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Electronic Code of Federal Regulations

e-CFR data is current as of December 10, 2019

Title 21Chapter ISubchapter EPart 522 → §522.820


Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS


§522.820   Erythromycin.

(a) Specifications—(1) Each milliliter (mL) of solution contains 100 milligrams (mg) erythromycin base.

(2) Each mL of solution contains 200 mg erythromycin base.

(b) Sponsor. See No. 061133 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.230 of this chapter.

(d) Conditions of use—(1) Dog. Administer product described in paragraph (a)(1) of this section as follows:

(i) Amount. 3 to 5 mg per pound (/lb) body weight, intramuscularly, two to three times daily, for up to 5 days.

(ii) Indications for use. 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.

(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Cats. Administer product described in paragraph (a)(1) of this section as follows:

(i) Amount. 3 to 5 mg/lb body weight, intramuscularly, two to three times daily, for up to 5 days.

(ii) Indications for use. 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. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(3) Cattle. Administer products described in paragraph (a) of this section as follows:

(i) Amount. 4 mg/lb body weight by deep intramuscular injection 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. Do not use in female dairy cattle over 20 months of age. Do not slaughter treated animals within 6 days of last treatment. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. To avoid excess trim, do not slaughter within 21 days of last injection.

[72 FR 69142, Dec. 7, 2007, as amended at 79 FR 16187, Mar. 25, 2014; 84 FR 8973, Mar. 13, 2019]

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