21 CFR 522.88 - Sterile amoxicillin trihydrate for suspension.

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§ 522.88 Sterile amoxicillin trihydrate for suspension.
(a)
(1) Specifications. Each vial contains 3 grams of amoxicillin as the trihydrate. The powder is reconstituted with sterile water for injection USP to a concentration of 100 or 250 milligrams per milliliter for use as in paragraph (d) of this section.
(2) Each vial contains 25 grams of amoxicillin as the trihydrate. The powder is reconstituted with sterile water for injection USP to a concentration of 250 milligrams per milliliter for use as in paragraph (e).
(b) Sponsor. See 000069 in § 510.600(c) of this chapter.
(c) Related tolerance. See § 556.38 of this chapter.
(d) Conditions of use in dogs and cats—
(1) Amount. 5 milligrams per pound of body weight daily.
(2) Indications for use—
(i) Dogs. Treatment of infections caused by susceptible strains of organisms as follows: Respiratory infections (tonsillitis, tracheobronchitis) due to Staphylococcus aureus, Streptococcus spp., Escherichia coli, and Proteus mirabilis; genitourinary infections (cystitis) due to S. aureus, Streptococcus spp., E. coli, and P. mirabilis; gastrointestinal infections (bacterial gastroenteritis) due to S. aureus, Streptococcus spp., E. coli, and P. mirabilis; bacterial dermatitis due to S. aureus, Streptococcus spp., and P. mirabilis; soft tissue infections (abscesses, lacerations, and wounds), due to S. aureus, Streptococcus spp., E. coli, and P. mirabilis.
(ii) Cats. Treatment of infections caused by susceptible strains of organisms as follows: Upper respiratory infections due to S. aureus, Staphylococcus spp., Streptococcus spp., Hemophilus spp., E. coli, Pasteurella spp., and P. mirabilis; genitourinary infections (cystitis) due to S. aureus, Streptococcus spp., E. coli, P. mirabilis, and Corynebacterium spp.; gastrointestinal infections due to E. coli, Proteus spp., Staphylococcus spp., and Streptococcus spp.; skin and soft tissue infections (abscesses, lacerations, and wounds) due to S. aureus, Staphylococcus spp., Streptococcus spp., E. coli, and Pasteurella multocida.
(3) Limitations. For use in dogs and cats only. Administer once daily for up to 5 days by intramuscular or subcutaneous injection. Continue treatment for 48 hours after the animal has become afebrile or asymptomatic. If no improvement is seen within 5 days, review the diagnosis and change therapy. As with all antibiotics, appropriate in vitro culturing susceptibility testing of samples taken before treatment should be conducted. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(e) Condition of use. Cattle—
(1) Amount. 3 to 5 milligrams per pound of body weight once a day according to the animal being treated, the severity of infection, and the animal's response.
(2) Indications for use. Treatment of diseases due to amoxicillin-susceptible organisms as follows: Respiratory tract infections (shipping fever, pneumonia) due to P. multocida, P. hemolytica, Hemophilus spp., Staphylococcus spp., and Streptococcus spp. and acute necrotic pododermatitis (foot rot) due to Fusobacterium necrophorum.
(3) Limitations. Administer once daily for up to 5 days by intramuscular or subcutaneous injection. Continue treatment for 48 to 72 hours after the animal has become afebrile or asymptomatic. Do not continue treatment beyond 5 days. Treated animals must not be slaughtered for food during treatment and for 25 days after the last treatment. As with all antibiotics, appropriate in vitro culturing and susceptibility testing of samples taken before treatment should be conducted. Milk from treated cows must not be used for human consumption during treatment or for 96 hours (8 milkings) after last treatment. Maximum volume per injection should not exceed 30 milliliters. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[57 FR 37330, Aug. 18, 1992; 60 FR 55659, Nov. 2, 1995]

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.

  • 2014-07-31; vol. 79 # 147 - Thursday, July 31, 2014
    1. 79 FR 44277 - New Animal Drugs; Bacitracin Methylene Disalicylate; Dinoprost Solution; Gonadorelin Hydrochloride; Progesterone Intravaginal Inserts; Salinomycin; Ractopamine; Tylosin
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective July 31, 2014.
      21 CFR Parts 520, 522, 529, 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.

  • 2014-07-31; vol. 79 # 147 - Thursday, July 31, 2014
    1. 79 FR 44277 - New Animal Drugs; Bacitracin Methylene Disalicylate; Dinoprost Solution; Gonadorelin Hydrochloride; Progesterone Intravaginal Inserts; Salinomycin; Ractopamine; Tylosin
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective July 31, 2014.
      21 CFR Parts 520, 522, 529, and 558