CFR - Code of Federal Regulations Title 21

The information on this page is current as of Mar 28, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR522.90c]

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 522 -- IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

Sec. 522.90c Ampicillin sodium.

(a) Specifications. Each milliliter of aqueous solution constituted from ampicillin sodium powder contains 300 milligrams (mg) ampicillin equivalents.

(b) See Nos. 042791 and 054771 in § 510.600(c) of this chapter.

(c) Conditions of use in horses - (1) Amount : 3 mg per pound of body weight twice daily by intravenous or intramuscular injection.

(2) Indications for use. For the treatment of respiratory tract infections (pneumonia and strangles) due to Staphylococcus spp., Streptococcus spp. (including S. equi ), Escherichia coli , and Proteus mirabilis , and skin and soft tissue infections (abscesses and wounds) due to Staphylococcus spp., Streptococcus spp., E. coli , and P. mirabilis , when caused by susceptible organisms.

(3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[72 FR 45158, Aug. 13, 2007, as amended at 79 FR 16184, Mar. 25, 2014; 86 FR 57997, Oct. 20, 2021]