subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_code: "520"
part_subject: "ORAL DOSAGE FORM NEW ANIMAL DRUGS"
subpart_code: "B"
subpart_subject: "Specific Administrative Rulings and Decisions"
section_number: "520.443"
section_subject: "Chlortetracycline tablets and boluses."
cfr_reference: "21 CFR 520.443"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 500 to 599"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
---
(a)Specifications. Each tablet/bolus contains 25, 250, or 500 milligrams (mg) chlortetracycline hydrochloride.
(b)Sponsor. See Nos. 016592 and 069043 in § 510.600(c) of this chapter.
(c)Related tolerances. See § 556.150 of this chapter.
(d)Conditions of use in calves—(1) Amount. One 250 milligram bolus per 50 pounds of body weight twice a day for 3 to 5 days.
(i)Indications for use. Treatment of bacterial enteritis (scours) caused by Escherichia coli and bacterial pneumonia associated with Pasteurella spp., Klesbsiella spp., and Haemophilus spp.
(ii)Limitations. Administer bolus directly by mouth or crush and dissolve in milk or water for drenching or bucket feeding; if no improvement is noted after 3 days of treatment, consult a veterinarian; do not use for more than 5 days; do not administer within 24 hours of slaughter.
(2)Amount. One 25 milligram tablet for each 5 pounds of body weight every 12 hours daily for 3 to 5 days.
(i)Indications for use. Control and treatment of bacterial enteritis (scours) caused by E. coli and Salmonella spp. and bacterial pneumonia associated with Pasteurella spp., Haemophilus spp., and Klebsiella spp., susceptible to chlortetracycline.
(ii)Limitations. Administer tablet directly by mouth or crush and dissolve in water for drenching; if no improvement is noted after 3 days of treatment, consult a veterinarian; do not use for more than 5 days; when feeding milk or milk replacer, administration 1 hour before or 2 hours after feeding; do not administer within 24 hours of slaughter.
(3)Amount. One 500 milligram bolus per 100 pounds of body weight twice a day for 3 to 5 days.
(i)Indications for use. Treatment of bacterial enteritis (scours) caused by E. coli and Salmonella spp., and bacterial pneumonia associated with Pasteurella spp., Haemophilus spp., and Klebsiella spp., susceptible to chlortetracycline.
(ii)Limitations. Administer directly by mouth or crush and dissolve in water for drenching; if no improvement is noted after 3 days of treatment, consult a veterinarian; do not use for more than 5 days; do not administer within 24 hours of slaughter.