21 CFR 522.90a - Ampicillin trihydrate sterile suspension.

Status message

There are 4 Updates appearing in the Federal Register for 21 CFR 522. View below or at eCFR (GPOAccess)
§ 522.90a Ampicillin trihydrate sterile suspension.
(a) Specifications. Each milliliter contains ampicillin trihydrate equivalent to 200 milligrams of ampicillin.
(1) Sponsor. See No. 053501 in § 510.600(c) of this chapter.
(2) Related tolerances. See § 556.40 of this chapter.
(3) Conditions of use—
(i) Calves.
(A) Amount. For enteritis: 3 milligrams per pound of body weight, intramuscularly, once or twice daily, for up to 3 days. For pneumonia: 3 milligrams per pound of body weight, intramuscularly, twice daily, for up to 3 days.
(B) Indications for use. Treatment of bacterial enteritis caused by Escherichia coli and bacterial pneumonia caused by Pasteurella spp. susceptible to ampicillin.
(C) Limitations. Not for use in other animals raised for food production. 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.
(ii) Dogs.
(A) Amount. 3 to 6 milligrams per pound of body weight intramuscularly, once or twice daily.
(B) Indications for use. 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.
(C) Limitations. Continue treatment at least 48 hours after the animal's temperature has returned to normal and other signs of infection have subsided. Usual treatment is 3 to 5 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(iii) Cats.
(A) Amount. 5 to 10 milligrams per pound of body weight intramuscularily or subcutaneously, once or twice daily.
(B) Indications for use. Treatment of generalized infections (septicemia) associated with abscesses, lacerations, and wounds due to Staphylococcus spp., Streptococcus spp., and Pasteurella spp.
(C) Limitations. Continue treatment at least 48 hours after the animal's temperature has returned to normal and other signs of infection have subsided. Usual treatment is 3 to 5 days. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(iv) Swine.
(A) Amount. 3 milligrams per pound of body weight, intramuscularily, once or twice daily, for up to 3 days.
(B) Indications for use. Treatment of bacterial enteritis (colibacillosis) caused by E. coli and bacterial pneumonia caused by Pasteurella spp. susceptible to ampicillin.
(C) 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.
(b) Specifications. Each milliliter contains ampicillin trihydrate equivalent to 150 milligrams of ampicillin.
(1) Sponsor. See No. 000069 in § 510.600(c) of this chapter.
(2) Related tolerances. See § 556.40 of this chapter.
(3) Conditions of use. Dogs—
(i) Amount. 3 to 5 milligrams of ampicillin per pound of body weight, once a day for up to 4 days.
(ii) Indications for use. 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. Administer intramuscularly. If continued treatment is indicated, oral dosage is recommended. As with all antibiotics, appropriate in vitro culturing and susceptibility tests of samples taken before treatment are recommended. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[57 FR 37330, Aug. 18, 1992, as amended at 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.

  • 2014-09-08; 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

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


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