21 CFR 522.1660a - Oxytetracycline solution, 200 milligrams/milliliter.
(a) Specifications. Each milliliter of sterile solution contains 200 milligrams of oxytetracycline base.
(b) Sponsors. See Nos. 000010, 016592, 048164, 054771, 055529, 057561, and 061623 in § 510.600(c) of this chapter.
(c) Related tolerances. See § 556.500 of this chapter.
(d) Special considerations. When labeled for the treatment of anaplasmosis or anthrax, labeling shall also bear the following: “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”
(e) Conditions of use -
(1) Beef cattle, dairy cattle, and calves including prerumenative (veal) calves -
(i) Amounts and indications for use - (A) 3 to 5 mg per pound of body weight (mg/lb BW) per day (/day) intramuscularly, subcutaneously, or intravenously for treatment of pneumonia and shipping fever complex associated with Pasteurella spp. and Haemophilus spp., foot-rot and diphtheria caused by Fusobacterium necrophorum, bacterial enteritis (scours) caused by Escherichia coli, wooden tongue caused by Actinobacillus lignieresii, leptospirosis caused by Leptospira pomona, wound infections and acute metritis caused by Staphylococcus spp. and Streptococcus spp., and anthrax caused by Bacillus anthracis.
(B) 5 mg/lb BW/day intramuscularly or intravenously for treatment of anaplasmosis caused by Anaplasma marginale, severe foot-rot, and advanced cases of other indicated diseases.
(C) 9 mg/lb BW intramuscularly or subcutaneously as single dosage where retreatment of calves and yearlings for bacterial pneumonia is impractical, for treatment of infectious bovine keratoconjunctivitis (pinkeye) caused by Moraxella bovis, or where retreatment for anaplasmosis is impractical.
(ii) Limitations. Exceeding the highest recommended level of drug per pound of bodyweight per day, administering more than the recommended number of treatments, and/or exceeding 10 mL intramuscularly or subcutaneously per injection site may result in antibiotic residues beyond the withdrawal time. Rapid intravenous administration in cattle may result in animal collapse. Oxytetracycline should be administered intravenously slowly over a period of at least 5 minutes. Discontinue treatment at least 28 days prior to slaughter. Milk taken from animals during treatment and for 96 hours after the last treatment must not be used for food.
(2) Swine -
(i) Amounts and indications for use - (A) Sows: 3 mg/lb BW intramuscularly once, approximately 8 hours before farrowing or immediately after completion of farrowing, as an aid in control of infectious enteritis (baby pig scours, colibacillosis) in suckling pigs caused by E. coli.
(B) 3 to 5 mg/lb BW/day intramuscularly for treatment of bacterial enteritis (scours, colibacillosis) caused by E. coli, pneumonia caused by Pasteurella multocida, and leptospirosis caused by Leptospira pomona.
(C) 9 mg/lb BW as a single dosage where retreatment for pneumonia is impractical.
(ii) Limitations. Administer intramuscularly. Do not inject more than 5 mL per site in adult swine. Discontinue treatment at least 28 days prior to slaughter.
Title 21 published on 2015-04-01
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 522 after this date.