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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 April 1 2019.

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2019]
[CITE: 21CFR558.128]



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. 558.128 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) No. 054771: 50, 70, 80, 90, or 100 grams per pound (g/lb) Type A medicated article.

(2) No. 066104: 10, 20, 30, 50, 70, or 100 g/lb of Type A medicated article.

(3) No. 069254: 50, 90, or 100 g/lb of Type A medicated article.

(c) Related tolerances. See 556.150 of this chapter.

(d) Special considerations. (1) Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. See 558.6 for additional requirements.

(2) The expiration date of VFDs for chlortetracycline medicated feeds must not exceed 6 months from the date of issuance. VFDs for chlortetracycline shall not be refilled.

(3) 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."

(4) Manufacture for use in free-choice feeds as in paragraph (e)(4)(iii) of this section must conform to 510.455 of this chapter.

(5) When manufactured for use as in paragraph (e)(5)(iii) 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 Combination in grams/ton Indications for use Limitations Sponsor
(i) 100 to 200 g/tonChickens: For control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracyclineFeed continuously for 7 to 14 days. For No. 066104: Do not feed to chickens producing eggs for human consumption054771 066104 069254
(ii) 100 to 200 g/tonClopidol, 113.5Broiler and replacement chickens: As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. mivati, and E. brunetti; and for control of infectious synovitis caused by M. synoviae susceptible to chlortetracyclineFeed continuously as the sole ration from the time chicks are placed in floor pens for 7 to 14 days. Do not feed to chickens over 16 weeks of age. Do not feed to chickens producing eggs for human consumption. Chlortetracycline as provided by No. 054771; clopidol as provided by No. 016592 in 510.600(c) of this chapter016592
(iii) 100 to 200 g/tonDecoquinate, 27.2Chickens: For prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. mivati, E. acervulina, E. maxima, and E. brunetti; and for control of infectious synovitis caused by M, synoviae susceptible to chlortetracyclineFeed continuously for 7 to 14 days. Bentonite should not be used in decoquinate feeds. Do not feed to chickens producing eggs for human consumption
Chlortetracycline and decoquinate as provided by No. 054771 in 510.600(c) of this chapter
054771
(iv) 100 g/tonRobenidine, 30Broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix; as an aid in the control of chronic respiratory disease (CRD) caused by Mycoplasma gallisepticum susceptible to chlortetracycline; and as an aid in the control of infectious synovitis caused by M. synoviae susceptible to chlortetracyclineFeed continuously as sole ration. Do not use this product in feeds conta
Chlortetracycline and robenidine as provided by No.054771 in 510.600(c) of this chapter
054771
(v) 200 to 400 g/tonChickens: For the control of chronic respiratory disease (CRD) and air sac infection caused by M. gallisepticum and Escherichia coli susceptible to chlortetracyclineFeed continuously for 7 to 14 days. For No. 066104: Do not feed to chickens producing eggs for human consumption054771 066104 069254
(vi) 200 g/tonAmprolium, 227 and ethopabate, 3.6For chickens where immunity to coccidiosis is not desired: For prevention of coccidiosis; and for treatment of chronic respiratory disease (CRD) caused by M. gallisepticum susceptible to chlortetracyclineUse in low calcium feed containing 0.8% dietary calcium and 1.5% sodium sulfate; feed continuously as sole ration for 7 to 14 days; do not feed to chickens producing eggs for human consumption. Chlortetracycline as provided by No.054771; amprolium and ethopabate as provided by No. 016592 in 510.600(c) of this chapter054771
(vii) 200 g/tonDecoquinate, 27.2Broilers: As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. mivati, E. maxima, and E. brunetti; and for the treatment of chronic respiratory disease (air sac infection) and the prevention of synovitisFeed continuously as the sole ration for no more than 8 weeks. Use in low calcium feed containing 0.8% dietary calcium. Bentonite should not be used in decoquinate feeds. Do not feed to chickens producing eggs for human consumption
Chlortetracycline and decoquinate as provided by No. 054771 in 510.600(c) of this chapter
054771
(viii) 200 g/tonRobenidine 30Broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by E. mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix; as an aid in the control of chronic respiratory disease (CRD) caused by M. gallisepticum susceptible to chlortetracycline; and as an aid in the control of infectious synovitis caused by M. synoviae susceptible to chlortetracyclineFeed continuously as sole ration. Do not use this product in feeds containing bentonite. Do not feed to chickens producing eggs for human consumption. Withdraw 5 days prior to slaughter
Chlortetracycline and robenidine as provided by No. 054771 in 510.600(c) of this chapter
054771
(ix) 500 g/tonChickens: For the reduction of mortality due to E. coli infections susceptible to chlortetracycline1. Feed for 5 days. To sponsor No. 054771 under NADA 048-761 and No. 069254 under ANADA 200-510: zero withdrawal time054771 069254
2. Feed for 5 days; withdraw 24 hours prior to slaughter. Do not feed to chickens producing eggs for human consumption054771
066104
069254
(x) 500 g/tonMonensin, 90 to 110Chickens: As an aid in the reduction of mortality due to E. coli infections susceptible to chlortetracycline; and as an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivatiFeed for 5 days as the sole ration. Do not feed to laying chickens. Not to be fed continuously for more than 5 days. Do not feed to chickens over 16 weeks of age. Withdraw 24 hours before slaughter. See 558.355(d) of this chapter. Chlortetracycline as provided by No. 054771; monensin as provided by No. 058198 in 510.600(c) of this chapter054771 069254
(xi) 500 g/tonRobenidine, 30Broiler and fryer chickens: As an aid in the prevention of coccidiosis caused by Eimeria mivati, E. brunetti, E. tenella, E. acervulina, E. maxima, and E. necatrix; as an aid in the reduction of mortality due to E. coli susceptible to chlortetracyclineFeed continuously as sole ration for up to 5 days. Do not use this product in feeds containing bentonite. Do not feed to chickens producing eggs for human consumption. Withdraw 5 days prior to slaughter
Chlortetracycline and robenidine as provided by No. 054771 in 510.600(c) of this chapter
054771
(xii) 500 g/tonSalinomycin, 40 to 60Broiler chickens: As an aid in the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti, and E. mivati; and as an aid in the reduction of mortality due to E. coli susceptible to chlortetracyclineFor use in low calcium feeds containing 0.8% calcium. Not approved for use with pellet binders. Not to be fed continuously for more than 5 days. Do not feed to laying chickens producing eggs for human consumption. Withdraw 24 hours before slaughter. May be fatal if accidentally fed to adult turkeys or horses. Chlortetracycline as provided by Nos. 054771 or 069254; salinomycin as provided by Nos. 054771 or 016592 in 510.600(c) of this chapter016592 054771 069254

