21 CFR 522.2220 - Sulfadimethoxine injection.

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§ 522.2220 Sulfadimethoxine injection.
(a)
(1) Specifications. Sulfadimethoxine injection containing 400 milligrams per milliliter.
(2) Sponsor.
(i) See No. 000069 in § 510.600(c) of this chapter for conditions of use as in paragraphs (a)(3)(i) through (a)(3)(iii) of this section.
(ii) See No. 057561 for conditions of use as in paragraph (a)(3) of this section.
(iii) See No. 000859 for use as in paragraph (a)(3)(iii) of this section.
(3) Conditions of use.
(i) It is used or intended for use in dogs and cats as follows:
(a) For the treatment of respiratory, genitourinary tract, enteric, and soft tissue infections when caused by Streptococci, Staphylococci, Escherichia, Salmonella, Klebsiella, Proteus, or Shigella organisms sensitive to sulfadimethoxine, and in the treatment of canine bacterial enteritis associated with coccidiosis and canine Salmonellosis.
(b) It is administered by intravenous or subcutaneous injection at an initial dose of 55 milligrams per kilogram of body weight followed by 27.5 milligrams per kilogram of body weight every 24 hours.
(c) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(ii) It is used or intended for use in horses as follows:
(a) For the treatment of respiratory disease caused by Streptococcus equi (strangles).
(b) It is administered by intravenous injection at an initial dose of 55 milligrams per kilogram of body weight followed by 27.5 milligrams per kilogram of body weight every 24 hours until the patient is asymptomatic for 48 hours.
(c) Not for use in horses intended for food.
(d) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(iii) It is used or intended for use in cattle as follows:
(a) For the treatment of shipping fever complex, bacterial pneumonia, calf diphtheria, and foot-rot.
(b) It is administered by intravenous injection at an initial dose of 25 milligrams per pound of body weight followed by 12.5 milligrams per pound of body weight every 24 hours until the animal is asymptomatic for 48 hours.
(c) Milk taken from animals during treatment and for 60 hours (5 milkings) after the latest treatment must not be used for food. Do not administer within 5 days of slaughter. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal.
(d) Tissue damage may result from perivascular infiltration.
(b) [Reserved]
(c)
(1) Specifications. Sulfadimethoxine containing 100 milligrams per milliliter.
(2) Sponsor. See No. 000010 in § 510.600(c) of this chapter.
(3) Conditions of use.
(i) It is used or intended for use in the treatment of sulfadimethoxine-susceptible bacterial infections in dogs.
(ii) It is administered by subcutaneous, intramuscular, or intravenous injection at an initial dose of 25 milligrams per pound of body weight followed by 12.5 milligrams per pound of body weight every 24 hours thereafter. Continue treatment until the animal is free from symptoms for 48 hours.
(iii) For use by or on the order of a licensed veterinarian.
(d) Related tolerances. See § 556.640 of this chapter.
[40 FR 13858, Mar. 27, 1975, as amended at 40 FR 34112, Aug. 14, 1975; 40 FR 42007, Sept. 10, 1975; 50 FR 254, Jan. 3, 1985; 53 FR 40728, Oct. 18, 1988; 54 FR 30205, July 19, 1989; 58 FR 38972, July 21, 1993; 59 FR 56000, Nov. 10, 1994; 61 FR 4875, Feb. 9, 1996; 62 FR 23128, Apr. 29, 1997; 62 FR 35076, June 30, 1997; 70 FR 16935, Apr. 4, 2005; 78 FR 17597, Mar. 22, 2013]

Title 21 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-09-08; vol. 79 # 173 - Monday, September 8, 2014
    1. 79 FR 53134 - New Animal Drugs; Buprenorphine; Carprofen; Danofloxacin; Follicle Stimulating Hormone; Ractopamine; Salinomycin; Tylosin
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective September 8, 2014.
      21 CFR Parts 520, 522, and 558

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United States Code
U.S. Code: Title 21 - FOOD AND DRUGS

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 522 after this date.

  • 2014-09-08; vol. 79 # 173 - Monday, September 8, 2014
    1. 79 FR 53134 - New Animal Drugs; Buprenorphine; Carprofen; Danofloxacin; Follicle Stimulating Hormone; Ractopamine; Salinomycin; Tylosin
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective September 8, 2014.
      21 CFR Parts 520, 522, and 558