[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: 21CFR526.820]

[Page 321-322]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 526--INTRAMAMMARY DOSAGE FORMS--Table of Contents
 
Sec.  526.820  Erythromycin.

    (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 Sec.  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,

[[Page 322]]

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]