(2) Turkeys. It is used as follows:

Chlortetracycline amount Combination in
grams/ton
Indications for use Limitations Sponsor
(i) 200 g/tonTurkeys: For control of infectious synovitis caused by M. synoviae susceptible to chlortetracyclineFeed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption054771
066104
069254
(ii) 400 g/ton1. Turkeys: For control of hexamitiasis caused by Hexamita meleagridis susceptible to chlortetracyclineFeed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption054771
066104
069254
2. Turkey poults not over 4 weeks of age: For reduction of mortality due to paratyphoid caused by Salmonella typhimurium susceptible to chlortetracycline054771
066104
069254
(iii) 25 mg/lb of body weightTurkeys: For control of complicating bacterial organisms associated with bluecomb (transmissible enteritis; coronaviral enteritis) susceptible to chlortetracyclineFeed continuously for 7 to 14 days. Do not feed to turkeys producing eggs for human consumption054771
066104
069254

(3) Swine. It is used as follows:

Chlortetracycline amount Combination in
grams/ton
Indications for use Limitations Sponsor
(i) 50 to 100 g/tonSwine: For reducing the incidence of cervical lymphadenitis (jowl abscesses) caused by Group E Streptococci susceptible to chlortetracycline054771
066104
069254
(ii) 400 g/tonBreeding swine: For the control of leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to chlortetracyclineFeed continuously for not more than 14 days054771
066104
069254
(iii) 10 mg/lb of body weightSwine: For treatment of bacterial enteritis caused by Escherichia coli and S. choleraesuis and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline; for the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetracyclineFeed approximately 400 g/ton, varying with body weight and feed consumption to provide 10 mg/lb per day. Feed for not more than 14 days. Withdraw 5 d prior to slaughter for sponsor No. 069254 in 510.600(c) of this chapter054771
066104
069254
(iv) 10 mg/lb of body weightBacitracin methylenedisalicylate, 10 to 30Swine: For treatment of bacterial enteritis caused by E. coli and S. choleraesuis and bacterial pneumonia caused by P. multocida susceptible to chlortetracycline; for the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetracycline; and for increased rate of weight gain and improved feed efficiencyFeed approximately 400 g/ton, varying with body weight and feed consumption to provide 10 mg/lb per day. Feed for not more than 14 days. Chlortetracycline and bacitracin methylenedisalicylate as provided by No. 054771 in 510.600(c) of this chapter054771
(v) 10 mg/lb of body weightBacitracin methylenedisalicylate, 10 to 30Swine: For treatment of bacterial enteritis caused by E. coli and S. choleraesuis and bacterial pneumonia caused by P. multocida susceptible to chlortetracycline; and for increased rate of weight gain and improved feed efficiencyFeed chlortetracycline at approximately 400 g/ton of feed, varying with body weight and food consumption, to provide 10 mg/lb of body weight. Feed for not more than 14 days. Withdraw 5 d prior to slaughter for sponsor No. 069254. Bacitracin methylenedisalicylate provided by No. 054771; chlortetracycline provided by Nos. 054771 and 069254 in 510.600(c) of this chapter054771
069254
(vi) 10 mg/lb of body weightTiamulin hydrogen fumarate, 35For control of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema) hyodysenteriae susceptible to tiamulin and for treatment of swine bacterial enteritis caused by E. coli and Salmonella choleraesuis sensitive to chlortetracycline and treatment of bacterial pneumonia caused by P. multocida sensitive to chlortetracyclineFeed chlortetracycline at approximately 400 g/ton of feed, varying with body weight and food consumption, to provide 10 mg/lb of body weight. Feed continuously as the sole ration for 14 days. Withdraw medicated feed 2 days before slaughter. Tiamulin as provided by Nos. 058198 or 069254 in 510.600(c) of this chapter058198
069254

(4) Cattle. It is used as follows:

