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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 Oct 01, 2021.

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[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR520.441]



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 520 -- ORAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 520.441 Chlortetracycline powder.

(a) Specifications. Chlortetracycline powder contains not less than 15 milligrams per gram chlortetracycline hydrochloride, or chlortetracycline bisulfate equivalent to 25.6, 64 or 102.4 grams per pound (56.4, 141 or 225.6 milligrams per gram) chlortetracycline hydrochloride.

(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section.

(1) Nos. 000010, 016592, 054771, and 069254 for use as in paragraph (d) of this section.

(2) No. 066104 for use as in paragraphs (d)(4)(i)(A), (d)(4)(i)(B), and (d)(4)(ii) through (d)(4)(iv) of this section.

(3) Nos. 069043, 069254, and 076475 for use as in paragraphs (d)(4)(i)(A), (d)(4)(i)(B), (d)(4)(ii), and (d)(4)(iii) of this section.

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

(d) Conditions of use. (1) Use as chlortetracycline hydrochloride in drinking water as follows:

(i) Swine - (A) Amount. Ten milligrams per pound of body weight daily in divided doses.

(1 ) Indications for use. Control and treatment of bacterial enteritis (scours) caused by Escherichia coli and bacterial pneumonia associated with Pasteurella spp., Actinobacillus pleuropneumoniae (Haemophilus spp.), and Klebsiella spp.

(2) Limitations. Prepare a fresh solution twice daily; as sole source of chlortetracycline; administer for not more than 5 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(B) [Reserved]

(ii) [Reserved]

(2) Use as chlortetracycline hydrochloride in a drench or drinking water as follows:

(i) Calves - (A) Amount. Ten milligrams per pound of body weight daily in divided doses.

(1 ) Control and treatment of bacterial enteritis (scours) caused by E. coli and bacterial pneumonia (shipping fever) associated with Pasteurella spp., A. pleuropneumoniae (Haemophilus spp.), and Klebsiella spp.

(2) Limitations. Prepare fresh solution daily; as sole source of chlortetracycline; administer for not more than 5 days; do not slaughter animals for food within 24 hours of treatment; do not administer this product with milk or milk replacers; administer 1 hour before or 2 hours after feeding milk or milk replacers; a withdrawal period has not been established in preruminating calves; do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(B) [Reserved]

(ii) [Reserved]

(3) [Reserved]

(4) The following uses of chlortetracycline hydrochloride or chlortetracycline bisulfate in drinking water or drench were reviewed by the National Academy of Sciences/National Research Council (NAS/NRC) and found effective:

(i) Chickens - (A) Amount. 200 to 400 milligrams per gallon.

(1 ) Indications for use. Control of infectious synovitis caused by Mycoplasma synoviae.

(2 ) Limitations. Prepare fresh solution daily; as sole source of chlortetracycline; do not use for more than 14 days; do not slaughter animals for food within 24 hours of treatment; do not use in laying chickens. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(B) Amount. 400 to 800 milligrams per gallon.

(1 ) Indications for use. Control of chronic respiratory disease and air-sac infections caused by M. gallisepticum and E. coli.

(2 ) Limitations. Prepare fresh solution daily; as sole source of chlortetracycline; do not use for more than 14 days; do not slaughter animals for food within 24 hours of treatment; do not use in laying chickens. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(C) Amount. One thousand milligrams per gallon.

(1 ) Indications for use. Control of mortality due to fowl cholera caused by Pasteurella multocida susceptible to chlortetracycline.

(2 ) Limitations. See paragraph (d)(4)(i)(A)(2 ) of this section.

(ii) Growing turkeys - (A) Amount. 400 milligrams per gallon.

(1 ) Indications for use. Control of infectious synovitis caused by M. synoviae.

(2 ) Limitations. Prepare fresh solution daily; as sole source of chlortetracycline; do not use for more than 14 days; do not slaughter animals for food within 24 hours of treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(B) Amount. 25 milligrams per pound of body weight daily.

(1 ) Indications for use. Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis).

(2 ) Limitations. Prepare fresh solution daily; as sole source of chlortetracycline; do not use for more than 14 days; do not slaughter animals for food within 24 hours of treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(iii) Swine - (A) Amount. 10 milligrams per pound body weight daily in divided doses.

