[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR522.820]

[Page 236-237]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec.  522.820  Erythromycin injection.

    (a) Sponsor. See 061623 in Sec.  510.600(c) of this chapter.
    (b) NAS/NRC status. The conditions of use have been reviewed by NAS/
NRC and found effective.
    (c) Dogs and cats--(1) Specifications. Each milliliter of 
polyethylene glycol vehicle contains 100 milligrams of erythromycin base 
with 2 percent butyl aminobenzoate.
    (2) Conditions of use--(i) Amount. 3 to 5 milligrams per pound of 
body weight, intramuscularly, two to three times daily, for up to 5 
days.
    (ii) Indications for use--(A) Dogs. For the treatment of bacterial 
pneumonia, upper respiratory infections (tonsillitis, bronchitis, 
tracheitis, pharyngitis, pleurisy), endometritis and metritis, and 
bacterial wound infections caused by Staphylococcus spp., Streptococcus 
spp., and Corynebacterium spp., sensitive to erythromycin.
    (B) Cats. For the treatment of bacterial pneumonia, upper 
respiratory infections (rhinitis, bronchitis), secondary infections 
associated with panleukopenia, and bacterial wound infections caused by 
Staphylococcus spp. and Streptococcus spp., susceptible to erythromycin.
    (iii) Limitations. Administer by deep intramuscular injection into 
the heavy muscles of the neck and limbs. Do not administer intravenously 
or intraperitoneally. Avoid subscutaneous use. Do not administer from 
moist or

[[Page 237]]

wet syringe. As with all antibiotics, appropriate in vitro culturing and 
susceptibility testing of samples taken before treatment should be 
conducted. Do not administer in conjunction with penicillin. As with all 
antibiotics, excessive continuous use may result in an overgrowth of 
nonsusceptible organisms. Federal law restricts this drug to use by or 
on the order of a licensed veterinarian.
    (d) Cattle.--(1) Specifications. Each milliliter of nonaqueous, 
buffered, alcohol base sterile solution contains 200 milligrams of 
erythromycin base.
    (2) Related tolerances. See Sec.  556.230 of this chapter.
    (3) Conditions of use--(i) Amount. 4 milligrams of erythromycin base 
per pound of body weight once daily for up to 5 days.
    (ii) Indications for use. For the treatment of bovine respiratory 
disease (shipping fever complex and bacterial pneumonia) associated with 
Pasteurella multocida susceptible to erythromycin.
    (iii) Limitations. For intramuscular use only. Do not use in female 
dairy cattle over 20 months of age. Do not slaughter treated animals 
within 6 days of last treatment. To avoid excess trim, do not slaughter 
within 21 days of last injection.

[58 FR 43795, Aug. 18, 1993, as amended at 66 FR 14073, Mar. 9, 2001; 68 
FR 4915, Jan. 31, 2003]