Chlortetracycline amount Combination in grams/ton Indications for use Limitations Sponsor
(i) 0.5 mg/lb of body weight dailyBeef cattle (over 700 lb): For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracyclineWithdraw 48 hours prior to slaughter. To sponsor Nos. 054771 and 069254: Zero withdrawal time054771
066104
069254
(ii) 25 to 1,100 to provide 0.5 mg/lb of body weight dailyLasalocid, 30 to 600Pasture cattle (slaughter, stocker, feeder cattle, beef replacement heifers) over 700 pounds: For control of active infection of anaplasmosis caused by A. marginale susceptible to chlortetracycline; and for increased rate of weight gainFeed continuously on a hand-fed basis 0.5 mg chlortetracycline per lb. body weight per day and not less than 60 mg or more than 300 mg lasalocid per head daily in at least 1 pound of feed. Daily lasalocid intakes in excess of 200 mg/head/day in pasture cattle have not been shown to be more effective than 200 mg lasalocid/head/day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in 510.600(c) of this chapter054771
069254
(iii) 0.5 to 2.0 mg/lb of body weight dailyBeef cattle and nonlactating dairy cattle: As an aid in the control of active infection of anaplasmosis caused by A. marginale susceptible to chlortetracyclineIn free-choice cattle feeds such as feed blocks or salt-mineral mixes manufactured from approved Type A articles. See paragraph (d)(4) of this section054771 069254
(iv) 10 mg/lb of body weight daily1. Calves, beef and nonlactating dairy cattle: For treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracyclineFeed approximately 400 g/ton, varying with body weight and feed consumption to provide 10 mg/lb per day. Treat for not more than 5 days. In feed including milk replacers withdraw 10 days prior to slaughter. To sponsor Nos. 054771 and 069254: zero withdrawal time. See paragraph (d)(3) of this section054771 066104 069254
2. Calves (up to 250 lb): For the treatment of bacterial enteritis caused by E. coli susceptible to chlortetracyclineSee paragraph (d)(3) of this section054771
066104
069254
(v) 10 mg/lb of body weight dailyLaidlomycin, 5Cattle fed in confinement for slaughter: For treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline; and for increased rate of weight and improved feed efficiencyFeed continuously at a rate of 30 to 75 mg laidlomycin propionate potassium per head per day for not more than 5 days. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in 510.600(c) of this chapter054771
(vi) 10 mg/lb of body weight dailyLaidlomycin, 5 to 10Cattle fed in confinement for slaughter: For treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline; and for improved feed efficiencyFeed continuously at a rate of 30 to 75 mg laidlomycin propionate potassium per head per day for not more than 5 days. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in 510.600(c) of this chapter054771
(vii) 500 to 2,000 to provide 10 mg/lb of body weight dailyLasalocid, 10 to 30Cattle fed in confinement for slaughter: For treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline; and for improved feed efficiencyFeed continuously in complete feed for not more than 5 days to provide 10 mg chlortetracycline per lb. body weight per day and not less than 100 mg or more than 360 mg lasalocid per head per day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in 510.600(c) of this chapter054771
069254
(viii) 500 to 1,200 to provide 10 mg/lb of body weight dailyLasalocid, 25 to 30Cattle fed in confinement for slaughter: For treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline; and for increased rate of weight gain and improved feed efficiencyFeed continuously in complete feed for not more than 5 days to provide 10 mg chlortetracycline per lb. body weight per day and not less than 250 mg or more than 360 mg lasalocid per head per day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in 510.600(c) of this chapter054771
069254
(ix) 500 to 4,000 to provide 10 mg/lb of body weight dailyLasalocid, 30 to 600Pasture cattle (slaughter, stocker, feeder cattle, dairy and beef replacement heifers): For treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline; and for increased rate of weight gainFeed continuously on a hand-fed basis for not more than 5 days to provide 10 mg chlortetracycline per lb. body weight per day and not less than 60 mg or more than 300 mg lasalocid per head per day in at least 1 pound of feed. Daily lasalocid intakes in excess of 200 mg/head/day in pasture cattle have not been shown to be more effective than 200 mg lasalocid/head/day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in 510.600(c) of this chapter054771
069254
