21 CFR 520.90f - Ampicillin trihydrate boluses.

Code of Federal Regulations - Title 21: Food and Drugs

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TITLE 21 - FOOD AND DRUGS

CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 520 - ORAL DOSAGE FORM NEW ANIMAL DRUGS

520.90f - Ampicillin trihydrate boluses.

  (a) Specifications. Each bolus contains ampicillin trihydrate equivalent to 400 milligrams of ampicillin.

  (b) Sponsor. See No. 055529 in 510.600(c) of this chapter for use as in paragraph (d)(1), 000069 for use as in paragraph (d)(2).

  (c) Related tolerances. See 556.40 of this chapter.

  (d) Conditions of use. Nonruminating calves(1) Amount. 5 milligrams per pound of body weight twice daily for up to 5 days.

  (i) Indications for use. Oral treatment of colibacillosis caused by Escherichia coli, bacterial enteritis caused by Salmonella spp., and bacterial pneumonia caused by Pasteurella spp.

  (ii) Limitations. Treated calves must not be slaughtered for food during treatment and for 15 days after the last treatment. Not for use in other animals raised for food production. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  (2) Amount. 5 milligrams per pound of body weight twice daily not to exceed 4 days.

  (i) Indications for use. Oral treatment of bacterial enteritis (colibacillosis) caused by E. coli.

  (ii) Limitations. Treated calves must not be slaughtered for food during treatment and for 7 days after the last treatment. Not for use in other animals raised for food production. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[57 FR 37322, Aug. 18, 1992, as amended at 58 FR 61016, Nov. 19, 1993; 60 FR 55659, Nov. 2, 1995]

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