[Code of Federal Regulations] [Title 21, Volume 6] [Revised as of January 1, 2003] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR558.128] [Page 391-394] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS--Table of Contents Subpart B--Specific New Animal Drugs for Use in Animal Feeds Sec. 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 Sec. 510.600(c) of this chapter for use as in paragraph (e) of this section. (1) Nos. 046573, 053389, 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 Sec. 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 Sec. 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: [[Page 392]] ---------------------------------------------------------------------------------------------------------------- Chlortetracycline amount Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (i) 10 to 50 g/ton Chickens: For increased rate of ................................ 046573. weight gain and improved feed ................................ ............. efficiency. Do not feed to chickens 017519, producing eggs for human 046573, consumption. 053389, 066104. ---------------------------------------------------------------------------------------------------------------- (ii) 100 to 200 g/ton Chickens: For control of infectious 1. Feed continuously for 7 to 14 046573. synovitis caused by Mycoplasma d. ............. synoviae susceptible to ................................ 017519, chlortetracycline. 2. Feed continuously for 7 to 14 046573, d; do not feed to chickens 053389, producing eggs for human 066104. consumption. ---------------------------------------------------------------------------------------------------------------- (iii) 200 to 400 g/ton Chickens: For the control of chronic 1. Feed continuously for 7 to 14 046573. respiratory disease (CRD) and air d. ............. sac infection caused by M. ................................ 017519, gallisepticum and Escherichia coli 2. Feed continuously for 7 to 14 046573, susceptible to chlortetracycline. d; do not feed to chickens 053389, producing eggs for human 066104. consumption. ---------------------------------------------------------------------------------------------------------------- (iv) 500 g/ton Chickens: For the reduction of 1. Feed for 5 d. 046573. mortality due to E. coli infections ................................ ............. susceptible to chlortetracycline. 2. Feed for 5 d; do not feed to 017519, chickens producing eggs for 046573, human consumption. 053389, 066104. ---------------------------------------------------------------------------------------------------------------- (2) Turkeys. It is used as follows: ---------------------------------------------------------------------------------------------------------------- Chlortetracycline amount Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (i) 10 to 50 g/ton Growing turkeys: For increased rate Do not feed to turkeys producing 017519, of weight gain and improved feed eggs for human consumption. 046573, efficiency. 053389, 066104. ---------------------------------------------------------------------------------------------------------------- (ii) 200 g/ton Turkeys: For control of infectious Feed continuously for 7 to 14 d; 017519, synovitis caused by M. synoviae do not feed to turkeys 046573, susceptible to chlortetracycline. producing eggs for human 053389, consumption. 066104. ---------------------------------------------------------------------------------------------------------------- (iii) 400 g/ton 1. Turkeys: For control of Feed continuously for 7 to 14 d; 017519, hexamitiasis caused by Hexamita do not feed to turkeys 046573, meleagrides susceptible to producing eggs for human 053389, chlortetracycline. consumption. 066104. ..................................... ................................ ............. 2. Turkey poults not over 4 weeks of 017519, age: For reduction of mortality due 046573, to paratyphoid caused by Salmonella 053389, typhimurium susceptible to 066104. chlortetracycline. ---------------------------------------------------------------------------------------------------------------- (iv) 25 mg/lb of body Turkeys: For control of complicating Feed continuously for 7 to 14 d; 017519, weight bacterial organisms associated with do not feed to turkeys 046573, bluecomb (transmissible enteritis; producing eggs for human 053389, coronaviral enteritis) susceptible consumption. 066104. to chlortetracycline. ---------------------------------------------------------------------------------------------------------------- (3) Swine. It is used as follows: ---------------------------------------------------------------------------------------------------------------- Chlortetracycline amount Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (i) 10 to 50 g/ton Growing swine: For increased rate of ................................ 017519, weight gain and improved feed 046573, efficiency. 053389, 066104. ---------------------------------------------------------------------------------------------------------------- [[Page 393]] (ii) 50 to 100 g/ton Swine: For reducing the incidence of ................................ 017519, cervical lymphadenitis (jowl 046573, abscesses) caused by Group E. 053389, Streptococci susceptible to 066104. chlortetracycline. ---------------------------------------------------------------------------------------------------------------- (iii) 400 g/ton Breeding swine: For the control of Feed continuously for not more 017519, leptospirosis (reducing the than 14 d. 046573, incidence of abortion and shedding 053389, of leptospirae) caused by Leptospira 066104. pomona susceptible to chlortetracycline. ---------------------------------------------------------------------------------------------------------------- (iv) 10 mg/lb of body 1. Swine: For the treatment of Feed approximately 400 g/t, 017519, weight bacterial enteritis caused by E. varying with body weight and 046573, coli and S. choleraesuis and feed consumption to provide 10 053389, bacterial pneumonia caused by mg/lb per day. Feed for not 066104. Pasteurella multocida susceptible to more than 14 d; withdraw 5 d chlortetracycline. prior to slaughter for sponsor 017519. ..................................... ................................ ............. 2. Swine: For the control of porcine Feed for not more than 14 d. 046573. proliferative enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetracycline. ---------------------------------------------------------------------------------------------------------------- (4) Cattle. It is used as follows: ---------------------------------------------------------------------------------------------------------------- Chlortetracycline amount Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (i) 0.1 mg/lb of body Calves (up to 250 lb): For increased See paragraph (d)(1) of this 017519, weight daily. rate of weight gain and improved section. 