(x) 500 to 4,000 g/tonCalves, beef and nonlactating dairy cattle: For the treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida susceptible to chlortetracyclineFeed continuously for not more than 5 days to provide 10 mg/lb body weight per day. To sponsor No. 054771 under NADA 046-699: 24-hour withdrawal period. To sponsor No. 054771 under NADA 048-761 and No. 069254 under ANADA 200-510: Zero withdrawal period054771
069254
(xi) 500 to 4,000Decoquinate, 12.9 to 90.8Calves, beef and non-lactating dairy cattle: For the treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline; and for the prevention of coccidiosis caused by Eimeria bovis and E. zuerniiFeed at a rate of 1g chlortetracycline per 100 lb body weight/day and 22.7 mg decoquinate per 100 lb of body weight/day for not more than 5 days. When it is fully consumed, resume feeding 22.7 mg decoquinate per 100 lb of body weight/day for a total of 28 days to prevent coccidiosis. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Do not feed to animals producing milk for food. Decoquinate as provided by No. 054771 in 510.600(c) of this chapter054771
069254
(xii) 4,000 to 20,000 g/tonCalves, beef and nonlactating dairy cattle: For the treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracyclineAs a top dress, varying with body weight and feed consumption, to provide 10 mg/lb per day. Treat for not more than 5 days. See paragraph (d)(3) of this section054771 069254
(xiii) 4,000 to 20,000 g/tonDecoquinate, 90.8 to 535.7Calves, beef and non-lactating dairy cattle: For the treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline; and for the prevention of coccidiosis caused by E. bovis and E. zuerniiAdminister as a top dress supplement or mix into the daily ration to provide 22.7 mg decoquinate per 100 lb of body weight per day and 1 g chlortetracycline per 100 lb body weight/day for not more than 5 days. When it is fully consumed, resume feeding 22.7 mg decoquinate per 100 lb of body weight/day for a total of 28 days to prevent coccidiosis. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Do not feed to animals producing milk for food. Decoquinate as provided by No. 054771 in 510.600(c) of this chapter054771
(xiv) 70 mg/head/dayGrowing cattle (over 400 lb): For reduction of incidence of liver abscessesSee paragraph (d)(3) of this section054771
066104
069254
(xv) 350 mg/head/day1. Beef cattle: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracyclineTo sponsor No. 054771 under NADAs 046-699 and 049-287, No. 066104 under NADA 092-286, and No. 069254 under NADA 048-480: Withdraw 48 hours prior to slaughter. To sponsor No. 069254 under NADA 138-935 and ANADA 200-510: Zero withdrawal period*
2. Beef cattle (under 700 lb): For control of active infection of anaplasmosis caused by A. marginale susceptible to chlortetracyclineTo sponsor No. 054771 under NADAs 046-699 and 049-287, No. 066104 under NADA 092-286, and No. 069254 under NADA 048-480: Withdraw 48 h prior to slaughter. To sponsor No. 054771 under NADA 048-761 and No. 069254 under NADA 138-935 and ANADA 200-510: Zero withdrawal time*
(xvi) 20 to 350 g/tonBeef cattle and replacement dairy heifers: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracyclineFeed to provide chlortetracycline at the rate of 350 mg per head per day. This drug is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. To sponsor No. 054771 under NADA 048-761: Zero withdrawal period054771
(xvii) 350 mg/head/dayLaidlomycin, 5Cattle fed in confinement for slaughter: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline; and for increased rate of weight and improved feed efficiencyFeed continuously at a rate of 30 to 75 mg laidlomycin propionate potassium per head per day. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in 510.600(c) of this chapter054771
(xviii) 350 mg/head/dayLaidlomycin, 5 to 10Cattle fed in confinement for slaughter: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline; and for improved feed efficiencyFeed continuously at a rate of 30 to 75 mg laidlomycin propionate potassium per head per day. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See 558.305(d) of this chapter. Laidlomycin as provided by No. 054771 in 510.600(c) of this chapter054771
(xix) 25 to 42.2 g/ton to provide 350 mg/head/dayLasalocid, 25 to 30Cattle under 700 pounds fed in confinement for slaughter: For control of active infection of anaplasmosis caused by A. marginale susceptible to chlortetracycline; and for increased rate of weight gain and improved feed efficiencyFeed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 250 mg nor more than 360 mg lasalocid per head daily. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in 510.600(c) of this chapter054771
069254