(B) Indications for use. Control and treatment of bacterial enteritis (scours) caused by E. coli and Salmonella spp. and bacterial pneumonia associated with Pasteurella spp., Actinobacillus pleuropneumoniae (Haemophilus spp.), and Klebsiella spp.

(C) Limitations. Prepare fresh solution daily; as sole source of chlortetracycline; do not use for more than 5 days. For Nos. 016592 and 021930, do not slaughter animals for food within 5 days of treatment. For No. 016592, do not slaughter animals for food within 24 hours of treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(iv) Calves, beef cattle, and nonlactating dairy cattle - (A) Amount. 10 milligrams per pound daily in divided doses.

(B) Indications for use. Control and treatment of bacterial enteritis (scours) caused by E. coli and Salmonella spp. and bacterial pneumonia (shipping fever complex) associated with Pasteurella spp., A. pleuropneumoniae (Haemophilus spp.), and Klebsiella spp.

(C) Limitations. Prepare fresh solution daily; use as a drench; as sole source of chlortetracycline; do not use for more than 5 days; do not slaughter animals for food within 24 hours of treatment; do not use in lactating cattle; do not administer this product with milk or milk replacers; administer 1 hour before or 2 hours after feeding milk or milk replacers; a withdrawal period has not been established in preruminating calves; do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(5) Use in a drench or drinking water as follows:

(i) Chickens - (A) Amount. 200 to 400 mg/gal, for 7 to 14 days.

(1 ) Indications for use. Control of infectious synovitis caused by M. synoviae susceptible to chlortetracycline.

(2 ) Limitations. Prepare fresh solution daily; use as the sole source of chlortetracycline; do not use for more than 14 consecutive days; do not use in laying chickens; do not administer to chickens within 24 hours of slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(B) Amount. 400 to 800 mg/gal, for 7 to 14 days.

(1 ) Indications for use. Control of chronic respiratory disease (CRD) and air-sac infections caused by M. gallisepticum and E. coli susceptible to chlortetracycline.

(2 ) Limitations. As in paragraph (d)(5)(i)(A)(2 ) of this section.

(C) Amount. One thousand mg/gal, for 7 to 14 days.

(1 ) Indications for use. Control of mortality due to fowl cholera caused by Pasteurella multocida susceptible to chlortetracycline.

(2 ) Limitations. As in paragraph (d)(5)(i)(A)(2 ) of this section.

(ii) Growing Turkeys - (A) Amount. 400 mg/gal, for 7 to 14 days.

(1 ) Indications for use. Control of infectious synovitis caused by Mycoplasma synoviae susceptible to chlortetracycline.

(2 ) Limitations. Prepare fresh solution daily; use as the sole source of chlortetracycline; do not use for more than 14 consecutive days; do not administer to growing turkeys within 24 hours of slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(B) Amount. 25 mg/lb body weight daily, for 7 to 14 days.

(1 ) Indications for use. Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis) susceptible to chlortetracycline.

(2 ) Limitations. As in paragraph (d)(5)(ii)(A)(2 ) of this section.

(iii) Swine - (A) Amount. 10 mg/lb body weight daily, for 3 to 5 days.

(B) Indications for use. Control and treatment of bacterial enteritis (scours) caused by E. coli and Salmonella spp., and bacterial pneumonia associated with Pasteurella spp., A. pleuropneumoniae , and Klebsiella spp. susceptible to chlortetracycline.

(C) Limitations. Prepare fresh solution daily; use as the sole source of chlortetracycline; do not use for more than 5 days; do not administer to swine within 24 hours of slaughter. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(iv) Calves, beef cattle, and nonlactating dairy cattle - (A) Amount. 10 mg/lb body weight daily in divided doses, for 3 to 5 days.

(B) Indications for use. Control and treatment of bacterial enteritis (scours) caused by Escherichia coli and Salmonella spp., and bacterial pneumonia associated with Pasteurella spp., Histophilus spp., and Klebsiella spp. susceptible to chlortetracycline.

(C) Limitations. Prepare fresh solution daily; use as a drench; use as the sole source of chlortetracycline; do not use for more than 5 days; do not administer to cattle within 24 hours of slaughter; do not use in lactating dairy cattle; do not administer this product with milk or milk replacers; administer 1 hour before or 2 hours after feeding milk or milk replacers; a withdrawal period has not been established in preruminating calves; do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37324, Aug. 18, 1992]

Editorial Note:

For Federal Register citations affecting § 520.441, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.govinfo.gov.

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