[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: 21CFR526.464b]

[Page 320-321]
 
                        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.  526.464b  Cloxacillin benzathine for intramammary infusion, sterile.

    (a) Specifications. Each 6 milliliter dose contains cloxacillin 
benzathine equivalent to 500 milligrams of cloxacillin.
    (b) Related tolerances. See Sec.  556.165 of this chapter.
    (c) Sponsor. See No. 055529 in Sec.  510.600(c) of this chapter.
    (1) Amount. 6 milliliters per infected quarter aseptically 
immediately after last milking at the time of drying-off of the cow.
    (2) Indications for use. Treatment of mastitis caused by 
Staphylococcus aureus and Streptococus agalactiae in dairy cows at the 
time of drying-off of the cow.
    (3) Limitations. For use in dry cows only. Not to be used within 30 
days of calving. Milk taken from treated cows prior to 72 hours (6 
milkings) after calving must not be used for human food. Animals infused 
with this product must not be slaughtered for food from the time of 
infusion until 72 hours after calving. Federal law restricts this drug 
to use by or on the order of a licensed veterinarian.
    (d) Sponsor. See No. 000069 in Sec.  510.600(c) of this chapter.

[[Page 321]]

    (1) Amount. One dose per infected quarter immediately after last 
milking.
    (2) Indications for use. Treatment and prophylaxis of bovine 
mastitis in nonlactating cows due to Streptococcus agalactiae and 
Staphylococcus aureus.
    (3) Limitations. For use in dry cows only. Not to be used within 4 
weeks (28 days) of calving. Animals infused with this product must not 
be slaughtered for food use for 4 weeks (28 days) after the latest 
infusion. Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[57 FR 37334, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992, as amended at 
58 FR 61016, Nov. 19, 1993; 60 FR 55660, Nov. 2, 1995]