(xx) 25 to 42.2 g/ton to provide 350 mg/head/dayLasalocid, 25 to 30Cattle fed in confinement for slaughter: For control of bacterial pneumonia associated with shipping fever complex caused by P. multocida organisms susceptible to chlortetracycline; and for increased rate of weight gain and improved feed efficiencyFeed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 250 mg nor more than 360 mg lasalocid per head daily. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in 510.600(c) of this chapter054771
069254
(xxi) 25 to 100 g/ton to provide 350 mg/head/dayLasalocid, 10 to 30Cattle under 700 pounds fed in confinement for slaughter: For control of active infection of anaplasmosis caused by A. marginale susceptible to chlortetracycline; and for improved feed efficiencyFeed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 100 mg nor more than 360 mg lasalocid per head daily. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in 510.600(c) of this chapter054771
069254
(xxii) 25 to 100 g/ton to provide 350 mg/head/dayLasalocid, 10 to 30Cattle fed in confinement for slaughter: For control of bacterial pneumonia associated with shipping fever complex caused by P. multocida organisms susceptible to chlortetracycline; and for improved feed efficiencyFeed continuously in complete feed at a rate of 350 mg chlortetracycline and not less than 100 mg nor more than 360 mg lasalocid per head daily. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in 510.600(c) of this chapter054771
069254
(xxiii) 25 to 700 to provide 350 mg/head/dayLasalocid, 30 to 600Pasture cattle (slaughter, stocker, feeder cattle, dairy and beef replacement heifers): For control of bacterial pneumonia associated with shipping fever complex caused by P. multocida organisms susceptible to chlortetracycline; and for increased rate of weight gainFeed continuously on a hand-fed basis at a rate of 350 mg chlortetracycline and not less than 60 mg nor more than 300 mg lasalocid per head per day in at least 1 pound of feed. Daily lasalocid intakes in excess of 200 mg/head/day in pasture cattle have not been shown to be more effective than 200 mg lasalocid/head/day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in 510.600(c) of this chapter054771
069254
(xxiv) 25 to 700 to provide 350 mg/head/dayLasalocid, 30 to 600Pasture cattle (slaughter, stocker, feeder cattle, beef replacement heifers) under 700 pounds: For control of active infection of anaplasmosis caused by A. marginale susceptible to chlortetracycline; and for increased rate of weight gainFeed continuously on a hand-fed basis at a rate of 350 mg chlortetracycline and not less than 60 mg nor more than 300 mg lasalocid per head per day in at least 1 pound of feed. Daily lasalocid intakes in excess of 200 mg/head/day in pasture cattle have not been shown to be more effective than 200 mg lasalocid/head/day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in 510.600(c) of this chapter054771
069254
(xxv) 25 to 2,800 to provide 350 mg/head/dayLasalocid, 30 to 181.8Beef cattle weighing under 700 pounds: For control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline; and for the control of coccidiosis caused by Eimeria bovis and E. zuerniiHand feed continuously at a rate of 350 mg chlortetracycline and 1 mg lasalocid per 2.2 lb. body weight daily to cattle with a maximum of 360 mg of lasalocid per head per day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See 558.311(d) of this chapter. Chlortetracycline and lasalocid as provided by No. 054771 in 510.600(c) of this chapter054771
069254
(xxvi) 25 to 2,800 to provide 350 mg/head/dayLasalocid, 30 to 181.8Beef cattle weighing up to 800 pounds: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline; and for the control of coccidiosis caused by E. bovis and E. zuerniiHand feed continuously at a rate of 350 mg chlortetracycline and 1 mg lasalocid per 2.2 lb. body weight daily to cattle with a maximum of 360 mg of lasalocid per head per day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in 510.600(c) of this chapter054771
069254
(xxvii) 500 to 4,000 to provide 10 mg/head/dayLasalocid, 30 to 181.8Cattle weighing up to 800 pounds: For the treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida susceptible to chlortetracycline; and for the control of coccidiosis caused by Eimeria bovis and E. zuerniiHand feed continuously for not more than 5 days at a rate of 10 mg chlortetracycline and 1 mg lasalocid per 2.2 lb. body weight daily to cattle with a maximum of 360 mg of lasalocid per head per day. Do not allow horses or other equines access to feeds containing lasalocid. No withdrawal period is required. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. See 558.311(d) of this chapter. Lasalocid as provided by No. 054771 in 510.600(c) of this chapter054771
069254

