21 CFR 522.1044 - Gentamicin.

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There are 4 Updates appearing in the Federal Register for 21 CFR 522. View below or at eCFR (GPOAccess)
§ 522.1044 Gentamicin.
(a) Specifications. Each milliliter of solution contains gentamicin sulfate equivalent to 5, 50, or 100 milligrams (mg) gentamicin.
(b) Sponsors. See sponsors in § 510.600(c) of this chapter for use as in paragraph (d) of this section.
(1) No. 000061 for use of 5 mg per milliliter (/mL) solution in swine as in paragraph (d)(4), 50 mg/mL solution in dogs and cats as in paragraph (d)(1), 50 mg/mL and 100 mg/mL solution in chickens and turkeys as in paragraphs (d)(2) and (d)(3) of this section.
(2) No. 058005 for use of 5 mg/mL solution in swine as in paragraph (d)(4) of this section.
(3) No. 054628 for use of 50 mg/mL solution in dogs as in paragraph (d)(5) of this section.
(4) No. 000859 for use of 100 mg/mL solution in turkeys as in paragraph (d)(2) and in chickens as in paragraph (d)(3) of this section.
(c) Related tolerances. See § 556.300 of this chapter.
(d) Conditions of use—
(1) Dogs and cats—
(i) Amount. Two milligrams of gentamicin per pound of body weight, twice daily on the first day, once daily thereafter, using a 50 milligram-per-milliliter solution.
(ii) Indications for use— (a) Dogs. For the treatment of infections of urinary tract (cystitis, nephritis), respiratory tract (tonsillitis, pneumonia, tracheobronchitis), skin and soft tissue (pyodermatitis, wounds, lacerations, peritonitis).
(b) Cats. For the treatment of infections of urinary tract (cystitis, nephritis), respiratory tract (pneumonitis, pneumonia, upper respiratory tract infections), skin and soft tissue (wounds, lacerations, peritonitis), and as supportive therapy for secondary bacterial infections associated with panleucopenia.
(iii) Limitations. Administer intramuscularly or subcutaneously. If response is not noted after 7 days, the antibiotic sensitivity of the infecting organism should be retested. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Turkeys—
(i) Amount. One milligram of gentamicin per 0.2 milliliter dose, using the 50- or 100-milligrams-per-milliliter product diluted with sterile saline to a concentration of 5 milligrams-per-milliliter.
(ii) Indications for use. As an aid in the prevention of early mortality due to Arizona paracolon infections susceptible to gentamicin.
(iii) Limitations. For 1- to 3-day old turkey poults. Administer subcutaneously in the neck. Injected poults must not be slaughtered for food for at least 9 weeks after treatment.
(3) Chickens—
(i) Amount. 0.2 milligram of gentamicin per 0.2 milliliter dose, using the 50- or 100-milligrams-per-milliliter product diluted with sterile saline to a concentration of 1.0 milligram-per-milliliter.
(ii) Indications for use. In day-old chickens, for prevention of early mortality caused by Escherichia coli. Salmonella typhimurium, and Pseudomonas aeruginosa that are susceptible to gentamicin.
(iii) Limitations. For use in day-old chickens only. Administer aseptically, injecting the diluted product subcutaneously in the neck. Do not slaughter treated animals for food for at least 5 weeks after treatment.
(4) Swine—
(i) Amount. 5 milligrams of gentamicin as a single intramuscular dose using 5 milligram-per-milliliter solution.
(ii) Indications for use. In piglets up to 3 days old for treatment of porcine colibacillosis caused by strains of E. coli sensitive to gentamicin.
(iii) Limitations. For single intramuscular dose in pigs up to 3 days of age only. Do not slaughter treated animals for food for at least 40 days following treatment.
(5) Dogs—
(i) Amount. 2 milligrams of gentamicin per pound of body weight, twice daily on the first day, then once daily.
(ii) Indications for use. For use in the treatment of urinary tract infections (cystitis) caused by Proteus mirabilis, Escherichia coli, and Staphylococcus aureus.
(iii) Limitations. Administer intramuscularly or subcutaneously. If no improvement is seen after 3 days, treatment should be discontinued and the diagnosis reevaluated. Treatment not to exceed 7 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[43 FR 1942, Jan. 13, 1978, as amended at 48 FR 791, Jan. 7, 1983; 51 FR 15606, Apr. 25, 1986; 52 FR 7832, Mar. 13, 1987; 53 FR 40727, Oct. 18, 1988; 60 FR 29985, June 7, 1995; 61 FR 24441, May 15, 1996; 62 FR 45157, Aug. 26, 1997; 63 FR 59714, Nov. 5, 1998; 63 FR 68182, Dec. 10, 1998; 65 FR 45877, July 26, 2000; 71 FR 76901, Dec. 22, 2006; 78 FR 17597, Mar. 22, 2013; 78 FR 21060, Apr. 9, 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