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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§ 558.128 Chlortetracycline.
(a) Specifications. Type A medicated articles containing either chlortetracycline calcium complex equivalent to chlortetracycline hydrochloride or, for products intended for use in milk replacer, chlortetracycline hydrochloride.
(b) Approvals. See sponsors in §510.600(c) of this chapter for use as in paragraph (e) of this section.
(1) Nos. 046573, 048164, and 066104: 50 to 100 grams per pound (g/lb) of Type A medicated article.
(2) No. 017519: 50 g/lb of Type A medicated article.
(c) Related tolerances. See §556.150 of this chapter.
(d) Special considerations. (1) In milk replacers or starter feed; include on labeling the warning: “A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.”
(2) Manufacture for use in free-choice feeds as in paragraph (e)(4)(iii) of this section must conform to §510.455 of this chapter.
(3) When manufactured for use as in paragraph (e)(5)(iv) of this section, include on labeling the warning: “Psittacosis, avian chlamydiosis, or ornithosis is a reportable communicable disease, transmissible between wild and domestic birds, other animals, and man. Contact appropriate public health and regulatory officials.”
(e) Conditions of use—(1) Chickens. It is used as follows:
---------------------------------------------------------------------------------------------------------------- Chlortetracycline amount Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 10 to 50 g/ton...................... Chickens: For increased rate ............................. 046573. of weight gain and improved ............................. ........ feed efficiency.. Do not feed to chickens 017519, producing eggs for human 046573, consumption.. 048164, 066104.(ii) 100 to 200 g/ton................... Chickens: For control of 1. Feed continuously for 7 to 046573. infectious synovitis caused 14 d.. ........ by Mycoplasma synoviae ............................. 017519, susceptible to 2. Feed continuously for 7 to 046573, chlortetracycline.. 14 d; do not feed to 048164, chickens producing eggs for 066104. human consumption..(iii) 200 to 400 g/ton.................. Chickens: For the control of 1. Feed continuously for 7 to 046573. chronic respiratory disease 14 d.. ........ (CRD) and air sac infection ............................. 017519, caused by M. gallisepticum 2. Feed continuously for 7 to 046573, and Escherichia coli 14 d; do not feed to 048164, susceptible to chickens producing eggs for 066104. chlortetracycline.. human consumption..(iv) 500 g/ton.......................... Chickens: For the reduction 1. Feed for 5 d; 0-day 046573. of mortality due to E. coli withdrawal time when ........ infections susceptible to formulated from AUREOMYCIN ........ chlortetracycline.. Type A medicated articles or ........ Type B medicated feeds under 017519, NADA 48-761.. 046573, 2. Feed for 5 d; withdraw 24 048164, h prior to slaughter; do not 066104. feed to chickens producing eggs for human consumption..----------------------------------------------------------------------------------------------------------------
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(2) Turkeys. It is used as follows:
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---------------------------------------------------------------------------------------------------------------- Chlortetracycline amount Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 10 to 50 g/ton...................... Growing turkeys: For increased Do not feed to turkeys 017519, rate of weight gain and producing eggs for human 046573, improved feed efficiency.. consumption.. 048164, 066104.(ii) 200 g/ton.......................... Turkeys: For control of Feed continuously for 7 to 017519, infectious synovitis caused 14 d; do not feed to 046573, by M. synoviae susceptible to turkeys producing eggs for 048164, chlortetracycline.. human consumption.. 066104.(iii) 400 g/ton......................... 1. Turkeys: For control of Feed continuously for 7 to 017519, hexamitiasis caused by 14 d; do not feed to 046573, Hexamita meleagrides turkeys producing eggs for 048164, susceptible to human consumption.. 066104. chlortetracycline.. .............................. ........................... ......... 2. Turkey poults not over 4 017519, weeks of age: For reduction 046573, of mortality due to 048164, paratyphoid caused by 066104. Salmonella typhimurium susceptible to chlortetracycline..(iv) 25 mg/lb of body weight............ Turkeys: For control of Feed continuously for 7 to 017519, complicating bacterial 14 d; do not feed to 046573, organisms associated with turkeys producing eggs for 048164, bluecomb (transmissible human consumption.. 066104. enteritis; coronaviral enteritis) susceptible to chlortetracycline..----------------------------------------------------------------------------------------------------------------
