight daily..                             increased rate of weight      replacers or starter feed.                                            gain and improved feed                                            efficiency.(iii) To provide 10 mg/lb of body weight   1. Calves and beef and        Feed continuously for 7 to       066104 daily.                                     nonlactating dairy cattle:    14 d; in feed or milk                                            For treatment of bacterial    replacers. If symptoms                                            enteritis caused by E. coli   persist after using for 2                                            and bacterial pneumonia       or 3 d, consult a                                            (shipping fever complex)      veterinarian. Treatment                                            caused by P. multocida        should continue 24 to 48                                            susceptible to                hours beyond remission of                                            oxytetracycline; treatment    disease symptoms. A                                            and control of                withdrawal period has not                                            colibacillosis (bacterial     been established for use in                                            enteritis) caused by E.       preruminating calves. Do                                            coli susceptible to           not use in calves to be                                            neomycin.                     processed for veal. A milk                                                                          discard time has not been                                                                          established for use in                                                                          lactating dairy cattle. Do                                                                          not use in female dairy                                                                          cattle 20 months of age or                                                                          older. Withdraw 5 d before                                                                          slaughter.                                           2. Calves (up to 250 lb):     Feed continuously for 7 to       066104                                            For treatment of bacterial    14 d; in milk replacers or                                            enteritis caused by E. coli   starter feed. If symptoms                                            susceptible to                persist after using for 2                                            oxytetracycline; treatment    or 3 d, consult a                                            and control of                veterinarian. Treatment                                            colibacillosis (bacterial     should continue 24 to 48                                            enteritis) caused by E.       hours beyond remission of                                            coli susceptible to           disease symptoms. A                                            neomycin.                     withdrawal period has not                                                                          been established for use in                                                                          preruminating calves. Do                                                                          not use in calves to be                                                                          processed for veal. A milk                                                                          discard time has not been                                                                          established for use in                                                                          lactating dairy cattle. Do                                                                          not use in female dairy                                                                          cattle 20 months of age or                                                                          older. Withdraw 5 d before                                                                          slaughter.                                           3. Sheep: For treatment of    Feed continuously for 7 to       066104                                            bacterial enteritis caused    14 d. If symptoms persist                                            by E. coli and bacterial      after using for 2 or 3 d,                                            pneumonia caused by P.        consult a veterinarian.                                            multocida susceptible to      Treatment should continue                                            oxytetracycline; treatment    24 to 48 hours beyond                                            and control of                remission of disease                                            colibacillosis (bacterial     symptoms. Withdraw 5 d                                            enteritis) caused by E.       before slaughter.                                            coli susceptible to                                            neomycin.(iv) To provide 25 mg/head/day...........  Calves (250 to 400 lb): For   ............................     066104                                            increased rate of weight                                            gain and improved feed                                            efficiency.(v) To provide 75 mg/head/day............  Growing cattle (over 400      ............................     066104                                            lb): For increased rate of                                            weight gain; improved feed                                            efficiency, and reduction                                            of liver condemnation due                                            to liver abscesses.(vi) To provide 0.5 to 2.0 g/head/day....  Cattle: For prevention and    Feed 3 to 5 d before and         066104                                            treatment of the early        after arrival in feedlots.                                            stages of shipping fever      A withdrawal period has not                                            complex.                      been established for use in                                                                          preruminating calves. Do                                                                          not use in calves to be                                                                          processed for veal. A milk                                                                          discard time has not been                                                                          established for use in                                                                          lactating dairy cattle. Do                                                                          not use in female dairy                                                                          cattle 20 months of age or                                                                          older.----------------------------------------------------------------------------------------------------------------

[71 FR 16225, Mar. 31, 2006]

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