CFR > 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 (parts 500 to 590) > PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS > SUBPART B—Specific New Animal Drugs for Use in Animal Feeds (§558.55 to §558.680) > 558.128—Chlortetracycline.

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. 012286: 50, 90, or 100 grams per pound 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 of weight gain and improved feed efficiency. Do not feed to chickens producing eggs for human consumption. 046573.012286, 046573, 048164, 066104.
(ii) 100 to 200 g/ton Chickens: For control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline. 1. Feed continuously for 7 to 14 d.2. Feed continuously for 7 to 14 d; do not feed to chickens producing eggs for human consumption. 046573.012286, 046573, 048164, 066104.
(iii) 200 to 400 g/ton Chickens: For the control of chronic respiratory disease (CRD) and air sac infection caused by M. gallisepticum and Escherichia coli susceptible to chlortetracycline. 1. Feed continuously for 7 to 14 d.2. Feed continuously for 7 to 14 d; do not feed to chickens producing eggs for human consumption. 046573.012286, 046573, 048164, 066104.
(iv) 500 g/ton Chickens: For the reduction of mortality due to E. coli infections susceptible to chlortetracycline. 1. Feed for 5 d; 0-day withdrawal time when formulated from AUREOMYCIN Type A medicated articles or Type B medicated feeds under NADA 48-761.2. Feed for 5 d; withdraw 24 h prior to slaughter; do not feed to chickens producing eggs for human consumption. 046573.012286, 046573, 048164, 066104.
Code of Federal Regulations 414
(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 of weight gain and improved feed efficiency. Do not feed to turkeys producing eggs for human consumption. 012286,046573, 048164, 066104.
(ii) 200 g/ton Turkeys: For control of infectious synovitis caused by M. synoviae susceptible to chlortetracycline. Feed continuously for 7 to 14 d; do not feed to turkeys producing eggs for human consumption. 012286,046573, 048164, 066104.
(iii) 400 g/ton 1. Turkeys: For control of hexamitiasis caused by Hexamita meleagridis susceptible to chlortetracycline. Feed continuously for 7 to 14 d; do not feed to turkeys producing eggs for human consumption. 012286,046573, 048164, 066104.
2. Turkey poults not over 4 weeks of age: For reduction of mortality due to paratyphoid caused by Salmonella typhimurium susceptible to chlortetracycline. 012286, 046573, 048164, 066104.
(iv) 25 mg/lb of body weight Turkeys: For control of complicating bacterial organisms associated with bluecomb (transmissible enteritis; coronaviral enteritis) susceptible to chlortetracycline. Feed continuously for 7 to 14 d; do not feed to turkeys producing eggs for human consumption. 012286,046573, 048164, 066104.
(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 weight gain and improved feed efficiency. 012286,046573, 048164, 066104.
(ii) 50 to 100 g/ton Swine: For reducing the incidence of cervical lymphadenitis (jowl abscesses) caused by Group E. Streptococci susceptible to chlortetracycline. 012286,046573, 048164, 066104.
(iii) 400 g/ton Breeding swine: For the control of leptospirosis (reducing the incidence of abortion and shedding of leptospirae) caused by Leptospira pomona susceptible to chlortetracycline. Feed continuously for not more than 14 d. 012286,046573, 048164, 066104.
(iv) 10 mg/lb of body weight 1. Swine: For the treatment of bacterial enteritis caused by E. coli and S. choleraesuis and bacterial pneumonia caused by Pasteurella multocida susceptible to chlortetracycline. Feed approximately 400 g/t, varying with body weight and feed consumption to provide 10 mg/lb per day. Feed for not more than 14 d; withdraw 5 d prior to slaughter for sponsor 012286. 012286,046573, 048164, 066104.
2. Swine: For the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis susceptible to chlortetracycline. Feed for not more than 14 d. 046573.
(4) Cattle. It is used as follows:
Chlortetracycline amount Indications for use Limitations Sponsor
(i) 0.1 mg/lb of body weight daily. Calves (up to 250 lb): For increased rate of weight gain and improved feed efficiency. See paragraph (d)(1) of this section. 012286,046573, 048164, 066104.
(ii) 0.5 mg/lb of body weight daily. Beef cattle (over 700 lb); control of active infection of anaplasmosis caused by Anaplasma marginale susceptible to chlortetracycline. Withdraw 48 h prior to slaughter. To sponsor Nos. 046573 and 048164: zero withdrawal time. 012286,046573, 048164, 066104.