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(3) Swine. It is used as follows:
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---------------------------------------------------------------------------------------------------------------- Chlortetracycline amount Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 10 to 50 g/ton...................... Growing swine: For increased ........................... 017519, rate of weight gain and 046573, improved feed efficiency.. 048164, 066104.(ii) 50 to 100 g/ton.................... Swine: For reducing the ........................... 017519, incidence of cervical 046573, lymphadenitis (jowl 048164, abscesses) caused by Group E. 066104. Streptococci susceptible to chlortetracycline..(iii) 400 g/ton......................... Breeding swine: For the Feed continuously for not 017519, control of leptospirosis more than 14 d.. 046573, (reducing the incidence of 048164, abortion and shedding of 066104. leptospirae) caused by Leptospira pomona susceptible to chlortetracycline..(iv) 10 mg/lb of body weight............ 1. Swine: For the treatment of Feed approximately 400 g/t, 017519, bacterial enteritis caused by varying with body weight 046573, E. coli and S. choleraesuis and feed consumption to 048164, and bacterial pneumonia provide 10 mg/lb per day. 066104. caused by Pasteurella Feed for not more than 14 multocida susceptible to d; withdraw 5 d prior to chlortetracycline.. slaughter for sponsor 017519.. .............................. ........................... ......... 2. Swine: For the control of Feed for not more than 14 046573. porcine proliferative d.. enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetracycline..----------------------------------------------------------------------------------------------------------------
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(4) Cattle. It is used as follows:
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---------------------------------------------------------------------------------------------------------------- Chlortetracycline amount Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 0.1 mg/lb of body weight daily...... Calves (up to 250 lb): For See paragraph (d)(1) of 017519, increased rate of weight gain this section.. 046573, and improved feed efficiency.. 048164, 066104.(ii) 0.5 mg/lb of body weight daily..... Beef cattle (over 700 lb); Withdraw 48 h prior to 017519, control of active infection slaughter. To sponsor Nos. 046573, of anaplasmosis caused by 046573 and 048164: zero 048164, Anaplasma marginale withdrawal time.. 066104. susceptible to chlortetracycline..(iii) 0.5 to 2.0 mg/lb of body weight Beef cattle and nonlactating In free-choice cattle feeds 046573. daily.. dairy cattle: As an aid in such as feed blocks or the control of active salt-mineral mixes infection of anaplsmosis manufactured from approved caused by A. marginale Type A articles. See susceptible to paragraph (d)(2) of this chlortetracycline.. section..(iv) 10 mg/lb of body weight daily...... 1. Calves, beef and Feed approximately 400 g/ 017519, nonlactating dairy cattle; ton, varying with body 046573, treatment of bacterial weight and feed 048164, enteritis caused by E. coli consumption to provide 10 066104. and bacterial pneumonia mg/lb per day. Treat for caused by P. multocida not more than 5 d; in feed organisms susceptible to including milk replacers; chlortetracycline.. withdraw 10 d prior to slaughter. To sponsor Nos. 046573 and 048164: zero withdrawal time. To sponsor No. 046573: zero withdrawal time. See paragraph (d)(1) of this section.. .............................. ........................... ......... 2. Calves (up to 250 lb): For See paragraph (d)(1) of 017519, the treatment of bacterial this section.. 046573, enteritis caused by E. coli 048164, susceptible to 066104. chlortetracycline..(v) 500 to 4,000 g/ton.................. Calves, beef and nonlactating Hand feed continuously for 046573. dairy cattle; treatment of not more than 5 days to bacterial enteritis caused by provide 10 mg/lb body E. coli and bacterial weight per day.. pneumonia caused by P. multocida organisms susceptible to chlortetracycline..