21 CFR 522.90a - Ampicillin trihydrate suspension.

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There are 5 Updates appearing in the Federal Register for 21 CFR 522. View below or at eCFR (GPOAccess)
§ 522.90a Ampicillin trihydrate suspension.
(a) Specifications.
(1) Each milliliter contains ampicillin trihydrate equivalent to 200 milligrams (mg) of ampicillin.
(2) Each milliliter contains ampicillin trihydrate equivalent to 150 mg of ampicillin.
(b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter.
(1) No. 054771 for use of product described in paragraph (a)(1) as in paragraphs (d)(1), (d)(2), (d)(3)(i)(A), (d)(3)(ii)(A), (d)(3)(iii), and (d)(4) of this section.
(2) No. 054771 for use of product described in paragraph (a)(2) as in paragraphs (d)(3)(i)(B), (d)(3)(ii)(B), and (d)(3)(iii) of this section.
(c) Related tolerances. See § 556.40 of this chapter.
(d) Conditions of use—
(1) Cattle—
(i) Amount. For enteritis: 3 mg per pound of body weight, intramuscularly, once or twice daily, for up to 3 days. For pneumonia: 3 mg per pound of body weight, intramuscularly, twice daily, for up to 3 days.
(ii) Indications for use. For treatment of bacterial enteritis in calves caused by Escherichia coli and bacterial pneumonia caused by Pasteurella spp. susceptible to ampicillin.
(iii) Limitations. Treated animals must not be slaughtered for food use during treatment or for 9 days after the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Swine—
(i) Amount. 3 mg per pound of body weight by intramuscular injection, once or twice daily, for up to 3 days.
(ii) Indications for use. Treatment of bacterial enteritis (colibacillosis) caused by E. coli and bacterial pneumonia caused by Pasteurella spp. susceptible to ampicillin.
(iii) Limitations. Treated animals must not be slaughtered for food use during treatment or for 15 days after the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(3) Dogs—
(i) Amount—
(A) 3 to 6 mg per pound of body weight by intramuscular injection, once or twice daily. Usual treatment is 3 to 5 days.
(B) 3 to 5 mg of ampicillin per pound of body weight, once a day for up to 4 days.
(ii) Indications for use—
(A) Treatment of respiratory tract infections due to E. coli, Pseudomonas spp., Proteus spp., Staphylococcus spp., and Streptococcus spp.; tonsillitis due to E. coli, Pseudomonas spp., Streptococcus spp., and Staphylococcus spp.; generalized infections (septicemia) associated with abscesses, lacerations, and wounds due to Staphylococcus spp. and Streptococcus spp.
(B) Treatment of bacterial infections of the upper respiratory tract (tonsillitis) due to Streptococcus spp., Staphylococcus spp., E. coli, Proteus spp., and Pasteurella spp., and soft tissue infections (abscesses, lacerations, and wounds) due to Staphylococcus spp., Streptococcus spp., and E. coli, when caused by susceptible organisms.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(4) Cats—
(i) Amount. 5 to 10 mg per pound of body weight by intramuscular or subcutaneous injection, once or twice daily. Usual treatment is 3 to 5 days.
(ii) Indications for use. Treatment of generalized infections (septicemia) associated with abscesses, lacerations, and wounds due to Staphylococcus spp., Streptococcus spp., and Pasteurella spp.
(iii) Limitations. 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