(5) Minor species. It is used as follows:

Chlortetracycline amount Indications for use Limitations Sponsor
(i) 80 mg/head/dayBreeding sheep; reducing the incidence of (vibrionic) abortion caused by Campylobacter fetus infection susceptible to chlortetracycline054771
066104
069254
(ii) 200 to 400 g/tonDucks: For the control and treatment of fowl cholera caused by Pasteurella multocida susceptible to chlortetracyclineFeed in complete ration to provide from 8 to 28 mg/lb of body weight per day, depending upon age and severity of disease, for not more than 21 days. Do not feed to ducks producing eggs for human consumption054771 069254
(iii) 10 mg/g of finished feed dailyPsittacine birds (cockatoos, macaws, and parrots) suspected or known to be infected with psittacosis caused by Chlamydia psittaci sensitive to chlortetracyclineFeed continuously for 45 days. Each bird should consume daily an amount of medicated feed equal to one fifth of its body weight. See paragraph (d)(5) of this section054771 069254

(6) It is used as a free-choice, loose mineral Type C feed as follows:

(i) Specifications.

Ingredient Percent International feed No.
Dicalcium Phosphate46.206-26-335
Sodium Chloride (Salt)15.006-04-152
Magnesium Oxide10.676-02-756
Cottonseed Meal10.005-01-625
Trace Mineral/Vitamin Premix 13.80
Calcium Carbonate3.506-01-069
Dried Cane Molasses3.004-04-695
Potassium Chloride2.006-03-755
Mineral Oil2.008-03-123
Iron Oxide0.506-02-431
Chlortetracycline Type A medicated article (90 gram/lb)3.33

1Content of vitamin and trace mineral premixes may be varied. However, they should be comparable to those used for other free-choice feeds. Formulation modifications require FDA approval prior to marketing. Selenium must comply with 21 CFR 573.920. Ethylenediamine dihydroiodide (EDDI) should comply with FDA Compliance Policy Guides Sec. 651.100 (CPG 7125.18).

(ii) Amount. 6,000 grams per ton.

(iii) Indications for use. Beef and nonlactating dairy cattle: As an aid in the control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline.

(iv) Limitations. Feed continuously on a free-choice basis at a rate of 0.5 to 2.0 mg chlortetracycline per pound of body weight per day.

(v) Sponsors. See Nos. 054771 and 069254 in 510.600(c) of this chapter.

[81 FR 94995, Dec. 27, 2016, as amended at 82 FR 21691, May 10, 2017; 82 FR 43485, Sept. 18, 2017; 83 FR 13636, Mar. 30, 2018; 83 FR 14588, Apr. 5, 2018; 83 FR 48947, Sept. 28, 2018; 83 FR 64741, Dec. 18, 2018; 84 FR 8975, Mar. 13, 2019; 84 FR 39185, Aug. 9, 2019]

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