046573, feed efficiency. 053389, 066104. ---------------------------------------------------------------------------------------------------------------- (ii) 0.5 mg/lb of body Beef cattle (over 700 lb); control of Withdraw 48 h prior to 017519, weight daily. active infection of anaplasmosis slaughter. To sponsor No. 046573, caused by Anaplasma marginale 046573: zero withdrawal time. 053389, susceptible to chlortetracycline. To sponsor No. 053389: 1 d 066104. withdrawal time. ---------------------------------------------------------------------------------------------------------------- (iii) 0.5 to 2.0 mg/lb Beef cattle and nonlactating dairy In free-choice cattle feeds such 046573. of body weight daily. cattle: As an aid in the control of as feed blocks or salt-mineral active infection of anaplsmosis mixes manufactured from caused by A. marginale susceptible approved Type A articles. See to chlortetracycline. paragraph (d)(2) of this section. ---------------------------------------------------------------------------------------------------------------- (iv) 10 mg/lb of body 1. Calves, beef and nonlactating Feed approximately 400 g/ton, 017519, weight daily. dairy cattle; treatment of bacterial varying with body weight and 046573, enteritis caused by E. coli and feed consumption to provide 10 053389, bacterial pneumonia caused by P. mg/lb per day. Treat for not 066104. multocida organisms susceptible to more than 5 d; in feed chlortetracycline. including milk replacers; withdraw 10 d prior to slaughter. To sponsor No. 053389: 1 d withdrawal time. To sponsor No. 046573: zero withdrawal time. See paragraph (d)(1) of this section. ..................................... ................................ ............. 2. Calves (up to 250 lb): For the See paragraph (d)(1) of this 017519, treatment of bacterial enteritis section. 046573, caused by E. coli susceptible to 053389, chlortetracycline. 066104. ---------------------------------------------------------------------------------------------------------------- (v) 4,000 to 20,000 g/ Calves, beef and nonlactating dairy As a top dress, varying with 046573. ton cattle; treatment of bacterial body weight and feed enteritis caused by E. coli and consumption, to provide 10 mg/ bacterial pneumonia caused by P. lb per day. Treat for not more multocida organisms susceptible to than 5 days. See paragraph chlortetracycline. (d)(1) of this section. ---------------------------------------------------------------------------------------------------------------- (vi) 25 to 70 mg/head/ Calves (250 to 400 lb): For increased See paragraph (d)(1) of this 017519, day rate of weight gain and improved section. 046573, feed efficiency. 053389, 066104. ---------------------------------------------------------------------------------------------------------------- [[Page 394]] (vii) 70 mg/head/day Growing cattle (over 400 lb): For See paragraph (d)(1) of this 017519, increased rate of weight gain, section. 046573, improved feed efficiency, and 053389, reduction of liver condemnation due 066104. to liver abscesses. ---------------------------------------------------------------------------------------------------------------- (viii) 350 mg/head/day 1. Beef cattle: For control of Withdraw 48 h prior to 017519, bacterial pneumonia associated with slaughter. For sponsor 046573: 046573, shipping fever complex caused by zero withdrawal time. For 053389, Pasteurellaspp. susceptible to sponsor 053389: 1 d withdrawal 066104. chlortetracycline. time. ..................................... ................................ ............. 2. Beef cattle (under 700 lb): For Withdraw 48 h prior to 017519, control of active infection of slaughter. For sponsor 046573: 046573, anaplasmosis caused by A. marginale zero withdrawal time. For 053389, susceptible to chlortetracycline. sponsor 053389: 1 d withdrawal 066104. time. ---------------------------------------------------------------------------------------------------------------- (5) Minor species. It is used as follows: ---------------------------------------------------------------------------------------------------------------- Chlortetracycline amount Indications for use Limitations Sponsor ---------------------------------------------------------------------------------------------------------------- (i) 20 to 50 g/ton Growing sheep; increased rate of ................................ 046573, weight gain and improved feed 053389, efficiency. 066104. ---------------------------------------------------------------------------------------------------------------- (ii) 80 mg/head/day Breeding sheep; reducing the ................................ 046573, incidence of (vibrionic) abortion 053389, caused by Campylobacter fetus 066104. infection susceptible to chlortetracycline. ---------------------------------------------------------------------------------------------------------------- (iii) 200 to 400 g/ton Ducks: For the control and treatment Feed in complete ration to 046573. of fowl cholera caused by P. provide from 8 to 28 mg/lb of multocida susceptible to body weight per day depending chlortetracycline. upon age and 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 Psittacine birds (cockatoos, macaws, Feed continuously for 45 d; each 046573. feed daily. and parrots) suspected or known to bird should consume daily an be infected with psittacosis caused amount of medicated feed equal by Chlamydia psittaci sensitive to to one fifth of its body chlortetracycline. weight. ................................ See paragraph (d)(3) of this section. ---------------------------------------------------------------------------------------------------------------- (6) Chlortetracycline. It may be used in accordance with this section in combinations as follows: (i) Amprolium in accordance with Sec. 558.55. (ii) Amprolium plus ethopabate in accordance with Sec. 558.58. (iii) Bacitracin methylene disalicylate in accordance with Sec. 558.76. (iv) Clopidol in accordance with Sec. 558.175. (v) Decoquinate in accordance with Sec. 558.195. (vi) Hygromycin B in accordance with Sec. 558.274. (vii) Laidlomycin in accordance with Sec. 558.305. (viii) Monensin in accordance with Sec. 558.355. (ix) Robenidine hydrochloride in accordance with Sec. 558.515. (x) Roxarsone in accordance with Sec. 558.530. (xi) Salinomycin alone or with roxarsone in accordance with Sec. 558.550. (xii) Tiamulin in accordance with Sec. 558.600. (xiii) Zoalene in accordance with Sec. 558.680. [41 FR 10995, Mar. 15, 1976] Editorial Note: For Federal Register citations affecting Sec. 558.128, see the List of Sections Affected, which appears in the Finding Aids section of the printed volume and on GPO Access. [[Page 395]]