(iii) 0.5 to 2.0 mg/lb of body weight daily. Beef cattle and nonlactating dairy cattle: As an aid in the control of active infection of anaplsmosis caused by A. marginale susceptible to chlortetracycline. In free-choice cattle feeds such as feed blocks or salt-mineral mixes manufactured from approved Type A articles. See paragraph (d)(2) of this section. 046573.
(iv) 10 mg/lb of body weight daily 1. Calves, beef and nonlactating dairy cattle; treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline. Feed approximately 400 g/ton, varying with body weight and feed consumption to provide 10 mg/lb per day. Treat for not more than 5 d; in feed including milk replacers; withdraw 10 d prior to slaughter. To sponsor No. 048164: zero withdrawal time. See paragraph (d)(1) of this section. 012286,048164, 066104.
2. Calves (up to 250 lb): For the treatment of bacterial enteritis caused by E. coli susceptible to chlortetracycline. See paragraph (d)(1) of this section. 012286,046573, 048164, 066104.
(v) 500 to 4,000 g/ton Calves, beef and nonlactating dairy cattle; treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline. Feed continuously for not more than 5 days to provide 10 mg/lb body weight per day. To sponsor No. 046573 under NADA 046-699: 24-h withdrawal time. To sponsor No. 046573 under NADA 048-761: zero withdrawal time. 046573.
(vi) 4,000 to 20,000 g/ton Calves, beef and nonlactating dairy cattle; treatment of bacterial enteritis caused by E. coli and bacterial pneumonia caused by P. multocida organisms susceptible to chlortetracycline. As 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)(1) of this section. 046573.
(vii) 25 to 70 mg/head/day Calves (250 to 400 lb): For increased rate of weight gain and improved feed efficiency. See paragraph (d)(1) of this section. 012286,046573, 048164, 066104.
(viii) 70 mg/head/day Growing cattle (over 400 lb): For increased rate of weight gain, improved feed efficiency, and reduction of liver condemnation due to liver abscesses. See paragraph (d)(1) of this section. 012286,046573, 048164, 066104.
(ix) 350 mg/head/day 1. Beef cattle: For control of bacterial pneumonia associated with shipping fever complex caused by Pasteurella spp. susceptible to chlortetracycline. Withdraw 48 h prior to slaughter. To sponsor No. 046573 under NADA 046-699: 48-h withdrawal time. To sponsor No. 046573 under NADA 048-761 and No. 048164: zero withdrawal time. 012286,046573, 048164, 066104.
2. Beef cattle (under 700 lb): For control of active infection of anaplasmosis caused by A. marginale susceptible to chlortetracycline. Withdraw 48 h prior to slaughter. To sponsor No. 046573 under NADA 046-699: 48-h withdrawal time. To sponsor No. 046573 under NADA 048-761 and No. 048164: zero withdrawal time. 012286,046573, 048164, 066104.
(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 weight gain and improved feed efficiency. 046573,048164, 066104.
(ii) 80 mg/head/day Breeding sheep; reducing the incidence of (vibrionic) abortion caused by Campylobacter fetus infection susceptible to chlortetracycline. 046573,048164, 066104.
(iii) 200 to 400 g/ton Ducks: For the control and treatment of fowl cholera caused by P. multocida susceptible to chlortetracycline. Feed 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 d. Do not feed to ducks producing eggs for human consumption. 046573.
Code of Federal Regulations 416
(iv) 10 mg/g of finished feed daily. Psittacine birds (cockatoos, macaws, and parrots) suspected or known to be infected with psittacosis caused by Chlamydia psittaci sensitive to chlortetracycline. Feed continuously for 45 d; each bird should consume daily an amount of medicated feed equal to one fifth of its body weight.See paragraph (d)(3) of this section. 046573.
(6) It is used as a free-choice, loose mineral Type C feed as follows:
(i) Specifications.
Ingredient Percent International Feed No.
Dicalcium Phosphate 46.20 6-26-335
Sodium Chloride (Salt) 15.00 6-04-152
Magnesium Oxide 10.67 6-02-756
Cottonseed Meal 10.00 5-01-625
Trace Mineral/Vitamin Premix1 3.80
Calcium Carbonate 3.50 6-01-069
Dried Cane Molasses 3.00 4-04-695
Potassium Chloride 2.00 6-03-755
Mineral Oil 2.00 8-03-123
Iron Oxide 0.50 6-02-431
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 head per day.
(v) Sponsor. See No. 046573 in § 510.600(c) of this chapter.
(7) 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.

Code of Federal Regulations

[41 FR 10995, Mar. 15, 1976]

Code of Federal Regulations

Editorial Note: For Federal Register citations affecting § 558.128 , see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.