(vi) 4,000 to 20,000 g/ton.............. Calves, beef and nonlactating As a top dress, varying 046573. dairy cattle; treatment of with body weight and feed bacterial enteritis caused by consumption, to provide 10 E. coli and bacterial mg/lb per day. Treat for pneumonia caused by P. not more than 5 days. See multocida organisms paragraph (d)(1) of this susceptible to section.. chlortetracycline..(vii) 25 to 70 mg/head/day.............. Calves (250 to 400 lb): For See paragraph (d)(1) of 017519, increased rate of weight gain this section.. 046573, and improved feed efficiency.. 048164, 066104.(viii) 70 mg/head/day................... Growing cattle (over 400 lb): See paragraph (d)(1) of 017519, For increased rate of weight this section.. 046573, gain, improved feed 048164, efficiency, and reduction of 066104. liver condemnation due to liver abscesses..(ix) 350 mg/head/day.................... 1. Beef cattle: For control of Withdraw 48 h prior to 017519, bacterial pneumonia slaughter. To sponsor Nos. 046573, associated with shipping 046573 and 048164: zero 048164, fever complex caused by withdrawal time.. 066104. Pasteurellaspp. susceptible to chlortetracycline.. .............................. ........................... ......... 2. Beef cattle (under 700 lb): Withdraw 48 h prior to 017519, For control of active slaughter. To sponsor Nos. 046573, infection of anaplasmosis 046573 and 048164: zero 048164, caused by A. marginale withdrawal time.. 066104. susceptible to chlortetracycline..----------------------------------------------------------------------------------------------------------------
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(5) Minor species. It is used as follows:
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---------------------------------------------------------------------------------------------------------------- Chlortetracycline amount Indications for use Limitations Sponsor----------------------------------------------------------------------------------------------------------------(i) 20 to 50 g/ton...................... Growing sheep; increased rate ........................... 046573, of weight gain and improved 048164, feed efficiency.. 066104.(ii) 80 mg/head/day..................... Breeding sheep; reducing the ........................... 046573, incidence of (vibrionic) 048164, abortion caused by 066104. Campylobacter fetus infection susceptible to chlortetracycline..(iii) 200 to 400 g/ton.................. Ducks: For the control and Feed in complete ration to 046573. treatment of fowl cholera provide from 8 to 28 mg/lb caused by P. multocida of body weight per day susceptible to depending upon age and chlortetracycline.. severity of disease, for not more than 21 d. Do not feed to ducks producing eggs for human consumption..(iv) 10 mg/g of finished feed daily..... Psittacine birds (cockatoos, Feed continuously for 45 d; 046573. macaws, and parrots) each bird should consume suspected or known to be daily an amount of infected with psittacosis medicated feed equal to caused by Chlamydia psittaci one fifth of its body sensitive to weight.. chlortetracycline.. ........................... See paragraph (d)(3) of this section..----------------------------------------------------------------------------------------------------------------
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(6) Chlortetracycline. It may be used in accordance with this section in combinations as follows:
(i) Amprolium in accordance with §558.55.
(ii) Amprolium plus ethopabate in accordance with §558.58.
(iii) Bacitracin methylene disalicylate in accordance with §558.76.
(iv) Clopidol in accordance with §558.175.
(v) Decoquinate in accordance with §558.195.
(vi) Hygromycin B in accordance with §558.274.
(vii) Laidlomycin in accordance with §558.305.
(viii) Lasalocid in accordance with §558.311.
(ix) Monensin in accordance with §558.355.
(x) Robenidine hydrochloride in accordance with §558.515.
(xi) Roxarsone in accordance with §558.530.
(xii) Salinomycin alone or with roxarsone in accordance with §558.550.
(xiii) Tiamulin in accordance with §558.600.
(xiv) Zoalene in accordance with §558.680.
[41 FR 10995, Mar. 15, 1976]
Editorial Note: For Federal Register citations affecting §558.128, see the List of Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access.
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