21 CFR 522.88 - Amoxicillin.

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There are 5 Updates appearing in the Federal Register for 21 CFR 522. View below or at eCFR (GPOAccess)
§ 522.88 Amoxicillin.
(a) Specifications—
(1) Each vial contains 3 grams (g) of amoxicillin trihydrate. Each milliliter of constituted suspension contains 100 or 250 milligrams (mg) amoxicillin trihydrate for use as in paragraph (d)(1) of this section.
(2) Each vial contains 25 g of amoxicillin trihydrate. Each milliliter of constituted suspension contains 250 mg amoxicillin trihydrate for use as in paragraph (d)(2) of this section.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Related tolerance. See § 556.38 of this chapter.
(d) Conditions of use—
(1) Dogs and cats—
(i) Amount. Administer 5 mg per pound of body weight daily for up to 5 days by intramuscular or subcutaneous injection.
(ii) Indications for use—
(A) Dogs. For 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.
(B) Cats. For treatment of infections caused by susceptible strains of organisms as follows: Upper respiratory infections due to S. aureus, Staphylococcus spp., Streptococcus spp., Haemophilus 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.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Cattle—
(i) Amount. Administer 3 to 5 mg per pound of body weight daily for up to 5 days by intramuscular or subcutaneous injection.
(ii) Indications for use. For treatment of diseases due to amoxicillin-susceptible organisms as follows: Respiratory tract infections (shipping fever, pneumonia) due to P. multocida, P. hemolytica, Haemophilus spp., Staphylococcus spp., and Streptococcus spp. and acute necrotic pododermatitis (foot rot) due to Fusobacterium necrophorum.
(iii) Limitations. Treated animals must not be slaughtered for food during treatment and for 25 days after the last treatment. Milk from treated cows must not be used for human consumption during treatment or for 96 hours (8 milkings) after last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[79 FR 16183, Mar. 25, 2014]

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.

  • 2014-10-28; vol. 79 # 208 - Tuesday, October 28, 2014
    1. 79 FR 64114 - New Animal Drugs; Alfaxalone; Dinoprost; Ivermectin and Clorsulon; Nitrofurazone; Trenbolone and Estradiol Benzoate; Trimethoprim and Sulfadiazine; Tylosin; Change of Sponsor
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule, technical amendment.
      This rule is effective October 28, 2014.
      21 CFR Parts 510, 520, 522, 524, and 556

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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.

  • 2014-10-28; vol. 79 # 208 - Tuesday, October 28, 2014
    1. 79 FR 64114 - New Animal Drugs; Alfaxalone; Dinoprost; Ivermectin and Clorsulon; Nitrofurazone; Trenbolone and Estradiol Benzoate; Trimethoprim and Sulfadiazine; Tylosin; Change of Sponsor
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule, technical amendment.
      This rule is effective October 28, 2014.
      21 CFR Parts 510, 520, 522, 524, and 556