21 C.F.R. § 526.820 Erythromycin.
Title 21 - Food and Drugs
(a) Specifications. (1) Each 6-milliliter, single-dose, disposable syringe contains 300 milligrams of erythromycin (as the base), 0.45 milligram of butylated hydroxyanisole, and 0.45 milligram of butylated hydroxytoluene. (2) Each 12-milliliter, single-dose, disposable syringe contains 600 milligrams of erythromycin (as the base), 0.90 milligram of butylated hydroxyanisole, and 0.90 milligram of butylated hydroxytoluene. (3) The vehicle is triglyceride of saturated fatty acids from coconut oil. (4) The drug may or may not be sterile. (b) Sponsor. See No. 061623 in §510.600(c) of this chapter. (c) Conditions of use—(1) Amount. (i) Lactating cows: After milking, cleaning, and disinfecting, infuse contents of a single 6-milliliter syringe into each infected quarter; repeat procedure at 12-hour intervals for a maximum of 3 consecutive infusions. (ii) Dry cows: After milking, cleaning, and disinfecting, infuse contents of a single 12-milliliter syringe into each infected quarter at the time of drying off. (2) Indications for use. Treatment of mastitis due to Staphylococcus aureus, Streptococcus agalactiae, Streptococcus dysgalactiae, and Streptococcus uberis in lactating or dry cows. (3) Limitations. Milk taken from animals during treatment and for 36 hours (3 milkings) after the latest treatment must not be used for food. [47 FR 15772, Apr. 13, 1982, as amended at 66 FR 14074, Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003]
Title 21: Food and Drugs
PART 526—INTRAMAMMARY DOSAGE FORMS
§ 526.820 Erythromycin.
